Procalcitonin helps ID pneumonia patients needing intubation

Procalcitonin alone cannot diagnose pneumonia
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Procalcitonin can help predict which patients with community-acquired pneumonia may require intubation for respiratory failure during a hospital admission.

Compared to those with undetectable levels, patients with a procalcitonin of 5 ng/mL were three times more likely to require invasive respiratory support, and those with a 10 ng/mL level were five times more likely, reported Wesley Self, MD, and his colleagues (Chest. 2016;150[4]:819-28. doi: 10.1016/j.chest.2016.04.010).

While predictive accuracy isn’t good enough to merit use of procalcitonin as a stand-alone test, adding it to existing clinical management tools “is likely to improve identification of patients needing intensive care,” wrote Dr. Self of Vanderbilt University, Nashville, and his colleagues. “An elevated procalcitonin level may help identify these patients without overt clinical signs of impending respiratory failure or shock but who would benefit from early [intensive care unit] admission.”

The team examined serum procalcitonin as a biomarker in a subgroup of patients included in the Etiology of Pneumonia in the Community (EPIC) study of adults hospitalized with community-acquire pneumonia. The primary outcome was the need for invasive respiratory and/or vasopressor support (IRVS) within 72 hours.

Secondarily, they looked at whether adding procalcitonin boosted the performance of accepted pneumonia risk scores, including the American Thoracic Society minor criteria (ATS).

The cohort comprised 1,770 patients with a median age of 57 years. Of these, 115 (6.5%) needed IRVS within 72 hours of admission. Almost 16% were admitted directly into an intensive care unit; almost 7% experienced a delayed transfer from a medical unit into an ICU. The in-hospital mortality was about 2%.

Most (1,642) had an ATS score of less than 3; among these, about 5% needed IRVS. The remainder had a score of 3 or higher; about 30% required IRVS. All had procalcitonin levels pulled at admission. The levels were significantly higher among patients who required IRVS than those who didn’t (1.43 ng/mL vs. 0.14 ng/mL).

A multivariate analysis found that procalcitonin was strongly associated with the risk of IRVS. In patients with undetectable levels, the risk was 4%. At 5-10 ng/mL, the overall risk of IRVS was about 14%. Every 1-ng/mL increase in this range boosted the risk of IRVS by 1%-2%.

Adding the measurement of procalcitonin to traditional pneumonia severity risk scores significantly improved the patients’ performance. When stratified by ATS minor criteria, the risk of IRVS was 4.7% among low-risk patients. That decreased to 2.4% with the addition of undetectable procalcitonin, and increased to 12% with the addition of a 10 ng/mL level.

Conversely, without considering procalcitonin, ATS high-risk patients had almost a 30% risk of IRVS. Among these high-risk patients, IRVS risk dropped to 13% with undetectable procalcitonin and increased to 36% with high procalcitonin.

Adding the biomarker level to the ATS system improved its ability to correctly classify patients, the team said. “Using at least 3 ATS minor criteria alone to indicate high risk, 77 (4.4%) of the 1,770 total patients were misclassified as low-risk and experienced IRVS. Including procalcitonin of at least 0.83 ng/ml in addition … as a high-risk indicator reduced the number of patients with IRVS misclassified as low risk to 44 (2.5%). Adding procalcitonin of at least 0.83 ng/mL as a high-risk indicator resulted in 370 additional patients being classified as high risk, with 33 correctly classified as having IRVS.”

Dr. Self reported financial relationships with multiple pharmaceutical companies.

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While measuring procalcitonin adds valuable information to pneumonia risk stratification schemes, this process lacks the accuracy needed to enable the diagnosis of pneumonia as a stand-alone test, Daiana Stolz, MD, MPH, FCCP, wrote in an editorial.

“This study further supports the notion that procalcitonin has a limited prognostic accuracy as a stand-alone test. It also does not seem to outperform the risk estimation of a combination of clinical and laboratorial parameters. However, it also emphasizes its potential to capture nuances elusive to the clinical assessment, which do not seem to be consistently reflected even in elaborated severity scores recommended for clinical routine use,” she said (Chest. 2016;150[4]:769-71. doi: 10.1016/j.chest.2016.07.017).

[Procalcitonin] values vary according to the pneumonia severity and this association is stronger than the one between disease severity and other clinical and laboratory variables,” she said.

Risk scores like the ATS system can be weak, “in particular with regard to positive predictive values,” Dr. Stolz wrote. And this is an important issue. “It is clear that patients fulfilling major criteria (endotracheal intubation and mechanical ventilation; shock-requiring vasopressors) should be considered for ICU admission; however, there is still controversy about the value of the minor criteria. ICU care is costly and a limited resource worldwide.”

She called for “a randomized study evaluating the outcome and cost-effectiveness of a procalcitonin-refined clinical score in severe [community acquired pneumonia].”

Dr. Stolz is a pulmonologist at the University Hospital Basel, Switzerland. She reported financial relationships with several pharmaceutical companies.

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While measuring procalcitonin adds valuable information to pneumonia risk stratification schemes, this process lacks the accuracy needed to enable the diagnosis of pneumonia as a stand-alone test, Daiana Stolz, MD, MPH, FCCP, wrote in an editorial.

“This study further supports the notion that procalcitonin has a limited prognostic accuracy as a stand-alone test. It also does not seem to outperform the risk estimation of a combination of clinical and laboratorial parameters. However, it also emphasizes its potential to capture nuances elusive to the clinical assessment, which do not seem to be consistently reflected even in elaborated severity scores recommended for clinical routine use,” she said (Chest. 2016;150[4]:769-71. doi: 10.1016/j.chest.2016.07.017).

[Procalcitonin] values vary according to the pneumonia severity and this association is stronger than the one between disease severity and other clinical and laboratory variables,” she said.

Risk scores like the ATS system can be weak, “in particular with regard to positive predictive values,” Dr. Stolz wrote. And this is an important issue. “It is clear that patients fulfilling major criteria (endotracheal intubation and mechanical ventilation; shock-requiring vasopressors) should be considered for ICU admission; however, there is still controversy about the value of the minor criteria. ICU care is costly and a limited resource worldwide.”

She called for “a randomized study evaluating the outcome and cost-effectiveness of a procalcitonin-refined clinical score in severe [community acquired pneumonia].”

Dr. Stolz is a pulmonologist at the University Hospital Basel, Switzerland. She reported financial relationships with several pharmaceutical companies.

Body

 

While measuring procalcitonin adds valuable information to pneumonia risk stratification schemes, this process lacks the accuracy needed to enable the diagnosis of pneumonia as a stand-alone test, Daiana Stolz, MD, MPH, FCCP, wrote in an editorial.

“This study further supports the notion that procalcitonin has a limited prognostic accuracy as a stand-alone test. It also does not seem to outperform the risk estimation of a combination of clinical and laboratorial parameters. However, it also emphasizes its potential to capture nuances elusive to the clinical assessment, which do not seem to be consistently reflected even in elaborated severity scores recommended for clinical routine use,” she said (Chest. 2016;150[4]:769-71. doi: 10.1016/j.chest.2016.07.017).

[Procalcitonin] values vary according to the pneumonia severity and this association is stronger than the one between disease severity and other clinical and laboratory variables,” she said.

Risk scores like the ATS system can be weak, “in particular with regard to positive predictive values,” Dr. Stolz wrote. And this is an important issue. “It is clear that patients fulfilling major criteria (endotracheal intubation and mechanical ventilation; shock-requiring vasopressors) should be considered for ICU admission; however, there is still controversy about the value of the minor criteria. ICU care is costly and a limited resource worldwide.”

She called for “a randomized study evaluating the outcome and cost-effectiveness of a procalcitonin-refined clinical score in severe [community acquired pneumonia].”

Dr. Stolz is a pulmonologist at the University Hospital Basel, Switzerland. She reported financial relationships with several pharmaceutical companies.

Title
Procalcitonin alone cannot diagnose pneumonia
Procalcitonin alone cannot diagnose pneumonia

 

Procalcitonin can help predict which patients with community-acquired pneumonia may require intubation for respiratory failure during a hospital admission.

Compared to those with undetectable levels, patients with a procalcitonin of 5 ng/mL were three times more likely to require invasive respiratory support, and those with a 10 ng/mL level were five times more likely, reported Wesley Self, MD, and his colleagues (Chest. 2016;150[4]:819-28. doi: 10.1016/j.chest.2016.04.010).

While predictive accuracy isn’t good enough to merit use of procalcitonin as a stand-alone test, adding it to existing clinical management tools “is likely to improve identification of patients needing intensive care,” wrote Dr. Self of Vanderbilt University, Nashville, and his colleagues. “An elevated procalcitonin level may help identify these patients without overt clinical signs of impending respiratory failure or shock but who would benefit from early [intensive care unit] admission.”

The team examined serum procalcitonin as a biomarker in a subgroup of patients included in the Etiology of Pneumonia in the Community (EPIC) study of adults hospitalized with community-acquire pneumonia. The primary outcome was the need for invasive respiratory and/or vasopressor support (IRVS) within 72 hours.

Secondarily, they looked at whether adding procalcitonin boosted the performance of accepted pneumonia risk scores, including the American Thoracic Society minor criteria (ATS).

The cohort comprised 1,770 patients with a median age of 57 years. Of these, 115 (6.5%) needed IRVS within 72 hours of admission. Almost 16% were admitted directly into an intensive care unit; almost 7% experienced a delayed transfer from a medical unit into an ICU. The in-hospital mortality was about 2%.

Most (1,642) had an ATS score of less than 3; among these, about 5% needed IRVS. The remainder had a score of 3 or higher; about 30% required IRVS. All had procalcitonin levels pulled at admission. The levels were significantly higher among patients who required IRVS than those who didn’t (1.43 ng/mL vs. 0.14 ng/mL).

A multivariate analysis found that procalcitonin was strongly associated with the risk of IRVS. In patients with undetectable levels, the risk was 4%. At 5-10 ng/mL, the overall risk of IRVS was about 14%. Every 1-ng/mL increase in this range boosted the risk of IRVS by 1%-2%.

Adding the measurement of procalcitonin to traditional pneumonia severity risk scores significantly improved the patients’ performance. When stratified by ATS minor criteria, the risk of IRVS was 4.7% among low-risk patients. That decreased to 2.4% with the addition of undetectable procalcitonin, and increased to 12% with the addition of a 10 ng/mL level.

Conversely, without considering procalcitonin, ATS high-risk patients had almost a 30% risk of IRVS. Among these high-risk patients, IRVS risk dropped to 13% with undetectable procalcitonin and increased to 36% with high procalcitonin.

Adding the biomarker level to the ATS system improved its ability to correctly classify patients, the team said. “Using at least 3 ATS minor criteria alone to indicate high risk, 77 (4.4%) of the 1,770 total patients were misclassified as low-risk and experienced IRVS. Including procalcitonin of at least 0.83 ng/ml in addition … as a high-risk indicator reduced the number of patients with IRVS misclassified as low risk to 44 (2.5%). Adding procalcitonin of at least 0.83 ng/mL as a high-risk indicator resulted in 370 additional patients being classified as high risk, with 33 correctly classified as having IRVS.”

Dr. Self reported financial relationships with multiple pharmaceutical companies.

 

Procalcitonin can help predict which patients with community-acquired pneumonia may require intubation for respiratory failure during a hospital admission.

Compared to those with undetectable levels, patients with a procalcitonin of 5 ng/mL were three times more likely to require invasive respiratory support, and those with a 10 ng/mL level were five times more likely, reported Wesley Self, MD, and his colleagues (Chest. 2016;150[4]:819-28. doi: 10.1016/j.chest.2016.04.010).

While predictive accuracy isn’t good enough to merit use of procalcitonin as a stand-alone test, adding it to existing clinical management tools “is likely to improve identification of patients needing intensive care,” wrote Dr. Self of Vanderbilt University, Nashville, and his colleagues. “An elevated procalcitonin level may help identify these patients without overt clinical signs of impending respiratory failure or shock but who would benefit from early [intensive care unit] admission.”

The team examined serum procalcitonin as a biomarker in a subgroup of patients included in the Etiology of Pneumonia in the Community (EPIC) study of adults hospitalized with community-acquire pneumonia. The primary outcome was the need for invasive respiratory and/or vasopressor support (IRVS) within 72 hours.

Secondarily, they looked at whether adding procalcitonin boosted the performance of accepted pneumonia risk scores, including the American Thoracic Society minor criteria (ATS).

The cohort comprised 1,770 patients with a median age of 57 years. Of these, 115 (6.5%) needed IRVS within 72 hours of admission. Almost 16% were admitted directly into an intensive care unit; almost 7% experienced a delayed transfer from a medical unit into an ICU. The in-hospital mortality was about 2%.

Most (1,642) had an ATS score of less than 3; among these, about 5% needed IRVS. The remainder had a score of 3 or higher; about 30% required IRVS. All had procalcitonin levels pulled at admission. The levels were significantly higher among patients who required IRVS than those who didn’t (1.43 ng/mL vs. 0.14 ng/mL).

A multivariate analysis found that procalcitonin was strongly associated with the risk of IRVS. In patients with undetectable levels, the risk was 4%. At 5-10 ng/mL, the overall risk of IRVS was about 14%. Every 1-ng/mL increase in this range boosted the risk of IRVS by 1%-2%.

Adding the measurement of procalcitonin to traditional pneumonia severity risk scores significantly improved the patients’ performance. When stratified by ATS minor criteria, the risk of IRVS was 4.7% among low-risk patients. That decreased to 2.4% with the addition of undetectable procalcitonin, and increased to 12% with the addition of a 10 ng/mL level.

Conversely, without considering procalcitonin, ATS high-risk patients had almost a 30% risk of IRVS. Among these high-risk patients, IRVS risk dropped to 13% with undetectable procalcitonin and increased to 36% with high procalcitonin.

Adding the biomarker level to the ATS system improved its ability to correctly classify patients, the team said. “Using at least 3 ATS minor criteria alone to indicate high risk, 77 (4.4%) of the 1,770 total patients were misclassified as low-risk and experienced IRVS. Including procalcitonin of at least 0.83 ng/ml in addition … as a high-risk indicator reduced the number of patients with IRVS misclassified as low risk to 44 (2.5%). Adding procalcitonin of at least 0.83 ng/mL as a high-risk indicator resulted in 370 additional patients being classified as high risk, with 33 correctly classified as having IRVS.”

Dr. Self reported financial relationships with multiple pharmaceutical companies.

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Key clinical point: Procalcitonin can help predict which patients with community-acquired pneumonia require invasive respiratory support during a hospital admission.

Major finding: At a procalcitonin level of 5-10 ng/mL, the overall risk of invasive respiratory and/or vasopressor support was about 14%.

Data source: The analysis comprised 1,770 patients.

Disclosures: Dr. Self reported financial relationships with several pharmaceutical companies.

Beta-blockers reduce pain, opioid use in osteoarthritis

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Beta-blockers were associated with less pain and lower opioid consumption in a case-control study of nearly 900 patients with osteoarthritis, Ana Valdes, PhD, and her colleagues reported in Arthritis Care & Research.

There is some mechanistic support for the association, which has been observed in other pain disorders, noted Dr. Valdes of the University of Nottingham (England) and her coauthors (Arthritis Care Res. 2016 Oct 1. doi: 10.1002/acr.23091).

An older man bends over in pain with his hands on his left knee.
©KatarzynaBialasiewicz/Thinkstock.com
“Adrenergic neurotransmission is an integral part of the pathways that regulate the response to pain and stress,” the investigators wrote. “The increase in alpha1-adrenoceptor expression after nerve and tissue injury plays a role in neuropathic pain syndromes, and beta2-adrenergic receptor modulates the response to morphine. ... Importantly, both in patients with fibromyalgia and in those with temporomandibular joint disorder the number of painful body sites and self-reported pain severity is significantly lower after beta blockade when compared to placebo.”

The cohort was drawn from the Genetics of Osteoarthritis and Lifestyle (GOAL) study. Dr. Valdes and her associates examined the effect of beta-blocker use on pain as measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score in 873 patients with knee and/or hip osteoarthritis. All were already taking at least one antihypertensive drug. The presence of “joint pain” was defined as a WOMAC score of less than 75. The multivariate analysis adjusted for age, gender, body mass index, knee or hip OA, history of other joint replacement, anxiety, and depression. Patients were a mean of about 69 years old; 347 were taking a beta-blocker.

After adjusting for the confounders, those taking the drugs were 32% less likely to report joint pain (odds ratio, 0.68). The effect seemed time bound: For every year on a beta-blocker, patients had a 4% decline in the risk of joint pain. The benefit was of similar magnitude regardless of whether patients had joint replacement. Beta-blockers also reduced the rate of opioid prescription by 27% (OR, 0.73), the authors noted.

They also found a similar benefit to the use of adrenergic blockers in general, but not with alpha-blockers. No other class of antihypertensive drugs showed any association with joint pain or with prescription of analgesics.

“These results might raise some future research questions for the treatment of hypertension in individuals with joint pain. Current guidance [in both the United Kingdom and United States] state that beta-blockers should no longer be preferred as an initial therapy for routine hypertension and should be used only when there is a compelling indication other than blood pressure control (for example, angina or chronic heart failure). If confirmed in randomized controlled trials, the data presented here could suggest that, in people with chronic joint pain beta-blockers may be considered as part of their antihypertensive regimen.”

The study was funded by the Arthritis Research UK Pain Centre, the European League Against Rheumatism, and AstraZeneca. Dr. Valdes had no financial disclosure, but one coauthor reported owning AstraZeneca stock.

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Beta-blockers were associated with less pain and lower opioid consumption in a case-control study of nearly 900 patients with osteoarthritis, Ana Valdes, PhD, and her colleagues reported in Arthritis Care & Research.

There is some mechanistic support for the association, which has been observed in other pain disorders, noted Dr. Valdes of the University of Nottingham (England) and her coauthors (Arthritis Care Res. 2016 Oct 1. doi: 10.1002/acr.23091).

An older man bends over in pain with his hands on his left knee.
©KatarzynaBialasiewicz/Thinkstock.com
“Adrenergic neurotransmission is an integral part of the pathways that regulate the response to pain and stress,” the investigators wrote. “The increase in alpha1-adrenoceptor expression after nerve and tissue injury plays a role in neuropathic pain syndromes, and beta2-adrenergic receptor modulates the response to morphine. ... Importantly, both in patients with fibromyalgia and in those with temporomandibular joint disorder the number of painful body sites and self-reported pain severity is significantly lower after beta blockade when compared to placebo.”

The cohort was drawn from the Genetics of Osteoarthritis and Lifestyle (GOAL) study. Dr. Valdes and her associates examined the effect of beta-blocker use on pain as measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score in 873 patients with knee and/or hip osteoarthritis. All were already taking at least one antihypertensive drug. The presence of “joint pain” was defined as a WOMAC score of less than 75. The multivariate analysis adjusted for age, gender, body mass index, knee or hip OA, history of other joint replacement, anxiety, and depression. Patients were a mean of about 69 years old; 347 were taking a beta-blocker.

After adjusting for the confounders, those taking the drugs were 32% less likely to report joint pain (odds ratio, 0.68). The effect seemed time bound: For every year on a beta-blocker, patients had a 4% decline in the risk of joint pain. The benefit was of similar magnitude regardless of whether patients had joint replacement. Beta-blockers also reduced the rate of opioid prescription by 27% (OR, 0.73), the authors noted.

They also found a similar benefit to the use of adrenergic blockers in general, but not with alpha-blockers. No other class of antihypertensive drugs showed any association with joint pain or with prescription of analgesics.

“These results might raise some future research questions for the treatment of hypertension in individuals with joint pain. Current guidance [in both the United Kingdom and United States] state that beta-blockers should no longer be preferred as an initial therapy for routine hypertension and should be used only when there is a compelling indication other than blood pressure control (for example, angina or chronic heart failure). If confirmed in randomized controlled trials, the data presented here could suggest that, in people with chronic joint pain beta-blockers may be considered as part of their antihypertensive regimen.”

The study was funded by the Arthritis Research UK Pain Centre, the European League Against Rheumatism, and AstraZeneca. Dr. Valdes had no financial disclosure, but one coauthor reported owning AstraZeneca stock.

 

Beta-blockers were associated with less pain and lower opioid consumption in a case-control study of nearly 900 patients with osteoarthritis, Ana Valdes, PhD, and her colleagues reported in Arthritis Care & Research.

There is some mechanistic support for the association, which has been observed in other pain disorders, noted Dr. Valdes of the University of Nottingham (England) and her coauthors (Arthritis Care Res. 2016 Oct 1. doi: 10.1002/acr.23091).

An older man bends over in pain with his hands on his left knee.
©KatarzynaBialasiewicz/Thinkstock.com
“Adrenergic neurotransmission is an integral part of the pathways that regulate the response to pain and stress,” the investigators wrote. “The increase in alpha1-adrenoceptor expression after nerve and tissue injury plays a role in neuropathic pain syndromes, and beta2-adrenergic receptor modulates the response to morphine. ... Importantly, both in patients with fibromyalgia and in those with temporomandibular joint disorder the number of painful body sites and self-reported pain severity is significantly lower after beta blockade when compared to placebo.”

The cohort was drawn from the Genetics of Osteoarthritis and Lifestyle (GOAL) study. Dr. Valdes and her associates examined the effect of beta-blocker use on pain as measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score in 873 patients with knee and/or hip osteoarthritis. All were already taking at least one antihypertensive drug. The presence of “joint pain” was defined as a WOMAC score of less than 75. The multivariate analysis adjusted for age, gender, body mass index, knee or hip OA, history of other joint replacement, anxiety, and depression. Patients were a mean of about 69 years old; 347 were taking a beta-blocker.

After adjusting for the confounders, those taking the drugs were 32% less likely to report joint pain (odds ratio, 0.68). The effect seemed time bound: For every year on a beta-blocker, patients had a 4% decline in the risk of joint pain. The benefit was of similar magnitude regardless of whether patients had joint replacement. Beta-blockers also reduced the rate of opioid prescription by 27% (OR, 0.73), the authors noted.

They also found a similar benefit to the use of adrenergic blockers in general, but not with alpha-blockers. No other class of antihypertensive drugs showed any association with joint pain or with prescription of analgesics.

“These results might raise some future research questions for the treatment of hypertension in individuals with joint pain. Current guidance [in both the United Kingdom and United States] state that beta-blockers should no longer be preferred as an initial therapy for routine hypertension and should be used only when there is a compelling indication other than blood pressure control (for example, angina or chronic heart failure). If confirmed in randomized controlled trials, the data presented here could suggest that, in people with chronic joint pain beta-blockers may be considered as part of their antihypertensive regimen.”

The study was funded by the Arthritis Research UK Pain Centre, the European League Against Rheumatism, and AstraZeneca. Dr. Valdes had no financial disclosure, but one coauthor reported owning AstraZeneca stock.

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Key clinical point: Patients with OA who took beta-blockers for hypertension reported less pain and lower opioid consumption.

Major finding: The likelihood of joint pain was 32% and opioid use 27% lower in patients taking beta-blockers, compared with those not taking them.

Data source: The case-control study comprised 873 patients.

Disclosures: The study was funded by the Arthritis Research UK Pain Centre, the European League Against Rheumatism, and AstraZeneca. Dr. Valdes had no financial disclosure, but one coauthor reported owning AstraZeneca stock.

Four of five health care providers get flu shot

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nfluenza vaccine coverage among U.S. health care personnel increased very slightly during the 2015-2016 flu season, with 79% reporting that they received the shot, compared with 77% in 2014-2015.

Hospital personnel were most likely to be covered (91%) and long-term care personnel least likely to be covered (69%), Carla L. Black, PhD, wrote in the Sept. 30 issue of Morbidity and Mortality Weekly Report (2016;65:1026-31). Coverage among health care personnel working in long-term care settings did increase, however, from 64% in the 2014-2015 seasons to 69% in the 2015-2016 season, Dr. Black and colleagues noted.

“Although low, this is the only setting with an appreciable increase in coverage, compared with last season. Influenza vaccination among health care personnel in long-term care settings is especially important because influenza vaccine effectiveness is generally lowest in the elderly,” according to Dr Black, an epidemiologist with the Centers for Disease Control and Prevention.

CDC conducted the Internet survey of 2,258 health care workers from March to April, 2016.

Physicians had the highest level of coverage (95.6%), while health care assistants and aides had the lowest (64.5%). Employers also exerted an influence on coverage. Most respondents (73%) were vaccinated at work. Coverage was highest (96.5%) at facilities where vaccination was required and lowest (45%) where vaccination was not required, promoted, or offered on site.

“Employer vaccination requirements likely contributed to the observed gradual increase in vaccination among health care personnel working in settings with the lowest coverage,” the investigators noted. “In the absence of vaccination requirements, expanding the number of health care locations offering vaccination on site, over multiple days, and at no cost might help sustain and improve influenza vaccination coverage among health care personnel, including in long-term care settings.”

As a CDC employee, Dr. Black has no financial conflicts.

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nfluenza vaccine coverage among U.S. health care personnel increased very slightly during the 2015-2016 flu season, with 79% reporting that they received the shot, compared with 77% in 2014-2015.

Hospital personnel were most likely to be covered (91%) and long-term care personnel least likely to be covered (69%), Carla L. Black, PhD, wrote in the Sept. 30 issue of Morbidity and Mortality Weekly Report (2016;65:1026-31). Coverage among health care personnel working in long-term care settings did increase, however, from 64% in the 2014-2015 seasons to 69% in the 2015-2016 season, Dr. Black and colleagues noted.

“Although low, this is the only setting with an appreciable increase in coverage, compared with last season. Influenza vaccination among health care personnel in long-term care settings is especially important because influenza vaccine effectiveness is generally lowest in the elderly,” according to Dr Black, an epidemiologist with the Centers for Disease Control and Prevention.

CDC conducted the Internet survey of 2,258 health care workers from March to April, 2016.

Physicians had the highest level of coverage (95.6%), while health care assistants and aides had the lowest (64.5%). Employers also exerted an influence on coverage. Most respondents (73%) were vaccinated at work. Coverage was highest (96.5%) at facilities where vaccination was required and lowest (45%) where vaccination was not required, promoted, or offered on site.

“Employer vaccination requirements likely contributed to the observed gradual increase in vaccination among health care personnel working in settings with the lowest coverage,” the investigators noted. “In the absence of vaccination requirements, expanding the number of health care locations offering vaccination on site, over multiple days, and at no cost might help sustain and improve influenza vaccination coverage among health care personnel, including in long-term care settings.”

As a CDC employee, Dr. Black has no financial conflicts.

 

nfluenza vaccine coverage among U.S. health care personnel increased very slightly during the 2015-2016 flu season, with 79% reporting that they received the shot, compared with 77% in 2014-2015.

Hospital personnel were most likely to be covered (91%) and long-term care personnel least likely to be covered (69%), Carla L. Black, PhD, wrote in the Sept. 30 issue of Morbidity and Mortality Weekly Report (2016;65:1026-31). Coverage among health care personnel working in long-term care settings did increase, however, from 64% in the 2014-2015 seasons to 69% in the 2015-2016 season, Dr. Black and colleagues noted.

“Although low, this is the only setting with an appreciable increase in coverage, compared with last season. Influenza vaccination among health care personnel in long-term care settings is especially important because influenza vaccine effectiveness is generally lowest in the elderly,” according to Dr Black, an epidemiologist with the Centers for Disease Control and Prevention.

CDC conducted the Internet survey of 2,258 health care workers from March to April, 2016.

Physicians had the highest level of coverage (95.6%), while health care assistants and aides had the lowest (64.5%). Employers also exerted an influence on coverage. Most respondents (73%) were vaccinated at work. Coverage was highest (96.5%) at facilities where vaccination was required and lowest (45%) where vaccination was not required, promoted, or offered on site.

“Employer vaccination requirements likely contributed to the observed gradual increase in vaccination among health care personnel working in settings with the lowest coverage,” the investigators noted. “In the absence of vaccination requirements, expanding the number of health care locations offering vaccination on site, over multiple days, and at no cost might help sustain and improve influenza vaccination coverage among health care personnel, including in long-term care settings.”

As a CDC employee, Dr. Black has no financial conflicts.

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Key clinical point: Overall, flu vaccine coverage stayed the same in 2015-2016 as it was the year before.

Major finding: The flu vaccination rate was 79% among health care workers.

Data source: An Internet survey contained data on 2,258 people.

Disclosures: As a CDC employee, Dr. Black has no financial disclosures.

For HPV-negative women, longer screening intervals are effective

Extending the screening interval: Is longer better?
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It may be safe to extend cervical cancer screening intervals beyond 5 years, at least for women who are not infected with human papillomavirus.

The rate of cervical cancers was the same among HPV-negative women, whether they had gone through two or three rounds of 5-year exams using both HPV testing and cervical cytology, a large Dutch study has found. This suggests a longer period between screenings wouldn’t significantly increase the risk of letting new cancers go unnoticed, Maaike G Dijkstra, MD, and associates reported (BMJ. 2016;355:i4924. doi: 10.1136/bmj.i4924).

The picture, however, is very different for women with an HPV infection, the researchers noted. These women were 12 times more likely to develop cervical cancer and up to 29 times more likely to have a cervical intraepithelial neoplasia of at least grade 3 (CIN3+), compared with women who were HPV negative.

The findings bring a measure of reassurance to the Dutch population, the researchers wrote. The Netherlands intends to lengthen its cervical cancer screening interval to 10 years for HPV-negative women aged 40 years or older.

“HPV-negative women have a very low risk of CIN3+ in the long term, indicating that extension of the current screening interval in the Netherlands to 10 years seems justifiable,” wrote Dr. Dijkstra of the VU University Medical Centre, Amsterdam, and her colleagues. “For HPV positive, triage negative women, the long term risk of CIN3+ was too high to support an extension of the screening interval beyond 5 years.”

The study assessed the 14-year risks of cervical cancer and CIN3+ in 43,339 women aged 29 years and older. As per national guidelines, all women underwent cervical cancer screening every 5 years, resulting in three rounds. They were randomized to receive HPV and cytology testing or cytology only.

Among HPV-negative women in the double-screening group, the cumulative cervical cancer incidence was 0.03% after round two and 0.09% after round three – not a statistically significant difference.

After round three, cervical cancer incidence among HPV-negative women with negative cytology (double negative) was similar to that among cytology-negative women from the control group after round two.

In the cytology-only group, the rates among negative women were 0.09% after round two of screening and 0.19% after round three.

“This indicated that a negative HPV test provides longer reassurance against cervical cancer than negative cytology,” the researchers noted.

HPV-positive women, however, faced much higher risks, regardless of the screening protocol. Even with negative cytology, they were 12 times more likely to have a cancer by round three than HPV-negative women. The risk of CIN3+ was up to 29 times higher. Even HPV-positive women with negative cytology, negative HPV 16/18 genotyping, and negative repeat cytology faced a 10-fold increased risk of CIN+3, the researchers reported.

Dr. Dijkstra reported having no financial disclosures. Several of the coauthors disclosed financial relationships with various pharmaceutical companies.

Body

 

The ultimate goal of cervical cancer screening is to minimize unnecessary procedures while maximizing identification of preinvasive disease. The recent article by Dr. Dijkstra and her associates provides 14-year follow-up for a national population-based cervical screening randomized trial.

The authors, who focused their analysis on patients older than age 40, describe how HPV results allow for a more targeted intervention triage than cytology alone. The study is impressive in its large patient cohort and extremely low detection rate of cervical cancer among HPV-negative patients in the intervention group. Their main argument stems from identifying an equivalent risk for CIN3+ between patients who were negative for HPV at 10 years and those with negative cytology at 5 years.

In the United States, current guidelines endorse cotesting for patients in this age group, with a negative cotest requiring repeat testing at 5 years. Changes to the screening protocol in the United States are often met with skepticism and slow uptake. This study certainly shows strong data to support HPV testing as the preferred option, but when does the time gap between screenings become too large, particularly for women whose only health care evaluation is through the gynecologist? Patients often think that not needing yearly Pap test equates to no need for routine examinations. We may be missing out on the opportunity to not only grow the patient-physician relationship, but also impact other aspects of the patients’ general health.

This article may not change practice, but it does add considerable weight to the growing literature on primary HPV screening, especially in an older population.
 

Ritu Salani, MD, is associate professor of gynecologic oncology at Ohio State University in Columbus. Robert T. Neff, MD, is a second-year fellow in gynecologic oncology at the university. They reported having no relevant financial disclosures.

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The ultimate goal of cervical cancer screening is to minimize unnecessary procedures while maximizing identification of preinvasive disease. The recent article by Dr. Dijkstra and her associates provides 14-year follow-up for a national population-based cervical screening randomized trial.

The authors, who focused their analysis on patients older than age 40, describe how HPV results allow for a more targeted intervention triage than cytology alone. The study is impressive in its large patient cohort and extremely low detection rate of cervical cancer among HPV-negative patients in the intervention group. Their main argument stems from identifying an equivalent risk for CIN3+ between patients who were negative for HPV at 10 years and those with negative cytology at 5 years.

In the United States, current guidelines endorse cotesting for patients in this age group, with a negative cotest requiring repeat testing at 5 years. Changes to the screening protocol in the United States are often met with skepticism and slow uptake. This study certainly shows strong data to support HPV testing as the preferred option, but when does the time gap between screenings become too large, particularly for women whose only health care evaluation is through the gynecologist? Patients often think that not needing yearly Pap test equates to no need for routine examinations. We may be missing out on the opportunity to not only grow the patient-physician relationship, but also impact other aspects of the patients’ general health.

This article may not change practice, but it does add considerable weight to the growing literature on primary HPV screening, especially in an older population.
 

Ritu Salani, MD, is associate professor of gynecologic oncology at Ohio State University in Columbus. Robert T. Neff, MD, is a second-year fellow in gynecologic oncology at the university. They reported having no relevant financial disclosures.

Body

 

The ultimate goal of cervical cancer screening is to minimize unnecessary procedures while maximizing identification of preinvasive disease. The recent article by Dr. Dijkstra and her associates provides 14-year follow-up for a national population-based cervical screening randomized trial.

The authors, who focused their analysis on patients older than age 40, describe how HPV results allow for a more targeted intervention triage than cytology alone. The study is impressive in its large patient cohort and extremely low detection rate of cervical cancer among HPV-negative patients in the intervention group. Their main argument stems from identifying an equivalent risk for CIN3+ between patients who were negative for HPV at 10 years and those with negative cytology at 5 years.

In the United States, current guidelines endorse cotesting for patients in this age group, with a negative cotest requiring repeat testing at 5 years. Changes to the screening protocol in the United States are often met with skepticism and slow uptake. This study certainly shows strong data to support HPV testing as the preferred option, but when does the time gap between screenings become too large, particularly for women whose only health care evaluation is through the gynecologist? Patients often think that not needing yearly Pap test equates to no need for routine examinations. We may be missing out on the opportunity to not only grow the patient-physician relationship, but also impact other aspects of the patients’ general health.

This article may not change practice, but it does add considerable weight to the growing literature on primary HPV screening, especially in an older population.
 

Ritu Salani, MD, is associate professor of gynecologic oncology at Ohio State University in Columbus. Robert T. Neff, MD, is a second-year fellow in gynecologic oncology at the university. They reported having no relevant financial disclosures.

Title
Extending the screening interval: Is longer better?
Extending the screening interval: Is longer better?

 

It may be safe to extend cervical cancer screening intervals beyond 5 years, at least for women who are not infected with human papillomavirus.

The rate of cervical cancers was the same among HPV-negative women, whether they had gone through two or three rounds of 5-year exams using both HPV testing and cervical cytology, a large Dutch study has found. This suggests a longer period between screenings wouldn’t significantly increase the risk of letting new cancers go unnoticed, Maaike G Dijkstra, MD, and associates reported (BMJ. 2016;355:i4924. doi: 10.1136/bmj.i4924).

The picture, however, is very different for women with an HPV infection, the researchers noted. These women were 12 times more likely to develop cervical cancer and up to 29 times more likely to have a cervical intraepithelial neoplasia of at least grade 3 (CIN3+), compared with women who were HPV negative.

The findings bring a measure of reassurance to the Dutch population, the researchers wrote. The Netherlands intends to lengthen its cervical cancer screening interval to 10 years for HPV-negative women aged 40 years or older.

“HPV-negative women have a very low risk of CIN3+ in the long term, indicating that extension of the current screening interval in the Netherlands to 10 years seems justifiable,” wrote Dr. Dijkstra of the VU University Medical Centre, Amsterdam, and her colleagues. “For HPV positive, triage negative women, the long term risk of CIN3+ was too high to support an extension of the screening interval beyond 5 years.”

The study assessed the 14-year risks of cervical cancer and CIN3+ in 43,339 women aged 29 years and older. As per national guidelines, all women underwent cervical cancer screening every 5 years, resulting in three rounds. They were randomized to receive HPV and cytology testing or cytology only.

Among HPV-negative women in the double-screening group, the cumulative cervical cancer incidence was 0.03% after round two and 0.09% after round three – not a statistically significant difference.

After round three, cervical cancer incidence among HPV-negative women with negative cytology (double negative) was similar to that among cytology-negative women from the control group after round two.

In the cytology-only group, the rates among negative women were 0.09% after round two of screening and 0.19% after round three.

“This indicated that a negative HPV test provides longer reassurance against cervical cancer than negative cytology,” the researchers noted.

HPV-positive women, however, faced much higher risks, regardless of the screening protocol. Even with negative cytology, they were 12 times more likely to have a cancer by round three than HPV-negative women. The risk of CIN3+ was up to 29 times higher. Even HPV-positive women with negative cytology, negative HPV 16/18 genotyping, and negative repeat cytology faced a 10-fold increased risk of CIN+3, the researchers reported.

Dr. Dijkstra reported having no financial disclosures. Several of the coauthors disclosed financial relationships with various pharmaceutical companies.

 

It may be safe to extend cervical cancer screening intervals beyond 5 years, at least for women who are not infected with human papillomavirus.

The rate of cervical cancers was the same among HPV-negative women, whether they had gone through two or three rounds of 5-year exams using both HPV testing and cervical cytology, a large Dutch study has found. This suggests a longer period between screenings wouldn’t significantly increase the risk of letting new cancers go unnoticed, Maaike G Dijkstra, MD, and associates reported (BMJ. 2016;355:i4924. doi: 10.1136/bmj.i4924).

The picture, however, is very different for women with an HPV infection, the researchers noted. These women were 12 times more likely to develop cervical cancer and up to 29 times more likely to have a cervical intraepithelial neoplasia of at least grade 3 (CIN3+), compared with women who were HPV negative.

The findings bring a measure of reassurance to the Dutch population, the researchers wrote. The Netherlands intends to lengthen its cervical cancer screening interval to 10 years for HPV-negative women aged 40 years or older.

“HPV-negative women have a very low risk of CIN3+ in the long term, indicating that extension of the current screening interval in the Netherlands to 10 years seems justifiable,” wrote Dr. Dijkstra of the VU University Medical Centre, Amsterdam, and her colleagues. “For HPV positive, triage negative women, the long term risk of CIN3+ was too high to support an extension of the screening interval beyond 5 years.”

The study assessed the 14-year risks of cervical cancer and CIN3+ in 43,339 women aged 29 years and older. As per national guidelines, all women underwent cervical cancer screening every 5 years, resulting in three rounds. They were randomized to receive HPV and cytology testing or cytology only.

Among HPV-negative women in the double-screening group, the cumulative cervical cancer incidence was 0.03% after round two and 0.09% after round three – not a statistically significant difference.

After round three, cervical cancer incidence among HPV-negative women with negative cytology (double negative) was similar to that among cytology-negative women from the control group after round two.

In the cytology-only group, the rates among negative women were 0.09% after round two of screening and 0.19% after round three.

“This indicated that a negative HPV test provides longer reassurance against cervical cancer than negative cytology,” the researchers noted.

HPV-positive women, however, faced much higher risks, regardless of the screening protocol. Even with negative cytology, they were 12 times more likely to have a cancer by round three than HPV-negative women. The risk of CIN3+ was up to 29 times higher. Even HPV-positive women with negative cytology, negative HPV 16/18 genotyping, and negative repeat cytology faced a 10-fold increased risk of CIN+3, the researchers reported.

Dr. Dijkstra reported having no financial disclosures. Several of the coauthors disclosed financial relationships with various pharmaceutical companies.

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Key clinical point: When screening with both HPV testing and cytology, rates of cervical cancer among HPV-negative women were similar after screening at 5 and 10 years.

Major finding: The cumulative cervical cancer incidence was 0.03% after round two and 0.09% after round three – not a statistically significant difference.

Data source: The 14-year study randomized more than 43,000 women to either the double-method screen or just to cervical cytology.

Disclosures: Dr. Dijkstra reported having no financial disclosures. Several of the coauthors disclosed financial relationships with various pharmaceutical companies.

Fulminant HBV reactivation associated with HCV treatment

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Fri, 01/18/2019 - 16:15


Sudden and fulminant reactivation of hepatitis B virus (HBV) infections are occurring among some patients who received direct-acting antiviral (DAA) medicines for concomitant chronic hepatitis C virus, the U.S. Food and Drug Administration has said.

HBV reactivation has been reported in 24 patients since 2013, the agency said in an Oct. 4 statement. One patient died, and one required a liver transplant, likely because of treatment delay, as HBV reactivation wasn’t a primary diagnostic candidate.

The potential for reactivation wasn’t studied in these drugs’ developmental phases, since coinfected patients were always excluded from the clinical trials, the agency noted. It’s unclear why the reactivation happens.

“The mechanism through which HBV reactivation occurs with DAAs is currently unknown. These medicines are not known to cause immunosuppression, but HBV reactivation may result from a complex interplay of host immunologic responses in the setting of infection with two hepatitis viruses.”

In response to the findings, the FDA will require a black box warning on all DAA medications. Before prescribing the drugs, clinicians should screen patients for evidence of current or prior HBV infection. Patients with evidence of current or prior HBV infection should be monitored for HBV surface antigen and HBV DNA, as well as serum aminotransferase bilirubin levels, and watched for signs of hepatitis flare or HBV reactivation during and after DAA treatment. Suspected cases should be reported to FDA MedWatch.

The reactivations occurred within 4-8 weeks of beginning a DAA, the FDA said. “A common sequence of events was initiation of DAA-based HCV treatment, rapid drop of HCV RNA to undetectable levels within 1-2 weeks after normalization of transaminase levels (if they were elevated), followed by a rise in HBV DNA with or without increase in transaminases between weeks 4 and 8.”

Half of the patients did eventually receive HBV antiviral treatment (tenofovir or entecavir). Treatment data were absent on six patients. The remaining six patients did not receive HBV treatment, for unclear reasons.

In eight cases, the initial transaminase increase was interpreted as a DAA drug reaction and the medicine was discontinued. These patients either failed to improve or deteriorated, prompting concerns about HBV reactivation. FDA couldn’t find any commonalities in the cases.

“The patients who developed HBV reactivation were heterogeneous in terms of HCV genotype. These patients were also heterogeneous in terms of baseline HBV disease, fitting into three general categories of patients: those with detectable HBV viral load (seven), those with positive HB surface antigen and undetectable HBV viral load (four), and those with negative HB surface antigen and undetectable HBV viral load (three).”

For the remaining 10 patients, HB surface antigen status was either not known or baseline HBV could not be interpreted.

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Sudden and fulminant reactivation of hepatitis B virus (HBV) infections are occurring among some patients who received direct-acting antiviral (DAA) medicines for concomitant chronic hepatitis C virus, the U.S. Food and Drug Administration has said.

HBV reactivation has been reported in 24 patients since 2013, the agency said in an Oct. 4 statement. One patient died, and one required a liver transplant, likely because of treatment delay, as HBV reactivation wasn’t a primary diagnostic candidate.

The potential for reactivation wasn’t studied in these drugs’ developmental phases, since coinfected patients were always excluded from the clinical trials, the agency noted. It’s unclear why the reactivation happens.

“The mechanism through which HBV reactivation occurs with DAAs is currently unknown. These medicines are not known to cause immunosuppression, but HBV reactivation may result from a complex interplay of host immunologic responses in the setting of infection with two hepatitis viruses.”

In response to the findings, the FDA will require a black box warning on all DAA medications. Before prescribing the drugs, clinicians should screen patients for evidence of current or prior HBV infection. Patients with evidence of current or prior HBV infection should be monitored for HBV surface antigen and HBV DNA, as well as serum aminotransferase bilirubin levels, and watched for signs of hepatitis flare or HBV reactivation during and after DAA treatment. Suspected cases should be reported to FDA MedWatch.

The reactivations occurred within 4-8 weeks of beginning a DAA, the FDA said. “A common sequence of events was initiation of DAA-based HCV treatment, rapid drop of HCV RNA to undetectable levels within 1-2 weeks after normalization of transaminase levels (if they were elevated), followed by a rise in HBV DNA with or without increase in transaminases between weeks 4 and 8.”

Half of the patients did eventually receive HBV antiviral treatment (tenofovir or entecavir). Treatment data were absent on six patients. The remaining six patients did not receive HBV treatment, for unclear reasons.

In eight cases, the initial transaminase increase was interpreted as a DAA drug reaction and the medicine was discontinued. These patients either failed to improve or deteriorated, prompting concerns about HBV reactivation. FDA couldn’t find any commonalities in the cases.

“The patients who developed HBV reactivation were heterogeneous in terms of HCV genotype. These patients were also heterogeneous in terms of baseline HBV disease, fitting into three general categories of patients: those with detectable HBV viral load (seven), those with positive HB surface antigen and undetectable HBV viral load (four), and those with negative HB surface antigen and undetectable HBV viral load (three).”

For the remaining 10 patients, HB surface antigen status was either not known or baseline HBV could not be interpreted.


Sudden and fulminant reactivation of hepatitis B virus (HBV) infections are occurring among some patients who received direct-acting antiviral (DAA) medicines for concomitant chronic hepatitis C virus, the U.S. Food and Drug Administration has said.

HBV reactivation has been reported in 24 patients since 2013, the agency said in an Oct. 4 statement. One patient died, and one required a liver transplant, likely because of treatment delay, as HBV reactivation wasn’t a primary diagnostic candidate.

The potential for reactivation wasn’t studied in these drugs’ developmental phases, since coinfected patients were always excluded from the clinical trials, the agency noted. It’s unclear why the reactivation happens.

“The mechanism through which HBV reactivation occurs with DAAs is currently unknown. These medicines are not known to cause immunosuppression, but HBV reactivation may result from a complex interplay of host immunologic responses in the setting of infection with two hepatitis viruses.”

In response to the findings, the FDA will require a black box warning on all DAA medications. Before prescribing the drugs, clinicians should screen patients for evidence of current or prior HBV infection. Patients with evidence of current or prior HBV infection should be monitored for HBV surface antigen and HBV DNA, as well as serum aminotransferase bilirubin levels, and watched for signs of hepatitis flare or HBV reactivation during and after DAA treatment. Suspected cases should be reported to FDA MedWatch.

The reactivations occurred within 4-8 weeks of beginning a DAA, the FDA said. “A common sequence of events was initiation of DAA-based HCV treatment, rapid drop of HCV RNA to undetectable levels within 1-2 weeks after normalization of transaminase levels (if they were elevated), followed by a rise in HBV DNA with or without increase in transaminases between weeks 4 and 8.”

Half of the patients did eventually receive HBV antiviral treatment (tenofovir or entecavir). Treatment data were absent on six patients. The remaining six patients did not receive HBV treatment, for unclear reasons.

In eight cases, the initial transaminase increase was interpreted as a DAA drug reaction and the medicine was discontinued. These patients either failed to improve or deteriorated, prompting concerns about HBV reactivation. FDA couldn’t find any commonalities in the cases.

“The patients who developed HBV reactivation were heterogeneous in terms of HCV genotype. These patients were also heterogeneous in terms of baseline HBV disease, fitting into three general categories of patients: those with detectable HBV viral load (seven), those with positive HB surface antigen and undetectable HBV viral load (four), and those with negative HB surface antigen and undetectable HBV viral load (three).”

For the remaining 10 patients, HB surface antigen status was either not known or baseline HBV could not be interpreted.

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Key clinical point: Some patients coinfected with HCV and HBV have experienced serious HBV reactivation after receiving direct-acting antivirals.

Major finding: HBV reactivation has been reported in 24 patients since 2013.

Data source: Reports were made to the FDA MedWatch system.

Disclosures: No conflicts of interest were reported.

Most children with JIA get different diagnosis as adults

For many children, is JIA really something else?
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Changed
Tue, 02/07/2023 - 16:59

 

Two-thirds of children diagnosed with juvenile idiopathic arthritis are classified later as having a different form of arthritis as adults, with 72% of them requiring disease-modifying medication and 13% forced into retirement, according to a cross-sectional analysis of a registry database.

But among patients with inactive disease, more than one-third are off medication, and the majority have either no or very mild disabilities, reported Filipa Oliveira-Ramos, MD, of Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Lisbon, and her colleagues (RMD Open 2016;2:e000304. doi: 10.1136/rmdopen-2016-000304).

utah778/Thinkstock
“This study shows that JIA [juvenile idiopathic arthritis] represents a group of very different diseases that evolve differently in adulthood,” the investigators wrote. “We found that most patients with JIA who are followed in adult rheumatology clinics fulfilled classification criteria for adult rheumatic diseases, [and] maintain active disease and functional impairment at long-term follow-up.”

The team used data from the Rheumatic Diseases Portuguese Register database to discern how rheumatic disease classifications evolve as people with JIA grow into adulthood. The analysis comprised 426 patients and examined fulfillment of adult classification criteria, function as assessed by the Health Assessment Questionnaire (HAQ), clinical disease characteristics as assessed by the Juvenile Arthritis Damage Index–articular (JADI-A) and Juvenile Arthritis Damage Index–extra-articular (JADI-E), and disease activity.

The patients were a mean of 34 years old at the time of the last visit entered into the database. The patients’ mean disease duration was 22.5 years, including 80% with at least 10 years and 24% with more than 30 years.

All had been diagnosed with JIA, at a mean age of about 10 years. Disease categories were persistent oligoarthritis (19%), extended oligoarthritis (14%), rheumatoid factor–positive polyarthritis (17%), rheumatoid factor–negative polyarthritis (18%), systemic disease (10%), enthesitis-related arthritis (19%), psoriatic arthritis (3%), and undifferentiated arthritis (1%).

A total of 72% of patients were still employed, although 13% had retired because of disease-related disability. Most (67%) still had active disease, and 72% were taking a disease-modifying antirheumatic drug.

JIA had evolved into numerous new diagnoses, the team observed. Most patients with systemic-onset JIA (92%) were classified as having adult Still’s disease – more than half (58%) with persistent systemic features and about 42% with predominately polyarticular involvement.

The majority of patients with RF-positive polyarthritis (96%) and of those with RF-negative polyarthritis as children (57%) fulfilled the adult criteria for rheumatoid arthritis.

Patients who had persistent oligoarthritis as children were, as adults, most likely be classified with spondyloarthritis (35%), although 59% remained unclassifiable.

Most of the patients with extended oligoarthritis as children were later classified as having either rheumatoid arthritis (39%) or spondyloarthritis (26%). Most patients with juvenile enthesitis-related arthritis were also reclassified as having spondyloarthritis (95%).

All of those with childhood psoriatic arthritis retained that classification as adults.

A smaller portion of patients (21%) were unclassified as adults, the investigators said. Most of these patients had RF-negative polyarticular or oligoarticular classifications as children.

In a series of multivariate analyses, the team found a number of significant associations with adult outcomes. After adjustment for International League of Associations for Rheumatology (ILAR) category, inactive adult disease was associated with shorter disease duration, less delay in diagnosis, a lower HAQ score, and less exposure to corticosteroids. A higher HAQ score was associated with a longer disease duration and exposure to biologics, while a lower HAQ was associated with the persistence of systemic disease features.

Higher JADI-A scores were associated with disability-related retirement, longer disease duration, and past or current use of biologics.

Another series of multivariate models assessed outcomes associated with inactive disease. Patients who were older at disease onset were more likely to have inactive disease as adults. A positive test for anticitrullinated protein antibodies decreased the likelihood of disease inactivity by 93%.

Finally, the investigators evaluated associations with function and clinical characteristics. Younger age at disease onset was associated with higher HAQ and JADI scores in adulthood. Patients with RF-positive polyarthritis and systemic-onset JIA were more likely to have worse JADI-A and JADI-E scores, compared with patients who had persistent oligoarthritis. Corticosteroid exposure was also predictive of worse extra-articular scores on the JADI.

“Understanding the way these juvenile diseases progress could add useful information for the ongoing discussion of a new classification capable of better unifying the language between pediatric and adult care,” the authors concluded.

None of the authors had financial disclosures.

Body

 

This is an important article in that it highlights one of the fundamental flaws of the juvenile idiopathic arthritis classification.

The manifestations of the rheumatic diseases often evolve over time. There may be psoriasis before arthritis, but there also may be arthritis before psoriasis. Similarly, children with an ultimate diagnosis of Crohn’s disease may first present to the rheumatologist with arthritis.

The definition of JIA requires only the onset of arthritis lasting more than 3 weeks before 16 years of age with the exclusion of other obvious cause. A careful reading of the subclassification criteria quickly reveals that many children are “unclassifiable” because of family history or other factors.

The present study makes it clear that by the time they reach adulthood, a significant number of individuals who were told they had JIA will, in fact, meet criteria for a different classification. This would be of only casual interest were it not for the fact that these children will have previously been entered into databases about the natural history of JIA with erroneous classifications.

More worrisome is that fact that some will have been included in therapeutic trials with erroneous classifications as well. The pediatric rheumatology community would do well to recognize the urgent need for a reassessment of the classification criteria and nomenclature to better reflect the diversity of causes of childhood arthritis.

Thomas Lehman, MD, is chief of pediatric rheumatology at the Hospital for Special Surgery, New York. He has no relevant disclosures.

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This is an important article in that it highlights one of the fundamental flaws of the juvenile idiopathic arthritis classification.

The manifestations of the rheumatic diseases often evolve over time. There may be psoriasis before arthritis, but there also may be arthritis before psoriasis. Similarly, children with an ultimate diagnosis of Crohn’s disease may first present to the rheumatologist with arthritis.

The definition of JIA requires only the onset of arthritis lasting more than 3 weeks before 16 years of age with the exclusion of other obvious cause. A careful reading of the subclassification criteria quickly reveals that many children are “unclassifiable” because of family history or other factors.

The present study makes it clear that by the time they reach adulthood, a significant number of individuals who were told they had JIA will, in fact, meet criteria for a different classification. This would be of only casual interest were it not for the fact that these children will have previously been entered into databases about the natural history of JIA with erroneous classifications.

More worrisome is that fact that some will have been included in therapeutic trials with erroneous classifications as well. The pediatric rheumatology community would do well to recognize the urgent need for a reassessment of the classification criteria and nomenclature to better reflect the diversity of causes of childhood arthritis.

Thomas Lehman, MD, is chief of pediatric rheumatology at the Hospital for Special Surgery, New York. He has no relevant disclosures.

Body

 

This is an important article in that it highlights one of the fundamental flaws of the juvenile idiopathic arthritis classification.

The manifestations of the rheumatic diseases often evolve over time. There may be psoriasis before arthritis, but there also may be arthritis before psoriasis. Similarly, children with an ultimate diagnosis of Crohn’s disease may first present to the rheumatologist with arthritis.

The definition of JIA requires only the onset of arthritis lasting more than 3 weeks before 16 years of age with the exclusion of other obvious cause. A careful reading of the subclassification criteria quickly reveals that many children are “unclassifiable” because of family history or other factors.

The present study makes it clear that by the time they reach adulthood, a significant number of individuals who were told they had JIA will, in fact, meet criteria for a different classification. This would be of only casual interest were it not for the fact that these children will have previously been entered into databases about the natural history of JIA with erroneous classifications.

More worrisome is that fact that some will have been included in therapeutic trials with erroneous classifications as well. The pediatric rheumatology community would do well to recognize the urgent need for a reassessment of the classification criteria and nomenclature to better reflect the diversity of causes of childhood arthritis.

Thomas Lehman, MD, is chief of pediatric rheumatology at the Hospital for Special Surgery, New York. He has no relevant disclosures.

Title
For many children, is JIA really something else?
For many children, is JIA really something else?

 

Two-thirds of children diagnosed with juvenile idiopathic arthritis are classified later as having a different form of arthritis as adults, with 72% of them requiring disease-modifying medication and 13% forced into retirement, according to a cross-sectional analysis of a registry database.

But among patients with inactive disease, more than one-third are off medication, and the majority have either no or very mild disabilities, reported Filipa Oliveira-Ramos, MD, of Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Lisbon, and her colleagues (RMD Open 2016;2:e000304. doi: 10.1136/rmdopen-2016-000304).

utah778/Thinkstock
“This study shows that JIA [juvenile idiopathic arthritis] represents a group of very different diseases that evolve differently in adulthood,” the investigators wrote. “We found that most patients with JIA who are followed in adult rheumatology clinics fulfilled classification criteria for adult rheumatic diseases, [and] maintain active disease and functional impairment at long-term follow-up.”

The team used data from the Rheumatic Diseases Portuguese Register database to discern how rheumatic disease classifications evolve as people with JIA grow into adulthood. The analysis comprised 426 patients and examined fulfillment of adult classification criteria, function as assessed by the Health Assessment Questionnaire (HAQ), clinical disease characteristics as assessed by the Juvenile Arthritis Damage Index–articular (JADI-A) and Juvenile Arthritis Damage Index–extra-articular (JADI-E), and disease activity.

The patients were a mean of 34 years old at the time of the last visit entered into the database. The patients’ mean disease duration was 22.5 years, including 80% with at least 10 years and 24% with more than 30 years.

All had been diagnosed with JIA, at a mean age of about 10 years. Disease categories were persistent oligoarthritis (19%), extended oligoarthritis (14%), rheumatoid factor–positive polyarthritis (17%), rheumatoid factor–negative polyarthritis (18%), systemic disease (10%), enthesitis-related arthritis (19%), psoriatic arthritis (3%), and undifferentiated arthritis (1%).

A total of 72% of patients were still employed, although 13% had retired because of disease-related disability. Most (67%) still had active disease, and 72% were taking a disease-modifying antirheumatic drug.

JIA had evolved into numerous new diagnoses, the team observed. Most patients with systemic-onset JIA (92%) were classified as having adult Still’s disease – more than half (58%) with persistent systemic features and about 42% with predominately polyarticular involvement.

The majority of patients with RF-positive polyarthritis (96%) and of those with RF-negative polyarthritis as children (57%) fulfilled the adult criteria for rheumatoid arthritis.

Patients who had persistent oligoarthritis as children were, as adults, most likely be classified with spondyloarthritis (35%), although 59% remained unclassifiable.

Most of the patients with extended oligoarthritis as children were later classified as having either rheumatoid arthritis (39%) or spondyloarthritis (26%). Most patients with juvenile enthesitis-related arthritis were also reclassified as having spondyloarthritis (95%).

All of those with childhood psoriatic arthritis retained that classification as adults.

A smaller portion of patients (21%) were unclassified as adults, the investigators said. Most of these patients had RF-negative polyarticular or oligoarticular classifications as children.

In a series of multivariate analyses, the team found a number of significant associations with adult outcomes. After adjustment for International League of Associations for Rheumatology (ILAR) category, inactive adult disease was associated with shorter disease duration, less delay in diagnosis, a lower HAQ score, and less exposure to corticosteroids. A higher HAQ score was associated with a longer disease duration and exposure to biologics, while a lower HAQ was associated with the persistence of systemic disease features.

Higher JADI-A scores were associated with disability-related retirement, longer disease duration, and past or current use of biologics.

Another series of multivariate models assessed outcomes associated with inactive disease. Patients who were older at disease onset were more likely to have inactive disease as adults. A positive test for anticitrullinated protein antibodies decreased the likelihood of disease inactivity by 93%.

Finally, the investigators evaluated associations with function and clinical characteristics. Younger age at disease onset was associated with higher HAQ and JADI scores in adulthood. Patients with RF-positive polyarthritis and systemic-onset JIA were more likely to have worse JADI-A and JADI-E scores, compared with patients who had persistent oligoarthritis. Corticosteroid exposure was also predictive of worse extra-articular scores on the JADI.

“Understanding the way these juvenile diseases progress could add useful information for the ongoing discussion of a new classification capable of better unifying the language between pediatric and adult care,” the authors concluded.

None of the authors had financial disclosures.

 

Two-thirds of children diagnosed with juvenile idiopathic arthritis are classified later as having a different form of arthritis as adults, with 72% of them requiring disease-modifying medication and 13% forced into retirement, according to a cross-sectional analysis of a registry database.

But among patients with inactive disease, more than one-third are off medication, and the majority have either no or very mild disabilities, reported Filipa Oliveira-Ramos, MD, of Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Lisbon, and her colleagues (RMD Open 2016;2:e000304. doi: 10.1136/rmdopen-2016-000304).

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“This study shows that JIA [juvenile idiopathic arthritis] represents a group of very different diseases that evolve differently in adulthood,” the investigators wrote. “We found that most patients with JIA who are followed in adult rheumatology clinics fulfilled classification criteria for adult rheumatic diseases, [and] maintain active disease and functional impairment at long-term follow-up.”

The team used data from the Rheumatic Diseases Portuguese Register database to discern how rheumatic disease classifications evolve as people with JIA grow into adulthood. The analysis comprised 426 patients and examined fulfillment of adult classification criteria, function as assessed by the Health Assessment Questionnaire (HAQ), clinical disease characteristics as assessed by the Juvenile Arthritis Damage Index–articular (JADI-A) and Juvenile Arthritis Damage Index–extra-articular (JADI-E), and disease activity.

The patients were a mean of 34 years old at the time of the last visit entered into the database. The patients’ mean disease duration was 22.5 years, including 80% with at least 10 years and 24% with more than 30 years.

All had been diagnosed with JIA, at a mean age of about 10 years. Disease categories were persistent oligoarthritis (19%), extended oligoarthritis (14%), rheumatoid factor–positive polyarthritis (17%), rheumatoid factor–negative polyarthritis (18%), systemic disease (10%), enthesitis-related arthritis (19%), psoriatic arthritis (3%), and undifferentiated arthritis (1%).

A total of 72% of patients were still employed, although 13% had retired because of disease-related disability. Most (67%) still had active disease, and 72% were taking a disease-modifying antirheumatic drug.

JIA had evolved into numerous new diagnoses, the team observed. Most patients with systemic-onset JIA (92%) were classified as having adult Still’s disease – more than half (58%) with persistent systemic features and about 42% with predominately polyarticular involvement.

The majority of patients with RF-positive polyarthritis (96%) and of those with RF-negative polyarthritis as children (57%) fulfilled the adult criteria for rheumatoid arthritis.

Patients who had persistent oligoarthritis as children were, as adults, most likely be classified with spondyloarthritis (35%), although 59% remained unclassifiable.

Most of the patients with extended oligoarthritis as children were later classified as having either rheumatoid arthritis (39%) or spondyloarthritis (26%). Most patients with juvenile enthesitis-related arthritis were also reclassified as having spondyloarthritis (95%).

All of those with childhood psoriatic arthritis retained that classification as adults.

A smaller portion of patients (21%) were unclassified as adults, the investigators said. Most of these patients had RF-negative polyarticular or oligoarticular classifications as children.

In a series of multivariate analyses, the team found a number of significant associations with adult outcomes. After adjustment for International League of Associations for Rheumatology (ILAR) category, inactive adult disease was associated with shorter disease duration, less delay in diagnosis, a lower HAQ score, and less exposure to corticosteroids. A higher HAQ score was associated with a longer disease duration and exposure to biologics, while a lower HAQ was associated with the persistence of systemic disease features.

Higher JADI-A scores were associated with disability-related retirement, longer disease duration, and past or current use of biologics.

Another series of multivariate models assessed outcomes associated with inactive disease. Patients who were older at disease onset were more likely to have inactive disease as adults. A positive test for anticitrullinated protein antibodies decreased the likelihood of disease inactivity by 93%.

Finally, the investigators evaluated associations with function and clinical characteristics. Younger age at disease onset was associated with higher HAQ and JADI scores in adulthood. Patients with RF-positive polyarthritis and systemic-onset JIA were more likely to have worse JADI-A and JADI-E scores, compared with patients who had persistent oligoarthritis. Corticosteroid exposure was also predictive of worse extra-articular scores on the JADI.

“Understanding the way these juvenile diseases progress could add useful information for the ongoing discussion of a new classification capable of better unifying the language between pediatric and adult care,” the authors concluded.

None of the authors had financial disclosures.

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Key clinical point: Most children with JIA are reclassified as having a different form of arthritis as adults.

Major finding: The childhood diagnosis of JIA is reclassified to another form of arthritis in two-thirds of patients in adulthood.

Data source: The Rheumatic Diseases Portuguese Register.

Disclosures: None of the authors had financial disclosures.

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‘Bionic pancreas’ employs glucagon and insulin to stabilize blood sugar

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– A “bionic pancreas” that delivers glucagon as well as insulin fared well against conventional insulin pump therapy, significantly reducing mean glucose levels and minimizing time spent in hypoglycemia.

The iLet bionic pancreas is being developed by Beta Bionics in conjunction with Eli Lilly and with support from the National Institutes of Health. Beta Bionics bills itself as a public benefit corporation – “a for-profit entity also dedicated to social responsibility and a public benefit mission,” according to an article published by Boston University.

Michele G. Sullivan/Frontline Medical News
Dr. Steven J. Russell
The iLet consists of a continuous glucose monitoring system that feeds its data into an iPhone, Steven Russell, MD, said at the annual meeting of the European Association for the Study of Diabetes. The phone runs the treatment algorithm and wirelessly controls two pumps, one containing insulin and one containing glucagon.

Glucagon is the key that takes the bionic pancreas above and beyond what current insulin pump systems can do, said Dr. Russell, an endocrinologist at Massachusetts General Hospital, Boston.

“Even the pancreas, which has all the advantages of releasing insulin right into the portal vein and directly sensing glucose in the blood, uses the countering hormone, glucagon, to prevent hypoglycemia, particularly during exercise and in the late postprandial phase,” he said. “We are trying to mimic that capability. Glucagon gives us an additional tool to further reduce the risk of hypoglycemia.”

The algorithm is almost completely independent of user input – another key benefit, Dr. Russell said. It initializes with input about the patient’s weight and adapts its insulin delivery by essentially learning each user. There is no need to count carbohydrates, for example. The system “learns” over time its user’s typical meal patterns and can be programmed to deliver insulin accordingly.

“The user can enter, for example, ‘typical lunch,’ and the system will dispense some insulin before the meal and the rest later, in automatic delivery mode.”

The iLet has been studied in several settings and populations including, most recently, a successful crossover trial in 19 children at a diabetes camp (Lancet Diabetes Endocrinol. 2016; 4[3]:233-43).

The device was similarly successful in both teens and adults.

The study Dr. Russell reported at EASD 2016 comprised 39 patients with type 1 diabetes who were using an insulin pump. The mean age of the patients was 33 years, and mean disease duration was 17 years. The mean daily insulin dose was 0.6 U/kg. The mean baseline hemoglobin A1c was 7.7% and mean blood glucose, 176 mg/dL.

The crossover trial randomized patients to 11 days of treatment with their existing Medtronic insulin pump or the iLet system. The primary outcomes were the mean glucose level and time spent in hypoglycemic range (less than 60 mg/dL).

Under the usual care arm, “We saw a wide range of glucose values, which became much tighter when patients were using the bionic pancreas,” Dr. Russell said.

The overall average glucose level was 9 mmol/L in the usual care arm vs. 7.8 mmol/L in the bionic pancreas arm. Time in hypoglycemia was significantly reduced (27 minutes/24 hours vs. 9 minutes/24 hours).

“The standard deviation of the mean glucose was also larger in usual care, which is consistent with the automatic adaptive function of the bionic pancreas. If the mean glucose gets too high, it treats more aggressively; and if glucose is too low, it becomes less aggressive.”

The average amount of insulin used per day was similar (0.62 U/kg vs. 0.66 U/kg) and the average amount of glucagon used was 0.5 mg/day in each group.

During the night, the bionic pancreas kept mean blood glucose lower (134 mg/dL vs. 165 mg/dL) and more stable, reducing time in hypoglycemia (1.4 minutes/night vs. 4.8 minutes/night).

There was one incident of severe hypoglycemia in the usual-care arm, and none in the bionic-pancreas arm. There was a statistically significant increase in nausea associated with the glucagon, Dr. Russell noted, but the impact was still quite small. On a 0-10 rating scale, nausea in the bionic pancreas group was rated a 0.5 compared to a 0.05 in the usual care arm.

There were no changes in blood pressure, weight, or any lab test.

The ongoing studies continue to show “that automated bihormonal control of glycemia in the home-use setting is feasible,” Dr. Russell said. “Micro-dose glucagon was well tolerated and the bihormonal pancreas reduced both mean glucose and hypoglycemia relative to the patients’ usual care devices.”

The iLet continues to undergo modifications that are making it more user friendly, he added.

Dr. Stevens disclosed that he has a patent pending on “certain aspects” of the device, and that he is an unpaid scientific consultant for Beta Bionics. He also disclosed financial relationships with several pharmaceutical and device companies, including Eli Lilly and Medtronic.

 

 

 

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– A “bionic pancreas” that delivers glucagon as well as insulin fared well against conventional insulin pump therapy, significantly reducing mean glucose levels and minimizing time spent in hypoglycemia.

The iLet bionic pancreas is being developed by Beta Bionics in conjunction with Eli Lilly and with support from the National Institutes of Health. Beta Bionics bills itself as a public benefit corporation – “a for-profit entity also dedicated to social responsibility and a public benefit mission,” according to an article published by Boston University.

Michele G. Sullivan/Frontline Medical News
Dr. Steven J. Russell
The iLet consists of a continuous glucose monitoring system that feeds its data into an iPhone, Steven Russell, MD, said at the annual meeting of the European Association for the Study of Diabetes. The phone runs the treatment algorithm and wirelessly controls two pumps, one containing insulin and one containing glucagon.

Glucagon is the key that takes the bionic pancreas above and beyond what current insulin pump systems can do, said Dr. Russell, an endocrinologist at Massachusetts General Hospital, Boston.

“Even the pancreas, which has all the advantages of releasing insulin right into the portal vein and directly sensing glucose in the blood, uses the countering hormone, glucagon, to prevent hypoglycemia, particularly during exercise and in the late postprandial phase,” he said. “We are trying to mimic that capability. Glucagon gives us an additional tool to further reduce the risk of hypoglycemia.”

The algorithm is almost completely independent of user input – another key benefit, Dr. Russell said. It initializes with input about the patient’s weight and adapts its insulin delivery by essentially learning each user. There is no need to count carbohydrates, for example. The system “learns” over time its user’s typical meal patterns and can be programmed to deliver insulin accordingly.

“The user can enter, for example, ‘typical lunch,’ and the system will dispense some insulin before the meal and the rest later, in automatic delivery mode.”

The iLet has been studied in several settings and populations including, most recently, a successful crossover trial in 19 children at a diabetes camp (Lancet Diabetes Endocrinol. 2016; 4[3]:233-43).

The device was similarly successful in both teens and adults.

The study Dr. Russell reported at EASD 2016 comprised 39 patients with type 1 diabetes who were using an insulin pump. The mean age of the patients was 33 years, and mean disease duration was 17 years. The mean daily insulin dose was 0.6 U/kg. The mean baseline hemoglobin A1c was 7.7% and mean blood glucose, 176 mg/dL.

The crossover trial randomized patients to 11 days of treatment with their existing Medtronic insulin pump or the iLet system. The primary outcomes were the mean glucose level and time spent in hypoglycemic range (less than 60 mg/dL).

Under the usual care arm, “We saw a wide range of glucose values, which became much tighter when patients were using the bionic pancreas,” Dr. Russell said.

The overall average glucose level was 9 mmol/L in the usual care arm vs. 7.8 mmol/L in the bionic pancreas arm. Time in hypoglycemia was significantly reduced (27 minutes/24 hours vs. 9 minutes/24 hours).

“The standard deviation of the mean glucose was also larger in usual care, which is consistent with the automatic adaptive function of the bionic pancreas. If the mean glucose gets too high, it treats more aggressively; and if glucose is too low, it becomes less aggressive.”

The average amount of insulin used per day was similar (0.62 U/kg vs. 0.66 U/kg) and the average amount of glucagon used was 0.5 mg/day in each group.

During the night, the bionic pancreas kept mean blood glucose lower (134 mg/dL vs. 165 mg/dL) and more stable, reducing time in hypoglycemia (1.4 minutes/night vs. 4.8 minutes/night).

There was one incident of severe hypoglycemia in the usual-care arm, and none in the bionic-pancreas arm. There was a statistically significant increase in nausea associated with the glucagon, Dr. Russell noted, but the impact was still quite small. On a 0-10 rating scale, nausea in the bionic pancreas group was rated a 0.5 compared to a 0.05 in the usual care arm.

There were no changes in blood pressure, weight, or any lab test.

The ongoing studies continue to show “that automated bihormonal control of glycemia in the home-use setting is feasible,” Dr. Russell said. “Micro-dose glucagon was well tolerated and the bihormonal pancreas reduced both mean glucose and hypoglycemia relative to the patients’ usual care devices.”

The iLet continues to undergo modifications that are making it more user friendly, he added.

Dr. Stevens disclosed that he has a patent pending on “certain aspects” of the device, and that he is an unpaid scientific consultant for Beta Bionics. He also disclosed financial relationships with several pharmaceutical and device companies, including Eli Lilly and Medtronic.

 

 

 

 

– A “bionic pancreas” that delivers glucagon as well as insulin fared well against conventional insulin pump therapy, significantly reducing mean glucose levels and minimizing time spent in hypoglycemia.

The iLet bionic pancreas is being developed by Beta Bionics in conjunction with Eli Lilly and with support from the National Institutes of Health. Beta Bionics bills itself as a public benefit corporation – “a for-profit entity also dedicated to social responsibility and a public benefit mission,” according to an article published by Boston University.

Michele G. Sullivan/Frontline Medical News
Dr. Steven J. Russell
The iLet consists of a continuous glucose monitoring system that feeds its data into an iPhone, Steven Russell, MD, said at the annual meeting of the European Association for the Study of Diabetes. The phone runs the treatment algorithm and wirelessly controls two pumps, one containing insulin and one containing glucagon.

Glucagon is the key that takes the bionic pancreas above and beyond what current insulin pump systems can do, said Dr. Russell, an endocrinologist at Massachusetts General Hospital, Boston.

“Even the pancreas, which has all the advantages of releasing insulin right into the portal vein and directly sensing glucose in the blood, uses the countering hormone, glucagon, to prevent hypoglycemia, particularly during exercise and in the late postprandial phase,” he said. “We are trying to mimic that capability. Glucagon gives us an additional tool to further reduce the risk of hypoglycemia.”

The algorithm is almost completely independent of user input – another key benefit, Dr. Russell said. It initializes with input about the patient’s weight and adapts its insulin delivery by essentially learning each user. There is no need to count carbohydrates, for example. The system “learns” over time its user’s typical meal patterns and can be programmed to deliver insulin accordingly.

“The user can enter, for example, ‘typical lunch,’ and the system will dispense some insulin before the meal and the rest later, in automatic delivery mode.”

The iLet has been studied in several settings and populations including, most recently, a successful crossover trial in 19 children at a diabetes camp (Lancet Diabetes Endocrinol. 2016; 4[3]:233-43).

The device was similarly successful in both teens and adults.

The study Dr. Russell reported at EASD 2016 comprised 39 patients with type 1 diabetes who were using an insulin pump. The mean age of the patients was 33 years, and mean disease duration was 17 years. The mean daily insulin dose was 0.6 U/kg. The mean baseline hemoglobin A1c was 7.7% and mean blood glucose, 176 mg/dL.

The crossover trial randomized patients to 11 days of treatment with their existing Medtronic insulin pump or the iLet system. The primary outcomes were the mean glucose level and time spent in hypoglycemic range (less than 60 mg/dL).

Under the usual care arm, “We saw a wide range of glucose values, which became much tighter when patients were using the bionic pancreas,” Dr. Russell said.

The overall average glucose level was 9 mmol/L in the usual care arm vs. 7.8 mmol/L in the bionic pancreas arm. Time in hypoglycemia was significantly reduced (27 minutes/24 hours vs. 9 minutes/24 hours).

“The standard deviation of the mean glucose was also larger in usual care, which is consistent with the automatic adaptive function of the bionic pancreas. If the mean glucose gets too high, it treats more aggressively; and if glucose is too low, it becomes less aggressive.”

The average amount of insulin used per day was similar (0.62 U/kg vs. 0.66 U/kg) and the average amount of glucagon used was 0.5 mg/day in each group.

During the night, the bionic pancreas kept mean blood glucose lower (134 mg/dL vs. 165 mg/dL) and more stable, reducing time in hypoglycemia (1.4 minutes/night vs. 4.8 minutes/night).

There was one incident of severe hypoglycemia in the usual-care arm, and none in the bionic-pancreas arm. There was a statistically significant increase in nausea associated with the glucagon, Dr. Russell noted, but the impact was still quite small. On a 0-10 rating scale, nausea in the bionic pancreas group was rated a 0.5 compared to a 0.05 in the usual care arm.

There were no changes in blood pressure, weight, or any lab test.

The ongoing studies continue to show “that automated bihormonal control of glycemia in the home-use setting is feasible,” Dr. Russell said. “Micro-dose glucagon was well tolerated and the bihormonal pancreas reduced both mean glucose and hypoglycemia relative to the patients’ usual care devices.”

The iLet continues to undergo modifications that are making it more user friendly, he added.

Dr. Stevens disclosed that he has a patent pending on “certain aspects” of the device, and that he is an unpaid scientific consultant for Beta Bionics. He also disclosed financial relationships with several pharmaceutical and device companies, including Eli Lilly and Medtronic.

 

 

 

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Key clinical point: The bihormonal artificial pancreas controlled blood sugar more effectively than did a traditional insulin pump.

Major finding: The overall average glucose level was 9 mmol/L in the usual care arm vs. 7.8 mmol/L in the bionic pancreas arm.

Data source: The randomized crossover trial comprised 39 patients with type 1 diabetes.

Disclosures: Dr. Stevens disclosed that he has a patent pending on “certain aspects” of the device and that he is an unpaid scientific consultant for Beta Bionics. He disclosed financial relationships with several pharmaceutical and device companies, including Eli Lilly and Medtronic.

Genes that drive glucose levels also drive heart disease

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Genes that drive glucose levels also drive heart disease

MUNICH – A group of 12 genes that influence blood sugar appears to help drive the risk of heart disease, independent of type 2 diabetes.

The genome-wide association study determined that every 1 mmol/L increase in fasting glucose associated with these genes increased the risk of coronary heart disease by 43%, Jordi Merino, PhD, said at the annual meeting of the European Association for the Study of Diabetes.

“Our results quantify the causal relationship between isolated, genetically increased fasting glucose and heart disease risk beyond the genetic effect of type 2 diabetes,” said Dr. Merino of Massachusetts General Hospital, Boston. “They suggest that modulating glycemia may provide cardiovascular benefit.”

 

©Gio_tto/Thinkstock

It’s known that patients with type 2 diabetes have a higher incidence of coronary heart disease, even after accounting for traditional cardiovascular risk factors, he said. But five large prospective randomized studies – including the much-vaunted ACCORD – failed to find convincing evidence that managing blood glucose in patients with diabetes exerts any benefit on cardiovascular outcomes. In fact, patients assigned to intensive management (blood glucose targeted to below 6%) had a relative increase in all-cause mortality of 22% and an absolute increase of 1%, without any differences in cardiovascular mortality (5% vs. 4%; hazard ratio, 1.22) (N Engl J Med. 2008;358:2545-59).

However, a 2014 subanalysis of ACCORD found that outcomes for ischemic heart disease were significantly better in the intensively managed group. There was a 20% reduction in the risk of heart attack; a 19% reduction in a combined endpoint of heart attack; and similar reductions in the risk of coronary revascularization and unstable angina (Lancet. 2014;384:1936-41).

“We believed genetics might help to answer the question about this discrepancies in findings,” Dr. Merino said.

To investigate this, he and his colleagues plumbed the largest meta-analyses of genome-wide association studies of glucose and insulin regulation. MAGIC (the Meta-Analyses of Glucose and Insulin-related traits Consortium) is a collaborative effort that has combined genetic data from 55 studies.

MAGIC investigators have identified dozens of loci that influence levels of fasting glucose, fasting insulin, and hemoglobin A1c. The project includes data on 133,000 subjects without type 2 diabetes.

They used these data to conduct a Mendelian randomization analysis – a way of establishing causality between a specific gene and a specific clinical trait. Such an analysis is valid only when there are no other functional pathways between the genetic variant and the outcome and when confounding factors that could also affect the outcome can be controlled for.

MAGIC found 234 genetic variants that influence fasting glucose. Some of these also increase the risk of type 2 diabetes; after excluding those, Dr. Merino was left with 107 candidate genes. A disequilibrium analysis further pruned the group, leaving 12 genes that are independently associated with fasting glucose regulation.

He and his colleagues then applied data from the CARDIoGRAMplusC4D Consortium, which is searching for multiple risk loci for coronary artery disease and myocardial infarction in several large genetic studies. They created a five-level risk score for the glycemia-modulating genes and used to it determine how much genetically driven glucose variability affected the risk of heart disease in 5,000 subjects included in the Framingham Heart Study. The analysis controlled for lipids, blood pressure, and body mass index, he noted.

In a model that included all 12 of the variants, the investigators found that every 1 mmol/L increase in fasting glucose was associated with a significant 43% increase in the risk of heart disease.

A second analysis excluded one of the genes, but the significant association with increased risk of heart disease was preserved, at 34% per 1 mmol/L increase in fasting glucose. Individually, 10 of the genes raised the risk of coronary heart disease from a low of 6% (OR 1.06) to a high of almost 400% (OR 3.8).

The final pleiotropic analysis excluded all genes that could have more than one effect on heart disease; five genes survived to this level. Overall, they raised the risk of heart disease by 33%. Individually, the relative increased risks ranged from a low of 12% (odds ratio, 1.12) to a high of 87% (OR, 1.87). One gene was associated with a 25% risk reduction.

Dr. Merino had no financial disclosures.

msullivan@frontlinemedcom.com

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MUNICH – A group of 12 genes that influence blood sugar appears to help drive the risk of heart disease, independent of type 2 diabetes.

The genome-wide association study determined that every 1 mmol/L increase in fasting glucose associated with these genes increased the risk of coronary heart disease by 43%, Jordi Merino, PhD, said at the annual meeting of the European Association for the Study of Diabetes.

“Our results quantify the causal relationship between isolated, genetically increased fasting glucose and heart disease risk beyond the genetic effect of type 2 diabetes,” said Dr. Merino of Massachusetts General Hospital, Boston. “They suggest that modulating glycemia may provide cardiovascular benefit.”

 

©Gio_tto/Thinkstock

It’s known that patients with type 2 diabetes have a higher incidence of coronary heart disease, even after accounting for traditional cardiovascular risk factors, he said. But five large prospective randomized studies – including the much-vaunted ACCORD – failed to find convincing evidence that managing blood glucose in patients with diabetes exerts any benefit on cardiovascular outcomes. In fact, patients assigned to intensive management (blood glucose targeted to below 6%) had a relative increase in all-cause mortality of 22% and an absolute increase of 1%, without any differences in cardiovascular mortality (5% vs. 4%; hazard ratio, 1.22) (N Engl J Med. 2008;358:2545-59).

However, a 2014 subanalysis of ACCORD found that outcomes for ischemic heart disease were significantly better in the intensively managed group. There was a 20% reduction in the risk of heart attack; a 19% reduction in a combined endpoint of heart attack; and similar reductions in the risk of coronary revascularization and unstable angina (Lancet. 2014;384:1936-41).

“We believed genetics might help to answer the question about this discrepancies in findings,” Dr. Merino said.

To investigate this, he and his colleagues plumbed the largest meta-analyses of genome-wide association studies of glucose and insulin regulation. MAGIC (the Meta-Analyses of Glucose and Insulin-related traits Consortium) is a collaborative effort that has combined genetic data from 55 studies.

MAGIC investigators have identified dozens of loci that influence levels of fasting glucose, fasting insulin, and hemoglobin A1c. The project includes data on 133,000 subjects without type 2 diabetes.

They used these data to conduct a Mendelian randomization analysis – a way of establishing causality between a specific gene and a specific clinical trait. Such an analysis is valid only when there are no other functional pathways between the genetic variant and the outcome and when confounding factors that could also affect the outcome can be controlled for.

MAGIC found 234 genetic variants that influence fasting glucose. Some of these also increase the risk of type 2 diabetes; after excluding those, Dr. Merino was left with 107 candidate genes. A disequilibrium analysis further pruned the group, leaving 12 genes that are independently associated with fasting glucose regulation.

He and his colleagues then applied data from the CARDIoGRAMplusC4D Consortium, which is searching for multiple risk loci for coronary artery disease and myocardial infarction in several large genetic studies. They created a five-level risk score for the glycemia-modulating genes and used to it determine how much genetically driven glucose variability affected the risk of heart disease in 5,000 subjects included in the Framingham Heart Study. The analysis controlled for lipids, blood pressure, and body mass index, he noted.

In a model that included all 12 of the variants, the investigators found that every 1 mmol/L increase in fasting glucose was associated with a significant 43% increase in the risk of heart disease.

A second analysis excluded one of the genes, but the significant association with increased risk of heart disease was preserved, at 34% per 1 mmol/L increase in fasting glucose. Individually, 10 of the genes raised the risk of coronary heart disease from a low of 6% (OR 1.06) to a high of almost 400% (OR 3.8).

The final pleiotropic analysis excluded all genes that could have more than one effect on heart disease; five genes survived to this level. Overall, they raised the risk of heart disease by 33%. Individually, the relative increased risks ranged from a low of 12% (odds ratio, 1.12) to a high of 87% (OR, 1.87). One gene was associated with a 25% risk reduction.

Dr. Merino had no financial disclosures.

msullivan@frontlinemedcom.com

MUNICH – A group of 12 genes that influence blood sugar appears to help drive the risk of heart disease, independent of type 2 diabetes.

The genome-wide association study determined that every 1 mmol/L increase in fasting glucose associated with these genes increased the risk of coronary heart disease by 43%, Jordi Merino, PhD, said at the annual meeting of the European Association for the Study of Diabetes.

“Our results quantify the causal relationship between isolated, genetically increased fasting glucose and heart disease risk beyond the genetic effect of type 2 diabetes,” said Dr. Merino of Massachusetts General Hospital, Boston. “They suggest that modulating glycemia may provide cardiovascular benefit.”

 

©Gio_tto/Thinkstock

It’s known that patients with type 2 diabetes have a higher incidence of coronary heart disease, even after accounting for traditional cardiovascular risk factors, he said. But five large prospective randomized studies – including the much-vaunted ACCORD – failed to find convincing evidence that managing blood glucose in patients with diabetes exerts any benefit on cardiovascular outcomes. In fact, patients assigned to intensive management (blood glucose targeted to below 6%) had a relative increase in all-cause mortality of 22% and an absolute increase of 1%, without any differences in cardiovascular mortality (5% vs. 4%; hazard ratio, 1.22) (N Engl J Med. 2008;358:2545-59).

However, a 2014 subanalysis of ACCORD found that outcomes for ischemic heart disease were significantly better in the intensively managed group. There was a 20% reduction in the risk of heart attack; a 19% reduction in a combined endpoint of heart attack; and similar reductions in the risk of coronary revascularization and unstable angina (Lancet. 2014;384:1936-41).

“We believed genetics might help to answer the question about this discrepancies in findings,” Dr. Merino said.

To investigate this, he and his colleagues plumbed the largest meta-analyses of genome-wide association studies of glucose and insulin regulation. MAGIC (the Meta-Analyses of Glucose and Insulin-related traits Consortium) is a collaborative effort that has combined genetic data from 55 studies.

MAGIC investigators have identified dozens of loci that influence levels of fasting glucose, fasting insulin, and hemoglobin A1c. The project includes data on 133,000 subjects without type 2 diabetes.

They used these data to conduct a Mendelian randomization analysis – a way of establishing causality between a specific gene and a specific clinical trait. Such an analysis is valid only when there are no other functional pathways between the genetic variant and the outcome and when confounding factors that could also affect the outcome can be controlled for.

MAGIC found 234 genetic variants that influence fasting glucose. Some of these also increase the risk of type 2 diabetes; after excluding those, Dr. Merino was left with 107 candidate genes. A disequilibrium analysis further pruned the group, leaving 12 genes that are independently associated with fasting glucose regulation.

He and his colleagues then applied data from the CARDIoGRAMplusC4D Consortium, which is searching for multiple risk loci for coronary artery disease and myocardial infarction in several large genetic studies. They created a five-level risk score for the glycemia-modulating genes and used to it determine how much genetically driven glucose variability affected the risk of heart disease in 5,000 subjects included in the Framingham Heart Study. The analysis controlled for lipids, blood pressure, and body mass index, he noted.

In a model that included all 12 of the variants, the investigators found that every 1 mmol/L increase in fasting glucose was associated with a significant 43% increase in the risk of heart disease.

A second analysis excluded one of the genes, but the significant association with increased risk of heart disease was preserved, at 34% per 1 mmol/L increase in fasting glucose. Individually, 10 of the genes raised the risk of coronary heart disease from a low of 6% (OR 1.06) to a high of almost 400% (OR 3.8).

The final pleiotropic analysis excluded all genes that could have more than one effect on heart disease; five genes survived to this level. Overall, they raised the risk of heart disease by 33%. Individually, the relative increased risks ranged from a low of 12% (odds ratio, 1.12) to a high of 87% (OR, 1.87). One gene was associated with a 25% risk reduction.

Dr. Merino had no financial disclosures.

msullivan@frontlinemedcom.com

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Key clinical point: Twelve newly identified genes associated with glucose levels appear to be independent drivers of coronary heart disease.

Major finding: Altogether, the constellation of genes raises the risk of heart disease by 43% for every 1 mmol/L increase in blood glucose.

Data source: Analysis of 133,000 subjects without diabetes.

Disclosures: Dr. Merino had no financial disclosures.

Aspirin not prescribed appropriately to cut cardiovascular risk in diabetes

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MUNICH – Many patients with diabetes who could benefit from low-dose aspirin therapy may not be getting it – and many who are getting aspirin should not be, according to data presented at the annual meeting of the European Association for the Study of Diabetes.

A large, randomized trial concluded that 21% of diabetes patients who qualified for aspirin therapy for cardiovascular risk reduction were not getting it, and that it was contraindicated in almost 60% of those who were taking it, Lauren Crain, PhD, reported at the meeting.

 

Dr. Lauren Crain

Balancing the risks and benefits of aspirin therapy is not an easy challenge, said Dr. Crain, a health behavior researcher at HealthPartners Institute, Minneapolis. The clinical information necessary for the assessment is “rather lengthy, and not always readily available in primary care settings,” she said, and it’s clear from this study that clinicians could use some help in this area. Unfortunately, the electronic algorithm tested, which was meant to improve appropriate aspirin prescribing, didn’t improve the situation very much.

“At the final visit in the diabetes group [after the algorithm was employed], the total proportion of patients using aspirin was higher than at the first visit,” Dr. Crain noted. “However, that was the case regardless of whether patients were over- or underusing aspirin at the first visit.”

The aspirin findings were part of a large, randomized trial testing the algorithm as a way to reduce cardiovascular risk factors. The study was conducted in 19 primary care practices.

The decision-making algorithm, Cardiovascular Wizard, uses electronic health records to identify and advise patients with uncontrolled cardiovascular risk factors. Priorities and clinical recommendations are displayed for the provider and patient in the hope of facilitating shared decision making, Dr. Crain said.

One of the Wizard’s algorithms concerns aspirin prescribing. It is programmed with data from the United States Preventive Services Task Force, and recommends aspirin if cardiovascular risk scores are high and if consistent with providing a benefit greater than the risk of gastrointestinal bleeding. Aspirin is not recommended if the benefit is determined to be low or if major contraindications are present, including anticoagulant use or history of intracerebral hemorrhage.

The tool also alerts providers to the presence of other potential risks including aspirin allergy or intolerance, history of GI bleeds or risk conditions, and the concomitant use of nonsteroidal anti-inflammatory drugs.

The study comprised 11,000 adults, 4,000 of whom had diabetes. The remainder had high-risk, reversible cardiovascular risk factors (hypertension, dyslipidemia, or tobacco use). Each group was randomized to either cardiovascular risk assessment by usual care or with the Cardiovascular Wizard program.

The aspirin substudy looked at aspirin use at the baseline visit and the patient’s final, 1-year follow-up visit. At both visits, aspirin use was documented, and the clinician used the Wizard to assess whether or not it was indicated.

At the baseline visit, 71% of the diabetes group was using aspirin. However, according to the Wizard tool, more than one-third of them should not have been taking it – and among these, 57% were doing so. Among the remaining two-thirds of patients, all of whom should have been using aspirin, 21% were not taking it, Dr. Crain said.

Among the patients with reversible high-risk factors, 27% were using aspirin. However, according to the Wizard tool, the drug was contraindicated in 34% of those patients. “Most importantly, however, among those for whom aspirin was indicated, only 25% were using it – so, we’re talking about a 75% underusage,” Dr. Crain said.

By the 1-year follow-up visit, the situation was not much changed, despite the tool’s recommendations. Among those with diabetes, 56% in the usual care group and 60% in Wizard group were still overusing aspirin. Underuse was occurring in 21% of the usual care group and 17% of the Wizard group.

Patients with reversible high-risk factors fared a little better at 1 year, especially those who, at baseline, should have been taking aspirin but were not. Among these, 10% in the usual care group and 13% in the Wizard group had started taking aspirin.

The results were a bit of a disappointment, Dr. Crain said, but they don’t invalidate the investigators’ faith in an algorithmic advising system.

“We do think that electronic health record tools like this can help providers follow guidelines and improve the quality of their aspirin recommendations and prescribing, and hopefully reduce cardiovascular events and aspirin-related hazards,” she said. “Unfortunately, that didn’t happen here in the diabetes patients,” and the results in the second group were not stellar.

 

 

She added that the Wizard development team will be tweaking the tool to clarify some of the choices available as it guides patients and providers through the algorithm, in hopes of improving its efficacy.

Dr. Crain made no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

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MUNICH – Many patients with diabetes who could benefit from low-dose aspirin therapy may not be getting it – and many who are getting aspirin should not be, according to data presented at the annual meeting of the European Association for the Study of Diabetes.

A large, randomized trial concluded that 21% of diabetes patients who qualified for aspirin therapy for cardiovascular risk reduction were not getting it, and that it was contraindicated in almost 60% of those who were taking it, Lauren Crain, PhD, reported at the meeting.

 

Dr. Lauren Crain

Balancing the risks and benefits of aspirin therapy is not an easy challenge, said Dr. Crain, a health behavior researcher at HealthPartners Institute, Minneapolis. The clinical information necessary for the assessment is “rather lengthy, and not always readily available in primary care settings,” she said, and it’s clear from this study that clinicians could use some help in this area. Unfortunately, the electronic algorithm tested, which was meant to improve appropriate aspirin prescribing, didn’t improve the situation very much.

“At the final visit in the diabetes group [after the algorithm was employed], the total proportion of patients using aspirin was higher than at the first visit,” Dr. Crain noted. “However, that was the case regardless of whether patients were over- or underusing aspirin at the first visit.”

The aspirin findings were part of a large, randomized trial testing the algorithm as a way to reduce cardiovascular risk factors. The study was conducted in 19 primary care practices.

The decision-making algorithm, Cardiovascular Wizard, uses electronic health records to identify and advise patients with uncontrolled cardiovascular risk factors. Priorities and clinical recommendations are displayed for the provider and patient in the hope of facilitating shared decision making, Dr. Crain said.

One of the Wizard’s algorithms concerns aspirin prescribing. It is programmed with data from the United States Preventive Services Task Force, and recommends aspirin if cardiovascular risk scores are high and if consistent with providing a benefit greater than the risk of gastrointestinal bleeding. Aspirin is not recommended if the benefit is determined to be low or if major contraindications are present, including anticoagulant use or history of intracerebral hemorrhage.

The tool also alerts providers to the presence of other potential risks including aspirin allergy or intolerance, history of GI bleeds or risk conditions, and the concomitant use of nonsteroidal anti-inflammatory drugs.

The study comprised 11,000 adults, 4,000 of whom had diabetes. The remainder had high-risk, reversible cardiovascular risk factors (hypertension, dyslipidemia, or tobacco use). Each group was randomized to either cardiovascular risk assessment by usual care or with the Cardiovascular Wizard program.

The aspirin substudy looked at aspirin use at the baseline visit and the patient’s final, 1-year follow-up visit. At both visits, aspirin use was documented, and the clinician used the Wizard to assess whether or not it was indicated.

At the baseline visit, 71% of the diabetes group was using aspirin. However, according to the Wizard tool, more than one-third of them should not have been taking it – and among these, 57% were doing so. Among the remaining two-thirds of patients, all of whom should have been using aspirin, 21% were not taking it, Dr. Crain said.

Among the patients with reversible high-risk factors, 27% were using aspirin. However, according to the Wizard tool, the drug was contraindicated in 34% of those patients. “Most importantly, however, among those for whom aspirin was indicated, only 25% were using it – so, we’re talking about a 75% underusage,” Dr. Crain said.

By the 1-year follow-up visit, the situation was not much changed, despite the tool’s recommendations. Among those with diabetes, 56% in the usual care group and 60% in Wizard group were still overusing aspirin. Underuse was occurring in 21% of the usual care group and 17% of the Wizard group.

Patients with reversible high-risk factors fared a little better at 1 year, especially those who, at baseline, should have been taking aspirin but were not. Among these, 10% in the usual care group and 13% in the Wizard group had started taking aspirin.

The results were a bit of a disappointment, Dr. Crain said, but they don’t invalidate the investigators’ faith in an algorithmic advising system.

“We do think that electronic health record tools like this can help providers follow guidelines and improve the quality of their aspirin recommendations and prescribing, and hopefully reduce cardiovascular events and aspirin-related hazards,” she said. “Unfortunately, that didn’t happen here in the diabetes patients,” and the results in the second group were not stellar.

 

 

She added that the Wizard development team will be tweaking the tool to clarify some of the choices available as it guides patients and providers through the algorithm, in hopes of improving its efficacy.

Dr. Crain made no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

MUNICH – Many patients with diabetes who could benefit from low-dose aspirin therapy may not be getting it – and many who are getting aspirin should not be, according to data presented at the annual meeting of the European Association for the Study of Diabetes.

A large, randomized trial concluded that 21% of diabetes patients who qualified for aspirin therapy for cardiovascular risk reduction were not getting it, and that it was contraindicated in almost 60% of those who were taking it, Lauren Crain, PhD, reported at the meeting.

 

Dr. Lauren Crain

Balancing the risks and benefits of aspirin therapy is not an easy challenge, said Dr. Crain, a health behavior researcher at HealthPartners Institute, Minneapolis. The clinical information necessary for the assessment is “rather lengthy, and not always readily available in primary care settings,” she said, and it’s clear from this study that clinicians could use some help in this area. Unfortunately, the electronic algorithm tested, which was meant to improve appropriate aspirin prescribing, didn’t improve the situation very much.

“At the final visit in the diabetes group [after the algorithm was employed], the total proportion of patients using aspirin was higher than at the first visit,” Dr. Crain noted. “However, that was the case regardless of whether patients were over- or underusing aspirin at the first visit.”

The aspirin findings were part of a large, randomized trial testing the algorithm as a way to reduce cardiovascular risk factors. The study was conducted in 19 primary care practices.

The decision-making algorithm, Cardiovascular Wizard, uses electronic health records to identify and advise patients with uncontrolled cardiovascular risk factors. Priorities and clinical recommendations are displayed for the provider and patient in the hope of facilitating shared decision making, Dr. Crain said.

One of the Wizard’s algorithms concerns aspirin prescribing. It is programmed with data from the United States Preventive Services Task Force, and recommends aspirin if cardiovascular risk scores are high and if consistent with providing a benefit greater than the risk of gastrointestinal bleeding. Aspirin is not recommended if the benefit is determined to be low or if major contraindications are present, including anticoagulant use or history of intracerebral hemorrhage.

The tool also alerts providers to the presence of other potential risks including aspirin allergy or intolerance, history of GI bleeds or risk conditions, and the concomitant use of nonsteroidal anti-inflammatory drugs.

The study comprised 11,000 adults, 4,000 of whom had diabetes. The remainder had high-risk, reversible cardiovascular risk factors (hypertension, dyslipidemia, or tobacco use). Each group was randomized to either cardiovascular risk assessment by usual care or with the Cardiovascular Wizard program.

The aspirin substudy looked at aspirin use at the baseline visit and the patient’s final, 1-year follow-up visit. At both visits, aspirin use was documented, and the clinician used the Wizard to assess whether or not it was indicated.

At the baseline visit, 71% of the diabetes group was using aspirin. However, according to the Wizard tool, more than one-third of them should not have been taking it – and among these, 57% were doing so. Among the remaining two-thirds of patients, all of whom should have been using aspirin, 21% were not taking it, Dr. Crain said.

Among the patients with reversible high-risk factors, 27% were using aspirin. However, according to the Wizard tool, the drug was contraindicated in 34% of those patients. “Most importantly, however, among those for whom aspirin was indicated, only 25% were using it – so, we’re talking about a 75% underusage,” Dr. Crain said.

By the 1-year follow-up visit, the situation was not much changed, despite the tool’s recommendations. Among those with diabetes, 56% in the usual care group and 60% in Wizard group were still overusing aspirin. Underuse was occurring in 21% of the usual care group and 17% of the Wizard group.

Patients with reversible high-risk factors fared a little better at 1 year, especially those who, at baseline, should have been taking aspirin but were not. Among these, 10% in the usual care group and 13% in the Wizard group had started taking aspirin.

The results were a bit of a disappointment, Dr. Crain said, but they don’t invalidate the investigators’ faith in an algorithmic advising system.

“We do think that electronic health record tools like this can help providers follow guidelines and improve the quality of their aspirin recommendations and prescribing, and hopefully reduce cardiovascular events and aspirin-related hazards,” she said. “Unfortunately, that didn’t happen here in the diabetes patients,” and the results in the second group were not stellar.

 

 

She added that the Wizard development team will be tweaking the tool to clarify some of the choices available as it guides patients and providers through the algorithm, in hopes of improving its efficacy.

Dr. Crain made no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

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Key clinical point: Many diabetes patients who should be taking aspirin for cardiovascular risk reduction are not doing so, and many who should not be taking it are.

Major finding: Aspirin was underused in 21% of diabetes patients and overused in 57% of patients.

Data source: A randomized study of 11,000 patients.

Disclosures: Dr. Lauren Crain had no financial disclosures.

Adding foot screening to eye clinic catches diabetic neuropathy

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Adding foot screening to eye clinic catches diabetic neuropathy

MUNICH – A combined eye, foot, and renal screening clinic identified undiagnosed painful diabetic neuropathy in 12% of diabetic patients who attended.

The clinic in Sheffield, England, was well attended and well liked, with 85% patient approval. The patients appreciated that the visit assured attention to their feet and also let them combine several individual clinic visits for diabetes complications screening, Solomon Tesfaye, MD, said at the annual meeting of the European Association for the Study of Diabetes.

“Twenty percent of our attendants said they had never even had a foot exam before,” said Dr. Tesfaye, an endocrinologist at the University of Sheffield. “And almost half had never had any kind of diabetic foot education.”

Dr. Tesfaye said this lack of attention to foot care in diabetes patients in the United Kingdom is “completely unacceptable.” The country is facing an epidemic of diabetes-related foot amputations, he said.

“We have unacceptable numbers of amputations, on the order of 135 each week, and unfortunately that number is rising. Why is that? Because in the U.K., we tend to diagnose diabetic neuropathy mainly with the 10-g monofilament test, because that is reimbursed. And while it’s a good way of screening for foot ulceration risk, it’s not a good model of diagnosing neuropathy early. So we are now unfortunately diagnosing it late, when it’s advanced and completely irreversible.”

The consequences of foot damage are far-reaching, Dr. Tesfaye said. “Patients who have to be referred into a foot clinic have very high mortality, approaching 50% at 5 years. In the U.K., we’re adding more and more foot clinics every year, and this is not a measure of success. It’s a measure of failure.”

Diabetic retinopathy, however, is the country’s good news story. More than 90% of people – diabetic or not – attend an annual eye screening as part of their wellness visits. As a result, diabetic eye disease is no longer the leading cause of blindness in adults in the United Kingdom.

“Everyone attends this annual eye screening, which uses retinal photography, and anyone with early changes is referred to specialist care,” Dr. Tesfaye said. “This has resulted in a paradigm shift in blindness, and that’s fantastic news.”

It just made sense, he said, to use the popular eye screening visit as a chance to also intervene early in undiagnosed diabetic neuropathy. A recent German study underscored the importance of early intervention (Diabetes 2014 Jul;63[7]:2454-63).

This study demonstrated that intraepidermal nerve fibers were already significantly reduced in 20% of patients within a year of their diabetes diagnosis. Nerve conduction values and amplitude were already impacted as well.

“The neuropathic process starts early, but we are using very insensitive measures to diagnose it,” Dr. Tesfaye said.

The combination clinic used several devices to test nerve function in feet, in addition to the 10-g monofilament test:

• A handheld device called DPN-Check, which measures sural nerve conduction velocity and response amplitude.

• Sudoscan, which measures sudomotor dysfunction – one of the earliest neurophysiologic changes in distal small fiber neuropathies.

• The Toronto Clinical Scoring System, a clinical tool that assesses symptoms, reflexes, and sensory function.

The entire foot exam takes 15 minutes and is done after the patient receives the eyedrops necessary for the ocular exam. The renal screening consists of a blood draw for tests of renal function.

The study group comprised 180 patients, with a mean age of 64 years. Type 1 diabetes was present in 6%; the rest had type 2 disease.

The Toronto score was 5 or higher, indicating the presence of diabetic neuropathy, in almost 32%.

The Sudoscan identified small nerve dysfunction consistent with neuropathy in 40%. The DPN-Check score identified neuropathy in 55%. However, the monofilament test was positive in 12%.

In addition to the increased number of neuropathy patients identified, “we also had new diagnoses of painful diabetic neuropathy in about 12% of the group,” Dr. Tesfaye said.

The devices had very good individual diagnostic accuracy, and when the devices were combined, the results were “really staggering,” he said. The Sudoscan alone had a sensitivity of 79% and a specificity of 60%; the DPN-Check alone, a sensitivity of 91% and a specificity of 73%. But when combined, the two diagnostic tools yielded an overall sensitivity of 94% and specificity of 63%. This correlated very well with the Toronto Clinical Scoring System, he added.

“It’s obvious that the 10-g monofilament test grossly underestimated the true presence of diabetic neuropathy. But using these combined point-of-care devices, we were able to detect it with an extremely high sensitivity. This service enables our patients to be referred early to podiatric services. Whether this early referral will result in the reversal of these neuropathic changes is yet to be determined.”

 

 

Dr. Tesfaye reported relationships with NeuroMetrix, Impeto Medical, Eli Lilly, Pfizer, Worwag Pharma, and TRIGOcare International.

msullivan@frontlinemedcom.com

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MUNICH – A combined eye, foot, and renal screening clinic identified undiagnosed painful diabetic neuropathy in 12% of diabetic patients who attended.

The clinic in Sheffield, England, was well attended and well liked, with 85% patient approval. The patients appreciated that the visit assured attention to their feet and also let them combine several individual clinic visits for diabetes complications screening, Solomon Tesfaye, MD, said at the annual meeting of the European Association for the Study of Diabetes.

“Twenty percent of our attendants said they had never even had a foot exam before,” said Dr. Tesfaye, an endocrinologist at the University of Sheffield. “And almost half had never had any kind of diabetic foot education.”

Dr. Tesfaye said this lack of attention to foot care in diabetes patients in the United Kingdom is “completely unacceptable.” The country is facing an epidemic of diabetes-related foot amputations, he said.

“We have unacceptable numbers of amputations, on the order of 135 each week, and unfortunately that number is rising. Why is that? Because in the U.K., we tend to diagnose diabetic neuropathy mainly with the 10-g monofilament test, because that is reimbursed. And while it’s a good way of screening for foot ulceration risk, it’s not a good model of diagnosing neuropathy early. So we are now unfortunately diagnosing it late, when it’s advanced and completely irreversible.”

The consequences of foot damage are far-reaching, Dr. Tesfaye said. “Patients who have to be referred into a foot clinic have very high mortality, approaching 50% at 5 years. In the U.K., we’re adding more and more foot clinics every year, and this is not a measure of success. It’s a measure of failure.”

Diabetic retinopathy, however, is the country’s good news story. More than 90% of people – diabetic or not – attend an annual eye screening as part of their wellness visits. As a result, diabetic eye disease is no longer the leading cause of blindness in adults in the United Kingdom.

“Everyone attends this annual eye screening, which uses retinal photography, and anyone with early changes is referred to specialist care,” Dr. Tesfaye said. “This has resulted in a paradigm shift in blindness, and that’s fantastic news.”

It just made sense, he said, to use the popular eye screening visit as a chance to also intervene early in undiagnosed diabetic neuropathy. A recent German study underscored the importance of early intervention (Diabetes 2014 Jul;63[7]:2454-63).

This study demonstrated that intraepidermal nerve fibers were already significantly reduced in 20% of patients within a year of their diabetes diagnosis. Nerve conduction values and amplitude were already impacted as well.

“The neuropathic process starts early, but we are using very insensitive measures to diagnose it,” Dr. Tesfaye said.

The combination clinic used several devices to test nerve function in feet, in addition to the 10-g monofilament test:

• A handheld device called DPN-Check, which measures sural nerve conduction velocity and response amplitude.

• Sudoscan, which measures sudomotor dysfunction – one of the earliest neurophysiologic changes in distal small fiber neuropathies.

• The Toronto Clinical Scoring System, a clinical tool that assesses symptoms, reflexes, and sensory function.

The entire foot exam takes 15 minutes and is done after the patient receives the eyedrops necessary for the ocular exam. The renal screening consists of a blood draw for tests of renal function.

The study group comprised 180 patients, with a mean age of 64 years. Type 1 diabetes was present in 6%; the rest had type 2 disease.

The Toronto score was 5 or higher, indicating the presence of diabetic neuropathy, in almost 32%.

The Sudoscan identified small nerve dysfunction consistent with neuropathy in 40%. The DPN-Check score identified neuropathy in 55%. However, the monofilament test was positive in 12%.

In addition to the increased number of neuropathy patients identified, “we also had new diagnoses of painful diabetic neuropathy in about 12% of the group,” Dr. Tesfaye said.

The devices had very good individual diagnostic accuracy, and when the devices were combined, the results were “really staggering,” he said. The Sudoscan alone had a sensitivity of 79% and a specificity of 60%; the DPN-Check alone, a sensitivity of 91% and a specificity of 73%. But when combined, the two diagnostic tools yielded an overall sensitivity of 94% and specificity of 63%. This correlated very well with the Toronto Clinical Scoring System, he added.

“It’s obvious that the 10-g monofilament test grossly underestimated the true presence of diabetic neuropathy. But using these combined point-of-care devices, we were able to detect it with an extremely high sensitivity. This service enables our patients to be referred early to podiatric services. Whether this early referral will result in the reversal of these neuropathic changes is yet to be determined.”

 

 

Dr. Tesfaye reported relationships with NeuroMetrix, Impeto Medical, Eli Lilly, Pfizer, Worwag Pharma, and TRIGOcare International.

msullivan@frontlinemedcom.com

MUNICH – A combined eye, foot, and renal screening clinic identified undiagnosed painful diabetic neuropathy in 12% of diabetic patients who attended.

The clinic in Sheffield, England, was well attended and well liked, with 85% patient approval. The patients appreciated that the visit assured attention to their feet and also let them combine several individual clinic visits for diabetes complications screening, Solomon Tesfaye, MD, said at the annual meeting of the European Association for the Study of Diabetes.

“Twenty percent of our attendants said they had never even had a foot exam before,” said Dr. Tesfaye, an endocrinologist at the University of Sheffield. “And almost half had never had any kind of diabetic foot education.”

Dr. Tesfaye said this lack of attention to foot care in diabetes patients in the United Kingdom is “completely unacceptable.” The country is facing an epidemic of diabetes-related foot amputations, he said.

“We have unacceptable numbers of amputations, on the order of 135 each week, and unfortunately that number is rising. Why is that? Because in the U.K., we tend to diagnose diabetic neuropathy mainly with the 10-g monofilament test, because that is reimbursed. And while it’s a good way of screening for foot ulceration risk, it’s not a good model of diagnosing neuropathy early. So we are now unfortunately diagnosing it late, when it’s advanced and completely irreversible.”

The consequences of foot damage are far-reaching, Dr. Tesfaye said. “Patients who have to be referred into a foot clinic have very high mortality, approaching 50% at 5 years. In the U.K., we’re adding more and more foot clinics every year, and this is not a measure of success. It’s a measure of failure.”

Diabetic retinopathy, however, is the country’s good news story. More than 90% of people – diabetic or not – attend an annual eye screening as part of their wellness visits. As a result, diabetic eye disease is no longer the leading cause of blindness in adults in the United Kingdom.

“Everyone attends this annual eye screening, which uses retinal photography, and anyone with early changes is referred to specialist care,” Dr. Tesfaye said. “This has resulted in a paradigm shift in blindness, and that’s fantastic news.”

It just made sense, he said, to use the popular eye screening visit as a chance to also intervene early in undiagnosed diabetic neuropathy. A recent German study underscored the importance of early intervention (Diabetes 2014 Jul;63[7]:2454-63).

This study demonstrated that intraepidermal nerve fibers were already significantly reduced in 20% of patients within a year of their diabetes diagnosis. Nerve conduction values and amplitude were already impacted as well.

“The neuropathic process starts early, but we are using very insensitive measures to diagnose it,” Dr. Tesfaye said.

The combination clinic used several devices to test nerve function in feet, in addition to the 10-g monofilament test:

• A handheld device called DPN-Check, which measures sural nerve conduction velocity and response amplitude.

• Sudoscan, which measures sudomotor dysfunction – one of the earliest neurophysiologic changes in distal small fiber neuropathies.

• The Toronto Clinical Scoring System, a clinical tool that assesses symptoms, reflexes, and sensory function.

The entire foot exam takes 15 minutes and is done after the patient receives the eyedrops necessary for the ocular exam. The renal screening consists of a blood draw for tests of renal function.

The study group comprised 180 patients, with a mean age of 64 years. Type 1 diabetes was present in 6%; the rest had type 2 disease.

The Toronto score was 5 or higher, indicating the presence of diabetic neuropathy, in almost 32%.

The Sudoscan identified small nerve dysfunction consistent with neuropathy in 40%. The DPN-Check score identified neuropathy in 55%. However, the monofilament test was positive in 12%.

In addition to the increased number of neuropathy patients identified, “we also had new diagnoses of painful diabetic neuropathy in about 12% of the group,” Dr. Tesfaye said.

The devices had very good individual diagnostic accuracy, and when the devices were combined, the results were “really staggering,” he said. The Sudoscan alone had a sensitivity of 79% and a specificity of 60%; the DPN-Check alone, a sensitivity of 91% and a specificity of 73%. But when combined, the two diagnostic tools yielded an overall sensitivity of 94% and specificity of 63%. This correlated very well with the Toronto Clinical Scoring System, he added.

“It’s obvious that the 10-g monofilament test grossly underestimated the true presence of diabetic neuropathy. But using these combined point-of-care devices, we were able to detect it with an extremely high sensitivity. This service enables our patients to be referred early to podiatric services. Whether this early referral will result in the reversal of these neuropathic changes is yet to be determined.”

 

 

Dr. Tesfaye reported relationships with NeuroMetrix, Impeto Medical, Eli Lilly, Pfizer, Worwag Pharma, and TRIGOcare International.

msullivan@frontlinemedcom.com

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Key clinical point: The addition of diabetic foot screening to an eye clinic boosted the diagnosis of diabetic neuropathy.

Major finding: Painful diabetic neuropathy was diagnosed in 12% of those who attended.

Data source: A prospective study involving 180 patients.

Disclosures: Dr. Tesfaye disclosed relationships with numerous drug and device manufacturers.