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Even if successful, IVF may boost relapses in MS
SEATTLE – Failed in-vitro fertilization (IVF) treatment appears to boost the risk of relapse in women with multiple sclerosis (MS). Does successful IVF have the same effect? The preliminary results of a new study suggests it does, a finding that may influence how physicians track patients during pregnancy.
“We found that IVF can still cause a relapse even if it is successful,” study lead author Maria Claudia Manieri, a graduate student at Harvard Medical School’s Partners MS Center, said in an interview at the annual meeting of the Consortium of Multiple Sclerosis Centers, where she presented the findings.
Multiple studies have linked infertility treatment in women with MS to relapses. In a 2013 review, researchers analyzed several papers, and “all of them reported an increase in annualized relapse rate after ART [assisted reproductive treatment]. Furthermore, in a recent study, clinical worsening was associated with an increase in MRI activity” (Clin Immunol. 2013 Nov;149(2):219-24).
For the new report, based on statistics from the New England Multiple Sclerosis Pregnancy Prospective Cohort Study, Ms. Manieri and colleagues collected data on 91 women (mean age = 33). Eleven were unsuccessful in conceiving, and 80 successfully conceived.
Three of the 91 women (3%) used intrauterine insemination as a fertility treatment. Another 9 (10%) relied on ART; all used IVF except for 1 who underwent intracytoplasmic sperm injection.
The new report is a preliminary analysis of early data, Ms. Manieri said. The study has recruited about one-sixth of its participants, she said, and will track women beyond pregnancy to explore long-term outcomes in their children.
Eleven women relapsed during pregnancy, including 9 who were using fertility treatment (P = .003). Of those 9, 7 women (78%) used ART.
No other factor other than fertility treatment predicted intrapartum relapses. The relapses during pregnancy started at 21 weeks (± 12 weeks) of gestational age and lasted for 4 weeks (± 2 weeks).
Of those who successfully conceived, 4 of 5 (80%) who used fertility treatment relapsed, compared with 7 of 64 (11%) who didn’t use fertility treatment. Of women who did not successfully conceive, 2 of 3 (67%) relapsed among those who used fertility treatment vs. 1 of 7 (14%) of those who didn’t.
It’s not clear how infertility treatment may be boosting MS relapse in women, but the 2013 review offered these possibilities: “temporary interruption of disease modified therapies, stressful events associated with infertility, and immunological changes induced by hormones such as increase in pro-inflammatory cytokines and anti-MOG antibodies, as well as an increase in immune cell migration across the blood-brain-barrier.”
MS tends to improve during pregnancy, and it’s common for neurologists to not see patients for extended periods, Ms. Manieri said. In light of the findings, she said, it may be wise for neurologists to continue follow-up appointments during pregnancy. “Avoid delaying care and keep monitoring the patient,” she advised.
The study was funded by Sanofi Genzyme and a gift from Michelle and Christopher Rondeau. The study authors report no relevant disclosures.
SEATTLE – Failed in-vitro fertilization (IVF) treatment appears to boost the risk of relapse in women with multiple sclerosis (MS). Does successful IVF have the same effect? The preliminary results of a new study suggests it does, a finding that may influence how physicians track patients during pregnancy.
“We found that IVF can still cause a relapse even if it is successful,” study lead author Maria Claudia Manieri, a graduate student at Harvard Medical School’s Partners MS Center, said in an interview at the annual meeting of the Consortium of Multiple Sclerosis Centers, where she presented the findings.
Multiple studies have linked infertility treatment in women with MS to relapses. In a 2013 review, researchers analyzed several papers, and “all of them reported an increase in annualized relapse rate after ART [assisted reproductive treatment]. Furthermore, in a recent study, clinical worsening was associated with an increase in MRI activity” (Clin Immunol. 2013 Nov;149(2):219-24).
For the new report, based on statistics from the New England Multiple Sclerosis Pregnancy Prospective Cohort Study, Ms. Manieri and colleagues collected data on 91 women (mean age = 33). Eleven were unsuccessful in conceiving, and 80 successfully conceived.
Three of the 91 women (3%) used intrauterine insemination as a fertility treatment. Another 9 (10%) relied on ART; all used IVF except for 1 who underwent intracytoplasmic sperm injection.
The new report is a preliminary analysis of early data, Ms. Manieri said. The study has recruited about one-sixth of its participants, she said, and will track women beyond pregnancy to explore long-term outcomes in their children.
Eleven women relapsed during pregnancy, including 9 who were using fertility treatment (P = .003). Of those 9, 7 women (78%) used ART.
No other factor other than fertility treatment predicted intrapartum relapses. The relapses during pregnancy started at 21 weeks (± 12 weeks) of gestational age and lasted for 4 weeks (± 2 weeks).
Of those who successfully conceived, 4 of 5 (80%) who used fertility treatment relapsed, compared with 7 of 64 (11%) who didn’t use fertility treatment. Of women who did not successfully conceive, 2 of 3 (67%) relapsed among those who used fertility treatment vs. 1 of 7 (14%) of those who didn’t.
It’s not clear how infertility treatment may be boosting MS relapse in women, but the 2013 review offered these possibilities: “temporary interruption of disease modified therapies, stressful events associated with infertility, and immunological changes induced by hormones such as increase in pro-inflammatory cytokines and anti-MOG antibodies, as well as an increase in immune cell migration across the blood-brain-barrier.”
MS tends to improve during pregnancy, and it’s common for neurologists to not see patients for extended periods, Ms. Manieri said. In light of the findings, she said, it may be wise for neurologists to continue follow-up appointments during pregnancy. “Avoid delaying care and keep monitoring the patient,” she advised.
The study was funded by Sanofi Genzyme and a gift from Michelle and Christopher Rondeau. The study authors report no relevant disclosures.
SEATTLE – Failed in-vitro fertilization (IVF) treatment appears to boost the risk of relapse in women with multiple sclerosis (MS). Does successful IVF have the same effect? The preliminary results of a new study suggests it does, a finding that may influence how physicians track patients during pregnancy.
“We found that IVF can still cause a relapse even if it is successful,” study lead author Maria Claudia Manieri, a graduate student at Harvard Medical School’s Partners MS Center, said in an interview at the annual meeting of the Consortium of Multiple Sclerosis Centers, where she presented the findings.
Multiple studies have linked infertility treatment in women with MS to relapses. In a 2013 review, researchers analyzed several papers, and “all of them reported an increase in annualized relapse rate after ART [assisted reproductive treatment]. Furthermore, in a recent study, clinical worsening was associated with an increase in MRI activity” (Clin Immunol. 2013 Nov;149(2):219-24).
For the new report, based on statistics from the New England Multiple Sclerosis Pregnancy Prospective Cohort Study, Ms. Manieri and colleagues collected data on 91 women (mean age = 33). Eleven were unsuccessful in conceiving, and 80 successfully conceived.
Three of the 91 women (3%) used intrauterine insemination as a fertility treatment. Another 9 (10%) relied on ART; all used IVF except for 1 who underwent intracytoplasmic sperm injection.
The new report is a preliminary analysis of early data, Ms. Manieri said. The study has recruited about one-sixth of its participants, she said, and will track women beyond pregnancy to explore long-term outcomes in their children.
Eleven women relapsed during pregnancy, including 9 who were using fertility treatment (P = .003). Of those 9, 7 women (78%) used ART.
No other factor other than fertility treatment predicted intrapartum relapses. The relapses during pregnancy started at 21 weeks (± 12 weeks) of gestational age and lasted for 4 weeks (± 2 weeks).
Of those who successfully conceived, 4 of 5 (80%) who used fertility treatment relapsed, compared with 7 of 64 (11%) who didn’t use fertility treatment. Of women who did not successfully conceive, 2 of 3 (67%) relapsed among those who used fertility treatment vs. 1 of 7 (14%) of those who didn’t.
It’s not clear how infertility treatment may be boosting MS relapse in women, but the 2013 review offered these possibilities: “temporary interruption of disease modified therapies, stressful events associated with infertility, and immunological changes induced by hormones such as increase in pro-inflammatory cytokines and anti-MOG antibodies, as well as an increase in immune cell migration across the blood-brain-barrier.”
MS tends to improve during pregnancy, and it’s common for neurologists to not see patients for extended periods, Ms. Manieri said. In light of the findings, she said, it may be wise for neurologists to continue follow-up appointments during pregnancy. “Avoid delaying care and keep monitoring the patient,” she advised.
The study was funded by Sanofi Genzyme and a gift from Michelle and Christopher Rondeau. The study authors report no relevant disclosures.
REPORTING FROM CMSC 2019
MS patients pay big price for breaks from DMT
SEATTLE – Patients with multiple sclerosis (MS) who stopped taking their disease-modifying therapy (DMT) for more than 60 days had significantly higher rates of relapse, hospitalization, emergency department visits and outpatient visits, a new study finds. Their nonmedication health care costs were higher, too.
“This information will help to inform patients about downstream economic risks of being off therapy. This may also help to inform payers of the importance of making DMTs easily and quickly available to patients with MS to prevent greater costs of health care resource utilization down the road,” study lead author Jacqueline A. Nicholas, MD, MPH, a clinical neuroimmunologist at OhioHealth Multiple Sclerosis Center, said in an interview. She spoke prior to the presentation of the findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
Dr. Nicholas and her colleagues launched their study to better understand the economic and medical impacts of lapses in oral DMT.
The researchers used a claims database to track 8,779 patients with MS during 2011-2015 who had at least one claim for an oral DMT drug. The subjects were aged 18-63; 15% had a drug lapse of more than 60 days. After propensity matching, the subjects in both groups – 60-day lapse or not – had a mean age of 44 years.
An analysis found that “lapses in oral DMT use led to increased relapses, increased health care utilization, and higher costs incurred by individuals with MS,” Dr. Nicholas said.
Over an 18-month follow-up period, those with drug lapses of more than 60 days had 28% more relapses than did the other subjects (mean 1.2 vs. 0.8; P less than .0001).
Those with lapses greater than 60 days also had 40% more hospitalizations (0.2 vs. 0.1; P = .0003), 25% more emergency department visits (0.6 vs. 0.5; P = .0098), and 22% more outpatient visits (6.2 vs. 4.8; P less than .0001).
Nonmedication costs were 25% higher among patients with a greater than 60-day lapse ($16,012 vs. $12,092; P = .0006).
Moving forward, the researchers wrote, “more research is needed to better understand the reasons for lapses in therapy and the impact of lapse timing and lapse duration on outcomes in patients with MS receiving once- or twice-daily oral [disease-modifying drugs].”
The researchers noted that they don’t have information about the reasons why patients lapsed. They added that the information comes mainly from commercial insurers.
EMD Serono, a division of Merck KGaA, provided funding for the study. Dr. Nicholas disclosed grant support from EMD Serono, and two other study authors are employees of the company. Another two authors worked for a consulting firm that received funding from EMD Serono to conduct the study.
SEATTLE – Patients with multiple sclerosis (MS) who stopped taking their disease-modifying therapy (DMT) for more than 60 days had significantly higher rates of relapse, hospitalization, emergency department visits and outpatient visits, a new study finds. Their nonmedication health care costs were higher, too.
“This information will help to inform patients about downstream economic risks of being off therapy. This may also help to inform payers of the importance of making DMTs easily and quickly available to patients with MS to prevent greater costs of health care resource utilization down the road,” study lead author Jacqueline A. Nicholas, MD, MPH, a clinical neuroimmunologist at OhioHealth Multiple Sclerosis Center, said in an interview. She spoke prior to the presentation of the findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
Dr. Nicholas and her colleagues launched their study to better understand the economic and medical impacts of lapses in oral DMT.
The researchers used a claims database to track 8,779 patients with MS during 2011-2015 who had at least one claim for an oral DMT drug. The subjects were aged 18-63; 15% had a drug lapse of more than 60 days. After propensity matching, the subjects in both groups – 60-day lapse or not – had a mean age of 44 years.
An analysis found that “lapses in oral DMT use led to increased relapses, increased health care utilization, and higher costs incurred by individuals with MS,” Dr. Nicholas said.
Over an 18-month follow-up period, those with drug lapses of more than 60 days had 28% more relapses than did the other subjects (mean 1.2 vs. 0.8; P less than .0001).
Those with lapses greater than 60 days also had 40% more hospitalizations (0.2 vs. 0.1; P = .0003), 25% more emergency department visits (0.6 vs. 0.5; P = .0098), and 22% more outpatient visits (6.2 vs. 4.8; P less than .0001).
Nonmedication costs were 25% higher among patients with a greater than 60-day lapse ($16,012 vs. $12,092; P = .0006).
Moving forward, the researchers wrote, “more research is needed to better understand the reasons for lapses in therapy and the impact of lapse timing and lapse duration on outcomes in patients with MS receiving once- or twice-daily oral [disease-modifying drugs].”
The researchers noted that they don’t have information about the reasons why patients lapsed. They added that the information comes mainly from commercial insurers.
EMD Serono, a division of Merck KGaA, provided funding for the study. Dr. Nicholas disclosed grant support from EMD Serono, and two other study authors are employees of the company. Another two authors worked for a consulting firm that received funding from EMD Serono to conduct the study.
SEATTLE – Patients with multiple sclerosis (MS) who stopped taking their disease-modifying therapy (DMT) for more than 60 days had significantly higher rates of relapse, hospitalization, emergency department visits and outpatient visits, a new study finds. Their nonmedication health care costs were higher, too.
“This information will help to inform patients about downstream economic risks of being off therapy. This may also help to inform payers of the importance of making DMTs easily and quickly available to patients with MS to prevent greater costs of health care resource utilization down the road,” study lead author Jacqueline A. Nicholas, MD, MPH, a clinical neuroimmunologist at OhioHealth Multiple Sclerosis Center, said in an interview. She spoke prior to the presentation of the findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
Dr. Nicholas and her colleagues launched their study to better understand the economic and medical impacts of lapses in oral DMT.
The researchers used a claims database to track 8,779 patients with MS during 2011-2015 who had at least one claim for an oral DMT drug. The subjects were aged 18-63; 15% had a drug lapse of more than 60 days. After propensity matching, the subjects in both groups – 60-day lapse or not – had a mean age of 44 years.
An analysis found that “lapses in oral DMT use led to increased relapses, increased health care utilization, and higher costs incurred by individuals with MS,” Dr. Nicholas said.
Over an 18-month follow-up period, those with drug lapses of more than 60 days had 28% more relapses than did the other subjects (mean 1.2 vs. 0.8; P less than .0001).
Those with lapses greater than 60 days also had 40% more hospitalizations (0.2 vs. 0.1; P = .0003), 25% more emergency department visits (0.6 vs. 0.5; P = .0098), and 22% more outpatient visits (6.2 vs. 4.8; P less than .0001).
Nonmedication costs were 25% higher among patients with a greater than 60-day lapse ($16,012 vs. $12,092; P = .0006).
Moving forward, the researchers wrote, “more research is needed to better understand the reasons for lapses in therapy and the impact of lapse timing and lapse duration on outcomes in patients with MS receiving once- or twice-daily oral [disease-modifying drugs].”
The researchers noted that they don’t have information about the reasons why patients lapsed. They added that the information comes mainly from commercial insurers.
EMD Serono, a division of Merck KGaA, provided funding for the study. Dr. Nicholas disclosed grant support from EMD Serono, and two other study authors are employees of the company. Another two authors worked for a consulting firm that received funding from EMD Serono to conduct the study.
REPORTING FROM CMSC 2019
Evidence lacking in treatments for pain in MS
SEATTLE – When it comes to pain in patients with multiple sclerosis, two pain specialists offered this advice: Mind the gap. While pain is a major burden in MS, there’s a huge hole in research about the best treatments. That means medical professionals and patients can only rely on a few signposts for navigation.
But the medical literature does offer glimmers of insight into drug treatments, said Brett R. Stacey, MD, and Pamela Stitzlein Davies, MS, ARNP, FAANP, both of the University of Washington, Seattle, in presentations at the annual meeting of the Consortium of Multiple Sclerosis Centers.
An estimated 44%-66% of patients with MS report pain. Their experiences are similar to those of other patients with pain, Dr. Stacey said, although there are some exceptions. Trigeminal neuralgia is not uncommon in patients with MS, and level of pain fluctuates markedly in MS patients.
“There are no [Food and Drug Administration]–approved drugs specifically for painful MS. There are few clinical trials and no first-line evidence about first-choice medicine,” Dr. Stacey said. As a result, he said, all drug options are off-label.
Based on his experience, the best first-line options for pain in MS appear to be the antidepressants duloxetine (Cymbalta), venlafaxine (Effexor), nortriptyline (Pamelor), desipramine (Norpramin), and amitriptyline, as well as the nerve pain drugs pregabalin (Lyrica) and gabapentin.
In regard to antidepressants, “most patients you give these medications to are not going to have a meaningful response. None of them are typically a home run” for pain in MS, Dr. Stacey said.
Duloxetine, he added, is expensive even as a generic, and nausea is possible within the first few days. It’s time to try something else if nausea sticks around for 5 days, he said.
However, there is a special benefit for duloxetine, he said: “For lower back pain, nothing is better. But that doesn’t mean the evidence is fantastic.”
Gabapentin, he said, “is relatively benign in terms of serious adverse effects,” although significant weight gain is possible. “It does not work for pain that doesn’t have a sensitization element. A lot of people throw gabapentin at things for which it will never work.”
Pregabalin, on the other hand, “can be potentially effective when other things like gabapentin and tricyclics have failed,” he said.
Second-line treatments include the lidocaine patch, tramadol, and the capsaicin 8% patch (Qutenza). And third-line treatments include botulinum toxin A and opioids.
Ms. Davies, who focused her presentation on opioids and pain in MS, agreed about the appropriate role of opioids. “They should be considered third-line, fourth-line, fifth-line, further down,” she said. “There’s a limited role for them in pain related to MS,” she said, specifically in regard to neuropathic pain.
There’s very little research into opioids in MS, she added, and their role is limited by side effects and the possibility of overdose.
Another option is low-dose naltrexone (Revia, Vivitrol), a drug used to treat alcohol and drug dependence. “Here in our clinic, patient after patient asks about naltrexone for everything,” Dr. Stacey said.
The treatment requires the use of a compounding pharmacy, he said, and evidence in MS consists of small studies with mixed results.
Dr. Stacey also addressed trigeminal neuralgia, which affects an estimated 5%-10% of patients with MS. For this condition, he said, “everything works less well in MS patients than non-MS patients.” Drug treatments include the seizure/nerve pain medication carbamazepine (Equetro, Carbatrol, Tegretol) and the seizure medication oxcarbazepine (Oxtellar, Trileptal), he said. Surgery is also an option.
SEATTLE – When it comes to pain in patients with multiple sclerosis, two pain specialists offered this advice: Mind the gap. While pain is a major burden in MS, there’s a huge hole in research about the best treatments. That means medical professionals and patients can only rely on a few signposts for navigation.
But the medical literature does offer glimmers of insight into drug treatments, said Brett R. Stacey, MD, and Pamela Stitzlein Davies, MS, ARNP, FAANP, both of the University of Washington, Seattle, in presentations at the annual meeting of the Consortium of Multiple Sclerosis Centers.
An estimated 44%-66% of patients with MS report pain. Their experiences are similar to those of other patients with pain, Dr. Stacey said, although there are some exceptions. Trigeminal neuralgia is not uncommon in patients with MS, and level of pain fluctuates markedly in MS patients.
“There are no [Food and Drug Administration]–approved drugs specifically for painful MS. There are few clinical trials and no first-line evidence about first-choice medicine,” Dr. Stacey said. As a result, he said, all drug options are off-label.
Based on his experience, the best first-line options for pain in MS appear to be the antidepressants duloxetine (Cymbalta), venlafaxine (Effexor), nortriptyline (Pamelor), desipramine (Norpramin), and amitriptyline, as well as the nerve pain drugs pregabalin (Lyrica) and gabapentin.
In regard to antidepressants, “most patients you give these medications to are not going to have a meaningful response. None of them are typically a home run” for pain in MS, Dr. Stacey said.
Duloxetine, he added, is expensive even as a generic, and nausea is possible within the first few days. It’s time to try something else if nausea sticks around for 5 days, he said.
However, there is a special benefit for duloxetine, he said: “For lower back pain, nothing is better. But that doesn’t mean the evidence is fantastic.”
Gabapentin, he said, “is relatively benign in terms of serious adverse effects,” although significant weight gain is possible. “It does not work for pain that doesn’t have a sensitization element. A lot of people throw gabapentin at things for which it will never work.”
Pregabalin, on the other hand, “can be potentially effective when other things like gabapentin and tricyclics have failed,” he said.
Second-line treatments include the lidocaine patch, tramadol, and the capsaicin 8% patch (Qutenza). And third-line treatments include botulinum toxin A and opioids.
Ms. Davies, who focused her presentation on opioids and pain in MS, agreed about the appropriate role of opioids. “They should be considered third-line, fourth-line, fifth-line, further down,” she said. “There’s a limited role for them in pain related to MS,” she said, specifically in regard to neuropathic pain.
There’s very little research into opioids in MS, she added, and their role is limited by side effects and the possibility of overdose.
Another option is low-dose naltrexone (Revia, Vivitrol), a drug used to treat alcohol and drug dependence. “Here in our clinic, patient after patient asks about naltrexone for everything,” Dr. Stacey said.
The treatment requires the use of a compounding pharmacy, he said, and evidence in MS consists of small studies with mixed results.
Dr. Stacey also addressed trigeminal neuralgia, which affects an estimated 5%-10% of patients with MS. For this condition, he said, “everything works less well in MS patients than non-MS patients.” Drug treatments include the seizure/nerve pain medication carbamazepine (Equetro, Carbatrol, Tegretol) and the seizure medication oxcarbazepine (Oxtellar, Trileptal), he said. Surgery is also an option.
SEATTLE – When it comes to pain in patients with multiple sclerosis, two pain specialists offered this advice: Mind the gap. While pain is a major burden in MS, there’s a huge hole in research about the best treatments. That means medical professionals and patients can only rely on a few signposts for navigation.
But the medical literature does offer glimmers of insight into drug treatments, said Brett R. Stacey, MD, and Pamela Stitzlein Davies, MS, ARNP, FAANP, both of the University of Washington, Seattle, in presentations at the annual meeting of the Consortium of Multiple Sclerosis Centers.
An estimated 44%-66% of patients with MS report pain. Their experiences are similar to those of other patients with pain, Dr. Stacey said, although there are some exceptions. Trigeminal neuralgia is not uncommon in patients with MS, and level of pain fluctuates markedly in MS patients.
“There are no [Food and Drug Administration]–approved drugs specifically for painful MS. There are few clinical trials and no first-line evidence about first-choice medicine,” Dr. Stacey said. As a result, he said, all drug options are off-label.
Based on his experience, the best first-line options for pain in MS appear to be the antidepressants duloxetine (Cymbalta), venlafaxine (Effexor), nortriptyline (Pamelor), desipramine (Norpramin), and amitriptyline, as well as the nerve pain drugs pregabalin (Lyrica) and gabapentin.
In regard to antidepressants, “most patients you give these medications to are not going to have a meaningful response. None of them are typically a home run” for pain in MS, Dr. Stacey said.
Duloxetine, he added, is expensive even as a generic, and nausea is possible within the first few days. It’s time to try something else if nausea sticks around for 5 days, he said.
However, there is a special benefit for duloxetine, he said: “For lower back pain, nothing is better. But that doesn’t mean the evidence is fantastic.”
Gabapentin, he said, “is relatively benign in terms of serious adverse effects,” although significant weight gain is possible. “It does not work for pain that doesn’t have a sensitization element. A lot of people throw gabapentin at things for which it will never work.”
Pregabalin, on the other hand, “can be potentially effective when other things like gabapentin and tricyclics have failed,” he said.
Second-line treatments include the lidocaine patch, tramadol, and the capsaicin 8% patch (Qutenza). And third-line treatments include botulinum toxin A and opioids.
Ms. Davies, who focused her presentation on opioids and pain in MS, agreed about the appropriate role of opioids. “They should be considered third-line, fourth-line, fifth-line, further down,” she said. “There’s a limited role for them in pain related to MS,” she said, specifically in regard to neuropathic pain.
There’s very little research into opioids in MS, she added, and their role is limited by side effects and the possibility of overdose.
Another option is low-dose naltrexone (Revia, Vivitrol), a drug used to treat alcohol and drug dependence. “Here in our clinic, patient after patient asks about naltrexone for everything,” Dr. Stacey said.
The treatment requires the use of a compounding pharmacy, he said, and evidence in MS consists of small studies with mixed results.
Dr. Stacey also addressed trigeminal neuralgia, which affects an estimated 5%-10% of patients with MS. For this condition, he said, “everything works less well in MS patients than non-MS patients.” Drug treatments include the seizure/nerve pain medication carbamazepine (Equetro, Carbatrol, Tegretol) and the seizure medication oxcarbazepine (Oxtellar, Trileptal), he said. Surgery is also an option.
EXPERT ANALYSIS FROM CMSC 2019
Mental illness in MS: ‘Follow the why’
SEATTLE – , a neuropsychiatrist cautioned colleagues who treat MS.
For example, depression may strike a patient as a primary condition, just as it could in anyone. But it may also be a manifestation of MS itself, or a side effect of an MS medication, or spurred by the fatigue and pain caused by MS, said Laura T. Safar, MD, a psychiatrist affiliated with Brigham and Women's Hospital, Boston*. As a result, popular psychiatric treatments such as SSRIs might not necessarily be the best approach, said Dr. Safar, who spoke in an interview and during a presentation at the annual meeting of the Consortium of Multiple Sclerosis Centers.
“You need to follow the why,” she said in the interview, adding that it is crucial to view neurologic and mental health as one and the same in MS. “More integration,” she said, “continues to be the way to go.”
Here are some pearls and tips from Dr. Safar’s presentation on treating psychiatric conditions in patients with MS:
Mental illness incidence
Depression is estimated to affect 25%-45% of people with MS over their lifetimes, while bipolar disorder is thought to affect 6% of patients and a quarter are estimated to have anxiety.
Researchers also believe as many as 10% of patients are affected by pathological laughing and crying during their lives.
Psychiatric side effects
Interferon drugs are notoriously linked to depression and psychosis. Glatiramer acetate (Copaxone) and natalizumab (Tysabri) are also thought to cause psychiatric side effects in some cases – anxiety and depression, respectively. But drug-modifying therapies can also provide relief on the psychiatric front, Dr. Safar said.
Meanwhile, dozens of other drugs used to treat aspects of MS such as spasticity, pain, and fatigue have possible psychiatric side effects.
Alternatives to SSRIs
SSRIs are often a first option in psychiatric patients, but those with MS may need another option because so many – an estimated 80% – also have fatigue, Dr. Safar said.
Alternatives for patients with MS include serotonin and norepinephrine reuptake inhibitors (SNRIs), which may have an advantage over SSRIs, she said. Specifically, SNRIs and bupropion (Wellbutrin) may be better for patients with fatigue and cognitive problems, she said, while vortioxetine (Trintellix) may benefit cognition.
Treating anxiety
There are no data regarding the best drug treatment for anxiety in patients with MS, she said, and SSRIs are typically the starting point. Consider SNRIs and duloxetine, respectively, when patients also have significant fatigue and cognitive symptoms. Use benzodiazepines only in occasional cases (such as anxiety regarding an MRI) and severe cases, she said.
MS-specific side effects
Beware of MS-specific side effects, Dr. Safar said. Some common psychiatric drugs, especially citalopram (Celexa) and escitalopram (Lexapro), may increase the QTc interval and shouldn’t be used in combination with the MS drug fingolimod (Gilenya).
And, she said, bupropion is “a very helpful agent” but poses a rare risk of seizures. Dr. Safar said she has seen this side effect a couple times over 10 years, but both were in patients with “other factors involved.” Still, “it’s something to keep in mind.”
Also understand that serotonergic agents can worsen restless legs syndrome, which is more common in patients with MS. Dr. Safar advises monitoring for the condition.
Pathological laughing, crying
Episodes of so-called pathological laughing, crying, or both tend to be brief, frequent, and intense. They may be sparked by nothing at all, and more often feature crying.
Certain SSRIs have proved helpful for the condition in MS, Dr. Safar said. Research also supports a combination of dextromethorphan (cough suppressant) and quinidine (a drug used to treat arrhythmias and malaria). The combination is sold together as Nuedexta.
Other agents such as venlafaxine (Effexor) and duloxetine (Cymbalta) have very limited data and shouldn’t be first-line treatment, she said.
Dr. Safar reports no relevant disclosures.
Correction, 5/31/19: An earlier version of this article misstated Dr. Safar's hospital affiliation.
SEATTLE – , a neuropsychiatrist cautioned colleagues who treat MS.
For example, depression may strike a patient as a primary condition, just as it could in anyone. But it may also be a manifestation of MS itself, or a side effect of an MS medication, or spurred by the fatigue and pain caused by MS, said Laura T. Safar, MD, a psychiatrist affiliated with Brigham and Women's Hospital, Boston*. As a result, popular psychiatric treatments such as SSRIs might not necessarily be the best approach, said Dr. Safar, who spoke in an interview and during a presentation at the annual meeting of the Consortium of Multiple Sclerosis Centers.
“You need to follow the why,” she said in the interview, adding that it is crucial to view neurologic and mental health as one and the same in MS. “More integration,” she said, “continues to be the way to go.”
Here are some pearls and tips from Dr. Safar’s presentation on treating psychiatric conditions in patients with MS:
Mental illness incidence
Depression is estimated to affect 25%-45% of people with MS over their lifetimes, while bipolar disorder is thought to affect 6% of patients and a quarter are estimated to have anxiety.
Researchers also believe as many as 10% of patients are affected by pathological laughing and crying during their lives.
Psychiatric side effects
Interferon drugs are notoriously linked to depression and psychosis. Glatiramer acetate (Copaxone) and natalizumab (Tysabri) are also thought to cause psychiatric side effects in some cases – anxiety and depression, respectively. But drug-modifying therapies can also provide relief on the psychiatric front, Dr. Safar said.
Meanwhile, dozens of other drugs used to treat aspects of MS such as spasticity, pain, and fatigue have possible psychiatric side effects.
Alternatives to SSRIs
SSRIs are often a first option in psychiatric patients, but those with MS may need another option because so many – an estimated 80% – also have fatigue, Dr. Safar said.
Alternatives for patients with MS include serotonin and norepinephrine reuptake inhibitors (SNRIs), which may have an advantage over SSRIs, she said. Specifically, SNRIs and bupropion (Wellbutrin) may be better for patients with fatigue and cognitive problems, she said, while vortioxetine (Trintellix) may benefit cognition.
Treating anxiety
There are no data regarding the best drug treatment for anxiety in patients with MS, she said, and SSRIs are typically the starting point. Consider SNRIs and duloxetine, respectively, when patients also have significant fatigue and cognitive symptoms. Use benzodiazepines only in occasional cases (such as anxiety regarding an MRI) and severe cases, she said.
MS-specific side effects
Beware of MS-specific side effects, Dr. Safar said. Some common psychiatric drugs, especially citalopram (Celexa) and escitalopram (Lexapro), may increase the QTc interval and shouldn’t be used in combination with the MS drug fingolimod (Gilenya).
And, she said, bupropion is “a very helpful agent” but poses a rare risk of seizures. Dr. Safar said she has seen this side effect a couple times over 10 years, but both were in patients with “other factors involved.” Still, “it’s something to keep in mind.”
Also understand that serotonergic agents can worsen restless legs syndrome, which is more common in patients with MS. Dr. Safar advises monitoring for the condition.
Pathological laughing, crying
Episodes of so-called pathological laughing, crying, or both tend to be brief, frequent, and intense. They may be sparked by nothing at all, and more often feature crying.
Certain SSRIs have proved helpful for the condition in MS, Dr. Safar said. Research also supports a combination of dextromethorphan (cough suppressant) and quinidine (a drug used to treat arrhythmias and malaria). The combination is sold together as Nuedexta.
Other agents such as venlafaxine (Effexor) and duloxetine (Cymbalta) have very limited data and shouldn’t be first-line treatment, she said.
Dr. Safar reports no relevant disclosures.
Correction, 5/31/19: An earlier version of this article misstated Dr. Safar's hospital affiliation.
SEATTLE – , a neuropsychiatrist cautioned colleagues who treat MS.
For example, depression may strike a patient as a primary condition, just as it could in anyone. But it may also be a manifestation of MS itself, or a side effect of an MS medication, or spurred by the fatigue and pain caused by MS, said Laura T. Safar, MD, a psychiatrist affiliated with Brigham and Women's Hospital, Boston*. As a result, popular psychiatric treatments such as SSRIs might not necessarily be the best approach, said Dr. Safar, who spoke in an interview and during a presentation at the annual meeting of the Consortium of Multiple Sclerosis Centers.
“You need to follow the why,” she said in the interview, adding that it is crucial to view neurologic and mental health as one and the same in MS. “More integration,” she said, “continues to be the way to go.”
Here are some pearls and tips from Dr. Safar’s presentation on treating psychiatric conditions in patients with MS:
Mental illness incidence
Depression is estimated to affect 25%-45% of people with MS over their lifetimes, while bipolar disorder is thought to affect 6% of patients and a quarter are estimated to have anxiety.
Researchers also believe as many as 10% of patients are affected by pathological laughing and crying during their lives.
Psychiatric side effects
Interferon drugs are notoriously linked to depression and psychosis. Glatiramer acetate (Copaxone) and natalizumab (Tysabri) are also thought to cause psychiatric side effects in some cases – anxiety and depression, respectively. But drug-modifying therapies can also provide relief on the psychiatric front, Dr. Safar said.
Meanwhile, dozens of other drugs used to treat aspects of MS such as spasticity, pain, and fatigue have possible psychiatric side effects.
Alternatives to SSRIs
SSRIs are often a first option in psychiatric patients, but those with MS may need another option because so many – an estimated 80% – also have fatigue, Dr. Safar said.
Alternatives for patients with MS include serotonin and norepinephrine reuptake inhibitors (SNRIs), which may have an advantage over SSRIs, she said. Specifically, SNRIs and bupropion (Wellbutrin) may be better for patients with fatigue and cognitive problems, she said, while vortioxetine (Trintellix) may benefit cognition.
Treating anxiety
There are no data regarding the best drug treatment for anxiety in patients with MS, she said, and SSRIs are typically the starting point. Consider SNRIs and duloxetine, respectively, when patients also have significant fatigue and cognitive symptoms. Use benzodiazepines only in occasional cases (such as anxiety regarding an MRI) and severe cases, she said.
MS-specific side effects
Beware of MS-specific side effects, Dr. Safar said. Some common psychiatric drugs, especially citalopram (Celexa) and escitalopram (Lexapro), may increase the QTc interval and shouldn’t be used in combination with the MS drug fingolimod (Gilenya).
And, she said, bupropion is “a very helpful agent” but poses a rare risk of seizures. Dr. Safar said she has seen this side effect a couple times over 10 years, but both were in patients with “other factors involved.” Still, “it’s something to keep in mind.”
Also understand that serotonergic agents can worsen restless legs syndrome, which is more common in patients with MS. Dr. Safar advises monitoring for the condition.
Pathological laughing, crying
Episodes of so-called pathological laughing, crying, or both tend to be brief, frequent, and intense. They may be sparked by nothing at all, and more often feature crying.
Certain SSRIs have proved helpful for the condition in MS, Dr. Safar said. Research also supports a combination of dextromethorphan (cough suppressant) and quinidine (a drug used to treat arrhythmias and malaria). The combination is sold together as Nuedexta.
Other agents such as venlafaxine (Effexor) and duloxetine (Cymbalta) have very limited data and shouldn’t be first-line treatment, she said.
Dr. Safar reports no relevant disclosures.
Correction, 5/31/19: An earlier version of this article misstated Dr. Safar's hospital affiliation.
EXPERT ANALYSIS FROM CMSC 2019
Hazardous cannabis use in MS linked to anxiety, depression
SEATTLE – A small new study suggests that although it is not clear whether there is a cause-and-effect relationship. “We highly recommend screening for hazardous cannabis use in clinical settings,” said study lead author and rehabilitation psychologist Abbey J. Hughes, PhD, an assistant professor at Johns Hopkins University, Baltimore, in an interview. She spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
According to Dr. Hughes, research suggests that patients with MS are using cannabis more now than in the past, especially for medical reasons. It is not clear, however, how cannabis is affecting neurobehavior in patients with MS who use it, said Dr. Hughes, who works with patients with MS.
For the new study, researchers gave surveys to 100 patients with MS (76% female; mean age, 46 years) who sought outpatient care at an MS center. Of those, 31 said they had used cannabis within the past month.
The patients were screened via several tools: the Cannabis Use Disorders Identification Test–Revised (CUDIT-R) Fatigue Severity Scale; Patient Health Questionnaire–8; Generalized Anxiety Disorders Scale–7; and Brief International Cognitive Assessment for Multiple Sclerosis.
Subjects were considered to have a problem with “hazardous cannabis use” if they met or exceeded the CUDIT-R’s clinical cut-off of 8 points. The test asks about topics such as hazardous behavior while using cannabis, problems with memory or concentration after using it, and inability to stop using it. Twelve participants met this criteria, and they were more likely to have more symptoms of depression (beta = 0.32; P less than .01) and anxiety (beta = 0.24; P = .02), after researchers controlled for age, years of education, and MS subtype.
They also were slightly more likely to have more severe fatigue (beta = 0.20; P = .07) and poor sleep (beta = 0.20; P = .07).
The researchers found no link between cannabis use and scores on the cognitive test, although Dr. Hughes noted that other research has suggested such a link.
The study is cross-sectional and does not offer insight into cause and effect, Dr. Hughes said. She noted that it is possible that patients used cannabis because they had higher levels of anxiety and depression.
No study funding was reported and the authors report no relevant disclosures.
SEATTLE – A small new study suggests that although it is not clear whether there is a cause-and-effect relationship. “We highly recommend screening for hazardous cannabis use in clinical settings,” said study lead author and rehabilitation psychologist Abbey J. Hughes, PhD, an assistant professor at Johns Hopkins University, Baltimore, in an interview. She spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
According to Dr. Hughes, research suggests that patients with MS are using cannabis more now than in the past, especially for medical reasons. It is not clear, however, how cannabis is affecting neurobehavior in patients with MS who use it, said Dr. Hughes, who works with patients with MS.
For the new study, researchers gave surveys to 100 patients with MS (76% female; mean age, 46 years) who sought outpatient care at an MS center. Of those, 31 said they had used cannabis within the past month.
The patients were screened via several tools: the Cannabis Use Disorders Identification Test–Revised (CUDIT-R) Fatigue Severity Scale; Patient Health Questionnaire–8; Generalized Anxiety Disorders Scale–7; and Brief International Cognitive Assessment for Multiple Sclerosis.
Subjects were considered to have a problem with “hazardous cannabis use” if they met or exceeded the CUDIT-R’s clinical cut-off of 8 points. The test asks about topics such as hazardous behavior while using cannabis, problems with memory or concentration after using it, and inability to stop using it. Twelve participants met this criteria, and they were more likely to have more symptoms of depression (beta = 0.32; P less than .01) and anxiety (beta = 0.24; P = .02), after researchers controlled for age, years of education, and MS subtype.
They also were slightly more likely to have more severe fatigue (beta = 0.20; P = .07) and poor sleep (beta = 0.20; P = .07).
The researchers found no link between cannabis use and scores on the cognitive test, although Dr. Hughes noted that other research has suggested such a link.
The study is cross-sectional and does not offer insight into cause and effect, Dr. Hughes said. She noted that it is possible that patients used cannabis because they had higher levels of anxiety and depression.
No study funding was reported and the authors report no relevant disclosures.
SEATTLE – A small new study suggests that although it is not clear whether there is a cause-and-effect relationship. “We highly recommend screening for hazardous cannabis use in clinical settings,” said study lead author and rehabilitation psychologist Abbey J. Hughes, PhD, an assistant professor at Johns Hopkins University, Baltimore, in an interview. She spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
According to Dr. Hughes, research suggests that patients with MS are using cannabis more now than in the past, especially for medical reasons. It is not clear, however, how cannabis is affecting neurobehavior in patients with MS who use it, said Dr. Hughes, who works with patients with MS.
For the new study, researchers gave surveys to 100 patients with MS (76% female; mean age, 46 years) who sought outpatient care at an MS center. Of those, 31 said they had used cannabis within the past month.
The patients were screened via several tools: the Cannabis Use Disorders Identification Test–Revised (CUDIT-R) Fatigue Severity Scale; Patient Health Questionnaire–8; Generalized Anxiety Disorders Scale–7; and Brief International Cognitive Assessment for Multiple Sclerosis.
Subjects were considered to have a problem with “hazardous cannabis use” if they met or exceeded the CUDIT-R’s clinical cut-off of 8 points. The test asks about topics such as hazardous behavior while using cannabis, problems with memory or concentration after using it, and inability to stop using it. Twelve participants met this criteria, and they were more likely to have more symptoms of depression (beta = 0.32; P less than .01) and anxiety (beta = 0.24; P = .02), after researchers controlled for age, years of education, and MS subtype.
They also were slightly more likely to have more severe fatigue (beta = 0.20; P = .07) and poor sleep (beta = 0.20; P = .07).
The researchers found no link between cannabis use and scores on the cognitive test, although Dr. Hughes noted that other research has suggested such a link.
The study is cross-sectional and does not offer insight into cause and effect, Dr. Hughes said. She noted that it is possible that patients used cannabis because they had higher levels of anxiety and depression.
No study funding was reported and the authors report no relevant disclosures.
REPORTING FROM CMSC 2019
Why aren’t preferred DMTs prescribed for MS? Neurologists point to insurers, patients
SEATTLE –
Specifically, “it appears that patient reluctance to start moderate-efficacy DMTs is a major factor and may be impeding a significant uptake of the oral drugs in treatment-naive patients,” said study lead author Virginia Schobel, MSc, of the consulting firm Spherix Global Insights, who spoke in an interview prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
The third annual survey of neurologists was conducted in December 2018, and 218 neurologists took part. Participants answered questions via an online survey and provided cross-sectional retrospective chart reviews of 1,059 MS patients who started their first DMT over the previous 3 months. The survey participants managed the initial DMT selection in 935 of the cases.
For this survey, Ms. Schobel said, researchers focused on exploring reasons why data aren’t showing a major trend toward oral DMTs as first-line treatment. “A good proportion of neurologists agree that this is their preferred method, but we are not seeing the market move,” she said.
The survey asked neurologists if they agree with this statement: “When initiating a patient on DMT therapy, I prefer to use a DMT aggressive approach, using a high-efficacy agent as opposed to a therapy escalation approach whereby I start with a traditional first-line DMT and only progress to second line if/when the patient does not have an optimal response.” Nearly half (49%) of the neurologists agreed, while 16% disagreed and 36% were neutral.
Neurologists reported initiating their preferred DMT 77% of the time (standard efficacy DMTs), 81% of the time (moderate efficacy), and 75% (high efficacy).
When asked why they weren’t able to prescribe their top recommended DMT, neurologists offered these answers:
** In standard-efficacy cases (n = 96), insurance hitches – formulary limitations or denial – were responsible 67% of the time. Patient refusal or preference for another DMT were responsible 33% of the time, and other reasons accounted for 1%.
Why do patients face insurance hassles for standard-efficacy drugs? Ms. Schobel noted that generics are available for these drugs, and insurers may prefer them.
** In moderate-efficacy cases (n = 63), insurance hitches accounted for 40% of cases, while patient refusal made up 59% with other reasons at 3%.
** In high-efficacy cases (n = 46), insurance hitches accounted for 59% of cases, while patient refusal explained 41% of cases. Of the latter group, reasons included tolerability concerns (42%) and safety concerns other than progressive multifocal leukoencephalopathy (PML) risks (37%)
No study funding is reported, and the study authors report no relevant disclosures.
SEATTLE –
Specifically, “it appears that patient reluctance to start moderate-efficacy DMTs is a major factor and may be impeding a significant uptake of the oral drugs in treatment-naive patients,” said study lead author Virginia Schobel, MSc, of the consulting firm Spherix Global Insights, who spoke in an interview prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
The third annual survey of neurologists was conducted in December 2018, and 218 neurologists took part. Participants answered questions via an online survey and provided cross-sectional retrospective chart reviews of 1,059 MS patients who started their first DMT over the previous 3 months. The survey participants managed the initial DMT selection in 935 of the cases.
For this survey, Ms. Schobel said, researchers focused on exploring reasons why data aren’t showing a major trend toward oral DMTs as first-line treatment. “A good proportion of neurologists agree that this is their preferred method, but we are not seeing the market move,” she said.
The survey asked neurologists if they agree with this statement: “When initiating a patient on DMT therapy, I prefer to use a DMT aggressive approach, using a high-efficacy agent as opposed to a therapy escalation approach whereby I start with a traditional first-line DMT and only progress to second line if/when the patient does not have an optimal response.” Nearly half (49%) of the neurologists agreed, while 16% disagreed and 36% were neutral.
Neurologists reported initiating their preferred DMT 77% of the time (standard efficacy DMTs), 81% of the time (moderate efficacy), and 75% (high efficacy).
When asked why they weren’t able to prescribe their top recommended DMT, neurologists offered these answers:
** In standard-efficacy cases (n = 96), insurance hitches – formulary limitations or denial – were responsible 67% of the time. Patient refusal or preference for another DMT were responsible 33% of the time, and other reasons accounted for 1%.
Why do patients face insurance hassles for standard-efficacy drugs? Ms. Schobel noted that generics are available for these drugs, and insurers may prefer them.
** In moderate-efficacy cases (n = 63), insurance hitches accounted for 40% of cases, while patient refusal made up 59% with other reasons at 3%.
** In high-efficacy cases (n = 46), insurance hitches accounted for 59% of cases, while patient refusal explained 41% of cases. Of the latter group, reasons included tolerability concerns (42%) and safety concerns other than progressive multifocal leukoencephalopathy (PML) risks (37%)
No study funding is reported, and the study authors report no relevant disclosures.
SEATTLE –
Specifically, “it appears that patient reluctance to start moderate-efficacy DMTs is a major factor and may be impeding a significant uptake of the oral drugs in treatment-naive patients,” said study lead author Virginia Schobel, MSc, of the consulting firm Spherix Global Insights, who spoke in an interview prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
The third annual survey of neurologists was conducted in December 2018, and 218 neurologists took part. Participants answered questions via an online survey and provided cross-sectional retrospective chart reviews of 1,059 MS patients who started their first DMT over the previous 3 months. The survey participants managed the initial DMT selection in 935 of the cases.
For this survey, Ms. Schobel said, researchers focused on exploring reasons why data aren’t showing a major trend toward oral DMTs as first-line treatment. “A good proportion of neurologists agree that this is their preferred method, but we are not seeing the market move,” she said.
The survey asked neurologists if they agree with this statement: “When initiating a patient on DMT therapy, I prefer to use a DMT aggressive approach, using a high-efficacy agent as opposed to a therapy escalation approach whereby I start with a traditional first-line DMT and only progress to second line if/when the patient does not have an optimal response.” Nearly half (49%) of the neurologists agreed, while 16% disagreed and 36% were neutral.
Neurologists reported initiating their preferred DMT 77% of the time (standard efficacy DMTs), 81% of the time (moderate efficacy), and 75% (high efficacy).
When asked why they weren’t able to prescribe their top recommended DMT, neurologists offered these answers:
** In standard-efficacy cases (n = 96), insurance hitches – formulary limitations or denial – were responsible 67% of the time. Patient refusal or preference for another DMT were responsible 33% of the time, and other reasons accounted for 1%.
Why do patients face insurance hassles for standard-efficacy drugs? Ms. Schobel noted that generics are available for these drugs, and insurers may prefer them.
** In moderate-efficacy cases (n = 63), insurance hitches accounted for 40% of cases, while patient refusal made up 59% with other reasons at 3%.
** In high-efficacy cases (n = 46), insurance hitches accounted for 59% of cases, while patient refusal explained 41% of cases. Of the latter group, reasons included tolerability concerns (42%) and safety concerns other than progressive multifocal leukoencephalopathy (PML) risks (37%)
No study funding is reported, and the study authors report no relevant disclosures.
REPORTING FROM CMSC 2019
Modest evidence for benefit in studies of cannabis in MS
SEATTLE – Reviewers found modest evidence of benefit and plenty of room for more research.
“Cannabis-based medicine may be useful for refractory MS symptoms, especially spasticity and pain, and side effects are usually well tolerated,” study lead author Natasha Breward, a graduate student at the College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, said in an interview. Ms. Breward spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
For the review, Ms. Breward and colleagues focused on 60 studies - 26 randomized controlled trials and 34 trials with other designs. Forty of the studies used nabiximols (Sativex), an oromucosal spray that is derived from the cannabis sativa plant and approved for use in multiple countries but not yet in the United States.
According to Ms. Breward, some of the other treatments included dried cannabis that is smoked or eaten and cannabidiol that’s typically delivered with tetrahydrocannabinol (THC) either oromucosally or as an oral capsule.
MS symptoms treated in the studies included spasticity (n = 29), pain (n = 8) and cognition (n = 6).
The researchers considered 22 studies to be poor quality, 14 to be fair quality, and 24 to be good/excellent quality.
As for results, the researchers found that the cannabis-based medicine “significantly reduced spasticity and pain in several individual good-quality studies,” Ms. Breward said. The drugs seem to work by inhibiting neurotransmitter release via cannabinoids, she said.
“However,” she added, “the variability in study quality – and in the products and regimens studied – make it hard to draw any conclusions about specific products and doses that may have the most potential benefit.”
As for adverse effects, dried cannabis was linked to decreased long-term cognitive function, which is distinct from being temporarily high, Ms. Breward said.
“Further research should focus on the use of different products and formulations of cannabis-based medicine such as cannabis oil and cannabidiol-prominent products, as no studies have focused on this area,” she said. “Research should also look at the potential of cannabis-based medicine for the treatment of disease progression, as cannabinoids are anti-inflammatory and immunomodulatory. Finally, more research regarding the potentially synergistic effects of cannabis-based medicine administered with current MS medications would also be useful.”
No study funding is reported and the authors report no relevant disclosures.
SEATTLE – Reviewers found modest evidence of benefit and plenty of room for more research.
“Cannabis-based medicine may be useful for refractory MS symptoms, especially spasticity and pain, and side effects are usually well tolerated,” study lead author Natasha Breward, a graduate student at the College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, said in an interview. Ms. Breward spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
For the review, Ms. Breward and colleagues focused on 60 studies - 26 randomized controlled trials and 34 trials with other designs. Forty of the studies used nabiximols (Sativex), an oromucosal spray that is derived from the cannabis sativa plant and approved for use in multiple countries but not yet in the United States.
According to Ms. Breward, some of the other treatments included dried cannabis that is smoked or eaten and cannabidiol that’s typically delivered with tetrahydrocannabinol (THC) either oromucosally or as an oral capsule.
MS symptoms treated in the studies included spasticity (n = 29), pain (n = 8) and cognition (n = 6).
The researchers considered 22 studies to be poor quality, 14 to be fair quality, and 24 to be good/excellent quality.
As for results, the researchers found that the cannabis-based medicine “significantly reduced spasticity and pain in several individual good-quality studies,” Ms. Breward said. The drugs seem to work by inhibiting neurotransmitter release via cannabinoids, she said.
“However,” she added, “the variability in study quality – and in the products and regimens studied – make it hard to draw any conclusions about specific products and doses that may have the most potential benefit.”
As for adverse effects, dried cannabis was linked to decreased long-term cognitive function, which is distinct from being temporarily high, Ms. Breward said.
“Further research should focus on the use of different products and formulations of cannabis-based medicine such as cannabis oil and cannabidiol-prominent products, as no studies have focused on this area,” she said. “Research should also look at the potential of cannabis-based medicine for the treatment of disease progression, as cannabinoids are anti-inflammatory and immunomodulatory. Finally, more research regarding the potentially synergistic effects of cannabis-based medicine administered with current MS medications would also be useful.”
No study funding is reported and the authors report no relevant disclosures.
SEATTLE – Reviewers found modest evidence of benefit and plenty of room for more research.
“Cannabis-based medicine may be useful for refractory MS symptoms, especially spasticity and pain, and side effects are usually well tolerated,” study lead author Natasha Breward, a graduate student at the College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, said in an interview. Ms. Breward spoke prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
For the review, Ms. Breward and colleagues focused on 60 studies - 26 randomized controlled trials and 34 trials with other designs. Forty of the studies used nabiximols (Sativex), an oromucosal spray that is derived from the cannabis sativa plant and approved for use in multiple countries but not yet in the United States.
According to Ms. Breward, some of the other treatments included dried cannabis that is smoked or eaten and cannabidiol that’s typically delivered with tetrahydrocannabinol (THC) either oromucosally or as an oral capsule.
MS symptoms treated in the studies included spasticity (n = 29), pain (n = 8) and cognition (n = 6).
The researchers considered 22 studies to be poor quality, 14 to be fair quality, and 24 to be good/excellent quality.
As for results, the researchers found that the cannabis-based medicine “significantly reduced spasticity and pain in several individual good-quality studies,” Ms. Breward said. The drugs seem to work by inhibiting neurotransmitter release via cannabinoids, she said.
“However,” she added, “the variability in study quality – and in the products and regimens studied – make it hard to draw any conclusions about specific products and doses that may have the most potential benefit.”
As for adverse effects, dried cannabis was linked to decreased long-term cognitive function, which is distinct from being temporarily high, Ms. Breward said.
“Further research should focus on the use of different products and formulations of cannabis-based medicine such as cannabis oil and cannabidiol-prominent products, as no studies have focused on this area,” she said. “Research should also look at the potential of cannabis-based medicine for the treatment of disease progression, as cannabinoids are anti-inflammatory and immunomodulatory. Finally, more research regarding the potentially synergistic effects of cannabis-based medicine administered with current MS medications would also be useful.”
No study funding is reported and the authors report no relevant disclosures.
REPORTING FROM CMSC 2019
General neurologists lag on prescribing high-efficacy MS drugs
SEATTLE – It is not clear if the greater reluctance among general neurologists to prescribe the drugs is hurting the health of patients, and the study does not examine whether general neurologists are referring their toughest patients to their subspecialist colleagues.
Still, the findings raise questions because “starting highly effective drugs early can prevent long-term disability,” said study lead author and neurologist Casey V. Farin, MD, a clinical fellow in the department of neurology at Duke University, Durham, N.C., who spoke in an interview prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers. “A lot of our general neurologists are prescribing the traditional platform therapies that have fallen a bit out of favor in the MS community,” she said.
Dr. Farin and colleagues launched their study to better understand whether “therapeutic inertia” is affecting how general neurologists treat MS. The term refers to “staying with one drug just because it is easier not to rock the boat,” she said. For the purposes of their study, the term encompasses reluctance of neurologists to escalate therapy or prescribe high-efficacy drugs.
“There have been small studies comparing subspecialists and general neurologists using surveys of theoretical cases,” she said. “No studies have looked at how people are prescribing disease-modifying therapy.”
In the new age of high-efficacy treatment, guidelines about early MS treatment are lacking. As the study abstract notes, “in the absence of robust head-to-head clinical data, neurologists do not have an accepted algorithm for initiation and escalation of therapy, although recent research indicates a benefit in initiating highly effective therapies early in the disease course.”
For the study, researchers tracked 4,753 patients with MS who were treated at the Duke University Health System from 2016 to 2018.
General neurologists prescribed platform therapies – interferons, glatiramer acetate (Copaxone) and dimethyl fumarate (Tecfidera) more often than did MS subspecialists (16% vs. 5%, P less than .0001, 12% vs. 6%, P = .001 and 31% vs. 11%, P less than .0001, respectively).
In regard to high-efficacy MS drugs, there was no significant difference in prescription rates of fingolimod (Gilenya) and natalizumab (Tysabri). But general neurologists were less likely to prescribe three other types than were general neurologists: Alemtuzumab (Lemtrada), ocrelizumab (Ocrevus) and rituximab (Rituxan) (0 vs. 8%, P = .0001, 3% vs. 27%, P less than .0001, and 2% vs. 7%, P = .0001, respectively).
Why might general neurologists be more resistant to embrace high-efficacy MS drugs? “They are newer and seen as more aggressive, and riskier,” Dr. Farin said. If general neurologists are not seeing many patients with MS and not prescribing these newer drugs very often, they may be more familiar with the older platform drugs, she said. “They may start with the ones that seem safer and are easier to start with.”
It is possible, she cautioned, that the study results may be confounded by general neurologists who refer patients to MS subspecialists when initial disease-modifying therapies fail.
No study funding was reported. Dr. Farin and two of the other four authors disclosed consulting fees from Biogen. No other disclosures were reported.
SOURCE: Farin CV et al. CMSC 2019. Abstract DXT44.
SEATTLE – It is not clear if the greater reluctance among general neurologists to prescribe the drugs is hurting the health of patients, and the study does not examine whether general neurologists are referring their toughest patients to their subspecialist colleagues.
Still, the findings raise questions because “starting highly effective drugs early can prevent long-term disability,” said study lead author and neurologist Casey V. Farin, MD, a clinical fellow in the department of neurology at Duke University, Durham, N.C., who spoke in an interview prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers. “A lot of our general neurologists are prescribing the traditional platform therapies that have fallen a bit out of favor in the MS community,” she said.
Dr. Farin and colleagues launched their study to better understand whether “therapeutic inertia” is affecting how general neurologists treat MS. The term refers to “staying with one drug just because it is easier not to rock the boat,” she said. For the purposes of their study, the term encompasses reluctance of neurologists to escalate therapy or prescribe high-efficacy drugs.
“There have been small studies comparing subspecialists and general neurologists using surveys of theoretical cases,” she said. “No studies have looked at how people are prescribing disease-modifying therapy.”
In the new age of high-efficacy treatment, guidelines about early MS treatment are lacking. As the study abstract notes, “in the absence of robust head-to-head clinical data, neurologists do not have an accepted algorithm for initiation and escalation of therapy, although recent research indicates a benefit in initiating highly effective therapies early in the disease course.”
For the study, researchers tracked 4,753 patients with MS who were treated at the Duke University Health System from 2016 to 2018.
General neurologists prescribed platform therapies – interferons, glatiramer acetate (Copaxone) and dimethyl fumarate (Tecfidera) more often than did MS subspecialists (16% vs. 5%, P less than .0001, 12% vs. 6%, P = .001 and 31% vs. 11%, P less than .0001, respectively).
In regard to high-efficacy MS drugs, there was no significant difference in prescription rates of fingolimod (Gilenya) and natalizumab (Tysabri). But general neurologists were less likely to prescribe three other types than were general neurologists: Alemtuzumab (Lemtrada), ocrelizumab (Ocrevus) and rituximab (Rituxan) (0 vs. 8%, P = .0001, 3% vs. 27%, P less than .0001, and 2% vs. 7%, P = .0001, respectively).
Why might general neurologists be more resistant to embrace high-efficacy MS drugs? “They are newer and seen as more aggressive, and riskier,” Dr. Farin said. If general neurologists are not seeing many patients with MS and not prescribing these newer drugs very often, they may be more familiar with the older platform drugs, she said. “They may start with the ones that seem safer and are easier to start with.”
It is possible, she cautioned, that the study results may be confounded by general neurologists who refer patients to MS subspecialists when initial disease-modifying therapies fail.
No study funding was reported. Dr. Farin and two of the other four authors disclosed consulting fees from Biogen. No other disclosures were reported.
SOURCE: Farin CV et al. CMSC 2019. Abstract DXT44.
SEATTLE – It is not clear if the greater reluctance among general neurologists to prescribe the drugs is hurting the health of patients, and the study does not examine whether general neurologists are referring their toughest patients to their subspecialist colleagues.
Still, the findings raise questions because “starting highly effective drugs early can prevent long-term disability,” said study lead author and neurologist Casey V. Farin, MD, a clinical fellow in the department of neurology at Duke University, Durham, N.C., who spoke in an interview prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers. “A lot of our general neurologists are prescribing the traditional platform therapies that have fallen a bit out of favor in the MS community,” she said.
Dr. Farin and colleagues launched their study to better understand whether “therapeutic inertia” is affecting how general neurologists treat MS. The term refers to “staying with one drug just because it is easier not to rock the boat,” she said. For the purposes of their study, the term encompasses reluctance of neurologists to escalate therapy or prescribe high-efficacy drugs.
“There have been small studies comparing subspecialists and general neurologists using surveys of theoretical cases,” she said. “No studies have looked at how people are prescribing disease-modifying therapy.”
In the new age of high-efficacy treatment, guidelines about early MS treatment are lacking. As the study abstract notes, “in the absence of robust head-to-head clinical data, neurologists do not have an accepted algorithm for initiation and escalation of therapy, although recent research indicates a benefit in initiating highly effective therapies early in the disease course.”
For the study, researchers tracked 4,753 patients with MS who were treated at the Duke University Health System from 2016 to 2018.
General neurologists prescribed platform therapies – interferons, glatiramer acetate (Copaxone) and dimethyl fumarate (Tecfidera) more often than did MS subspecialists (16% vs. 5%, P less than .0001, 12% vs. 6%, P = .001 and 31% vs. 11%, P less than .0001, respectively).
In regard to high-efficacy MS drugs, there was no significant difference in prescription rates of fingolimod (Gilenya) and natalizumab (Tysabri). But general neurologists were less likely to prescribe three other types than were general neurologists: Alemtuzumab (Lemtrada), ocrelizumab (Ocrevus) and rituximab (Rituxan) (0 vs. 8%, P = .0001, 3% vs. 27%, P less than .0001, and 2% vs. 7%, P = .0001, respectively).
Why might general neurologists be more resistant to embrace high-efficacy MS drugs? “They are newer and seen as more aggressive, and riskier,” Dr. Farin said. If general neurologists are not seeing many patients with MS and not prescribing these newer drugs very often, they may be more familiar with the older platform drugs, she said. “They may start with the ones that seem safer and are easier to start with.”
It is possible, she cautioned, that the study results may be confounded by general neurologists who refer patients to MS subspecialists when initial disease-modifying therapies fail.
No study funding was reported. Dr. Farin and two of the other four authors disclosed consulting fees from Biogen. No other disclosures were reported.
SOURCE: Farin CV et al. CMSC 2019. Abstract DXT44.
REPORTING FROM CMSC 2019
Key clinical point: MS subspecialists are more likely than are general neurologists to prescribe newer, high-efficacy MS therapies.
Major finding: General neurologists prescribed platform therapies – interferons, glatiramer acetate (Copaxone), and dimethyl fumarate (Tecfidera), more often than did MS subspecialists (16% vs. 5%, P less than .0001, 12% vs. 6%, P = .001, and 31% vs. 11%, P less than .0001, respectively).
Study details: Retrospective chart review of 4,753 patients with MS seen at the Duke University Health System.
Disclosures: Dr. Farin and two of the other four coauthors reported consulting fees from Biogen.
Source: Farin CV et al. CMSC 2019. Abstract DXT44.
MS linked to higher rates of hoarding behavior
SEATTLE – according to a small study that appears to be the first of its kind. It is not clear how MS and hoarding may be linked, but study author Joshua Bacon, PhD, an MS researcher and associate professor at New York University, and coauthors suspect that physical limitations are an important factor.
“It is important for clinicians to identify patients who might be hoarders and/or clutterers. It is very likely that this has an impact on the trajectory of their activities of daily living,” he said in an interview prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
Dr. Bacon said the study was inspired by his observation that hoarding and cluttering behavior appear to be common among patients with MS. “As I became more interested in it, it became clear there hasn’t been any work on this in the MS population.”
For the new study, Dr. Bacon and colleagues surveyed 139 consecutive patients with MS at the New York University MS Center. The patients had a mean age of 45 years and mean disease duration of 14 years; 71% were female, and 48% were non white. The researchers measured the patients on scales of hoarding behavior (Activities of Daily Living for Hoarding and the Hoarding Rating Scale) and disability (Patient-Determined Disability Steps).
The researchers found that nearly 12% showed signs of clinically significant hoarding behavior, compared with an estimated 5% of the general population (P = .0008). Researchers linked disability and Hoarding Rating Scale to the variability in degree of difficulty in performing activities of daily living (P less than .0001).
Dr. Bacon and colleagues do not believe MS is the direct cause of hoarding behaviors. “There has been no literature on this, and we do not know whether this is connected to the neurological condition,” he said. “I think it has more to do with physical capabilities.”
Patients with MS may have mobility problems that disrupt their ability to organize their homes, he said. “You can’t move things the way you can when you have normal mobility,” he said. “Things can start building up, and it is harder to get yourself out of the mess because you don’t have the wherewithal to move things out of that way.”
As a result, he said, patients may become more isolated if they become embarrassed about inviting people into their homes. To make matters worse, some patients with MS already suffer from social isolation, he said.
He added that some patients with MS may be “clutterers” who do not fit the definition of hoarders but are still affected. “Even cluttering can have an impact on quality of life. You do not have to have the disorder,” he said.
What can be done to help patients who are hoarders or clutterers? Dr. Bacon acknowledged that hoarding behavior is very difficult to treat successfully, but cluttering – a step below hoarding – may be easier to address.
“As therapists, we try to help MS patients confront the debilitating emotional distress that inevitably emerges from the loss of control as disability progresses,” he said. “A central emphasis in therapy is to turn the focus away from the neurological changes and their sequelae that cannot be changed to those facets of their lives over which they can have control and that can be nurtured and strengthened.”
No study funding was reported, and the study authors reported no relevant disclosures.
SEATTLE – according to a small study that appears to be the first of its kind. It is not clear how MS and hoarding may be linked, but study author Joshua Bacon, PhD, an MS researcher and associate professor at New York University, and coauthors suspect that physical limitations are an important factor.
“It is important for clinicians to identify patients who might be hoarders and/or clutterers. It is very likely that this has an impact on the trajectory of their activities of daily living,” he said in an interview prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
Dr. Bacon said the study was inspired by his observation that hoarding and cluttering behavior appear to be common among patients with MS. “As I became more interested in it, it became clear there hasn’t been any work on this in the MS population.”
For the new study, Dr. Bacon and colleagues surveyed 139 consecutive patients with MS at the New York University MS Center. The patients had a mean age of 45 years and mean disease duration of 14 years; 71% were female, and 48% were non white. The researchers measured the patients on scales of hoarding behavior (Activities of Daily Living for Hoarding and the Hoarding Rating Scale) and disability (Patient-Determined Disability Steps).
The researchers found that nearly 12% showed signs of clinically significant hoarding behavior, compared with an estimated 5% of the general population (P = .0008). Researchers linked disability and Hoarding Rating Scale to the variability in degree of difficulty in performing activities of daily living (P less than .0001).
Dr. Bacon and colleagues do not believe MS is the direct cause of hoarding behaviors. “There has been no literature on this, and we do not know whether this is connected to the neurological condition,” he said. “I think it has more to do with physical capabilities.”
Patients with MS may have mobility problems that disrupt their ability to organize their homes, he said. “You can’t move things the way you can when you have normal mobility,” he said. “Things can start building up, and it is harder to get yourself out of the mess because you don’t have the wherewithal to move things out of that way.”
As a result, he said, patients may become more isolated if they become embarrassed about inviting people into their homes. To make matters worse, some patients with MS already suffer from social isolation, he said.
He added that some patients with MS may be “clutterers” who do not fit the definition of hoarders but are still affected. “Even cluttering can have an impact on quality of life. You do not have to have the disorder,” he said.
What can be done to help patients who are hoarders or clutterers? Dr. Bacon acknowledged that hoarding behavior is very difficult to treat successfully, but cluttering – a step below hoarding – may be easier to address.
“As therapists, we try to help MS patients confront the debilitating emotional distress that inevitably emerges from the loss of control as disability progresses,” he said. “A central emphasis in therapy is to turn the focus away from the neurological changes and their sequelae that cannot be changed to those facets of their lives over which they can have control and that can be nurtured and strengthened.”
No study funding was reported, and the study authors reported no relevant disclosures.
SEATTLE – according to a small study that appears to be the first of its kind. It is not clear how MS and hoarding may be linked, but study author Joshua Bacon, PhD, an MS researcher and associate professor at New York University, and coauthors suspect that physical limitations are an important factor.
“It is important for clinicians to identify patients who might be hoarders and/or clutterers. It is very likely that this has an impact on the trajectory of their activities of daily living,” he said in an interview prior to the presentation of the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.
Dr. Bacon said the study was inspired by his observation that hoarding and cluttering behavior appear to be common among patients with MS. “As I became more interested in it, it became clear there hasn’t been any work on this in the MS population.”
For the new study, Dr. Bacon and colleagues surveyed 139 consecutive patients with MS at the New York University MS Center. The patients had a mean age of 45 years and mean disease duration of 14 years; 71% were female, and 48% were non white. The researchers measured the patients on scales of hoarding behavior (Activities of Daily Living for Hoarding and the Hoarding Rating Scale) and disability (Patient-Determined Disability Steps).
The researchers found that nearly 12% showed signs of clinically significant hoarding behavior, compared with an estimated 5% of the general population (P = .0008). Researchers linked disability and Hoarding Rating Scale to the variability in degree of difficulty in performing activities of daily living (P less than .0001).
Dr. Bacon and colleagues do not believe MS is the direct cause of hoarding behaviors. “There has been no literature on this, and we do not know whether this is connected to the neurological condition,” he said. “I think it has more to do with physical capabilities.”
Patients with MS may have mobility problems that disrupt their ability to organize their homes, he said. “You can’t move things the way you can when you have normal mobility,” he said. “Things can start building up, and it is harder to get yourself out of the mess because you don’t have the wherewithal to move things out of that way.”
As a result, he said, patients may become more isolated if they become embarrassed about inviting people into their homes. To make matters worse, some patients with MS already suffer from social isolation, he said.
He added that some patients with MS may be “clutterers” who do not fit the definition of hoarders but are still affected. “Even cluttering can have an impact on quality of life. You do not have to have the disorder,” he said.
What can be done to help patients who are hoarders or clutterers? Dr. Bacon acknowledged that hoarding behavior is very difficult to treat successfully, but cluttering – a step below hoarding – may be easier to address.
“As therapists, we try to help MS patients confront the debilitating emotional distress that inevitably emerges from the loss of control as disability progresses,” he said. “A central emphasis in therapy is to turn the focus away from the neurological changes and their sequelae that cannot be changed to those facets of their lives over which they can have control and that can be nurtured and strengthened.”
No study funding was reported, and the study authors reported no relevant disclosures.
REPORTING FROM CMSC 2019
Key clinical point: Given the effects of hoarding and cluttering behavior on health and psychological well-being in the general population, these study results highlight the importance of of identifying such behavior in patients with multiple sclerosis and developing effective interventions.
Major finding: Hoarding and cluttering behavior has a significantly higher prevalence in the MS population (11.5%) than in the general population (5%).
Study details: Retrospective review of 139 consecutive patients with MS attending the New York University MS Center.
Disclosures: The authors had nothing to disclose.
Risk factors for foot ulcers differ for type 1 and type 2 diabetes
Danish researchers have linked multiple factors to higher risk of first-time diabetic foot ulcers (DFUs) in patients with type 1 and type 2 diabetes, although some of the factors – according to the new study findings.
The authors suggest that since clinical information gathered from patients during routine follow-up visits often includes mention of the risk factors for first-time DFU, it could form the basis of a risk stratification process for first-time DFU that can be integrated into the electronic record system and easily incorporated into routine care.
DFU is a significant complication for both type 1 and type 2 diabetes, but no previous research has stratified the risk factors for first-time DFUs by type of diabetes, emphasized the study authors, led by Sine Hangaard, MSc, of Steno Diabetes Center Copenhagen.
For the new study, the researchers tracked 5,588 patients with type 1 diabetes and 7,113 with type 2, all of whom were treated at a hospital clinic in Denmark between 2001 and 2015. The authors noted that the patients with type 2 disease who were treated at the center were clinically more complicated and had a longer disease duration than average type 2 patients, whereas the patients with type 1 diabetes did not differ from average type 1 patients.
Several factors boosted the risk of first-time DFU in both types of disease, including high or low levels of albumin excretion, advanced diabetic retinopathy, limited or nonexistent vibration sense, symptoms of neuropathy, and absence of foot pulses per univariable regression (all P less than .01). The researchers linked the neuropathy and absences of foot pulses to especially high spikes in risk.
Female gender was protective for type 1 and type 2 disease (hazard ratios, 0.7 and 0.5, respectively; P = .0000). Various body mass index levels seemed to have no impact on risk.
Three factors that posed a higher risk for first-time DFU in type 1 disease, but not type 2, were: smoking (HR, 1.4 vs. no smoking, P = .0220), age of 60-79 years (HR, 1.7 vs. age 40-59; P = .0000), cardiovascular disease (HR, 2.2 vs. no cardiovascular disease; P = .0000), and diabetes duration of between 5 and 20 years (HR, 2.2 vs. less than 5 years; P = .0027) or 20 years or more (HR, 5.2 vs. less than 5 years; P = .0000).
The authors noted that “25% of all patients with diabetes develop DFU during their lifetime, and DFUs precede 80% of all lower leg amputations in patients with diabetes.” In addition, DFU often occurs in feet already compromised by neuropathy or peripheral vascular disease, and is therefore associated with greater risk for infection, poorer outcomes, recurrent ulceration, amputation, and increased mortality. These risks underscore the need for the earliest-possible identification of first-time DFU and timely adoption of effective, preventative strategies, they wrote.
The study was not funded. Several of the authors reported that they own shares in Novo Nordisk.
SOURCE: Hangaard S et al. Diabetes Res Clin Pract. 2019 Apr 18;151:177-86.
Danish researchers have linked multiple factors to higher risk of first-time diabetic foot ulcers (DFUs) in patients with type 1 and type 2 diabetes, although some of the factors – according to the new study findings.
The authors suggest that since clinical information gathered from patients during routine follow-up visits often includes mention of the risk factors for first-time DFU, it could form the basis of a risk stratification process for first-time DFU that can be integrated into the electronic record system and easily incorporated into routine care.
DFU is a significant complication for both type 1 and type 2 diabetes, but no previous research has stratified the risk factors for first-time DFUs by type of diabetes, emphasized the study authors, led by Sine Hangaard, MSc, of Steno Diabetes Center Copenhagen.
For the new study, the researchers tracked 5,588 patients with type 1 diabetes and 7,113 with type 2, all of whom were treated at a hospital clinic in Denmark between 2001 and 2015. The authors noted that the patients with type 2 disease who were treated at the center were clinically more complicated and had a longer disease duration than average type 2 patients, whereas the patients with type 1 diabetes did not differ from average type 1 patients.
Several factors boosted the risk of first-time DFU in both types of disease, including high or low levels of albumin excretion, advanced diabetic retinopathy, limited or nonexistent vibration sense, symptoms of neuropathy, and absence of foot pulses per univariable regression (all P less than .01). The researchers linked the neuropathy and absences of foot pulses to especially high spikes in risk.
Female gender was protective for type 1 and type 2 disease (hazard ratios, 0.7 and 0.5, respectively; P = .0000). Various body mass index levels seemed to have no impact on risk.
Three factors that posed a higher risk for first-time DFU in type 1 disease, but not type 2, were: smoking (HR, 1.4 vs. no smoking, P = .0220), age of 60-79 years (HR, 1.7 vs. age 40-59; P = .0000), cardiovascular disease (HR, 2.2 vs. no cardiovascular disease; P = .0000), and diabetes duration of between 5 and 20 years (HR, 2.2 vs. less than 5 years; P = .0027) or 20 years or more (HR, 5.2 vs. less than 5 years; P = .0000).
The authors noted that “25% of all patients with diabetes develop DFU during their lifetime, and DFUs precede 80% of all lower leg amputations in patients with diabetes.” In addition, DFU often occurs in feet already compromised by neuropathy or peripheral vascular disease, and is therefore associated with greater risk for infection, poorer outcomes, recurrent ulceration, amputation, and increased mortality. These risks underscore the need for the earliest-possible identification of first-time DFU and timely adoption of effective, preventative strategies, they wrote.
The study was not funded. Several of the authors reported that they own shares in Novo Nordisk.
SOURCE: Hangaard S et al. Diabetes Res Clin Pract. 2019 Apr 18;151:177-86.
Danish researchers have linked multiple factors to higher risk of first-time diabetic foot ulcers (DFUs) in patients with type 1 and type 2 diabetes, although some of the factors – according to the new study findings.
The authors suggest that since clinical information gathered from patients during routine follow-up visits often includes mention of the risk factors for first-time DFU, it could form the basis of a risk stratification process for first-time DFU that can be integrated into the electronic record system and easily incorporated into routine care.
DFU is a significant complication for both type 1 and type 2 diabetes, but no previous research has stratified the risk factors for first-time DFUs by type of diabetes, emphasized the study authors, led by Sine Hangaard, MSc, of Steno Diabetes Center Copenhagen.
For the new study, the researchers tracked 5,588 patients with type 1 diabetes and 7,113 with type 2, all of whom were treated at a hospital clinic in Denmark between 2001 and 2015. The authors noted that the patients with type 2 disease who were treated at the center were clinically more complicated and had a longer disease duration than average type 2 patients, whereas the patients with type 1 diabetes did not differ from average type 1 patients.
Several factors boosted the risk of first-time DFU in both types of disease, including high or low levels of albumin excretion, advanced diabetic retinopathy, limited or nonexistent vibration sense, symptoms of neuropathy, and absence of foot pulses per univariable regression (all P less than .01). The researchers linked the neuropathy and absences of foot pulses to especially high spikes in risk.
Female gender was protective for type 1 and type 2 disease (hazard ratios, 0.7 and 0.5, respectively; P = .0000). Various body mass index levels seemed to have no impact on risk.
Three factors that posed a higher risk for first-time DFU in type 1 disease, but not type 2, were: smoking (HR, 1.4 vs. no smoking, P = .0220), age of 60-79 years (HR, 1.7 vs. age 40-59; P = .0000), cardiovascular disease (HR, 2.2 vs. no cardiovascular disease; P = .0000), and diabetes duration of between 5 and 20 years (HR, 2.2 vs. less than 5 years; P = .0027) or 20 years or more (HR, 5.2 vs. less than 5 years; P = .0000).
The authors noted that “25% of all patients with diabetes develop DFU during their lifetime, and DFUs precede 80% of all lower leg amputations in patients with diabetes.” In addition, DFU often occurs in feet already compromised by neuropathy or peripheral vascular disease, and is therefore associated with greater risk for infection, poorer outcomes, recurrent ulceration, amputation, and increased mortality. These risks underscore the need for the earliest-possible identification of first-time DFU and timely adoption of effective, preventative strategies, they wrote.
The study was not funded. Several of the authors reported that they own shares in Novo Nordisk.
SOURCE: Hangaard S et al. Diabetes Res Clin Pract. 2019 Apr 18;151:177-86.
FROM DIABETES RESEARCH AND CLINICAL PRACTICE