The anti-inflammatory drug colchicine picked up new support as secondary prevention in chronic coronary disease, cutting the risk of cardiovascular events by one-third when added to standard prevention therapies in the double-blind LoDoCo2 study.

Across a median follow up of 29 months in more than 5,000 patients, almost 1 in 10 patients assigned to placebo experienced the primary endpoint of cardiovascular death, myocardial infarction (MI), ischemic stroke, or ischemia-driven coronary revascularization. That risk was 31% lower and resulted in 77 fewer events in those assigned to colchicine (hazard ratio, 0.69; 95% confidence interval, 0.57-0.83).

The beneficial effect of low-dose colchicine 0.5 mg daily was seen early on and accrued over time, extending to five of the eight secondary end points, including a near 30% reduction in the composite of major adverse cardiac events, as well as reductions in the individual endpoints of MI and ischemia-driven revascularization.

“It did that with broadly consistent effects across a range of clinical subgroups, which together speak to the strength of the effect of colchicine on cardiovascular outcomes in the sort of patients we routinely see in our clinics,” primary investigator Mark Nidorf, MD, MBBS, GenesisCare Western Australia, Perth, said at the virtual annual congress of the European Society of Cardiology.

The results were published simultaneously in the New England Journal of Medicine (2020 Aug 31. doi: 10.1056/NEJMoa2021372).

“The totality of evidence from the big three double-blind placebo controlled trials – CANTOS, COLCOT, and LoDoCo2 – are highly consistent and should be practice changing,” Paul Ridker, MD, MPH, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston, said in an interview.

Massimo Imazio, MD, the formal discussant for the study and professor of cardiology at the University of Turin, Italy, also called for repurposing the inexpensive gout medication for cardiovascular patients.

“I would like to congratulate the authors for a well-designed, large, randomized trial that in my view provides convincing evidence that colchicine is safe and efficacious for secondary prevention in chronic coronary syndrome, of course if tolerated,” he said.

Dr. Imazio noted that colchicine demonstrated similar benefits in the smaller, open-label LoDoCo trial, but that 1 in 10 patients couldn’t tolerate the drug, largely because of gastrointestinal issues. The LoCoDo2 investigators very wisely opted for a 30-day run-in period for tolerance without a loading dose, and 90% of patients in each arm continued study medication while 3.4% stopped because of perceived effects.

Clinicians should bear in mind the potential for side effects and interactions with other medications, particularly statins, observed Dr. Imazio. “So monitoring of repeat blood tests is indicated, especially blood cell count, transaminase, and [creatine kinase] CK.”

Colchicine can be problematic in patients with chronic kidney disease because it is renally excreted, particularly if patients also take some common antibiotics such as clarithromycin, said Dr. Ridker, who led the landmark CANTOS trial. “So while these data are exciting and confirm the importance of inflammation inhibition in stable coronary disease, colchicine is not for all patients.”

During the discussion of the results, Dr. Nidorf said: “We were very concerned at the outset that there would be an interaction because there is certainly literature there, particularly in renal patients. But as the data showed, the incidence of myotoxicity was decidedly rare.”

Further, myotoxic episodes were independently assessed by a blinded reviewer, and although there was one case of mild rhabdomyolysis in the treatment group, it was considered not primarily caused by colchicine, he said. “So we’re fairly comfortable that you can use colchicine at a low dose quite comfortably with full-dose statins.”

Notably, 94% of patients in both groups were taking statins, and two-thirds were on moderate- or high-dose statins. About one-quarter were on dual-antiplatelet therapy, and 12% were on an anticoagulant.

In all, 5,522 patients aged 35-82 years (mean, 66 years) were randomly assigned to colchicine 0.5 mg once daily or placebo on top of proven secondary prevention therapies, and all but one was available for analysis.

Most were male (85%), one-half had hypertension, 18% had diabetes, and 84% had a history of acute coronary syndrome, with an equal number having undergone revascularization. Patients with advanced renal disease, severe heart failure, or severe valvular heart disease were excluded.

Colchicine, when compared with placebo, was associated with significantly lower incidence rates of the top five ranked secondary endpoints:

• Cardiovascular death, MI, or ischemic stroke (4.2% vs. 5.7%; HR, 0.72).
• MI or ischemia-driven revascularization (5.6% vs. 8.1%; HR, 0.67).
• Cardiovascular death or MI (3.6% vs. 5.0%; HR, 0.71).
• Ischemia-driven revascularization (4.9% vs. 6.4%; HR, 0.75).
• MI (3.0% vs. 4.2%; HR, 0.70).

The incidence rates were similar among the remaining three secondary outcomes: ischemic stroke (0.6% vs. 0.9%), all-cause death (2.6% vs. 2.2%), and CV death (0.7% vs. 0.9%), Dr. Nidorf reported.

The effect of colchicine was consistent in 13 subgroups, including those with and without hypertension, diabetes, or prior acute coronary syndrome. Patients in Australia appeared to do better with colchicine than did those in the Netherlands, which was a bit unexpected but likely caused by the play of chance, Dr. Nidorf said.

“Importantly, the effect when we looked at the predictors of outcome of our patients in this trial, they related to factors such as age and diabetes, which were included in both populations. So we believe the effect of therapy to be universal,” he added.

Session moderator Stephan Achenbach, MD, chair of cardiology at the University of Erlangen (Germany), however, noted that event rates were about 3% per year and many patients had undergone coronary revascularizations for acute coronary syndromes, suggesting this may be a preselected, somewhat higher-risk cohort. “Do you think we can transfer these findings to the just-average patient who comes in with chest pain and gets an elective [percutaneous coronary intervention]?” he asked.

Dr. Nidorf replied that, unlike the patients in COLCOT, who were randomized to colchicine within 30 days of an MI, acute events occurred more than 24 months before randomization in most (68.2%) patients. As such, patients were quite stable, and major adverse cardiac event and cardiovascular death rates were also exceedingly low.

“We did not see them as a particularly high-risk group, which I think is one of the beauties of this study,” Dr. Nidorf said. “It looks at people that are very similar to those who come and meet us in our clinics for regular review and follow-up.”

“And in that regard, I think the next time we’re faced with patients in our rooms, we have to ask the question: Are we doing enough for this patient beyond aspirin and statins? Should we be considering treating the inflammatory axis? And now we have an opportunity to do that,” he said.

Serious adverse effects were similar in the colchicine and placebo groups, including hospitalizations for infection (5.0% vs. 5.2%), pneumonia (1.7% vs. 2.0%), or gastrointestinal reasons (1.9% vs. 1.8%). Myotoxicity occurred in four and three patients, respectively.

Although the signal for increased risk of infection observed in CANTOS and COLCOT was not borne out, Dr. Nidorf observed that chest infections can occur frequently in these patients and echoed cautions about a potential unfavorable interaction between clarithromycin and colchicine.

“If we are to use this drug widely, clinicians will need to learn how to use this drug and what drugs to avoid, and that’s an important teaching point,” he said.

Limitations of the study are the small number of women and lack of routine measurement of C-reactive protein or other inflammatory markers at baseline.

The study was supported by the National Health Medical Research Council of Australia, a grant from the Sir Charles Gairdner Research Advisory Committee, the Withering Foundation the Netherlands, the Netherlands Heart Foundation, the Netherlands Organization for Health Research and Development, and a consortium of Teva, Disphar, and Tiofarma in the Netherlands. The authors’ disclosures are listed in the article.
 

A version of this article originally appeared on Medscape.com.

The anti-inflammatory drug colchicine picked up new support as secondary prevention in chronic coronary disease, cutting the risk of cardiovascular events by one-third when added to standard prevention therapies in the double-blind LoDoCo2 study.

Across a median follow up of 29 months in more than 5,000 patients, almost 1 in 10 patients assigned to placebo experienced the primary endpoint of cardiovascular death, myocardial infarction (MI), ischemic stroke, or ischemia-driven coronary revascularization. That risk was 31% lower and resulted in 77 fewer events in those assigned to colchicine (hazard ratio, 0.69; 95% confidence interval, 0.57-0.83).

The beneficial effect of low-dose colchicine 0.5 mg daily was seen early on and accrued over time, extending to five of the eight secondary end points, including a near 30% reduction in the composite of major adverse cardiac events, as well as reductions in the individual endpoints of MI and ischemia-driven revascularization.

“It did that with broadly consistent effects across a range of clinical subgroups, which together speak to the strength of the effect of colchicine on cardiovascular outcomes in the sort of patients we routinely see in our clinics,” primary investigator Mark Nidorf, MD, MBBS, GenesisCare Western Australia, Perth, said at the virtual annual congress of the European Society of Cardiology.

The results were published simultaneously in the New England Journal of Medicine (2020 Aug 31. doi: 10.1056/NEJMoa2021372).

“The totality of evidence from the big three double-blind placebo controlled trials – CANTOS, COLCOT, and LoDoCo2 – are highly consistent and should be practice changing,” Paul Ridker, MD, MPH, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston, said in an interview.

Massimo Imazio, MD, the formal discussant for the study and professor of cardiology at the University of Turin, Italy, also called for repurposing the inexpensive gout medication for cardiovascular patients.

“I would like to congratulate the authors for a well-designed, large, randomized trial that in my view provides convincing evidence that colchicine is safe and efficacious for secondary prevention in chronic coronary syndrome, of course if tolerated,” he said.

Dr. Imazio noted that colchicine demonstrated similar benefits in the smaller, open-label LoDoCo trial, but that 1 in 10 patients couldn’t tolerate the drug, largely because of gastrointestinal issues. The LoCoDo2 investigators very wisely opted for a 30-day run-in period for tolerance without a loading dose, and 90% of patients in each arm continued study medication while 3.4% stopped because of perceived effects.

Clinicians should bear in mind the potential for side effects and interactions with other medications, particularly statins, observed Dr. Imazio. “So monitoring of repeat blood tests is indicated, especially blood cell count, transaminase, and [creatine kinase] CK.”

Colchicine can be problematic in patients with chronic kidney disease because it is renally excreted, particularly if patients also take some common antibiotics such as clarithromycin, said Dr. Ridker, who led the landmark CANTOS trial. “So while these data are exciting and confirm the importance of inflammation inhibition in stable coronary disease, colchicine is not for all patients.”

During the discussion of the results, Dr. Nidorf said: “We were very concerned at the outset that there would be an interaction because there is certainly literature there, particularly in renal patients. But as the data showed, the incidence of myotoxicity was decidedly rare.”

Further, myotoxic episodes were independently assessed by a blinded reviewer, and although there was one case of mild rhabdomyolysis in the treatment group, it was considered not primarily caused by colchicine, he said. “So we’re fairly comfortable that you can use colchicine at a low dose quite comfortably with full-dose statins.”

Notably, 94% of patients in both groups were taking statins, and two-thirds were on moderate- or high-dose statins. About one-quarter were on dual-antiplatelet therapy, and 12% were on an anticoagulant.

In all, 5,522 patients aged 35-82 years (mean, 66 years) were randomly assigned to colchicine 0.5 mg once daily or placebo on top of proven secondary prevention therapies, and all but one was available for analysis.

Most were male (85%), one-half had hypertension, 18% had diabetes, and 84% had a history of acute coronary syndrome, with an equal number having undergone revascularization. Patients with advanced renal disease, severe heart failure, or severe valvular heart disease were excluded.

Colchicine, when compared with placebo, was associated with significantly lower incidence rates of the top five ranked secondary endpoints:

• Cardiovascular death, MI, or ischemic stroke (4.2% vs. 5.7%; HR, 0.72).
• MI or ischemia-driven revascularization (5.6% vs. 8.1%; HR, 0.67).
• Cardiovascular death or MI (3.6% vs. 5.0%; HR, 0.71).
• Ischemia-driven revascularization (4.9% vs. 6.4%; HR, 0.75).
• MI (3.0% vs. 4.2%; HR, 0.70).

The incidence rates were similar among the remaining three secondary outcomes: ischemic stroke (0.6% vs. 0.9%), all-cause death (2.6% vs. 2.2%), and CV death (0.7% vs. 0.9%), Dr. Nidorf reported.

The effect of colchicine was consistent in 13 subgroups, including those with and without hypertension, diabetes, or prior acute coronary syndrome. Patients in Australia appeared to do better with colchicine than did those in the Netherlands, which was a bit unexpected but likely caused by the play of chance, Dr. Nidorf said.

“Importantly, the effect when we looked at the predictors of outcome of our patients in this trial, they related to factors such as age and diabetes, which were included in both populations. So we believe the effect of therapy to be universal,” he added.

Session moderator Stephan Achenbach, MD, chair of cardiology at the University of Erlangen (Germany), however, noted that event rates were about 3% per year and many patients had undergone coronary revascularizations for acute coronary syndromes, suggesting this may be a preselected, somewhat higher-risk cohort. “Do you think we can transfer these findings to the just-average patient who comes in with chest pain and gets an elective [percutaneous coronary intervention]?” he asked.

Dr. Nidorf replied that, unlike the patients in COLCOT, who were randomized to colchicine within 30 days of an MI, acute events occurred more than 24 months before randomization in most (68.2%) patients. As such, patients were quite stable, and major adverse cardiac event and cardiovascular death rates were also exceedingly low.

“We did not see them as a particularly high-risk group, which I think is one of the beauties of this study,” Dr. Nidorf said. “It looks at people that are very similar to those who come and meet us in our clinics for regular review and follow-up.”

“And in that regard, I think the next time we’re faced with patients in our rooms, we have to ask the question: Are we doing enough for this patient beyond aspirin and statins? Should we be considering treating the inflammatory axis? And now we have an opportunity to do that,” he said.

Serious adverse effects were similar in the colchicine and placebo groups, including hospitalizations for infection (5.0% vs. 5.2%), pneumonia (1.7% vs. 2.0%), or gastrointestinal reasons (1.9% vs. 1.8%). Myotoxicity occurred in four and three patients, respectively.

Although the signal for increased risk of infection observed in CANTOS and COLCOT was not borne out, Dr. Nidorf observed that chest infections can occur frequently in these patients and echoed cautions about a potential unfavorable interaction between clarithromycin and colchicine.

“If we are to use this drug widely, clinicians will need to learn how to use this drug and what drugs to avoid, and that’s an important teaching point,” he said.

Limitations of the study are the small number of women and lack of routine measurement of C-reactive protein or other inflammatory markers at baseline.

The study was supported by the National Health Medical Research Council of Australia, a grant from the Sir Charles Gairdner Research Advisory Committee, the Withering Foundation the Netherlands, the Netherlands Heart Foundation, the Netherlands Organization for Health Research and Development, and a consortium of Teva, Disphar, and Tiofarma in the Netherlands. The authors’ disclosures are listed in the article.
 

A version of this article originally appeared on Medscape.com.

The anti-inflammatory drug colchicine picked up new support as secondary prevention in chronic coronary disease, cutting the risk of cardiovascular events by one-third when added to standard prevention therapies in the double-blind LoDoCo2 study.

Across a median follow up of 29 months in more than 5,000 patients, almost 1 in 10 patients assigned to placebo experienced the primary endpoint of cardiovascular death, myocardial infarction (MI), ischemic stroke, or ischemia-driven coronary revascularization. That risk was 31% lower and resulted in 77 fewer events in those assigned to colchicine (hazard ratio, 0.69; 95% confidence interval, 0.57-0.83).

The beneficial effect of low-dose colchicine 0.5 mg daily was seen early on and accrued over time, extending to five of the eight secondary end points, including a near 30% reduction in the composite of major adverse cardiac events, as well as reductions in the individual endpoints of MI and ischemia-driven revascularization.

“It did that with broadly consistent effects across a range of clinical subgroups, which together speak to the strength of the effect of colchicine on cardiovascular outcomes in the sort of patients we routinely see in our clinics,” primary investigator Mark Nidorf, MD, MBBS, GenesisCare Western Australia, Perth, said at the virtual annual congress of the European Society of Cardiology.

The results were published simultaneously in the New England Journal of Medicine (2020 Aug 31. doi: 10.1056/NEJMoa2021372).

“The totality of evidence from the big three double-blind placebo controlled trials – CANTOS, COLCOT, and LoDoCo2 – are highly consistent and should be practice changing,” Paul Ridker, MD, MPH, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital in Boston, said in an interview.

Massimo Imazio, MD, the formal discussant for the study and professor of cardiology at the University of Turin, Italy, also called for repurposing the inexpensive gout medication for cardiovascular patients.

“I would like to congratulate the authors for a well-designed, large, randomized trial that in my view provides convincing evidence that colchicine is safe and efficacious for secondary prevention in chronic coronary syndrome, of course if tolerated,” he said.

Dr. Imazio noted that colchicine demonstrated similar benefits in the smaller, open-label LoDoCo trial, but that 1 in 10 patients couldn’t tolerate the drug, largely because of gastrointestinal issues. The LoCoDo2 investigators very wisely opted for a 30-day run-in period for tolerance without a loading dose, and 90% of patients in each arm continued study medication while 3.4% stopped because of perceived effects.

Clinicians should bear in mind the potential for side effects and interactions with other medications, particularly statins, observed Dr. Imazio. “So monitoring of repeat blood tests is indicated, especially blood cell count, transaminase, and [creatine kinase] CK.”

Colchicine can be problematic in patients with chronic kidney disease because it is renally excreted, particularly if patients also take some common antibiotics such as clarithromycin, said Dr. Ridker, who led the landmark CANTOS trial. “So while these data are exciting and confirm the importance of inflammation inhibition in stable coronary disease, colchicine is not for all patients.”

During the discussion of the results, Dr. Nidorf said: “We were very concerned at the outset that there would be an interaction because there is certainly literature there, particularly in renal patients. But as the data showed, the incidence of myotoxicity was decidedly rare.”

Further, myotoxic episodes were independently assessed by a blinded reviewer, and although there was one case of mild rhabdomyolysis in the treatment group, it was considered not primarily caused by colchicine, he said. “So we’re fairly comfortable that you can use colchicine at a low dose quite comfortably with full-dose statins.”

Notably, 94% of patients in both groups were taking statins, and two-thirds were on moderate- or high-dose statins. About one-quarter were on dual-antiplatelet therapy, and 12% were on an anticoagulant.

In all, 5,522 patients aged 35-82 years (mean, 66 years) were randomly assigned to colchicine 0.5 mg once daily or placebo on top of proven secondary prevention therapies, and all but one was available for analysis.

Most were male (85%), one-half had hypertension, 18% had diabetes, and 84% had a history of acute coronary syndrome, with an equal number having undergone revascularization. Patients with advanced renal disease, severe heart failure, or severe valvular heart disease were excluded.

Colchicine, when compared with placebo, was associated with significantly lower incidence rates of the top five ranked secondary endpoints:

• Cardiovascular death, MI, or ischemic stroke (4.2% vs. 5.7%; HR, 0.72).
• MI or ischemia-driven revascularization (5.6% vs. 8.1%; HR, 0.67).
• Cardiovascular death or MI (3.6% vs. 5.0%; HR, 0.71).
• Ischemia-driven revascularization (4.9% vs. 6.4%; HR, 0.75).
• MI (3.0% vs. 4.2%; HR, 0.70).

The incidence rates were similar among the remaining three secondary outcomes: ischemic stroke (0.6% vs. 0.9%), all-cause death (2.6% vs. 2.2%), and CV death (0.7% vs. 0.9%), Dr. Nidorf reported.

The effect of colchicine was consistent in 13 subgroups, including those with and without hypertension, diabetes, or prior acute coronary syndrome. Patients in Australia appeared to do better with colchicine than did those in the Netherlands, which was a bit unexpected but likely caused by the play of chance, Dr. Nidorf said.

“Importantly, the effect when we looked at the predictors of outcome of our patients in this trial, they related to factors such as age and diabetes, which were included in both populations. So we believe the effect of therapy to be universal,” he added.

Session moderator Stephan Achenbach, MD, chair of cardiology at the University of Erlangen (Germany), however, noted that event rates were about 3% per year and many patients had undergone coronary revascularizations for acute coronary syndromes, suggesting this may be a preselected, somewhat higher-risk cohort. “Do you think we can transfer these findings to the just-average patient who comes in with chest pain and gets an elective [percutaneous coronary intervention]?” he asked.

Dr. Nidorf replied that, unlike the patients in COLCOT, who were randomized to colchicine within 30 days of an MI, acute events occurred more than 24 months before randomization in most (68.2%) patients. As such, patients were quite stable, and major adverse cardiac event and cardiovascular death rates were also exceedingly low.

“We did not see them as a particularly high-risk group, which I think is one of the beauties of this study,” Dr. Nidorf said. “It looks at people that are very similar to those who come and meet us in our clinics for regular review and follow-up.”

“And in that regard, I think the next time we’re faced with patients in our rooms, we have to ask the question: Are we doing enough for this patient beyond aspirin and statins? Should we be considering treating the inflammatory axis? And now we have an opportunity to do that,” he said.

Serious adverse effects were similar in the colchicine and placebo groups, including hospitalizations for infection (5.0% vs. 5.2%), pneumonia (1.7% vs. 2.0%), or gastrointestinal reasons (1.9% vs. 1.8%). Myotoxicity occurred in four and three patients, respectively.

Although the signal for increased risk of infection observed in CANTOS and COLCOT was not borne out, Dr. Nidorf observed that chest infections can occur frequently in these patients and echoed cautions about a potential unfavorable interaction between clarithromycin and colchicine.

“If we are to use this drug widely, clinicians will need to learn how to use this drug and what drugs to avoid, and that’s an important teaching point,” he said.

Limitations of the study are the small number of women and lack of routine measurement of C-reactive protein or other inflammatory markers at baseline.

The study was supported by the National Health Medical Research Council of Australia, a grant from the Sir Charles Gairdner Research Advisory Committee, the Withering Foundation the Netherlands, the Netherlands Heart Foundation, the Netherlands Organization for Health Research and Development, and a consortium of Teva, Disphar, and Tiofarma in the Netherlands. The authors’ disclosures are listed in the article.
 

A version of this article originally appeared on Medscape.com.

Magnetic seizure therapy (MST) appears to be a viable alternative to electroconvulsive therapy (ECT) in reducing suicide risk in patients with treatment-resistant depression (TRD), early research suggests.

In a single-center, open-label study, MST produced complete remission from suicidality in almost half of the patients who received the treatment.

“The results are promising,” lead author Cory R. Weissman, MD, Centre for Addiction and Mental Health, University of Toronto, told Medscape Medical News.

“The field needs new ways of approaching suicidality because it’s becoming a bigger issue and a major concern, especially now with COVID. These are early but promising results that need to be followed up,” Weissman said.

The study was published online August 18 in JAMA Network Open.
 

Fewer side effects, less stigma

MST is similar to ECT, which is an effective treatment for suicidality in mood disorders. However, ECT is underutilized – fewer than 1% of patients with TRD receive the treatment – because of stigma and/or a perceived risk of cognitive adverse effects, he said.

“MST is a focal magnetic pulse that leads to discharge or depolarization within the frontal lobe of the brain with the goal of inducing a seizure. It works quite similarly to ECT, which we know is quite a good anti-suicidal treatment, especially in depression,” Weissman explained

However, MST has fewer side effects, particularly on cognition, and less stigma compared to ECT. It also has a different mechanism of action, with a “more focal treatment target in the brain than ECT to induce seizures,” Weissman said.

The Toronto group has been studying MST in various mood disorders for several years. As previously reported by Medscape Medical News, MST is effective in reducing suicidal thoughts in treatment-resistant bipolar disorder. 

The current study is a post hoc secondary analysis of data from the group’s original trial of MST as a treatment for treatment resistant depression in patients initially referred for ECT. The trial ran from February 2012 through June 2019 and with a post-treatment 6-month follow-up.

The secondary analysis was performed from January 2019 to November 2019.

The secondary analysis included 67 patients who underwent MST 2 to 3 times per week until they achieved remission from a depressive episode or until they reached a maximum of 24 sessions. All had baseline suicidality, as defined by a score greater than 0 on the Beck Scale for Suicidal Ideation (Beck SSI).

MST was administered using the MagPro MST device with Twin Coil-XS (MagVenture) applied over the frontal cortex at 100% machine output with low (25 Hz), moderate (50 or 60 Hz), or high (100 Hz) frequency.

“It’s very similar to ECT. The actual seizure lasts about a minute or two, and patients recover in about 10 to 15 minutes and they go home afterwards,” Weissman said.

The main outcome was remission from suicidality as measured by an end-point score of 0 on the Beck SSI. Of the 67 patients, 32 (47.8%) achieved remission from suicidality.

Low and moderate frequencies appeared to be more effective for suicidality; 16 of 29 patients (55.2%) receiving low frequency MST achieved remission, as did 12 of 22 patients (54.5%) receiving moderate frequency MST. Four of 16 patients (25%) who received high frequency MST achieved remission from suicidality.
 

A “valuable contribution”

Commenting on the findings for Medscape Medical News, Manish K. Jha, MD, Icahn School of Medicine at Mount Sinai in New York City, said there is an urgent need to develop safe and effective treatment for patients with treatment-resistant depression (TRD).

“The Sequenced Treatment Alternative to Relieve Depression (STAR*D) trial showed that after inadequate improvement with two antidepressants, the likelihood of improvement with a third or fourth antidepressant trial was very low. Therefore, we need effective treatment for TRD,” noted Jha, who was not involved in the research.

The current study represents a “valuable contribution, as it shows improvement in suicidal ideation with magnetic seizure therapy,” he added.

The study’s findings suggest that MST may offer a “viable new treatment” for patients with TRD. He added that the upcoming results of an ongoing clinical trial testing MST against ECT are of “great interest to the field.”

Although the findings are compelling, Jha also noted the study had several limitations, include a relatively “modest” sample size and no sham or active comparator.

In addition, he said, the level of suicidality in this study was limited because of eligibility restrictions, such as exclusion of individuals who had attempted suicide in the prior 6 months.

“While authors use a broad term of ‘suicidality,’ their study is focused on suicidal ideation. Future studies that target suicide behavior are urgently needed. This may mean that we need to study individuals with recent suicide attempts in settings such as emergency rooms and inpatient units,” said Jha.

The study had no specific funding. Weissman has disclosed no relevant financial relationships. Several other study authors reported relationships with industry. The full list can be found with the original article. Jha has received contract research grants from Acadia Pharmaceuticals and Janssen Research & Development, and honoraria for CME presentations from North American Center for Continuing Medical Education and Global Medical Education.

This article first appeared on Medscape.com.

Magnetic seizure therapy (MST) appears to be a viable alternative to electroconvulsive therapy (ECT) in reducing suicide risk in patients with treatment-resistant depression (TRD), early research suggests.

In a single-center, open-label study, MST produced complete remission from suicidality in almost half of the patients who received the treatment.

“The results are promising,” lead author Cory R. Weissman, MD, Centre for Addiction and Mental Health, University of Toronto, told Medscape Medical News.

“The field needs new ways of approaching suicidality because it’s becoming a bigger issue and a major concern, especially now with COVID. These are early but promising results that need to be followed up,” Weissman said.

The study was published online August 18 in JAMA Network Open.
 

Fewer side effects, less stigma

MST is similar to ECT, which is an effective treatment for suicidality in mood disorders. However, ECT is underutilized – fewer than 1% of patients with TRD receive the treatment – because of stigma and/or a perceived risk of cognitive adverse effects, he said.

“MST is a focal magnetic pulse that leads to discharge or depolarization within the frontal lobe of the brain with the goal of inducing a seizure. It works quite similarly to ECT, which we know is quite a good anti-suicidal treatment, especially in depression,” Weissman explained

However, MST has fewer side effects, particularly on cognition, and less stigma compared to ECT. It also has a different mechanism of action, with a “more focal treatment target in the brain than ECT to induce seizures,” Weissman said.

The Toronto group has been studying MST in various mood disorders for several years. As previously reported by Medscape Medical News, MST is effective in reducing suicidal thoughts in treatment-resistant bipolar disorder. 

The current study is a post hoc secondary analysis of data from the group’s original trial of MST as a treatment for treatment resistant depression in patients initially referred for ECT. The trial ran from February 2012 through June 2019 and with a post-treatment 6-month follow-up.

The secondary analysis was performed from January 2019 to November 2019.

The secondary analysis included 67 patients who underwent MST 2 to 3 times per week until they achieved remission from a depressive episode or until they reached a maximum of 24 sessions. All had baseline suicidality, as defined by a score greater than 0 on the Beck Scale for Suicidal Ideation (Beck SSI).

MST was administered using the MagPro MST device with Twin Coil-XS (MagVenture) applied over the frontal cortex at 100% machine output with low (25 Hz), moderate (50 or 60 Hz), or high (100 Hz) frequency.

“It’s very similar to ECT. The actual seizure lasts about a minute or two, and patients recover in about 10 to 15 minutes and they go home afterwards,” Weissman said.

The main outcome was remission from suicidality as measured by an end-point score of 0 on the Beck SSI. Of the 67 patients, 32 (47.8%) achieved remission from suicidality.

Low and moderate frequencies appeared to be more effective for suicidality; 16 of 29 patients (55.2%) receiving low frequency MST achieved remission, as did 12 of 22 patients (54.5%) receiving moderate frequency MST. Four of 16 patients (25%) who received high frequency MST achieved remission from suicidality.
 

A “valuable contribution”

Commenting on the findings for Medscape Medical News, Manish K. Jha, MD, Icahn School of Medicine at Mount Sinai in New York City, said there is an urgent need to develop safe and effective treatment for patients with treatment-resistant depression (TRD).

“The Sequenced Treatment Alternative to Relieve Depression (STAR*D) trial showed that after inadequate improvement with two antidepressants, the likelihood of improvement with a third or fourth antidepressant trial was very low. Therefore, we need effective treatment for TRD,” noted Jha, who was not involved in the research.

The current study represents a “valuable contribution, as it shows improvement in suicidal ideation with magnetic seizure therapy,” he added.

The study’s findings suggest that MST may offer a “viable new treatment” for patients with TRD. He added that the upcoming results of an ongoing clinical trial testing MST against ECT are of “great interest to the field.”

Although the findings are compelling, Jha also noted the study had several limitations, include a relatively “modest” sample size and no sham or active comparator.

In addition, he said, the level of suicidality in this study was limited because of eligibility restrictions, such as exclusion of individuals who had attempted suicide in the prior 6 months.

“While authors use a broad term of ‘suicidality,’ their study is focused on suicidal ideation. Future studies that target suicide behavior are urgently needed. This may mean that we need to study individuals with recent suicide attempts in settings such as emergency rooms and inpatient units,” said Jha.

The study had no specific funding. Weissman has disclosed no relevant financial relationships. Several other study authors reported relationships with industry. The full list can be found with the original article. Jha has received contract research grants from Acadia Pharmaceuticals and Janssen Research & Development, and honoraria for CME presentations from North American Center for Continuing Medical Education and Global Medical Education.

This article first appeared on Medscape.com.

Magnetic seizure therapy (MST) appears to be a viable alternative to electroconvulsive therapy (ECT) in reducing suicide risk in patients with treatment-resistant depression (TRD), early research suggests.

In a single-center, open-label study, MST produced complete remission from suicidality in almost half of the patients who received the treatment.

“The results are promising,” lead author Cory R. Weissman, MD, Centre for Addiction and Mental Health, University of Toronto, told Medscape Medical News.

“The field needs new ways of approaching suicidality because it’s becoming a bigger issue and a major concern, especially now with COVID. These are early but promising results that need to be followed up,” Weissman said.

The study was published online August 18 in JAMA Network Open.
 

Fewer side effects, less stigma

MST is similar to ECT, which is an effective treatment for suicidality in mood disorders. However, ECT is underutilized – fewer than 1% of patients with TRD receive the treatment – because of stigma and/or a perceived risk of cognitive adverse effects, he said.

“MST is a focal magnetic pulse that leads to discharge or depolarization within the frontal lobe of the brain with the goal of inducing a seizure. It works quite similarly to ECT, which we know is quite a good anti-suicidal treatment, especially in depression,” Weissman explained

However, MST has fewer side effects, particularly on cognition, and less stigma compared to ECT. It also has a different mechanism of action, with a “more focal treatment target in the brain than ECT to induce seizures,” Weissman said.

The Toronto group has been studying MST in various mood disorders for several years. As previously reported by Medscape Medical News, MST is effective in reducing suicidal thoughts in treatment-resistant bipolar disorder. 

The current study is a post hoc secondary analysis of data from the group’s original trial of MST as a treatment for treatment resistant depression in patients initially referred for ECT. The trial ran from February 2012 through June 2019 and with a post-treatment 6-month follow-up.

The secondary analysis was performed from January 2019 to November 2019.

The secondary analysis included 67 patients who underwent MST 2 to 3 times per week until they achieved remission from a depressive episode or until they reached a maximum of 24 sessions. All had baseline suicidality, as defined by a score greater than 0 on the Beck Scale for Suicidal Ideation (Beck SSI).

MST was administered using the MagPro MST device with Twin Coil-XS (MagVenture) applied over the frontal cortex at 100% machine output with low (25 Hz), moderate (50 or 60 Hz), or high (100 Hz) frequency.

“It’s very similar to ECT. The actual seizure lasts about a minute or two, and patients recover in about 10 to 15 minutes and they go home afterwards,” Weissman said.

The main outcome was remission from suicidality as measured by an end-point score of 0 on the Beck SSI. Of the 67 patients, 32 (47.8%) achieved remission from suicidality.

Low and moderate frequencies appeared to be more effective for suicidality; 16 of 29 patients (55.2%) receiving low frequency MST achieved remission, as did 12 of 22 patients (54.5%) receiving moderate frequency MST. Four of 16 patients (25%) who received high frequency MST achieved remission from suicidality.
 

A “valuable contribution”

Commenting on the findings for Medscape Medical News, Manish K. Jha, MD, Icahn School of Medicine at Mount Sinai in New York City, said there is an urgent need to develop safe and effective treatment for patients with treatment-resistant depression (TRD).

“The Sequenced Treatment Alternative to Relieve Depression (STAR*D) trial showed that after inadequate improvement with two antidepressants, the likelihood of improvement with a third or fourth antidepressant trial was very low. Therefore, we need effective treatment for TRD,” noted Jha, who was not involved in the research.

The current study represents a “valuable contribution, as it shows improvement in suicidal ideation with magnetic seizure therapy,” he added.

The study’s findings suggest that MST may offer a “viable new treatment” for patients with TRD. He added that the upcoming results of an ongoing clinical trial testing MST against ECT are of “great interest to the field.”

Although the findings are compelling, Jha also noted the study had several limitations, include a relatively “modest” sample size and no sham or active comparator.

In addition, he said, the level of suicidality in this study was limited because of eligibility restrictions, such as exclusion of individuals who had attempted suicide in the prior 6 months.

“While authors use a broad term of ‘suicidality,’ their study is focused on suicidal ideation. Future studies that target suicide behavior are urgently needed. This may mean that we need to study individuals with recent suicide attempts in settings such as emergency rooms and inpatient units,” said Jha.

The study had no specific funding. Weissman has disclosed no relevant financial relationships. Several other study authors reported relationships with industry. The full list can be found with the original article. Jha has received contract research grants from Acadia Pharmaceuticals and Janssen Research & Development, and honoraria for CME presentations from North American Center for Continuing Medical Education and Global Medical Education.

This article first appeared on Medscape.com.

SSRIs effectively treat depression following intracerebral hemorrhage (ICH) but also increase risk for recurrent hemorrhagic stroke, particularly in patients at high risk for repeat ICH, new research indicates.

“Clinicians must exercise judgment when weighing the use of SSRIs for ICH survivors in the high risk category – especially those with multiple ICH events,” study investigator Alessandro Biffi, MD, director, Aging and Brain Health Research (ABHR) Group, Departments of Neurology and Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, told Medscape Medical News.

The study was published online August 31 in JAMA Neurology.
 

Risks and benefits

Depression is common following stroke. SSRIs are generally considered first-line treatment for post-stroke depression but are associated with increased risk for first ICH, most likely owing to their antithrombotic effects. Less is known about SSRI use and recurrent ICH risk.

To investigate, Biffi and colleagues followed 1,279 adults (mean age, 71.3 years) for a median of 53.2 months (4.5 years) following primary ICH; 602 were women, 1049 were White, 89 Black, 77 Hispanic, and 64 were other race/ethnicity.

During follow-up, 128 adults suffered recurrent ICH (annual rate, 4.2%) and 766 (60%) were diagnosed with depression.

In multivariable analyses, SSRIs were associated with an increased likelihood of post-ICH depression remission (subhazard ratio, 1.53; 95% CI, 1.12-2.09; P = .009).

However, SSRI use was also an independent risk factor for recurrent ICH (SHR, 1.31; 95% CI, 1.08-1.59; P = .006).

High SSRI dose was associated with higher ICH recurrence risk (SHR, 1.61; 95% CI, 1.15-2.25), with a larger effect size (comparison P = .02) than low SSRI dose (SHR, 1.25; 95% CI, 1.01-1.55), but there was no difference in depression remission comparing low vs. high SSRI dose.

Among individuals at high risk for recurrent ICH, SSRI use was associated with further increased risk for ICH recurrence (SHR, 1.79; 95% CI, 1.22 - 2.64) compared with all other survivors of ICH (SHR, 1.20; 95% CI, 1.01-1.42; P = .008 for comparison of effect sizes).

These higher-risk subgroups included carriers of the APOE e2/e4 alleles, patients with lobar ICH, patients with prior ICH, and minority participants.

“Our analyses identified patients for whom the risks are higher, and therefore additional thought is warranted. This approach may in the future lead to personalized/precision medicine approaches to determining whether these patients should receive SSRIs or not,” said Biffi.
 

Experts weigh in

Commenting on the research for Medscape Medical News, Daniel G. Hackam, MD, division of clinical pharmacology, Western University, London, Ont., said the study is “an important contribution to the literature, as there are to date no data on the risk of ICH in prior ICH survivors in relation to SSRI exposure.”

“The bottom line is that I would be very cautious about initiating SSRIs in patients with a history of ICH,” said Hackam, who was not involved with the study.

“There are other nonserotonergic antidepressants that could be used instead, which do not inhibit platelet function. There was still a risk even in the lower-risk ICH survivors. ICH is a highly recurrent disease. We already avoid antiplatelets, anticoagulants, and high dose statins in these patients. I would add SSRI’s to that list, based on this study,” said Hackam.

Also weighing in, Amytis Towfighi, MD, associate professor of neurology, University of Southern California, Los Angeles, said this study addresses a “common clinical dilemma: how to manage depression among individuals with ICH, given the high risk of recurrent ICH among ICH survivors and potential for SSRIs to increase that risk. This scenario is common, and a source of debate for practicing clinicians.”

“The authors conducted an elegant study,” said Towfighi, by considering sociodemographic, historical, imaging, and genetic factors.

“One must interpret this study with caution as it is a single-center cohort study. However, it provides the most rigorous information to date regarding the associations between SSRI use and recurrent ICH,” she told Medscape Medical News.

The study was supported by the National Institutes of Health. Biffi, Hackam, and Towfighi have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

SSRIs effectively treat depression following intracerebral hemorrhage (ICH) but also increase risk for recurrent hemorrhagic stroke, particularly in patients at high risk for repeat ICH, new research indicates.

“Clinicians must exercise judgment when weighing the use of SSRIs for ICH survivors in the high risk category – especially those with multiple ICH events,” study investigator Alessandro Biffi, MD, director, Aging and Brain Health Research (ABHR) Group, Departments of Neurology and Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, told Medscape Medical News.

The study was published online August 31 in JAMA Neurology.
 

Risks and benefits

Depression is common following stroke. SSRIs are generally considered first-line treatment for post-stroke depression but are associated with increased risk for first ICH, most likely owing to their antithrombotic effects. Less is known about SSRI use and recurrent ICH risk.

To investigate, Biffi and colleagues followed 1,279 adults (mean age, 71.3 years) for a median of 53.2 months (4.5 years) following primary ICH; 602 were women, 1049 were White, 89 Black, 77 Hispanic, and 64 were other race/ethnicity.

During follow-up, 128 adults suffered recurrent ICH (annual rate, 4.2%) and 766 (60%) were diagnosed with depression.

In multivariable analyses, SSRIs were associated with an increased likelihood of post-ICH depression remission (subhazard ratio, 1.53; 95% CI, 1.12-2.09; P = .009).

However, SSRI use was also an independent risk factor for recurrent ICH (SHR, 1.31; 95% CI, 1.08-1.59; P = .006).

High SSRI dose was associated with higher ICH recurrence risk (SHR, 1.61; 95% CI, 1.15-2.25), with a larger effect size (comparison P = .02) than low SSRI dose (SHR, 1.25; 95% CI, 1.01-1.55), but there was no difference in depression remission comparing low vs. high SSRI dose.

Among individuals at high risk for recurrent ICH, SSRI use was associated with further increased risk for ICH recurrence (SHR, 1.79; 95% CI, 1.22 - 2.64) compared with all other survivors of ICH (SHR, 1.20; 95% CI, 1.01-1.42; P = .008 for comparison of effect sizes).

These higher-risk subgroups included carriers of the APOE e2/e4 alleles, patients with lobar ICH, patients with prior ICH, and minority participants.

“Our analyses identified patients for whom the risks are higher, and therefore additional thought is warranted. This approach may in the future lead to personalized/precision medicine approaches to determining whether these patients should receive SSRIs or not,” said Biffi.
 

Experts weigh in

Commenting on the research for Medscape Medical News, Daniel G. Hackam, MD, division of clinical pharmacology, Western University, London, Ont., said the study is “an important contribution to the literature, as there are to date no data on the risk of ICH in prior ICH survivors in relation to SSRI exposure.”

“The bottom line is that I would be very cautious about initiating SSRIs in patients with a history of ICH,” said Hackam, who was not involved with the study.

“There are other nonserotonergic antidepressants that could be used instead, which do not inhibit platelet function. There was still a risk even in the lower-risk ICH survivors. ICH is a highly recurrent disease. We already avoid antiplatelets, anticoagulants, and high dose statins in these patients. I would add SSRI’s to that list, based on this study,” said Hackam.

Also weighing in, Amytis Towfighi, MD, associate professor of neurology, University of Southern California, Los Angeles, said this study addresses a “common clinical dilemma: how to manage depression among individuals with ICH, given the high risk of recurrent ICH among ICH survivors and potential for SSRIs to increase that risk. This scenario is common, and a source of debate for practicing clinicians.”

“The authors conducted an elegant study,” said Towfighi, by considering sociodemographic, historical, imaging, and genetic factors.

“One must interpret this study with caution as it is a single-center cohort study. However, it provides the most rigorous information to date regarding the associations between SSRI use and recurrent ICH,” she told Medscape Medical News.

The study was supported by the National Institutes of Health. Biffi, Hackam, and Towfighi have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

SSRIs effectively treat depression following intracerebral hemorrhage (ICH) but also increase risk for recurrent hemorrhagic stroke, particularly in patients at high risk for repeat ICH, new research indicates.

“Clinicians must exercise judgment when weighing the use of SSRIs for ICH survivors in the high risk category – especially those with multiple ICH events,” study investigator Alessandro Biffi, MD, director, Aging and Brain Health Research (ABHR) Group, Departments of Neurology and Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, told Medscape Medical News.

The study was published online August 31 in JAMA Neurology.
 

Risks and benefits

Depression is common following stroke. SSRIs are generally considered first-line treatment for post-stroke depression but are associated with increased risk for first ICH, most likely owing to their antithrombotic effects. Less is known about SSRI use and recurrent ICH risk.

To investigate, Biffi and colleagues followed 1,279 adults (mean age, 71.3 years) for a median of 53.2 months (4.5 years) following primary ICH; 602 were women, 1049 were White, 89 Black, 77 Hispanic, and 64 were other race/ethnicity.

During follow-up, 128 adults suffered recurrent ICH (annual rate, 4.2%) and 766 (60%) were diagnosed with depression.

In multivariable analyses, SSRIs were associated with an increased likelihood of post-ICH depression remission (subhazard ratio, 1.53; 95% CI, 1.12-2.09; P = .009).

However, SSRI use was also an independent risk factor for recurrent ICH (SHR, 1.31; 95% CI, 1.08-1.59; P = .006).

High SSRI dose was associated with higher ICH recurrence risk (SHR, 1.61; 95% CI, 1.15-2.25), with a larger effect size (comparison P = .02) than low SSRI dose (SHR, 1.25; 95% CI, 1.01-1.55), but there was no difference in depression remission comparing low vs. high SSRI dose.

Among individuals at high risk for recurrent ICH, SSRI use was associated with further increased risk for ICH recurrence (SHR, 1.79; 95% CI, 1.22 - 2.64) compared with all other survivors of ICH (SHR, 1.20; 95% CI, 1.01-1.42; P = .008 for comparison of effect sizes).

These higher-risk subgroups included carriers of the APOE e2/e4 alleles, patients with lobar ICH, patients with prior ICH, and minority participants.

“Our analyses identified patients for whom the risks are higher, and therefore additional thought is warranted. This approach may in the future lead to personalized/precision medicine approaches to determining whether these patients should receive SSRIs or not,” said Biffi.
 

Experts weigh in

Commenting on the research for Medscape Medical News, Daniel G. Hackam, MD, division of clinical pharmacology, Western University, London, Ont., said the study is “an important contribution to the literature, as there are to date no data on the risk of ICH in prior ICH survivors in relation to SSRI exposure.”

“The bottom line is that I would be very cautious about initiating SSRIs in patients with a history of ICH,” said Hackam, who was not involved with the study.

“There are other nonserotonergic antidepressants that could be used instead, which do not inhibit platelet function. There was still a risk even in the lower-risk ICH survivors. ICH is a highly recurrent disease. We already avoid antiplatelets, anticoagulants, and high dose statins in these patients. I would add SSRI’s to that list, based on this study,” said Hackam.

Also weighing in, Amytis Towfighi, MD, associate professor of neurology, University of Southern California, Los Angeles, said this study addresses a “common clinical dilemma: how to manage depression among individuals with ICH, given the high risk of recurrent ICH among ICH survivors and potential for SSRIs to increase that risk. This scenario is common, and a source of debate for practicing clinicians.”

“The authors conducted an elegant study,” said Towfighi, by considering sociodemographic, historical, imaging, and genetic factors.

“One must interpret this study with caution as it is a single-center cohort study. However, it provides the most rigorous information to date regarding the associations between SSRI use and recurrent ICH,” she told Medscape Medical News.

The study was supported by the National Institutes of Health. Biffi, Hackam, and Towfighi have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Under the U.S. Medicare system, the cost of insulin is about 50% higher for beneficiaries who use insulin pumps than those who inject insulin, a new analysis reveals.

Courtesy Wikimedia Commons/Mbbradford/CC-by-3.0

A call to action as price of insulin rose, suddenly shifted, in 2017

In the article, the authors call for the Centers for Medicare & Medicaid Services to fix the situation with a series of actions, including better aligning the cost of insulin under Parts B and D, and determining reimbursement rates on a drug-by-drug basis, rather than lumping together all infused drugs.

The CMS said in a statement: “As with all relevant and topical research, CMS appreciates the input of the journal authors and considers external research in all potential future policymaking and initiatives.”

As outlined by the authors, the overall price of insulin in the United States has dramatically increased in the past 2 decades. For example, the average list price of one vial of insulin rose from $9.61 to $25.38 between January 2013 and July 2018, a 164% increase.

A provision in the 21st Century Cures Act, which went into effect Jan. 1, 2017, attempted to remedy past overpayment for DME-infused drugs covered under Medicare Part B by changing the pricing methodology. Prior to 2017, the drugs had been reimbursed based on 95% of the 2003 average wholesale price. With the new law, payments have been set to average sales price plus 6%.

As a result, the price of insulin rose by 251% overnight from Dec. 31, 2016, to Jan. 1, 2017, for Medicare beneficiaries using insulin pumps, whereas there was no change for those injecting their insulin.

And then in 2018, insulin manufacturers raised the price by another 53%, resulting in an overall 304% price increase under Part B over 2 years.

Meanwhile, on March 11, 2020, CMS announced a cap on insulin copays in Part D to $35 a month, which doesn’t apply to pump users.

Thus, as of now, the average monthly copay for insulin for pump users in Medicare is about $54.26, about 50% more than the $35 maximum for those who inject insulin.

“This is in the setting of patients skimping on insulin anyway because of the high cost. There’s reasonably good evidence that patients stretch out their insulin because of cost, including those in Medicare,” Dr. Vigersky emphasized.
 

What can be done?

The problem could have been avoided, the authors wrote in their commentary, if payments had simply been adjusted for the two pre-2017 most highly overpaid DME-infused drugs, milrinone lactate and immune globulin, rather than all of them. Doing that would have addressed 95% of the overpayments and saved $267 million without affecting insulin cost.

Unlike insulin, nearly all of the other infused drugs are used only for short periods of time, such as pain medications, antibiotics, or chemotherapy.

“People get these for a few months, but not for years and years. Some aren’t used much at all. It was sort of a wholesale way to change things, and insulin got caught in it, with more extensive consequences,” Dr. Vigersky noted.

He and his coauthors advised the CMS to test pricing methodologies before implementation to prevent further unintended consequences going forward, to ask the Inspector General’s office to reanalyze costs to see if savings targets are being met, and to notify patients and health care providers in advance of a change so that they can better prepare for increased costs.

For now, Dr. Vigersky advised that, when considering pump therapy for a given patient, “from a clinical standpoint, this is a shared decision with the patient.

“As much as the reality of costs is shared with the patient, there is good evidence that pump therapy is cost-effective. The patient has to make the decision as to whether this extra amount is worth the benefits in the long run that they will get from pump therapy.”

A version of this article was originally published on Medscape.com.

Under the U.S. Medicare system, the cost of insulin is about 50% higher for beneficiaries who use insulin pumps than those who inject insulin, a new analysis reveals.

Courtesy Wikimedia Commons/Mbbradford/CC-by-3.0

A call to action as price of insulin rose, suddenly shifted, in 2017

In the article, the authors call for the Centers for Medicare & Medicaid Services to fix the situation with a series of actions, including better aligning the cost of insulin under Parts B and D, and determining reimbursement rates on a drug-by-drug basis, rather than lumping together all infused drugs.

The CMS said in a statement: “As with all relevant and topical research, CMS appreciates the input of the journal authors and considers external research in all potential future policymaking and initiatives.”

As outlined by the authors, the overall price of insulin in the United States has dramatically increased in the past 2 decades. For example, the average list price of one vial of insulin rose from $9.61 to $25.38 between January 2013 and July 2018, a 164% increase.

A provision in the 21st Century Cures Act, which went into effect Jan. 1, 2017, attempted to remedy past overpayment for DME-infused drugs covered under Medicare Part B by changing the pricing methodology. Prior to 2017, the drugs had been reimbursed based on 95% of the 2003 average wholesale price. With the new law, payments have been set to average sales price plus 6%.

As a result, the price of insulin rose by 251% overnight from Dec. 31, 2016, to Jan. 1, 2017, for Medicare beneficiaries using insulin pumps, whereas there was no change for those injecting their insulin.

And then in 2018, insulin manufacturers raised the price by another 53%, resulting in an overall 304% price increase under Part B over 2 years.

Meanwhile, on March 11, 2020, CMS announced a cap on insulin copays in Part D to $35 a month, which doesn’t apply to pump users.

Thus, as of now, the average monthly copay for insulin for pump users in Medicare is about $54.26, about 50% more than the $35 maximum for those who inject insulin.

“This is in the setting of patients skimping on insulin anyway because of the high cost. There’s reasonably good evidence that patients stretch out their insulin because of cost, including those in Medicare,” Dr. Vigersky emphasized.
 

What can be done?

The problem could have been avoided, the authors wrote in their commentary, if payments had simply been adjusted for the two pre-2017 most highly overpaid DME-infused drugs, milrinone lactate and immune globulin, rather than all of them. Doing that would have addressed 95% of the overpayments and saved $267 million without affecting insulin cost.

Unlike insulin, nearly all of the other infused drugs are used only for short periods of time, such as pain medications, antibiotics, or chemotherapy.

“People get these for a few months, but not for years and years. Some aren’t used much at all. It was sort of a wholesale way to change things, and insulin got caught in it, with more extensive consequences,” Dr. Vigersky noted.

He and his coauthors advised the CMS to test pricing methodologies before implementation to prevent further unintended consequences going forward, to ask the Inspector General’s office to reanalyze costs to see if savings targets are being met, and to notify patients and health care providers in advance of a change so that they can better prepare for increased costs.

For now, Dr. Vigersky advised that, when considering pump therapy for a given patient, “from a clinical standpoint, this is a shared decision with the patient.

“As much as the reality of costs is shared with the patient, there is good evidence that pump therapy is cost-effective. The patient has to make the decision as to whether this extra amount is worth the benefits in the long run that they will get from pump therapy.”

A version of this article was originally published on Medscape.com.

Under the U.S. Medicare system, the cost of insulin is about 50% higher for beneficiaries who use insulin pumps than those who inject insulin, a new analysis reveals.

Courtesy Wikimedia Commons/Mbbradford/CC-by-3.0

A call to action as price of insulin rose, suddenly shifted, in 2017

In the article, the authors call for the Centers for Medicare & Medicaid Services to fix the situation with a series of actions, including better aligning the cost of insulin under Parts B and D, and determining reimbursement rates on a drug-by-drug basis, rather than lumping together all infused drugs.

The CMS said in a statement: “As with all relevant and topical research, CMS appreciates the input of the journal authors and considers external research in all potential future policymaking and initiatives.”

As outlined by the authors, the overall price of insulin in the United States has dramatically increased in the past 2 decades. For example, the average list price of one vial of insulin rose from $9.61 to $25.38 between January 2013 and July 2018, a 164% increase.

A provision in the 21st Century Cures Act, which went into effect Jan. 1, 2017, attempted to remedy past overpayment for DME-infused drugs covered under Medicare Part B by changing the pricing methodology. Prior to 2017, the drugs had been reimbursed based on 95% of the 2003 average wholesale price. With the new law, payments have been set to average sales price plus 6%.

As a result, the price of insulin rose by 251% overnight from Dec. 31, 2016, to Jan. 1, 2017, for Medicare beneficiaries using insulin pumps, whereas there was no change for those injecting their insulin.

And then in 2018, insulin manufacturers raised the price by another 53%, resulting in an overall 304% price increase under Part B over 2 years.

Meanwhile, on March 11, 2020, CMS announced a cap on insulin copays in Part D to $35 a month, which doesn’t apply to pump users.

Thus, as of now, the average monthly copay for insulin for pump users in Medicare is about $54.26, about 50% more than the $35 maximum for those who inject insulin.

“This is in the setting of patients skimping on insulin anyway because of the high cost. There’s reasonably good evidence that patients stretch out their insulin because of cost, including those in Medicare,” Dr. Vigersky emphasized.
 

What can be done?

The problem could have been avoided, the authors wrote in their commentary, if payments had simply been adjusted for the two pre-2017 most highly overpaid DME-infused drugs, milrinone lactate and immune globulin, rather than all of them. Doing that would have addressed 95% of the overpayments and saved $267 million without affecting insulin cost.

Unlike insulin, nearly all of the other infused drugs are used only for short periods of time, such as pain medications, antibiotics, or chemotherapy.

“People get these for a few months, but not for years and years. Some aren’t used much at all. It was sort of a wholesale way to change things, and insulin got caught in it, with more extensive consequences,” Dr. Vigersky noted.

He and his coauthors advised the CMS to test pricing methodologies before implementation to prevent further unintended consequences going forward, to ask the Inspector General’s office to reanalyze costs to see if savings targets are being met, and to notify patients and health care providers in advance of a change so that they can better prepare for increased costs.

For now, Dr. Vigersky advised that, when considering pump therapy for a given patient, “from a clinical standpoint, this is a shared decision with the patient.

“As much as the reality of costs is shared with the patient, there is good evidence that pump therapy is cost-effective. The patient has to make the decision as to whether this extra amount is worth the benefits in the long run that they will get from pump therapy.”

A version of this article was originally published on Medscape.com.

A significant proportion of patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and dysautonomia may have potentially treatable underlying autoimmune-associated small-fiber polyneuropathy (aaSFPN), pilot data suggest.

The findings, from a single-site study of 61 patients with ME/CFS, were presented August 21 at the virtual meeting of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis by Ryan Whelan, BS, a research assistant at Simmaron Research Institute, Incline Village, Nevada.

Recent evidence suggests an autoimmune etiology for some patients with ME/CFS, which is defined as experiencing for a period of at least 6 months profound, unexplained fatigue, postexertional malaise, and unrefreshing sleep, as well as cognitive dysfunction and/or orthostatic intolerance (OI).

OI is part of a spectrum of autonomic dysfunction commonly seen in ME/CFS patients, which may also include postural orthostatic tachycardia (POTS), peripheral temperature dysregulation and light sensitivity, neuropathic pain, and gastrointestinal complaints. Many of these symptoms overlap those reported by patients with aaSFPN, a common but underdiagnosed neurodegenerative disorder characterized by the loss of peripheral autonomic nerve fibers, Whelan explained.

Findings from the current study show that in more than half of ME/CFS patients, levels of at least one autoantibody were elevated. A majority had comorbid POTS or OI, and over a third had biopsy-confirmed aaSFPN.

“Given the overlap of symptoms and common etiological basis, it may be important to identify ME/CFS patients who present with comorbid aaSFPN, as it has been shown that immune modulatory agents, including intravenous gamma globulin [IVIG], reduce the autonomic symptom burden in aaSFPN patients,” Whelan said.

He noted that Anne Louise Oaklander, MD, a neurologist at Massachusetts General Hospital, Harvard Medical School, Boston, and colleagues previously linked aaSFPN with fibromyalgia. In addition, they’ve found a connection between small-fiber dysfunction and postexertional malaise, which is a hallmark ME/CFS symptom.

Asked to comment on Whelan’s presentation, IACFSME co-president Lily Chu, MD, told Medscape Medical News that the new findings are “valuable, because ME/CFS has always been looked upon as just subjective symptoms. When people have laboratory abnormalities, it can be due to a bunch of other causes, but...here’s pathology, here’s a biopsy of actual damage. It’s not just a transient finding. You can actually see it. ... It’s a solid concrete piece of evidence vs something that can fluctuate.”

Autoantibodies, Autonomic Dysfunction, and Small-Fiber Polyneuropathy

Whelan and colleagues conducted an extensive analysis of medical records of 364 patients with ME/CFS (72% female) to identify potential aaSFPN comorbidity. Such identifications were made on the basis of progress notes documenting autonomic dysfunction, laboratory results for serum autoantibodies, and questionnaire symptom self-reports.

They identified 61 patients as possibly having comorbid aaSFPN. Of those, 52% tested positive for at least 1 of 4 autoantibodies, including antimuscarinic cholinergic receptor 4 (47%), anti-beta-2 adrenergic (27%), antimuscarinic cholinergic 3 (25%), and anti-beta-1 adrenergic (13%). These autoantibodies were linked to ME/CFS in a recent Swedish cohort study.

“Evidence supports that these autoantibodies may bind to receptor sites, blocking ligands from reaching these receptors. Disturbances of adrenergic and cholinergic receptors by these autoantibodies may contribute to symptoms of autonomic dysfunction in ME/CFS,” Whelan said.

Although 22% of patients in the study group had POTS and 59% had OI, the authors found no correlation between autoantibody levels and either OI or POTS. However, 38% were confirmed to have small-fiber polyneuropathy on skin biopsy, and the vast majority of those patients (93%) had either POTS or OI.

IVIG May Be a Potential Treatment

Whelan notes that some data suggest that IVIG might help patients with small-fiber neuropathy, including those with autoimmunity.

In addition, he described anecdotal data from a single patient with ME/CFS who had neuropathic symptoms. The patient was treated at Simmaron. The 56-year-old received two IVIG infusions given 6 months apart. The patient experienced a dramatic reduction in levels of all four of the relevant autoantibodies and favorable symptom reduction, as shown in clinician follow-up records. “With the success of this case study, we intend to further evaluate IVIG as a potential treatment in ME/CFS patients. With this research, we hope to identify a subset of ME/CFS patients who will respond favorably to IVIG,” Whelan concluded.

Regarding use of IVIG, Chu commented, “We don’t know exactly how it works, but it seems to help certain conditions.” She pointed to another recent small study that reported clinical improvement in patients with ME/CFS through a different approach, immunoadsorption, for reducing the autoantibody levels.

Overall, Chu said, this line of research “is important because it shows there’s some type of abnormal biomarker for ME/CFS. And, it may lay a path toward understanding the pathophysiology of the disease and why people have certain symptoms, and could be used to target therapies. ... It’s intriguing.”

Whelan and Chu have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

A significant proportion of patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and dysautonomia may have potentially treatable underlying autoimmune-associated small-fiber polyneuropathy (aaSFPN), pilot data suggest.

The findings, from a single-site study of 61 patients with ME/CFS, were presented August 21 at the virtual meeting of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis by Ryan Whelan, BS, a research assistant at Simmaron Research Institute, Incline Village, Nevada.

Recent evidence suggests an autoimmune etiology for some patients with ME/CFS, which is defined as experiencing for a period of at least 6 months profound, unexplained fatigue, postexertional malaise, and unrefreshing sleep, as well as cognitive dysfunction and/or orthostatic intolerance (OI).

OI is part of a spectrum of autonomic dysfunction commonly seen in ME/CFS patients, which may also include postural orthostatic tachycardia (POTS), peripheral temperature dysregulation and light sensitivity, neuropathic pain, and gastrointestinal complaints. Many of these symptoms overlap those reported by patients with aaSFPN, a common but underdiagnosed neurodegenerative disorder characterized by the loss of peripheral autonomic nerve fibers, Whelan explained.

Findings from the current study show that in more than half of ME/CFS patients, levels of at least one autoantibody were elevated. A majority had comorbid POTS or OI, and over a third had biopsy-confirmed aaSFPN.

“Given the overlap of symptoms and common etiological basis, it may be important to identify ME/CFS patients who present with comorbid aaSFPN, as it has been shown that immune modulatory agents, including intravenous gamma globulin [IVIG], reduce the autonomic symptom burden in aaSFPN patients,” Whelan said.

He noted that Anne Louise Oaklander, MD, a neurologist at Massachusetts General Hospital, Harvard Medical School, Boston, and colleagues previously linked aaSFPN with fibromyalgia. In addition, they’ve found a connection between small-fiber dysfunction and postexertional malaise, which is a hallmark ME/CFS symptom.

Asked to comment on Whelan’s presentation, IACFSME co-president Lily Chu, MD, told Medscape Medical News that the new findings are “valuable, because ME/CFS has always been looked upon as just subjective symptoms. When people have laboratory abnormalities, it can be due to a bunch of other causes, but...here’s pathology, here’s a biopsy of actual damage. It’s not just a transient finding. You can actually see it. ... It’s a solid concrete piece of evidence vs something that can fluctuate.”

Autoantibodies, Autonomic Dysfunction, and Small-Fiber Polyneuropathy

Whelan and colleagues conducted an extensive analysis of medical records of 364 patients with ME/CFS (72% female) to identify potential aaSFPN comorbidity. Such identifications were made on the basis of progress notes documenting autonomic dysfunction, laboratory results for serum autoantibodies, and questionnaire symptom self-reports.

They identified 61 patients as possibly having comorbid aaSFPN. Of those, 52% tested positive for at least 1 of 4 autoantibodies, including antimuscarinic cholinergic receptor 4 (47%), anti-beta-2 adrenergic (27%), antimuscarinic cholinergic 3 (25%), and anti-beta-1 adrenergic (13%). These autoantibodies were linked to ME/CFS in a recent Swedish cohort study.

“Evidence supports that these autoantibodies may bind to receptor sites, blocking ligands from reaching these receptors. Disturbances of adrenergic and cholinergic receptors by these autoantibodies may contribute to symptoms of autonomic dysfunction in ME/CFS,” Whelan said.

Although 22% of patients in the study group had POTS and 59% had OI, the authors found no correlation between autoantibody levels and either OI or POTS. However, 38% were confirmed to have small-fiber polyneuropathy on skin biopsy, and the vast majority of those patients (93%) had either POTS or OI.

IVIG May Be a Potential Treatment

Whelan notes that some data suggest that IVIG might help patients with small-fiber neuropathy, including those with autoimmunity.

In addition, he described anecdotal data from a single patient with ME/CFS who had neuropathic symptoms. The patient was treated at Simmaron. The 56-year-old received two IVIG infusions given 6 months apart. The patient experienced a dramatic reduction in levels of all four of the relevant autoantibodies and favorable symptom reduction, as shown in clinician follow-up records. “With the success of this case study, we intend to further evaluate IVIG as a potential treatment in ME/CFS patients. With this research, we hope to identify a subset of ME/CFS patients who will respond favorably to IVIG,” Whelan concluded.

Regarding use of IVIG, Chu commented, “We don’t know exactly how it works, but it seems to help certain conditions.” She pointed to another recent small study that reported clinical improvement in patients with ME/CFS through a different approach, immunoadsorption, for reducing the autoantibody levels.

Overall, Chu said, this line of research “is important because it shows there’s some type of abnormal biomarker for ME/CFS. And, it may lay a path toward understanding the pathophysiology of the disease and why people have certain symptoms, and could be used to target therapies. ... It’s intriguing.”

Whelan and Chu have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

A significant proportion of patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and dysautonomia may have potentially treatable underlying autoimmune-associated small-fiber polyneuropathy (aaSFPN), pilot data suggest.

The findings, from a single-site study of 61 patients with ME/CFS, were presented August 21 at the virtual meeting of the International Association for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis by Ryan Whelan, BS, a research assistant at Simmaron Research Institute, Incline Village, Nevada.

Recent evidence suggests an autoimmune etiology for some patients with ME/CFS, which is defined as experiencing for a period of at least 6 months profound, unexplained fatigue, postexertional malaise, and unrefreshing sleep, as well as cognitive dysfunction and/or orthostatic intolerance (OI).

OI is part of a spectrum of autonomic dysfunction commonly seen in ME/CFS patients, which may also include postural orthostatic tachycardia (POTS), peripheral temperature dysregulation and light sensitivity, neuropathic pain, and gastrointestinal complaints. Many of these symptoms overlap those reported by patients with aaSFPN, a common but underdiagnosed neurodegenerative disorder characterized by the loss of peripheral autonomic nerve fibers, Whelan explained.

Findings from the current study show that in more than half of ME/CFS patients, levels of at least one autoantibody were elevated. A majority had comorbid POTS or OI, and over a third had biopsy-confirmed aaSFPN.

“Given the overlap of symptoms and common etiological basis, it may be important to identify ME/CFS patients who present with comorbid aaSFPN, as it has been shown that immune modulatory agents, including intravenous gamma globulin [IVIG], reduce the autonomic symptom burden in aaSFPN patients,” Whelan said.

He noted that Anne Louise Oaklander, MD, a neurologist at Massachusetts General Hospital, Harvard Medical School, Boston, and colleagues previously linked aaSFPN with fibromyalgia. In addition, they’ve found a connection between small-fiber dysfunction and postexertional malaise, which is a hallmark ME/CFS symptom.

Asked to comment on Whelan’s presentation, IACFSME co-president Lily Chu, MD, told Medscape Medical News that the new findings are “valuable, because ME/CFS has always been looked upon as just subjective symptoms. When people have laboratory abnormalities, it can be due to a bunch of other causes, but...here’s pathology, here’s a biopsy of actual damage. It’s not just a transient finding. You can actually see it. ... It’s a solid concrete piece of evidence vs something that can fluctuate.”

Autoantibodies, Autonomic Dysfunction, and Small-Fiber Polyneuropathy

Whelan and colleagues conducted an extensive analysis of medical records of 364 patients with ME/CFS (72% female) to identify potential aaSFPN comorbidity. Such identifications were made on the basis of progress notes documenting autonomic dysfunction, laboratory results for serum autoantibodies, and questionnaire symptom self-reports.

They identified 61 patients as possibly having comorbid aaSFPN. Of those, 52% tested positive for at least 1 of 4 autoantibodies, including antimuscarinic cholinergic receptor 4 (47%), anti-beta-2 adrenergic (27%), antimuscarinic cholinergic 3 (25%), and anti-beta-1 adrenergic (13%). These autoantibodies were linked to ME/CFS in a recent Swedish cohort study.

“Evidence supports that these autoantibodies may bind to receptor sites, blocking ligands from reaching these receptors. Disturbances of adrenergic and cholinergic receptors by these autoantibodies may contribute to symptoms of autonomic dysfunction in ME/CFS,” Whelan said.

Although 22% of patients in the study group had POTS and 59% had OI, the authors found no correlation between autoantibody levels and either OI or POTS. However, 38% were confirmed to have small-fiber polyneuropathy on skin biopsy, and the vast majority of those patients (93%) had either POTS or OI.

IVIG May Be a Potential Treatment

Whelan notes that some data suggest that IVIG might help patients with small-fiber neuropathy, including those with autoimmunity.

In addition, he described anecdotal data from a single patient with ME/CFS who had neuropathic symptoms. The patient was treated at Simmaron. The 56-year-old received two IVIG infusions given 6 months apart. The patient experienced a dramatic reduction in levels of all four of the relevant autoantibodies and favorable symptom reduction, as shown in clinician follow-up records. “With the success of this case study, we intend to further evaluate IVIG as a potential treatment in ME/CFS patients. With this research, we hope to identify a subset of ME/CFS patients who will respond favorably to IVIG,” Whelan concluded.

Regarding use of IVIG, Chu commented, “We don’t know exactly how it works, but it seems to help certain conditions.” She pointed to another recent small study that reported clinical improvement in patients with ME/CFS through a different approach, immunoadsorption, for reducing the autoantibody levels.

Overall, Chu said, this line of research “is important because it shows there’s some type of abnormal biomarker for ME/CFS. And, it may lay a path toward understanding the pathophysiology of the disease and why people have certain symptoms, and could be used to target therapies. ... It’s intriguing.”

Whelan and Chu have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Treatment with statins was associated with a reduced risk of a severe or fatal course of COVID-19 by 30%, a meta-analysis of four published studies has shown.

RogerAshford/Thinkstock

In the analysis that included almost 9,000 COVID-19 patients, there was a significantly reduced risk for fatal or severe COVID-19 among patients who were users of statins, compared with nonusers (pooled hazard ratio, 0.70; 95% confidence interval, 0.53-0.94).

Based on the findings, “it may be time we shift our focus to statins as the potential therapeutic options in COVID-19 patients,” authors Syed Shahzad Hasan, PhD, University of Huddersfield (England), and Chia Siang Kow, MPharm, International Medical University, Kuala Lumpur, Malaysia, said in an interview.

The study was published online August 11 in The American Journal of Cardiology.
 

Moderate- to good-quality data

The analysis included four studies published up to July 27 of this year. Eligible studies included those with a cohort or case-control designs, enrolled patients with confirmed COVID-19, and had data available allowing comparison of the risk of severe illness and/or mortality among statin users versus nonusers in adjusted analyses, the authors noted.

The four studies – one of “moderate” quality and three of “good” quality – included a total of 8,990 COVID-19 patients.

In the pooled analysis, there was a significantly reduced risk for fatal or severe COVID-19 with use of statins, compared with non-use of statins (pooled HR, 0.70; 95% CI, 0.53-0.94).

Their findings also “discredited the suggestion of harms with the use of statins in COVID-19 patients,” the authors concluded.

“Since our meta-analysis included a fairly large total number of COVID-19 patients from four studies in which three are large-scale studies that adjusted extensively for multiple potential confounding factors, the findings can be considered reliable,” Dr. Hasan and Mr. Kow wrote in their article.

Based on the results, “moderate- to high-intensity statin therapy is likely to be beneficial” in patients with COVID-19, they said.

However, they cautioned that more data from prospective studies are needed to substantiate the findings and to determine the appropriate regimen for a statin in COVID-19 patients.

Yibin Wang, PhD, of the University of California, Los Angeles, said that “this is a very simple meta-analysis from four published studies which consistently reported a protective or neutral effect of statin usage on mortality or severe complications in COVID-19 patients.”

Although the scope of this meta-analysis was “quite limited, the conclusion was not unexpected, as most of the clinical analysis so far reported supports the benefits or safety of statin usage in COVID-19 patients,” Dr. Wang said in an interview.
 

Nonetheless, questions remain

While there is “almost no dispute” about the safety of continuing statin therapy in COVID-19 patients, it remains to be determined if statin therapy can be implemented as an adjuvant or independent therapy and a part of the standard care for COVID-19 patients regardless of their hyperlipidemia status, said Dr. Wang, who was not associated with Dr. Hasan’s and Mr. Kow’s research.

“While statin usage is associated with several beneficial effects such as anti-inflammation and cytoprotection, these effects are usually observed from long-term usage rather than short-term/acute administration. Therefore, prospective studies and randomized trials should be conducted to test the efficacy of stain usage for COVID-19 patients with mild to severe symptoms,” he noted.

“Considering the excellent record of statins as a safe and cheap drug, it is certainly a worthwhile effort to consider its broad-based usage for COVID-19 in order to lower the overall death and severe complications,” Dr. Wang concluded.

Guillermo Rodriguez-Nava, MD, department of internal medicine, AMITA Health Saint Francis Hospital, Evanston, Ill., is first author on one of the studies included in this meta-analysis.

The retrospective, single-center study found slower progression to death associated with atorvastatin in older patients with COVID-19 admitted to the ICU. 

“Currently, there are hundreds of clinical trials evaluating a wide variety of pharmacological therapies for COVID-19. Unfortunately, these trials take time, and we are getting results in dribs and drabs,” Dr. Rodriguez-Nava said in an interview.

“In the meantime, the best available evidence is observational, and COVID-19 treatment regiments will continue to evolve. Whether atorvastatin is effective against COVID-19 is still under investigation. Nevertheless, clinicians should consider at least continuing them in patients with COVID-19,” he advised.

The study had no specific funding. Dr. Hasan, Mr. Kow, Dr. Wang, and Dr. Rodriguez-Nava disclosed no relationships relevant to this research.

A version of this article originally appeared on Medscape.com.

Treatment with statins was associated with a reduced risk of a severe or fatal course of COVID-19 by 30%, a meta-analysis of four published studies has shown.

RogerAshford/Thinkstock

In the analysis that included almost 9,000 COVID-19 patients, there was a significantly reduced risk for fatal or severe COVID-19 among patients who were users of statins, compared with nonusers (pooled hazard ratio, 0.70; 95% confidence interval, 0.53-0.94).

Based on the findings, “it may be time we shift our focus to statins as the potential therapeutic options in COVID-19 patients,” authors Syed Shahzad Hasan, PhD, University of Huddersfield (England), and Chia Siang Kow, MPharm, International Medical University, Kuala Lumpur, Malaysia, said in an interview.

The study was published online August 11 in The American Journal of Cardiology.
 

Moderate- to good-quality data

The analysis included four studies published up to July 27 of this year. Eligible studies included those with a cohort or case-control designs, enrolled patients with confirmed COVID-19, and had data available allowing comparison of the risk of severe illness and/or mortality among statin users versus nonusers in adjusted analyses, the authors noted.

The four studies – one of “moderate” quality and three of “good” quality – included a total of 8,990 COVID-19 patients.

In the pooled analysis, there was a significantly reduced risk for fatal or severe COVID-19 with use of statins, compared with non-use of statins (pooled HR, 0.70; 95% CI, 0.53-0.94).

Their findings also “discredited the suggestion of harms with the use of statins in COVID-19 patients,” the authors concluded.

“Since our meta-analysis included a fairly large total number of COVID-19 patients from four studies in which three are large-scale studies that adjusted extensively for multiple potential confounding factors, the findings can be considered reliable,” Dr. Hasan and Mr. Kow wrote in their article.

Based on the results, “moderate- to high-intensity statin therapy is likely to be beneficial” in patients with COVID-19, they said.

However, they cautioned that more data from prospective studies are needed to substantiate the findings and to determine the appropriate regimen for a statin in COVID-19 patients.

Yibin Wang, PhD, of the University of California, Los Angeles, said that “this is a very simple meta-analysis from four published studies which consistently reported a protective or neutral effect of statin usage on mortality or severe complications in COVID-19 patients.”

Although the scope of this meta-analysis was “quite limited, the conclusion was not unexpected, as most of the clinical analysis so far reported supports the benefits or safety of statin usage in COVID-19 patients,” Dr. Wang said in an interview.
 

Nonetheless, questions remain

While there is “almost no dispute” about the safety of continuing statin therapy in COVID-19 patients, it remains to be determined if statin therapy can be implemented as an adjuvant or independent therapy and a part of the standard care for COVID-19 patients regardless of their hyperlipidemia status, said Dr. Wang, who was not associated with Dr. Hasan’s and Mr. Kow’s research.

“While statin usage is associated with several beneficial effects such as anti-inflammation and cytoprotection, these effects are usually observed from long-term usage rather than short-term/acute administration. Therefore, prospective studies and randomized trials should be conducted to test the efficacy of stain usage for COVID-19 patients with mild to severe symptoms,” he noted.

“Considering the excellent record of statins as a safe and cheap drug, it is certainly a worthwhile effort to consider its broad-based usage for COVID-19 in order to lower the overall death and severe complications,” Dr. Wang concluded.

Guillermo Rodriguez-Nava, MD, department of internal medicine, AMITA Health Saint Francis Hospital, Evanston, Ill., is first author on one of the studies included in this meta-analysis.

The retrospective, single-center study found slower progression to death associated with atorvastatin in older patients with COVID-19 admitted to the ICU. 

“Currently, there are hundreds of clinical trials evaluating a wide variety of pharmacological therapies for COVID-19. Unfortunately, these trials take time, and we are getting results in dribs and drabs,” Dr. Rodriguez-Nava said in an interview.

“In the meantime, the best available evidence is observational, and COVID-19 treatment regiments will continue to evolve. Whether atorvastatin is effective against COVID-19 is still under investigation. Nevertheless, clinicians should consider at least continuing them in patients with COVID-19,” he advised.

The study had no specific funding. Dr. Hasan, Mr. Kow, Dr. Wang, and Dr. Rodriguez-Nava disclosed no relationships relevant to this research.

A version of this article originally appeared on Medscape.com.

Treatment with statins was associated with a reduced risk of a severe or fatal course of COVID-19 by 30%, a meta-analysis of four published studies has shown.

RogerAshford/Thinkstock

In the analysis that included almost 9,000 COVID-19 patients, there was a significantly reduced risk for fatal or severe COVID-19 among patients who were users of statins, compared with nonusers (pooled hazard ratio, 0.70; 95% confidence interval, 0.53-0.94).

Based on the findings, “it may be time we shift our focus to statins as the potential therapeutic options in COVID-19 patients,” authors Syed Shahzad Hasan, PhD, University of Huddersfield (England), and Chia Siang Kow, MPharm, International Medical University, Kuala Lumpur, Malaysia, said in an interview.

The study was published online August 11 in The American Journal of Cardiology.
 

Moderate- to good-quality data

The analysis included four studies published up to July 27 of this year. Eligible studies included those with a cohort or case-control designs, enrolled patients with confirmed COVID-19, and had data available allowing comparison of the risk of severe illness and/or mortality among statin users versus nonusers in adjusted analyses, the authors noted.

The four studies – one of “moderate” quality and three of “good” quality – included a total of 8,990 COVID-19 patients.

In the pooled analysis, there was a significantly reduced risk for fatal or severe COVID-19 with use of statins, compared with non-use of statins (pooled HR, 0.70; 95% CI, 0.53-0.94).

Their findings also “discredited the suggestion of harms with the use of statins in COVID-19 patients,” the authors concluded.

“Since our meta-analysis included a fairly large total number of COVID-19 patients from four studies in which three are large-scale studies that adjusted extensively for multiple potential confounding factors, the findings can be considered reliable,” Dr. Hasan and Mr. Kow wrote in their article.

Based on the results, “moderate- to high-intensity statin therapy is likely to be beneficial” in patients with COVID-19, they said.

However, they cautioned that more data from prospective studies are needed to substantiate the findings and to determine the appropriate regimen for a statin in COVID-19 patients.

Yibin Wang, PhD, of the University of California, Los Angeles, said that “this is a very simple meta-analysis from four published studies which consistently reported a protective or neutral effect of statin usage on mortality or severe complications in COVID-19 patients.”

Although the scope of this meta-analysis was “quite limited, the conclusion was not unexpected, as most of the clinical analysis so far reported supports the benefits or safety of statin usage in COVID-19 patients,” Dr. Wang said in an interview.
 

Nonetheless, questions remain

While there is “almost no dispute” about the safety of continuing statin therapy in COVID-19 patients, it remains to be determined if statin therapy can be implemented as an adjuvant or independent therapy and a part of the standard care for COVID-19 patients regardless of their hyperlipidemia status, said Dr. Wang, who was not associated with Dr. Hasan’s and Mr. Kow’s research.

“While statin usage is associated with several beneficial effects such as anti-inflammation and cytoprotection, these effects are usually observed from long-term usage rather than short-term/acute administration. Therefore, prospective studies and randomized trials should be conducted to test the efficacy of stain usage for COVID-19 patients with mild to severe symptoms,” he noted.

“Considering the excellent record of statins as a safe and cheap drug, it is certainly a worthwhile effort to consider its broad-based usage for COVID-19 in order to lower the overall death and severe complications,” Dr. Wang concluded.

Guillermo Rodriguez-Nava, MD, department of internal medicine, AMITA Health Saint Francis Hospital, Evanston, Ill., is first author on one of the studies included in this meta-analysis.

The retrospective, single-center study found slower progression to death associated with atorvastatin in older patients with COVID-19 admitted to the ICU. 

“Currently, there are hundreds of clinical trials evaluating a wide variety of pharmacological therapies for COVID-19. Unfortunately, these trials take time, and we are getting results in dribs and drabs,” Dr. Rodriguez-Nava said in an interview.

“In the meantime, the best available evidence is observational, and COVID-19 treatment regiments will continue to evolve. Whether atorvastatin is effective against COVID-19 is still under investigation. Nevertheless, clinicians should consider at least continuing them in patients with COVID-19,” he advised.

The study had no specific funding. Dr. Hasan, Mr. Kow, Dr. Wang, and Dr. Rodriguez-Nava disclosed no relationships relevant to this research.

A version of this article originally appeared on Medscape.com.

Nasal papules that resemble angiofibromas are rarely described in the literature as a sequela of acne, but researchers believe the condition could be an underrecognized problem, affecting patients with skin of color in particular, according to the authors of a case series published in Pediatric Dermatology.

Courtesy Dr. Jorge Roman

Jorge Roman, MD, and coauthors in the department of dermatology at New York (N.Y.) University identified 20 patients with a history of acne who had nasal papules, in a retrospective review of electronic medical records at NYU over 1 year (April 2018 to April 2019). The presentation ranged from “a few, small skin-colored papules to large, dome-shaped papulonodules, to more extensive rhinophymatous-like” changes with some patients having papular lesions on the chin in addition to the nose, they wrote in the report.

These papules greatly resembled angiofibromas, but appear to be a sequela of acne, according to the authors. In five patients who had biopsies, the results showed “a dome-shaped proliferation of spindle and stellate-shaped cells with thickened collagen bundles and dilated thin-walled blood vessels,” the authors wrote. “The histopathological findings of these nasal papules were indistinguishable from those of a conventional angiofibroma.”

In addition, the patients did not have evidence of underlying genetic conditions that could explain the angiofibroma-like lesions. “Although acne has not previously been implicated in the development of angiofibromas, based on the data available for our patients, it seems extremely unlikely that the lesions would be related to anything else,” Dr. Roman, a dermatology resident at New York University, said in an interview.

He said he first recognized the nasal papules in clinic as a first-year resident, but was surprised to find a lack of information on the condition. “Dermatology has a name for just about every skin disease imaginable, so I found it very odd when I couldn’t find much describing this condition,” he said. “There was a large disparity between what we were seeing in clinic and what was reported in the literature.”

Nearly all the patients were Hispanic (17 of 20) and adolescent males (17 patients), with a median age of 16 years at the time of presentation. There were two Black patients and one Asian patient. Race and ethnicity were not mentioned in two previous reports describing papular acne scarring, but Dr. Roman and colleagues noted that in their clinic, the condition appeared to affect adolescent patients with skin of color predominantly.

Reasons why nasal papules may be underreported are unclear, Dr. Roman noted. One possible explanation is lower use of dermatologic care among patients with skin of color. “Interestingly, previous research has shown that racial minorities are lower utilizers of dermatologic care. It is possible that the patient demographic most afflicted by this condition face significant barriers when seeking care,” he said.

Due to a low level of awareness of acne-related nasal papules, “clinicians may not recognize it as an acne-related scarring process. This is significant, as early recognition and treatment can prevent the development or progression of these potentially disfiguring sequelae,” Dr. Roman said.

Although the results are from a small case series at a single center, Dr. Roman said this condition may be more prevalent than realized. “Having been raised in a predominately Latino community in Texas, I can easily recall seeing people with these papules growing up. I don’t think it would be surprising for dermatologists reading our paper to say, ‘I’ve seen this in clinic before,’ ” he said.

Regarding treatment, there is an ongoing investigation into what treatments are effective for the acne-related nasal papules. “Physical treatment modalities such as ablative laser or surgical removal seem to be the most efficacious,” Dr. Roman said. “In the future, a prospective clinical study will help to better define the prevalence and risk factors for the condition,” he said.

He and coauthors reported no conflicts of interest. No funding source was listed.

SOURCE: Roman J et al. Pediatr Dermatol. 2020 Aug 7. doi: 10.1111/pde.14319.

Nasal papules that resemble angiofibromas are rarely described in the literature as a sequela of acne, but researchers believe the condition could be an underrecognized problem, affecting patients with skin of color in particular, according to the authors of a case series published in Pediatric Dermatology.

Courtesy Dr. Jorge Roman

Jorge Roman, MD, and coauthors in the department of dermatology at New York (N.Y.) University identified 20 patients with a history of acne who had nasal papules, in a retrospective review of electronic medical records at NYU over 1 year (April 2018 to April 2019). The presentation ranged from “a few, small skin-colored papules to large, dome-shaped papulonodules, to more extensive rhinophymatous-like” changes with some patients having papular lesions on the chin in addition to the nose, they wrote in the report.

These papules greatly resembled angiofibromas, but appear to be a sequela of acne, according to the authors. In five patients who had biopsies, the results showed “a dome-shaped proliferation of spindle and stellate-shaped cells with thickened collagen bundles and dilated thin-walled blood vessels,” the authors wrote. “The histopathological findings of these nasal papules were indistinguishable from those of a conventional angiofibroma.”

In addition, the patients did not have evidence of underlying genetic conditions that could explain the angiofibroma-like lesions. “Although acne has not previously been implicated in the development of angiofibromas, based on the data available for our patients, it seems extremely unlikely that the lesions would be related to anything else,” Dr. Roman, a dermatology resident at New York University, said in an interview.

He said he first recognized the nasal papules in clinic as a first-year resident, but was surprised to find a lack of information on the condition. “Dermatology has a name for just about every skin disease imaginable, so I found it very odd when I couldn’t find much describing this condition,” he said. “There was a large disparity between what we were seeing in clinic and what was reported in the literature.”

Nearly all the patients were Hispanic (17 of 20) and adolescent males (17 patients), with a median age of 16 years at the time of presentation. There were two Black patients and one Asian patient. Race and ethnicity were not mentioned in two previous reports describing papular acne scarring, but Dr. Roman and colleagues noted that in their clinic, the condition appeared to affect adolescent patients with skin of color predominantly.

Reasons why nasal papules may be underreported are unclear, Dr. Roman noted. One possible explanation is lower use of dermatologic care among patients with skin of color. “Interestingly, previous research has shown that racial minorities are lower utilizers of dermatologic care. It is possible that the patient demographic most afflicted by this condition face significant barriers when seeking care,” he said.

Due to a low level of awareness of acne-related nasal papules, “clinicians may not recognize it as an acne-related scarring process. This is significant, as early recognition and treatment can prevent the development or progression of these potentially disfiguring sequelae,” Dr. Roman said.

Although the results are from a small case series at a single center, Dr. Roman said this condition may be more prevalent than realized. “Having been raised in a predominately Latino community in Texas, I can easily recall seeing people with these papules growing up. I don’t think it would be surprising for dermatologists reading our paper to say, ‘I’ve seen this in clinic before,’ ” he said.

Regarding treatment, there is an ongoing investigation into what treatments are effective for the acne-related nasal papules. “Physical treatment modalities such as ablative laser or surgical removal seem to be the most efficacious,” Dr. Roman said. “In the future, a prospective clinical study will help to better define the prevalence and risk factors for the condition,” he said.

He and coauthors reported no conflicts of interest. No funding source was listed.

SOURCE: Roman J et al. Pediatr Dermatol. 2020 Aug 7. doi: 10.1111/pde.14319.

Nasal papules that resemble angiofibromas are rarely described in the literature as a sequela of acne, but researchers believe the condition could be an underrecognized problem, affecting patients with skin of color in particular, according to the authors of a case series published in Pediatric Dermatology.

Courtesy Dr. Jorge Roman

Jorge Roman, MD, and coauthors in the department of dermatology at New York (N.Y.) University identified 20 patients with a history of acne who had nasal papules, in a retrospective review of electronic medical records at NYU over 1 year (April 2018 to April 2019). The presentation ranged from “a few, small skin-colored papules to large, dome-shaped papulonodules, to more extensive rhinophymatous-like” changes with some patients having papular lesions on the chin in addition to the nose, they wrote in the report.

These papules greatly resembled angiofibromas, but appear to be a sequela of acne, according to the authors. In five patients who had biopsies, the results showed “a dome-shaped proliferation of spindle and stellate-shaped cells with thickened collagen bundles and dilated thin-walled blood vessels,” the authors wrote. “The histopathological findings of these nasal papules were indistinguishable from those of a conventional angiofibroma.”

In addition, the patients did not have evidence of underlying genetic conditions that could explain the angiofibroma-like lesions. “Although acne has not previously been implicated in the development of angiofibromas, based on the data available for our patients, it seems extremely unlikely that the lesions would be related to anything else,” Dr. Roman, a dermatology resident at New York University, said in an interview.

He said he first recognized the nasal papules in clinic as a first-year resident, but was surprised to find a lack of information on the condition. “Dermatology has a name for just about every skin disease imaginable, so I found it very odd when I couldn’t find much describing this condition,” he said. “There was a large disparity between what we were seeing in clinic and what was reported in the literature.”

Nearly all the patients were Hispanic (17 of 20) and adolescent males (17 patients), with a median age of 16 years at the time of presentation. There were two Black patients and one Asian patient. Race and ethnicity were not mentioned in two previous reports describing papular acne scarring, but Dr. Roman and colleagues noted that in their clinic, the condition appeared to affect adolescent patients with skin of color predominantly.

Reasons why nasal papules may be underreported are unclear, Dr. Roman noted. One possible explanation is lower use of dermatologic care among patients with skin of color. “Interestingly, previous research has shown that racial minorities are lower utilizers of dermatologic care. It is possible that the patient demographic most afflicted by this condition face significant barriers when seeking care,” he said.

Due to a low level of awareness of acne-related nasal papules, “clinicians may not recognize it as an acne-related scarring process. This is significant, as early recognition and treatment can prevent the development or progression of these potentially disfiguring sequelae,” Dr. Roman said.

Although the results are from a small case series at a single center, Dr. Roman said this condition may be more prevalent than realized. “Having been raised in a predominately Latino community in Texas, I can easily recall seeing people with these papules growing up. I don’t think it would be surprising for dermatologists reading our paper to say, ‘I’ve seen this in clinic before,’ ” he said.

Regarding treatment, there is an ongoing investigation into what treatments are effective for the acne-related nasal papules. “Physical treatment modalities such as ablative laser or surgical removal seem to be the most efficacious,” Dr. Roman said. “In the future, a prospective clinical study will help to better define the prevalence and risk factors for the condition,” he said.

He and coauthors reported no conflicts of interest. No funding source was listed.

SOURCE: Roman J et al. Pediatr Dermatol. 2020 Aug 7. doi: 10.1111/pde.14319.

Self-employed physicians have the highest salaries, largest homes, and greatest wealth – yet they feel the least fairly compensated, according to an analysis of data from over 17,000 physicians.

A new examination of survey responses from the Medscape Physician Compensation Report 2020, which included information about income, job satisfaction, and more, compared responses from self-employed physicians, independent contractors, and employed physicians.

Income and wealth, benefits, and job satisfaction were compared. From the results of the questionnaire, self-employed physicians stand out among their peers across all categories: They enjoy greater income, wealth, and benefits and appear to be more satisfied by their choice of practice.

“The survey confirms that self-employed is the most satisfying, although the trend in health care is to take employed positions,” said Robert Scroggins, JD, CPA, certified health care business consultant with ScrogginsGreer, Cincinnati. “Doctors who become employees primarily do that to escape the management responsibilities for the practice. It seems to be more a decision to get away from something than to go toward something.”
 

The financial and work picture for self-employed physicians

Self-employed physicians reported the largest salaries for 2019 (average, $360,752), followed by independent contractors ($336,005). Employees reported the lowest average salary ($297,332).

The largest percentage of self-employed physicians (46%) work in an office-based group practice, followed by those in office-based solo practices (30%). Almost two-thirds of self-employed respondents are owners and 37% are partners.

Self-employed physicians are more likely to be older than 45 years; 79% fall into that age bracket, compared with 57% of employees and 70% of independent contractors.

Self-employed physicians reported the highest levels of wealth among their peers. About 44% of self-employed respondents declared a net wealth of over $2 million, compared with 25% of employees. Only 6% of contractors and employed physicians reported a net wealth of over $5 million, compared with 13% of self-employed physicians.

Self-employed physicians also managed their personal expenses slightly differently. They were more likely to pool their income with their spouse in a common account used for bills and expenses, regardless of how much they each earned (63% of self-employed respondents, compared with 58% of employees and 50% of independent contractors).

Perhaps unsurprisingly, self-employed physicians also reported having the largest homes, with an average square footage of 3,629 square feet, compared with 3,023 square feet for employees and 2,984 square feet for independent contractors. Self-employed physicians’ mortgages (average, $240,389) were similar to those of employed physicians’ mortgages but were higher than those of independent contractors’ mortgages (average, $213,740).

Self-employed physicians were also most likely to highly appraise their own performance: Half of all self-employed respondents felt “very satisfied” with their job performance, compared with 40% of employees and 44% of independent contractors.

When asked what they consider to be the most rewarding aspect of their job, self-employed physicians were more likely to choose gratitude and patient relationships than their peers (32%, compared with 26% of employees and 19% of independent contractors).

Despite their higher net wealth and larger salaries, self-employed physicians were least likely to feel fairly compensated; 49% of self-employed physicians said they did not feel fairly compensated for their work, compared with 40% of employees and 40% of independent contractors.

“Self-employed physicians may be better compensated than others of the same specialty who are employees, so some of that may be perception,” said Mr. Scroggins. “Or they feel they should be compensated to a far greater degree than those who are employed.”

Self-employed physicians were also more likely to respond that they would choose the same practice setting again, though across all three categories, fewer than 50% of respondents would do so: 34% of self-employed physicians, compared with 29% of employees and 28% of independent contractors.
 

The financial and work picture for employed physicians

About a third (32%) of employed physician respondents work in hospitals; 28% work in private practices.

Employed physicians were most likely to report a salary increase from 2018 to 2019: 74%, compared with 45% of self-employed and 52% of independent contractors.

As for declines in income, self-employed physicians and independent contractors suffered a comparable loss, with 13% and 12% of them, respectively, reporting salary cuts greater than 10%. Decreases of up to 10% were felt mostly by the self-employed, with 17% experiencing such cuts, compared with 7% of employees and 10% of independent contractors.

In contrast, employees were the least likely of the three categories to have incurred large financial losses over the past year: 77% of employed respondents indicated that they had not experienced any significant financial losses in the past year, compared with 63% of self-employed physicians and 63% of independent contractors. They were also least likely to have made any investments at all over the past year – 21% of employees reported having made none at all in 2019, compared to 11% of self-employed physicians and 16% of independent contractors.
 

The financial and work picture for independent contractors

Just over half (52%) of all independent contractors who responded to our questionnaire work in hospitals, 15% work in group practices, 9% work in outpatient clinics, and just 2% work in solo practices.

Independent contractors were less likely than their peers to have received employment benefits such as health insurance, malpractice coverage, and paid time off. They were also less likely to be saving for retirement. Almost half (45%) of independent contractors said they received no employment benefits at all, compared to 20% of self-employed physicians and just 8% of employees.

What’s more, 27% of independent contractors do not currently put money into a 401(k) retirement account or tax-deferred college savings account on a regular basis, compared with 16% of self-employed physicians and 8% of employees. Similarly, they were less likely to put money into a taxable savings account (39% responded that they do not, compared with 32% of self-employed physicians and 27% of employees).

“Net worth and retirement funding findings do line up with what I’ve observed,” said Mr. Scroggins. “Those who have independent practices as opposed to working for a hospital do tend to more heavily fund retirement plan accounts, which is typically the biggest driver of building net worth.”

Despite the lack of retirement planning, independent contractors were more likely than their peers to derive satisfaction from making money at a job they like (18%, compared with 12% of employees and 11% of self-employed physicians). They’re also far more likely to be in emergency medicine (22% of independent contractors, compared with 3% of self-employed and 5% of employees) or psychiatry (11% of independent contractors, compared with 5% of self-employed and 6% of employees).

Among the three categories of physicians, independent contractors were least likely to say that they would choose the same practice setting again. Across all three categories, fewer than 50% of respondents would do so: 34% of self-employed physicians, compared with 29% of employees and 28% of independent contractors.

Physicians who are considering leaving their own practice for a hospital setting should do so with caution and fully understand what they are getting into, said Mr. Scroggins. “If they’re just looking at compensation, they also should be looking very carefully at retirement plan benefits. If that’s their main method of saving and building net worth, then that’s a dramatic difference.”

And of course, there’s always the intangible value of feeling connected to a practice and its patients: “Physicians got into this line of work to treat patients and help people become healthier, and in hospitals they end up being more disconnected from their patients,” Mr. Scroggins said. “That’s a big factor as well.”

Editor’s note: Only differences that are statistically significant at a 95% confidence level between categories of employment have been included. Of the 13,893 responses included in this analysis, 3,860 physicians identified as self-employed, 9,262 as employees, and 772 as independent contractors.

A version of this article originally appeared on Medscape.com.

Self-employed physicians have the highest salaries, largest homes, and greatest wealth – yet they feel the least fairly compensated, according to an analysis of data from over 17,000 physicians.

A new examination of survey responses from the Medscape Physician Compensation Report 2020, which included information about income, job satisfaction, and more, compared responses from self-employed physicians, independent contractors, and employed physicians.

Income and wealth, benefits, and job satisfaction were compared. From the results of the questionnaire, self-employed physicians stand out among their peers across all categories: They enjoy greater income, wealth, and benefits and appear to be more satisfied by their choice of practice.

“The survey confirms that self-employed is the most satisfying, although the trend in health care is to take employed positions,” said Robert Scroggins, JD, CPA, certified health care business consultant with ScrogginsGreer, Cincinnati. “Doctors who become employees primarily do that to escape the management responsibilities for the practice. It seems to be more a decision to get away from something than to go toward something.”
 

The financial and work picture for self-employed physicians

Self-employed physicians reported the largest salaries for 2019 (average, $360,752), followed by independent contractors ($336,005). Employees reported the lowest average salary ($297,332).

The largest percentage of self-employed physicians (46%) work in an office-based group practice, followed by those in office-based solo practices (30%). Almost two-thirds of self-employed respondents are owners and 37% are partners.

Self-employed physicians are more likely to be older than 45 years; 79% fall into that age bracket, compared with 57% of employees and 70% of independent contractors.

Self-employed physicians reported the highest levels of wealth among their peers. About 44% of self-employed respondents declared a net wealth of over $2 million, compared with 25% of employees. Only 6% of contractors and employed physicians reported a net wealth of over $5 million, compared with 13% of self-employed physicians.

Self-employed physicians also managed their personal expenses slightly differently. They were more likely to pool their income with their spouse in a common account used for bills and expenses, regardless of how much they each earned (63% of self-employed respondents, compared with 58% of employees and 50% of independent contractors).

Perhaps unsurprisingly, self-employed physicians also reported having the largest homes, with an average square footage of 3,629 square feet, compared with 3,023 square feet for employees and 2,984 square feet for independent contractors. Self-employed physicians’ mortgages (average, $240,389) were similar to those of employed physicians’ mortgages but were higher than those of independent contractors’ mortgages (average, $213,740).

Self-employed physicians were also most likely to highly appraise their own performance: Half of all self-employed respondents felt “very satisfied” with their job performance, compared with 40% of employees and 44% of independent contractors.

When asked what they consider to be the most rewarding aspect of their job, self-employed physicians were more likely to choose gratitude and patient relationships than their peers (32%, compared with 26% of employees and 19% of independent contractors).

Despite their higher net wealth and larger salaries, self-employed physicians were least likely to feel fairly compensated; 49% of self-employed physicians said they did not feel fairly compensated for their work, compared with 40% of employees and 40% of independent contractors.

“Self-employed physicians may be better compensated than others of the same specialty who are employees, so some of that may be perception,” said Mr. Scroggins. “Or they feel they should be compensated to a far greater degree than those who are employed.”

Self-employed physicians were also more likely to respond that they would choose the same practice setting again, though across all three categories, fewer than 50% of respondents would do so: 34% of self-employed physicians, compared with 29% of employees and 28% of independent contractors.
 

The financial and work picture for employed physicians

About a third (32%) of employed physician respondents work in hospitals; 28% work in private practices.

Employed physicians were most likely to report a salary increase from 2018 to 2019: 74%, compared with 45% of self-employed and 52% of independent contractors.

As for declines in income, self-employed physicians and independent contractors suffered a comparable loss, with 13% and 12% of them, respectively, reporting salary cuts greater than 10%. Decreases of up to 10% were felt mostly by the self-employed, with 17% experiencing such cuts, compared with 7% of employees and 10% of independent contractors.

In contrast, employees were the least likely of the three categories to have incurred large financial losses over the past year: 77% of employed respondents indicated that they had not experienced any significant financial losses in the past year, compared with 63% of self-employed physicians and 63% of independent contractors. They were also least likely to have made any investments at all over the past year – 21% of employees reported having made none at all in 2019, compared to 11% of self-employed physicians and 16% of independent contractors.
 

The financial and work picture for independent contractors

Just over half (52%) of all independent contractors who responded to our questionnaire work in hospitals, 15% work in group practices, 9% work in outpatient clinics, and just 2% work in solo practices.

Independent contractors were less likely than their peers to have received employment benefits such as health insurance, malpractice coverage, and paid time off. They were also less likely to be saving for retirement. Almost half (45%) of independent contractors said they received no employment benefits at all, compared to 20% of self-employed physicians and just 8% of employees.

What’s more, 27% of independent contractors do not currently put money into a 401(k) retirement account or tax-deferred college savings account on a regular basis, compared with 16% of self-employed physicians and 8% of employees. Similarly, they were less likely to put money into a taxable savings account (39% responded that they do not, compared with 32% of self-employed physicians and 27% of employees).

“Net worth and retirement funding findings do line up with what I’ve observed,” said Mr. Scroggins. “Those who have independent practices as opposed to working for a hospital do tend to more heavily fund retirement plan accounts, which is typically the biggest driver of building net worth.”

Despite the lack of retirement planning, independent contractors were more likely than their peers to derive satisfaction from making money at a job they like (18%, compared with 12% of employees and 11% of self-employed physicians). They’re also far more likely to be in emergency medicine (22% of independent contractors, compared with 3% of self-employed and 5% of employees) or psychiatry (11% of independent contractors, compared with 5% of self-employed and 6% of employees).

Among the three categories of physicians, independent contractors were least likely to say that they would choose the same practice setting again. Across all three categories, fewer than 50% of respondents would do so: 34% of self-employed physicians, compared with 29% of employees and 28% of independent contractors.

Physicians who are considering leaving their own practice for a hospital setting should do so with caution and fully understand what they are getting into, said Mr. Scroggins. “If they’re just looking at compensation, they also should be looking very carefully at retirement plan benefits. If that’s their main method of saving and building net worth, then that’s a dramatic difference.”

And of course, there’s always the intangible value of feeling connected to a practice and its patients: “Physicians got into this line of work to treat patients and help people become healthier, and in hospitals they end up being more disconnected from their patients,” Mr. Scroggins said. “That’s a big factor as well.”

Editor’s note: Only differences that are statistically significant at a 95% confidence level between categories of employment have been included. Of the 13,893 responses included in this analysis, 3,860 physicians identified as self-employed, 9,262 as employees, and 772 as independent contractors.

A version of this article originally appeared on Medscape.com.

Self-employed physicians have the highest salaries, largest homes, and greatest wealth – yet they feel the least fairly compensated, according to an analysis of data from over 17,000 physicians.

A new examination of survey responses from the Medscape Physician Compensation Report 2020, which included information about income, job satisfaction, and more, compared responses from self-employed physicians, independent contractors, and employed physicians.

Income and wealth, benefits, and job satisfaction were compared. From the results of the questionnaire, self-employed physicians stand out among their peers across all categories: They enjoy greater income, wealth, and benefits and appear to be more satisfied by their choice of practice.

“The survey confirms that self-employed is the most satisfying, although the trend in health care is to take employed positions,” said Robert Scroggins, JD, CPA, certified health care business consultant with ScrogginsGreer, Cincinnati. “Doctors who become employees primarily do that to escape the management responsibilities for the practice. It seems to be more a decision to get away from something than to go toward something.”
 

The financial and work picture for self-employed physicians

Self-employed physicians reported the largest salaries for 2019 (average, $360,752), followed by independent contractors ($336,005). Employees reported the lowest average salary ($297,332).

The largest percentage of self-employed physicians (46%) work in an office-based group practice, followed by those in office-based solo practices (30%). Almost two-thirds of self-employed respondents are owners and 37% are partners.

Self-employed physicians are more likely to be older than 45 years; 79% fall into that age bracket, compared with 57% of employees and 70% of independent contractors.

Self-employed physicians reported the highest levels of wealth among their peers. About 44% of self-employed respondents declared a net wealth of over $2 million, compared with 25% of employees. Only 6% of contractors and employed physicians reported a net wealth of over $5 million, compared with 13% of self-employed physicians.

Self-employed physicians also managed their personal expenses slightly differently. They were more likely to pool their income with their spouse in a common account used for bills and expenses, regardless of how much they each earned (63% of self-employed respondents, compared with 58% of employees and 50% of independent contractors).

Perhaps unsurprisingly, self-employed physicians also reported having the largest homes, with an average square footage of 3,629 square feet, compared with 3,023 square feet for employees and 2,984 square feet for independent contractors. Self-employed physicians’ mortgages (average, $240,389) were similar to those of employed physicians’ mortgages but were higher than those of independent contractors’ mortgages (average, $213,740).

Self-employed physicians were also most likely to highly appraise their own performance: Half of all self-employed respondents felt “very satisfied” with their job performance, compared with 40% of employees and 44% of independent contractors.

When asked what they consider to be the most rewarding aspect of their job, self-employed physicians were more likely to choose gratitude and patient relationships than their peers (32%, compared with 26% of employees and 19% of independent contractors).

Despite their higher net wealth and larger salaries, self-employed physicians were least likely to feel fairly compensated; 49% of self-employed physicians said they did not feel fairly compensated for their work, compared with 40% of employees and 40% of independent contractors.

“Self-employed physicians may be better compensated than others of the same specialty who are employees, so some of that may be perception,” said Mr. Scroggins. “Or they feel they should be compensated to a far greater degree than those who are employed.”

Self-employed physicians were also more likely to respond that they would choose the same practice setting again, though across all three categories, fewer than 50% of respondents would do so: 34% of self-employed physicians, compared with 29% of employees and 28% of independent contractors.
 

The financial and work picture for employed physicians

About a third (32%) of employed physician respondents work in hospitals; 28% work in private practices.

Employed physicians were most likely to report a salary increase from 2018 to 2019: 74%, compared with 45% of self-employed and 52% of independent contractors.

As for declines in income, self-employed physicians and independent contractors suffered a comparable loss, with 13% and 12% of them, respectively, reporting salary cuts greater than 10%. Decreases of up to 10% were felt mostly by the self-employed, with 17% experiencing such cuts, compared with 7% of employees and 10% of independent contractors.

In contrast, employees were the least likely of the three categories to have incurred large financial losses over the past year: 77% of employed respondents indicated that they had not experienced any significant financial losses in the past year, compared with 63% of self-employed physicians and 63% of independent contractors. They were also least likely to have made any investments at all over the past year – 21% of employees reported having made none at all in 2019, compared to 11% of self-employed physicians and 16% of independent contractors.
 

The financial and work picture for independent contractors

Just over half (52%) of all independent contractors who responded to our questionnaire work in hospitals, 15% work in group practices, 9% work in outpatient clinics, and just 2% work in solo practices.

Independent contractors were less likely than their peers to have received employment benefits such as health insurance, malpractice coverage, and paid time off. They were also less likely to be saving for retirement. Almost half (45%) of independent contractors said they received no employment benefits at all, compared to 20% of self-employed physicians and just 8% of employees.

What’s more, 27% of independent contractors do not currently put money into a 401(k) retirement account or tax-deferred college savings account on a regular basis, compared with 16% of self-employed physicians and 8% of employees. Similarly, they were less likely to put money into a taxable savings account (39% responded that they do not, compared with 32% of self-employed physicians and 27% of employees).

“Net worth and retirement funding findings do line up with what I’ve observed,” said Mr. Scroggins. “Those who have independent practices as opposed to working for a hospital do tend to more heavily fund retirement plan accounts, which is typically the biggest driver of building net worth.”

Despite the lack of retirement planning, independent contractors were more likely than their peers to derive satisfaction from making money at a job they like (18%, compared with 12% of employees and 11% of self-employed physicians). They’re also far more likely to be in emergency medicine (22% of independent contractors, compared with 3% of self-employed and 5% of employees) or psychiatry (11% of independent contractors, compared with 5% of self-employed and 6% of employees).

Among the three categories of physicians, independent contractors were least likely to say that they would choose the same practice setting again. Across all three categories, fewer than 50% of respondents would do so: 34% of self-employed physicians, compared with 29% of employees and 28% of independent contractors.

Physicians who are considering leaving their own practice for a hospital setting should do so with caution and fully understand what they are getting into, said Mr. Scroggins. “If they’re just looking at compensation, they also should be looking very carefully at retirement plan benefits. If that’s their main method of saving and building net worth, then that’s a dramatic difference.”

And of course, there’s always the intangible value of feeling connected to a practice and its patients: “Physicians got into this line of work to treat patients and help people become healthier, and in hospitals they end up being more disconnected from their patients,” Mr. Scroggins said. “That’s a big factor as well.”

Editor’s note: Only differences that are statistically significant at a 95% confidence level between categories of employment have been included. Of the 13,893 responses included in this analysis, 3,860 physicians identified as self-employed, 9,262 as employees, and 772 as independent contractors.

A version of this article originally appeared on Medscape.com.

Voiding trials after female pelvic floor surgery may detect similar rates of voiding dysfunction regardless of whether voiding occurs spontaneously or after the bladder is retrograde-filled with saline, according to a randomized study.

Nevertheless, patients may prefer the more common retrograde-fill approach.

In the study of 109 patients, those who underwent retrograde fill reported significantly greater satisfaction with their method of voiding evaluation, compared with patients whose voiding trials occurred spontaneously. The increased satisfaction could relate to the fact that retrograde-fill trials take less time, study investigator Patrick Popiel, MD, of Yale University, New Haven, Conn., suggested at the virtual annual scientific meeting of the Society of Gynecologic Surgeons. The exact reasons are unclear, however.

Voiding trials help identify patients who cannot sufficiently empty their bladder after surgery. Prior research has indicated that the incidence of voiding dysfunction after pelvic floor surgery is about 25%-35%. “Patients with voiding dysfunction are generally managed with an indwelling Foley catheter or clean intermittent self-catheterization,” Dr. Popiel said. “Catheterization increases the risk of urinary tract infection, increases anxiety, and decreases patient satisfaction. A large proportion of patients who are discharged home with a Foley catheter state that the catheter was the worst aspect of their experience.”

Dr. Popiel and colleagues conducted a randomized, prospective study to examine the rate of failed voiding trials that necessitate discharge home with an indwelling Foley catheter using spontaneous and retrograde-fill approaches. The study included women who required a voiding trial after surgery for pelvic organ prolapse or urinary incontinence. Patients who required prolonged catheterization after surgery, such as those with a urinary tract infection, bowel injury, or large amount of blood loss, were excluded.

Researchers analyzed data from 55 patients who were randomly assigned to the retrograde-fill group and 54 patients who were randomly assigned to the spontaneous trial group.

In the spontaneous group, patients were required to void at least 150 mL at one time within 6 hours of catheter removal to successfully complete the voiding trial.

In the retrograde-fill group, the bladder was filled in the postanesthesia care unit with 300 mL of saline or until the maximum volume tolerated by the patient (not exceeding 300 mL ) was reached. Patients in this group had to void at least 150 mL or 50% of the instilled volume at one time within 60 minutes of catheter removal to pass the trial.

The researchers documented postvoid residual (PVR) but did not use this measure to determine voiding function.

The baseline demographics of the two groups were similar, although prior hysterectomy was more common in the retrograde-fill group than in the spontaneous group (32.7% vs. 14.8%). The average age was 58.5 years in the retrograde-fill group and 61 years in the spontaneous group.

“There was no significant difference in our primary outcome,” Dr. Popiel said. “There was a 12.7% rate of failed voiding trial in the retrograde group versus 7.7% in the spontaneous group.”

No patients had urinary retention after initially passing their voiding trial. Force of stream did not differ between groups, and about 15% in each group had a postoperative urinary tract infection.

The study demonstrates that voiding assessment based on a spontaneous minimum void of 150 mL is safe and has similar pass rates, compared with the more commonly performed retrograde void trial, Dr. Popiel said. “If the voided amount is at least 150 mL, PVR is not critical to obtain. The study adds to the body of literature that supports less stringent criteria for evaluating voiding function and can limit postoperative urinary recatheterization.”

The investigators allowed patients with PVRs as high as 575 mL to return home without an alternative way to empty the bladder, C. Sage Claydon, MD, a urogynecologist who was not involved in the study, noted during a discussion after the presentation. In all, 6 patients who met the passing criteria for the spontaneous voiding trial had a PVR greater than 200 mL, with volumes ranging from 205-575 mL.

The patients received standardized counseling about postoperative voiding problems, said Dr. Popiel. “This is similar to the work done by Ingber et al. from 2011, where patients who reached a certain force of stream, greater than 5 out of 10, were discharged home regardless of PVR.”

Dr. Popiel had no relevant disclosures. Two coinvestigators disclosed ties to BlossomMed, Renovia, and ArmadaHealth.

jremaly@mdedge.com

SOURCE: Popiel P et al. SGS 2020, Abstract 14.

Voiding trials after female pelvic floor surgery may detect similar rates of voiding dysfunction regardless of whether voiding occurs spontaneously or after the bladder is retrograde-filled with saline, according to a randomized study.

Nevertheless, patients may prefer the more common retrograde-fill approach.

In the study of 109 patients, those who underwent retrograde fill reported significantly greater satisfaction with their method of voiding evaluation, compared with patients whose voiding trials occurred spontaneously. The increased satisfaction could relate to the fact that retrograde-fill trials take less time, study investigator Patrick Popiel, MD, of Yale University, New Haven, Conn., suggested at the virtual annual scientific meeting of the Society of Gynecologic Surgeons. The exact reasons are unclear, however.

Voiding trials help identify patients who cannot sufficiently empty their bladder after surgery. Prior research has indicated that the incidence of voiding dysfunction after pelvic floor surgery is about 25%-35%. “Patients with voiding dysfunction are generally managed with an indwelling Foley catheter or clean intermittent self-catheterization,” Dr. Popiel said. “Catheterization increases the risk of urinary tract infection, increases anxiety, and decreases patient satisfaction. A large proportion of patients who are discharged home with a Foley catheter state that the catheter was the worst aspect of their experience.”

Dr. Popiel and colleagues conducted a randomized, prospective study to examine the rate of failed voiding trials that necessitate discharge home with an indwelling Foley catheter using spontaneous and retrograde-fill approaches. The study included women who required a voiding trial after surgery for pelvic organ prolapse or urinary incontinence. Patients who required prolonged catheterization after surgery, such as those with a urinary tract infection, bowel injury, or large amount of blood loss, were excluded.

Researchers analyzed data from 55 patients who were randomly assigned to the retrograde-fill group and 54 patients who were randomly assigned to the spontaneous trial group.

In the spontaneous group, patients were required to void at least 150 mL at one time within 6 hours of catheter removal to successfully complete the voiding trial.

In the retrograde-fill group, the bladder was filled in the postanesthesia care unit with 300 mL of saline or until the maximum volume tolerated by the patient (not exceeding 300 mL ) was reached. Patients in this group had to void at least 150 mL or 50% of the instilled volume at one time within 60 minutes of catheter removal to pass the trial.

The researchers documented postvoid residual (PVR) but did not use this measure to determine voiding function.

The baseline demographics of the two groups were similar, although prior hysterectomy was more common in the retrograde-fill group than in the spontaneous group (32.7% vs. 14.8%). The average age was 58.5 years in the retrograde-fill group and 61 years in the spontaneous group.

“There was no significant difference in our primary outcome,” Dr. Popiel said. “There was a 12.7% rate of failed voiding trial in the retrograde group versus 7.7% in the spontaneous group.”

No patients had urinary retention after initially passing their voiding trial. Force of stream did not differ between groups, and about 15% in each group had a postoperative urinary tract infection.

The study demonstrates that voiding assessment based on a spontaneous minimum void of 150 mL is safe and has similar pass rates, compared with the more commonly performed retrograde void trial, Dr. Popiel said. “If the voided amount is at least 150 mL, PVR is not critical to obtain. The study adds to the body of literature that supports less stringent criteria for evaluating voiding function and can limit postoperative urinary recatheterization.”

The investigators allowed patients with PVRs as high as 575 mL to return home without an alternative way to empty the bladder, C. Sage Claydon, MD, a urogynecologist who was not involved in the study, noted during a discussion after the presentation. In all, 6 patients who met the passing criteria for the spontaneous voiding trial had a PVR greater than 200 mL, with volumes ranging from 205-575 mL.

The patients received standardized counseling about postoperative voiding problems, said Dr. Popiel. “This is similar to the work done by Ingber et al. from 2011, where patients who reached a certain force of stream, greater than 5 out of 10, were discharged home regardless of PVR.”

Dr. Popiel had no relevant disclosures. Two coinvestigators disclosed ties to BlossomMed, Renovia, and ArmadaHealth.

jremaly@mdedge.com

SOURCE: Popiel P et al. SGS 2020, Abstract 14.

Voiding trials after female pelvic floor surgery may detect similar rates of voiding dysfunction regardless of whether voiding occurs spontaneously or after the bladder is retrograde-filled with saline, according to a randomized study.

Nevertheless, patients may prefer the more common retrograde-fill approach.

In the study of 109 patients, those who underwent retrograde fill reported significantly greater satisfaction with their method of voiding evaluation, compared with patients whose voiding trials occurred spontaneously. The increased satisfaction could relate to the fact that retrograde-fill trials take less time, study investigator Patrick Popiel, MD, of Yale University, New Haven, Conn., suggested at the virtual annual scientific meeting of the Society of Gynecologic Surgeons. The exact reasons are unclear, however.

Voiding trials help identify patients who cannot sufficiently empty their bladder after surgery. Prior research has indicated that the incidence of voiding dysfunction after pelvic floor surgery is about 25%-35%. “Patients with voiding dysfunction are generally managed with an indwelling Foley catheter or clean intermittent self-catheterization,” Dr. Popiel said. “Catheterization increases the risk of urinary tract infection, increases anxiety, and decreases patient satisfaction. A large proportion of patients who are discharged home with a Foley catheter state that the catheter was the worst aspect of their experience.”

Dr. Popiel and colleagues conducted a randomized, prospective study to examine the rate of failed voiding trials that necessitate discharge home with an indwelling Foley catheter using spontaneous and retrograde-fill approaches. The study included women who required a voiding trial after surgery for pelvic organ prolapse or urinary incontinence. Patients who required prolonged catheterization after surgery, such as those with a urinary tract infection, bowel injury, or large amount of blood loss, were excluded.

Researchers analyzed data from 55 patients who were randomly assigned to the retrograde-fill group and 54 patients who were randomly assigned to the spontaneous trial group.

In the spontaneous group, patients were required to void at least 150 mL at one time within 6 hours of catheter removal to successfully complete the voiding trial.

In the retrograde-fill group, the bladder was filled in the postanesthesia care unit with 300 mL of saline or until the maximum volume tolerated by the patient (not exceeding 300 mL ) was reached. Patients in this group had to void at least 150 mL or 50% of the instilled volume at one time within 60 minutes of catheter removal to pass the trial.

The researchers documented postvoid residual (PVR) but did not use this measure to determine voiding function.

The baseline demographics of the two groups were similar, although prior hysterectomy was more common in the retrograde-fill group than in the spontaneous group (32.7% vs. 14.8%). The average age was 58.5 years in the retrograde-fill group and 61 years in the spontaneous group.

“There was no significant difference in our primary outcome,” Dr. Popiel said. “There was a 12.7% rate of failed voiding trial in the retrograde group versus 7.7% in the spontaneous group.”

No patients had urinary retention after initially passing their voiding trial. Force of stream did not differ between groups, and about 15% in each group had a postoperative urinary tract infection.

The study demonstrates that voiding assessment based on a spontaneous minimum void of 150 mL is safe and has similar pass rates, compared with the more commonly performed retrograde void trial, Dr. Popiel said. “If the voided amount is at least 150 mL, PVR is not critical to obtain. The study adds to the body of literature that supports less stringent criteria for evaluating voiding function and can limit postoperative urinary recatheterization.”

The investigators allowed patients with PVRs as high as 575 mL to return home without an alternative way to empty the bladder, C. Sage Claydon, MD, a urogynecologist who was not involved in the study, noted during a discussion after the presentation. In all, 6 patients who met the passing criteria for the spontaneous voiding trial had a PVR greater than 200 mL, with volumes ranging from 205-575 mL.

The patients received standardized counseling about postoperative voiding problems, said Dr. Popiel. “This is similar to the work done by Ingber et al. from 2011, where patients who reached a certain force of stream, greater than 5 out of 10, were discharged home regardless of PVR.”

Dr. Popiel had no relevant disclosures. Two coinvestigators disclosed ties to BlossomMed, Renovia, and ArmadaHealth.

jremaly@mdedge.com

SOURCE: Popiel P et al. SGS 2020, Abstract 14.

An ultralow dose of direct oral anticoagulant (DOAC) may safely cut the risk for stroke in very elderly patients with atrial fibrillation (AFib) whose bleeding risk is considered too high for standard dosages, suggests a randomized trial conducted in Japan.

Many of the study’s 984 mostly octogenarian patients were objectively frail with poor renal function, low body weight, a history of serious bleeding, or other conditions that made them poor candidates for regular-dose oral anticoagulation. Yet those who took the factor Xa inhibitor edoxaban (Savaysa) at the off-label dosage of 15 mg once daily showed a two-thirds drop in risk for stroke or systemic embolism (P < .001), compared with patients who received placebo. There were no fatal bleeds and virtually no intracranial hemorrhages.

For such high-risk patients with nonvalvular AFib who otherwise would not be given an OAC, edoxaban 15 mg “can be an acceptable treatment option in decreasing the risk of devastating stroke”; however, “it may increase the risk of gastrointestinal bleeding, so care should be given in every patient,” said Ken Okumura, MD, PhD. Indeed, the rate of gastrointestinal bleeding tripled among the patients who received edoxaban, compared with those given placebo, at about 2.3% per year versus 0.8% per year.

Although their 87% increased risk for major bleeding did not reach significance, it hit close, with a P value of .09 in the trial, called Edoxaban Low-Dose for Elder Care Atrial Fibrillation Patients (ELDERCARE-AF).

Dr. Okumura, of Saiseikai Kumamoto (Japan) Hospital, presented the study August 30 during the virtual annual congress of the European Society of Cardiology. He is lead author of an article describing the study, which was simultaneously published in the New England Journal of Medicine.

Many patients with AFib suffer strokes if they are not given oral anticoagulation because of “fear of major bleeding caused by standard OAC therapy,” Dr. Okumura noted. Others are inappropriately administered antiplatelets or anticoagulants at conventional dosages. “There is no standard of practice in Japan for patients like those in the present trial,” Dr. Okumura said. “However, I believe the present study opens a new possible path of thromboprophylaxis in such high-risk patients.”

Even with its relatively few bleeding events, ELDERCARE-AF “does suggest that the risk of the worst types of bleeds is not that high,” said Daniel E. Singer, MD, of Massachusetts General Hospital, Boston. “Gastrointestinal bleeding is annoying, and it will probably stop people from taking their edoxaban, but for the most part it doesn’t kill people.”

Moreover, he added, the trial suggests that low-dose edoxaban, in exchange for a steep reduction in thromboembolic risk, “doesn’t add to your risk of intracranial hemorrhage!”

ELDERCARE-AF may give practitioners “yet another reason to rethink” whether a low-dose DOAC such as edoxaban 15 mg/day may well be a good approach for such patients with AFib who are not receiving standard-dose OAC because of a perceived high risk for serious bleeding, said Dr. Singer, who was not involved in the study.

The trial randomly and evenly assigned 984 patients with AF in Japan to take either edoxaban 15 mg/day or placebo. The patients, who were at least 80 years old and had a CHADS2 score of 2 or higher, were judged inappropriate candidates for OAC at dosages approved for stroke prevention.

The mean age of the patients was 86.6, more than a decade older than patients “in the previous landmark clinical trials of direct oral anticoagulants,” and were 5-10 years older than the general AFib population, reported Dr. Okumura and colleagues.

Their mean weight was 52 kg, and mean creatinine clearance was 36.3 mL/min; 41% were classified as frail according to validated assessment tools.

Of the 303 patients who did not complete the trial, 158 voluntarily withdrew for various reasons. The withdrawal rate was similar in the two treatment arms. Outcomes were analyzed by intention to treat, the report noted.

The annualized rate of stroke or systemic embolism, the primary efficacy endpoint, was 2.3% for those who received edoxaban and 6.7% for the control group. Corresponding rates for the primary safety endpoint, major bleeding as determined by International Society on Thrombosis and Hemostasis criteria, were 3.3% and 1.8%, respectively.

“The question is, can the Food and Drug Administration act on this information? I doubt it can. What will be needed is to reproduce the study in a U.S. population to see if it holds,” Dr. Singer proposed.

“Edoxaban isn’t used much in the U.S. This could heighten interest. And who knows, there may be a gold rush,” he said, if the strategy were to pan out for the other DOACs, rivaroxaban (Xarelto), apixaban (Eliquis), and dabigatran (Pradaxa).

ELDERCARE-AF was funded by Daiichi Sankyo, from which Dr. Okumura reported receiving grants and personal fees; he also disclosed personal fees from Daiichi Sankyo, Boehringer Ingelheim, Bristol-Myers Squibb, Medtronic, Johnson & Johnson, and Bayer.

A version of this article originally appeared on Medscape.com.

An ultralow dose of direct oral anticoagulant (DOAC) may safely cut the risk for stroke in very elderly patients with atrial fibrillation (AFib) whose bleeding risk is considered too high for standard dosages, suggests a randomized trial conducted in Japan.

Many of the study’s 984 mostly octogenarian patients were objectively frail with poor renal function, low body weight, a history of serious bleeding, or other conditions that made them poor candidates for regular-dose oral anticoagulation. Yet those who took the factor Xa inhibitor edoxaban (Savaysa) at the off-label dosage of 15 mg once daily showed a two-thirds drop in risk for stroke or systemic embolism (P < .001), compared with patients who received placebo. There were no fatal bleeds and virtually no intracranial hemorrhages.

For such high-risk patients with nonvalvular AFib who otherwise would not be given an OAC, edoxaban 15 mg “can be an acceptable treatment option in decreasing the risk of devastating stroke”; however, “it may increase the risk of gastrointestinal bleeding, so care should be given in every patient,” said Ken Okumura, MD, PhD. Indeed, the rate of gastrointestinal bleeding tripled among the patients who received edoxaban, compared with those given placebo, at about 2.3% per year versus 0.8% per year.

Although their 87% increased risk for major bleeding did not reach significance, it hit close, with a P value of .09 in the trial, called Edoxaban Low-Dose for Elder Care Atrial Fibrillation Patients (ELDERCARE-AF).

Dr. Okumura, of Saiseikai Kumamoto (Japan) Hospital, presented the study August 30 during the virtual annual congress of the European Society of Cardiology. He is lead author of an article describing the study, which was simultaneously published in the New England Journal of Medicine.

Many patients with AFib suffer strokes if they are not given oral anticoagulation because of “fear of major bleeding caused by standard OAC therapy,” Dr. Okumura noted. Others are inappropriately administered antiplatelets or anticoagulants at conventional dosages. “There is no standard of practice in Japan for patients like those in the present trial,” Dr. Okumura said. “However, I believe the present study opens a new possible path of thromboprophylaxis in such high-risk patients.”

Even with its relatively few bleeding events, ELDERCARE-AF “does suggest that the risk of the worst types of bleeds is not that high,” said Daniel E. Singer, MD, of Massachusetts General Hospital, Boston. “Gastrointestinal bleeding is annoying, and it will probably stop people from taking their edoxaban, but for the most part it doesn’t kill people.”

Moreover, he added, the trial suggests that low-dose edoxaban, in exchange for a steep reduction in thromboembolic risk, “doesn’t add to your risk of intracranial hemorrhage!”

ELDERCARE-AF may give practitioners “yet another reason to rethink” whether a low-dose DOAC such as edoxaban 15 mg/day may well be a good approach for such patients with AFib who are not receiving standard-dose OAC because of a perceived high risk for serious bleeding, said Dr. Singer, who was not involved in the study.

The trial randomly and evenly assigned 984 patients with AF in Japan to take either edoxaban 15 mg/day or placebo. The patients, who were at least 80 years old and had a CHADS2 score of 2 or higher, were judged inappropriate candidates for OAC at dosages approved for stroke prevention.

The mean age of the patients was 86.6, more than a decade older than patients “in the previous landmark clinical trials of direct oral anticoagulants,” and were 5-10 years older than the general AFib population, reported Dr. Okumura and colleagues.

Their mean weight was 52 kg, and mean creatinine clearance was 36.3 mL/min; 41% were classified as frail according to validated assessment tools.

Of the 303 patients who did not complete the trial, 158 voluntarily withdrew for various reasons. The withdrawal rate was similar in the two treatment arms. Outcomes were analyzed by intention to treat, the report noted.

The annualized rate of stroke or systemic embolism, the primary efficacy endpoint, was 2.3% for those who received edoxaban and 6.7% for the control group. Corresponding rates for the primary safety endpoint, major bleeding as determined by International Society on Thrombosis and Hemostasis criteria, were 3.3% and 1.8%, respectively.

“The question is, can the Food and Drug Administration act on this information? I doubt it can. What will be needed is to reproduce the study in a U.S. population to see if it holds,” Dr. Singer proposed.

“Edoxaban isn’t used much in the U.S. This could heighten interest. And who knows, there may be a gold rush,” he said, if the strategy were to pan out for the other DOACs, rivaroxaban (Xarelto), apixaban (Eliquis), and dabigatran (Pradaxa).

ELDERCARE-AF was funded by Daiichi Sankyo, from which Dr. Okumura reported receiving grants and personal fees; he also disclosed personal fees from Daiichi Sankyo, Boehringer Ingelheim, Bristol-Myers Squibb, Medtronic, Johnson & Johnson, and Bayer.

A version of this article originally appeared on Medscape.com.

An ultralow dose of direct oral anticoagulant (DOAC) may safely cut the risk for stroke in very elderly patients with atrial fibrillation (AFib) whose bleeding risk is considered too high for standard dosages, suggests a randomized trial conducted in Japan.

Many of the study’s 984 mostly octogenarian patients were objectively frail with poor renal function, low body weight, a history of serious bleeding, or other conditions that made them poor candidates for regular-dose oral anticoagulation. Yet those who took the factor Xa inhibitor edoxaban (Savaysa) at the off-label dosage of 15 mg once daily showed a two-thirds drop in risk for stroke or systemic embolism (P < .001), compared with patients who received placebo. There were no fatal bleeds and virtually no intracranial hemorrhages.

For such high-risk patients with nonvalvular AFib who otherwise would not be given an OAC, edoxaban 15 mg “can be an acceptable treatment option in decreasing the risk of devastating stroke”; however, “it may increase the risk of gastrointestinal bleeding, so care should be given in every patient,” said Ken Okumura, MD, PhD. Indeed, the rate of gastrointestinal bleeding tripled among the patients who received edoxaban, compared with those given placebo, at about 2.3% per year versus 0.8% per year.

Although their 87% increased risk for major bleeding did not reach significance, it hit close, with a P value of .09 in the trial, called Edoxaban Low-Dose for Elder Care Atrial Fibrillation Patients (ELDERCARE-AF).

Dr. Okumura, of Saiseikai Kumamoto (Japan) Hospital, presented the study August 30 during the virtual annual congress of the European Society of Cardiology. He is lead author of an article describing the study, which was simultaneously published in the New England Journal of Medicine.

Many patients with AFib suffer strokes if they are not given oral anticoagulation because of “fear of major bleeding caused by standard OAC therapy,” Dr. Okumura noted. Others are inappropriately administered antiplatelets or anticoagulants at conventional dosages. “There is no standard of practice in Japan for patients like those in the present trial,” Dr. Okumura said. “However, I believe the present study opens a new possible path of thromboprophylaxis in such high-risk patients.”

Even with its relatively few bleeding events, ELDERCARE-AF “does suggest that the risk of the worst types of bleeds is not that high,” said Daniel E. Singer, MD, of Massachusetts General Hospital, Boston. “Gastrointestinal bleeding is annoying, and it will probably stop people from taking their edoxaban, but for the most part it doesn’t kill people.”

Moreover, he added, the trial suggests that low-dose edoxaban, in exchange for a steep reduction in thromboembolic risk, “doesn’t add to your risk of intracranial hemorrhage!”

ELDERCARE-AF may give practitioners “yet another reason to rethink” whether a low-dose DOAC such as edoxaban 15 mg/day may well be a good approach for such patients with AFib who are not receiving standard-dose OAC because of a perceived high risk for serious bleeding, said Dr. Singer, who was not involved in the study.

The trial randomly and evenly assigned 984 patients with AF in Japan to take either edoxaban 15 mg/day or placebo. The patients, who were at least 80 years old and had a CHADS2 score of 2 or higher, were judged inappropriate candidates for OAC at dosages approved for stroke prevention.

The mean age of the patients was 86.6, more than a decade older than patients “in the previous landmark clinical trials of direct oral anticoagulants,” and were 5-10 years older than the general AFib population, reported Dr. Okumura and colleagues.

Their mean weight was 52 kg, and mean creatinine clearance was 36.3 mL/min; 41% were classified as frail according to validated assessment tools.

Of the 303 patients who did not complete the trial, 158 voluntarily withdrew for various reasons. The withdrawal rate was similar in the two treatment arms. Outcomes were analyzed by intention to treat, the report noted.

The annualized rate of stroke or systemic embolism, the primary efficacy endpoint, was 2.3% for those who received edoxaban and 6.7% for the control group. Corresponding rates for the primary safety endpoint, major bleeding as determined by International Society on Thrombosis and Hemostasis criteria, were 3.3% and 1.8%, respectively.

“The question is, can the Food and Drug Administration act on this information? I doubt it can. What will be needed is to reproduce the study in a U.S. population to see if it holds,” Dr. Singer proposed.

“Edoxaban isn’t used much in the U.S. This could heighten interest. And who knows, there may be a gold rush,” he said, if the strategy were to pan out for the other DOACs, rivaroxaban (Xarelto), apixaban (Eliquis), and dabigatran (Pradaxa).

ELDERCARE-AF was funded by Daiichi Sankyo, from which Dr. Okumura reported receiving grants and personal fees; he also disclosed personal fees from Daiichi Sankyo, Boehringer Ingelheim, Bristol-Myers Squibb, Medtronic, Johnson & Johnson, and Bayer.

A version of this article originally appeared on Medscape.com.