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Rethinking diabetes nutrition: No more carb mixes?
SAN DIEGO – Weight loss isn’t always a top priority for people with diabetes. Patients can figure out their proper carb intake. And don’t fret over an optimal percentage mix of carbs, fat and proteins.
A nutrition consultant gave this advice to colleagues at the annual meeting of the American Association of Diabetes Educators, startling some of those in the audience. And no wonder: A few years ago, these kinds of tips would have surprised the educator herself, Mary Ann Hodorowicz, RN, MBA, a licensed registered dietitian and certified diabetes educator based in the Chicago area.
For instance, she was taught that specific percentages of our diets must come from carbohydrates, protein, and fat. “If you didn’t do it that way, you committed the most major mortal sin,” she said. “You’ll go to diabetes jail, and you’ll probably be fired from your job, and the patient will die.”
In fact, “there’s no evidence to support those percentages,” she said. “They don’t mean anything in terms of blood glucose control, although we do have percentages of fat to control lipids and percentages of protein for health and well-being.”
So how many carbs should diabetics eat? She acknowledges to patients that she doesn’t know: “I don’t have a clue.” Instead, she urges them to figure it out themselves: “How many can you get away with and reach your 2-hour post-meal target? My job is to teach you what how to measure, whether it’s by handfuls, exchanges, servings, or grams. Here’s a log sheet, go home and write about how many carbs you’re eating, and test your blood sugar 2 hours later. You’ll find out really quickly how many carbs you can eat to reach that post-meal target.”
Ms. Hodorowicz provided other “evidence-based” tips about nutrition for diabetes patients:
• Assess the need for weight loss in overweight and obese patients, and don’t assume that weight loss is always the top priority.
In new patients with type 2 diabetes, weight loss of 7% is optimal and can typically be achieved with an energy deficit of 500-750 calories a day: a limit of 1,200-1,500 calories for women and 1,500-1,800 for men.
However, “studies of sustained weight loss at 1 or more years have shown inconsistent effects on hemoglobin A1c, even though modest weight loss is shown to improve insulin resistance in overweight and obese insulin-resistant persons. This blows out what we’ve been taught in our careers,” she said.
Why? Weight reduction does improve blood glucose in these type 2 patients at first, she said, but they’ll go into insulin deficiency if they live long enough.
After that happens, she said, “weight loss is not that effective in controlling blood glucose. At that point, the gurus are saying that we really want to prevent weight gain and seek blood glucose control.”
• Don’t go overboard on the glycemic index.
Ms. Hodorowicz advises patients to substitute low-glycemic foods for high-glycemic foods. However, “the evidence does not support the glycemic index as the best meal planning strategy for a patient with diabetes. It doesn’t do better than controlling carbs.”
In addition, she said, teaching patients about the confusing glycemic index is a drag: “Good luck!” But, she said, “substituting foods is a good thing.”
• Be aware of the limited evidence supporting supplements for glucose control.
On the supplement front, chromium, cinnamon, herbs and vitamin D haven’t been clearly demonstrated to control glucose, she says.
• Encourage consumption – even via supplementation – of fiber and plant stanols and sterols.
Ms. Hodorowicz encourages patients to consume 1.6-3.0 grams a day in plant stanols and sterols, which can be purchased in over-the-counter capsules and via fortified foods like certain Minute Maid and Benecol products.
“You’re fooling the body into thinking it’s cholesterol,” she said, “but it’s innocuous.”
She also advises patients to boost viscous soluble fiber to 7-13 g/day. Since it’s not feasible to do this through food, she recommends supplements: “You really need to supplement your diet with psyllium fiber that you get in a bottle.”
Ms. Hodorowicz reported having no relevant financial disclosures.
SAN DIEGO – Weight loss isn’t always a top priority for people with diabetes. Patients can figure out their proper carb intake. And don’t fret over an optimal percentage mix of carbs, fat and proteins.
A nutrition consultant gave this advice to colleagues at the annual meeting of the American Association of Diabetes Educators, startling some of those in the audience. And no wonder: A few years ago, these kinds of tips would have surprised the educator herself, Mary Ann Hodorowicz, RN, MBA, a licensed registered dietitian and certified diabetes educator based in the Chicago area.
For instance, she was taught that specific percentages of our diets must come from carbohydrates, protein, and fat. “If you didn’t do it that way, you committed the most major mortal sin,” she said. “You’ll go to diabetes jail, and you’ll probably be fired from your job, and the patient will die.”
In fact, “there’s no evidence to support those percentages,” she said. “They don’t mean anything in terms of blood glucose control, although we do have percentages of fat to control lipids and percentages of protein for health and well-being.”
So how many carbs should diabetics eat? She acknowledges to patients that she doesn’t know: “I don’t have a clue.” Instead, she urges them to figure it out themselves: “How many can you get away with and reach your 2-hour post-meal target? My job is to teach you what how to measure, whether it’s by handfuls, exchanges, servings, or grams. Here’s a log sheet, go home and write about how many carbs you’re eating, and test your blood sugar 2 hours later. You’ll find out really quickly how many carbs you can eat to reach that post-meal target.”
Ms. Hodorowicz provided other “evidence-based” tips about nutrition for diabetes patients:
• Assess the need for weight loss in overweight and obese patients, and don’t assume that weight loss is always the top priority.
In new patients with type 2 diabetes, weight loss of 7% is optimal and can typically be achieved with an energy deficit of 500-750 calories a day: a limit of 1,200-1,500 calories for women and 1,500-1,800 for men.
However, “studies of sustained weight loss at 1 or more years have shown inconsistent effects on hemoglobin A1c, even though modest weight loss is shown to improve insulin resistance in overweight and obese insulin-resistant persons. This blows out what we’ve been taught in our careers,” she said.
Why? Weight reduction does improve blood glucose in these type 2 patients at first, she said, but they’ll go into insulin deficiency if they live long enough.
After that happens, she said, “weight loss is not that effective in controlling blood glucose. At that point, the gurus are saying that we really want to prevent weight gain and seek blood glucose control.”
• Don’t go overboard on the glycemic index.
Ms. Hodorowicz advises patients to substitute low-glycemic foods for high-glycemic foods. However, “the evidence does not support the glycemic index as the best meal planning strategy for a patient with diabetes. It doesn’t do better than controlling carbs.”
In addition, she said, teaching patients about the confusing glycemic index is a drag: “Good luck!” But, she said, “substituting foods is a good thing.”
• Be aware of the limited evidence supporting supplements for glucose control.
On the supplement front, chromium, cinnamon, herbs and vitamin D haven’t been clearly demonstrated to control glucose, she says.
• Encourage consumption – even via supplementation – of fiber and plant stanols and sterols.
Ms. Hodorowicz encourages patients to consume 1.6-3.0 grams a day in plant stanols and sterols, which can be purchased in over-the-counter capsules and via fortified foods like certain Minute Maid and Benecol products.
“You’re fooling the body into thinking it’s cholesterol,” she said, “but it’s innocuous.”
She also advises patients to boost viscous soluble fiber to 7-13 g/day. Since it’s not feasible to do this through food, she recommends supplements: “You really need to supplement your diet with psyllium fiber that you get in a bottle.”
Ms. Hodorowicz reported having no relevant financial disclosures.
SAN DIEGO – Weight loss isn’t always a top priority for people with diabetes. Patients can figure out their proper carb intake. And don’t fret over an optimal percentage mix of carbs, fat and proteins.
A nutrition consultant gave this advice to colleagues at the annual meeting of the American Association of Diabetes Educators, startling some of those in the audience. And no wonder: A few years ago, these kinds of tips would have surprised the educator herself, Mary Ann Hodorowicz, RN, MBA, a licensed registered dietitian and certified diabetes educator based in the Chicago area.
For instance, she was taught that specific percentages of our diets must come from carbohydrates, protein, and fat. “If you didn’t do it that way, you committed the most major mortal sin,” she said. “You’ll go to diabetes jail, and you’ll probably be fired from your job, and the patient will die.”
In fact, “there’s no evidence to support those percentages,” she said. “They don’t mean anything in terms of blood glucose control, although we do have percentages of fat to control lipids and percentages of protein for health and well-being.”
So how many carbs should diabetics eat? She acknowledges to patients that she doesn’t know: “I don’t have a clue.” Instead, she urges them to figure it out themselves: “How many can you get away with and reach your 2-hour post-meal target? My job is to teach you what how to measure, whether it’s by handfuls, exchanges, servings, or grams. Here’s a log sheet, go home and write about how many carbs you’re eating, and test your blood sugar 2 hours later. You’ll find out really quickly how many carbs you can eat to reach that post-meal target.”
Ms. Hodorowicz provided other “evidence-based” tips about nutrition for diabetes patients:
• Assess the need for weight loss in overweight and obese patients, and don’t assume that weight loss is always the top priority.
In new patients with type 2 diabetes, weight loss of 7% is optimal and can typically be achieved with an energy deficit of 500-750 calories a day: a limit of 1,200-1,500 calories for women and 1,500-1,800 for men.
However, “studies of sustained weight loss at 1 or more years have shown inconsistent effects on hemoglobin A1c, even though modest weight loss is shown to improve insulin resistance in overweight and obese insulin-resistant persons. This blows out what we’ve been taught in our careers,” she said.
Why? Weight reduction does improve blood glucose in these type 2 patients at first, she said, but they’ll go into insulin deficiency if they live long enough.
After that happens, she said, “weight loss is not that effective in controlling blood glucose. At that point, the gurus are saying that we really want to prevent weight gain and seek blood glucose control.”
• Don’t go overboard on the glycemic index.
Ms. Hodorowicz advises patients to substitute low-glycemic foods for high-glycemic foods. However, “the evidence does not support the glycemic index as the best meal planning strategy for a patient with diabetes. It doesn’t do better than controlling carbs.”
In addition, she said, teaching patients about the confusing glycemic index is a drag: “Good luck!” But, she said, “substituting foods is a good thing.”
• Be aware of the limited evidence supporting supplements for glucose control.
On the supplement front, chromium, cinnamon, herbs and vitamin D haven’t been clearly demonstrated to control glucose, she says.
• Encourage consumption – even via supplementation – of fiber and plant stanols and sterols.
Ms. Hodorowicz encourages patients to consume 1.6-3.0 grams a day in plant stanols and sterols, which can be purchased in over-the-counter capsules and via fortified foods like certain Minute Maid and Benecol products.
“You’re fooling the body into thinking it’s cholesterol,” she said, “but it’s innocuous.”
She also advises patients to boost viscous soluble fiber to 7-13 g/day. Since it’s not feasible to do this through food, she recommends supplements: “You really need to supplement your diet with psyllium fiber that you get in a bottle.”
Ms. Hodorowicz reported having no relevant financial disclosures.
EXPERT ANALYSIS FROM THE AADE ANNUAL MEETING
Aortomitral continuity calcification predicts new atrial fib after TAVR
PARIS – Aortomitral continuity calcification, a common finding on CT in patients undergoing transcatheter aortic valve replacement, predicts new-onset atrial fibrillation and the need for permanent pacemaker insertion, Marco Spaziano, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“Increased surveillance for arrhythmias in the 30 days post TAVR is warranted in patients with aortomitral continuity calcification,” declared Dr. Spaziano of the Paris South Cardiovascular Institute in Massy, France.
He presented a single-center retrospective study of 524 patients undergoing TAVR with a self-expandable or balloon-expandable device. Aortomitral continuity calcification (AMCC) was found on CT in 15.8% of them. Dr. Spaziano defined AMCC as the presence of calcium in the curtain linking the aortic and mitral valve annuli. The clinical implications of this common finding were unknown prior to this study.
The 83 patients with AMCC did not differ significantly from the 441 without that CT finding in terms of baseline demographics, Society of Thoracic Surgeons risk score, prevalence of peripheral vascular disease, QRS duration, left ventricular ejection fraction, complete left or right bundle branch block, or aortic valve calcification volume. The prevalence of atrial fibrillation at baseline was 25.6% in the AMCC group and closely similar at 26.3% in the group without AMCC. Sixteen percent of subjects in each group had a previous pacemaker.
Similarly, the two groups didn’t differ in terms of procedural characteristics, including device type, size, or depth of implantation, or need for a second valve, or annular rupture.
However, excluding from consideration the patients with prior AF, the incidence of new AF in the 30 days post-TAVR was 22.7% in patients with AMCC compared with just 7.6% in the no-AMCC group. In addition, 33% of patients with AMCC received a new permanent pacemaker, as did 21% of those with no AMCC.
Other key 30-day outcomes didn’t differ between the two populations, including rates of death, stroke, vascular complications, and moderate or severe paravalvular regurgitation.
In a multivariate regression analysis adjusted for age, sex, device type and implantation depth, preexisting right bundle branch block, and surgical risk score, AMCC was associated with a statistically significant 1.8-fold increased likelihood of new pacemaker insertion and a 3.4-fold greater risk of new AF.
Dr. Spaziano said that in brainstorming with electrophysiology and echocardiography colleagues, the group came up with two hypotheses to explain the study findings. One is that AMCC might be a biologic marker for concomitant mitral stenosis, a known strong predictor of AF.
“Oftentimes it’s very difficult to diagnose mitral stenosis when there is aortic stenosis, because of left ventricular compliance issues, so potentially the patients with this calcium ridge may also have mitral stenosis,” he observed.
The other proposed hypothesis is that AMCC reflects increased calcification and fibrosis in the electrical system of both the AV node and atrium, with a resultant increased risk of developing new AF after the TAVR procedure.
Session chair Mohammad Abdelghani, MD, wasn’t buying either hypothesis. If either were correct, the group with AMCC would be expected to have a higher baseline rate of AF preprocedurally, observed Dr. Abdelghani of the Academic Medical Center at Amsterdam.
He suggested an alternative explanation on the basis of a German study that showed patients with significant calcification of the left coronary cusp were at sixfold greater risk for pacemaker implantation post TAVR. He proposed that calcification in the left sector of the valve landing zone causes the device to end up being positioned a bit off-line.
“I think the device protrudes away from the calcium and towards the right coronary artery commisure, compressing the conduction system that we know lies there,” Dr. Abdelghani said.
Dr. Spaziano reported having no financial conflicts of interest regarding his study.
PARIS – Aortomitral continuity calcification, a common finding on CT in patients undergoing transcatheter aortic valve replacement, predicts new-onset atrial fibrillation and the need for permanent pacemaker insertion, Marco Spaziano, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“Increased surveillance for arrhythmias in the 30 days post TAVR is warranted in patients with aortomitral continuity calcification,” declared Dr. Spaziano of the Paris South Cardiovascular Institute in Massy, France.
He presented a single-center retrospective study of 524 patients undergoing TAVR with a self-expandable or balloon-expandable device. Aortomitral continuity calcification (AMCC) was found on CT in 15.8% of them. Dr. Spaziano defined AMCC as the presence of calcium in the curtain linking the aortic and mitral valve annuli. The clinical implications of this common finding were unknown prior to this study.
The 83 patients with AMCC did not differ significantly from the 441 without that CT finding in terms of baseline demographics, Society of Thoracic Surgeons risk score, prevalence of peripheral vascular disease, QRS duration, left ventricular ejection fraction, complete left or right bundle branch block, or aortic valve calcification volume. The prevalence of atrial fibrillation at baseline was 25.6% in the AMCC group and closely similar at 26.3% in the group without AMCC. Sixteen percent of subjects in each group had a previous pacemaker.
Similarly, the two groups didn’t differ in terms of procedural characteristics, including device type, size, or depth of implantation, or need for a second valve, or annular rupture.
However, excluding from consideration the patients with prior AF, the incidence of new AF in the 30 days post-TAVR was 22.7% in patients with AMCC compared with just 7.6% in the no-AMCC group. In addition, 33% of patients with AMCC received a new permanent pacemaker, as did 21% of those with no AMCC.
Other key 30-day outcomes didn’t differ between the two populations, including rates of death, stroke, vascular complications, and moderate or severe paravalvular regurgitation.
In a multivariate regression analysis adjusted for age, sex, device type and implantation depth, preexisting right bundle branch block, and surgical risk score, AMCC was associated with a statistically significant 1.8-fold increased likelihood of new pacemaker insertion and a 3.4-fold greater risk of new AF.
Dr. Spaziano said that in brainstorming with electrophysiology and echocardiography colleagues, the group came up with two hypotheses to explain the study findings. One is that AMCC might be a biologic marker for concomitant mitral stenosis, a known strong predictor of AF.
“Oftentimes it’s very difficult to diagnose mitral stenosis when there is aortic stenosis, because of left ventricular compliance issues, so potentially the patients with this calcium ridge may also have mitral stenosis,” he observed.
The other proposed hypothesis is that AMCC reflects increased calcification and fibrosis in the electrical system of both the AV node and atrium, with a resultant increased risk of developing new AF after the TAVR procedure.
Session chair Mohammad Abdelghani, MD, wasn’t buying either hypothesis. If either were correct, the group with AMCC would be expected to have a higher baseline rate of AF preprocedurally, observed Dr. Abdelghani of the Academic Medical Center at Amsterdam.
He suggested an alternative explanation on the basis of a German study that showed patients with significant calcification of the left coronary cusp were at sixfold greater risk for pacemaker implantation post TAVR. He proposed that calcification in the left sector of the valve landing zone causes the device to end up being positioned a bit off-line.
“I think the device protrudes away from the calcium and towards the right coronary artery commisure, compressing the conduction system that we know lies there,” Dr. Abdelghani said.
Dr. Spaziano reported having no financial conflicts of interest regarding his study.
PARIS – Aortomitral continuity calcification, a common finding on CT in patients undergoing transcatheter aortic valve replacement, predicts new-onset atrial fibrillation and the need for permanent pacemaker insertion, Marco Spaziano, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
“Increased surveillance for arrhythmias in the 30 days post TAVR is warranted in patients with aortomitral continuity calcification,” declared Dr. Spaziano of the Paris South Cardiovascular Institute in Massy, France.
He presented a single-center retrospective study of 524 patients undergoing TAVR with a self-expandable or balloon-expandable device. Aortomitral continuity calcification (AMCC) was found on CT in 15.8% of them. Dr. Spaziano defined AMCC as the presence of calcium in the curtain linking the aortic and mitral valve annuli. The clinical implications of this common finding were unknown prior to this study.
The 83 patients with AMCC did not differ significantly from the 441 without that CT finding in terms of baseline demographics, Society of Thoracic Surgeons risk score, prevalence of peripheral vascular disease, QRS duration, left ventricular ejection fraction, complete left or right bundle branch block, or aortic valve calcification volume. The prevalence of atrial fibrillation at baseline was 25.6% in the AMCC group and closely similar at 26.3% in the group without AMCC. Sixteen percent of subjects in each group had a previous pacemaker.
Similarly, the two groups didn’t differ in terms of procedural characteristics, including device type, size, or depth of implantation, or need for a second valve, or annular rupture.
However, excluding from consideration the patients with prior AF, the incidence of new AF in the 30 days post-TAVR was 22.7% in patients with AMCC compared with just 7.6% in the no-AMCC group. In addition, 33% of patients with AMCC received a new permanent pacemaker, as did 21% of those with no AMCC.
Other key 30-day outcomes didn’t differ between the two populations, including rates of death, stroke, vascular complications, and moderate or severe paravalvular regurgitation.
In a multivariate regression analysis adjusted for age, sex, device type and implantation depth, preexisting right bundle branch block, and surgical risk score, AMCC was associated with a statistically significant 1.8-fold increased likelihood of new pacemaker insertion and a 3.4-fold greater risk of new AF.
Dr. Spaziano said that in brainstorming with electrophysiology and echocardiography colleagues, the group came up with two hypotheses to explain the study findings. One is that AMCC might be a biologic marker for concomitant mitral stenosis, a known strong predictor of AF.
“Oftentimes it’s very difficult to diagnose mitral stenosis when there is aortic stenosis, because of left ventricular compliance issues, so potentially the patients with this calcium ridge may also have mitral stenosis,” he observed.
The other proposed hypothesis is that AMCC reflects increased calcification and fibrosis in the electrical system of both the AV node and atrium, with a resultant increased risk of developing new AF after the TAVR procedure.
Session chair Mohammad Abdelghani, MD, wasn’t buying either hypothesis. If either were correct, the group with AMCC would be expected to have a higher baseline rate of AF preprocedurally, observed Dr. Abdelghani of the Academic Medical Center at Amsterdam.
He suggested an alternative explanation on the basis of a German study that showed patients with significant calcification of the left coronary cusp were at sixfold greater risk for pacemaker implantation post TAVR. He proposed that calcification in the left sector of the valve landing zone causes the device to end up being positioned a bit off-line.
“I think the device protrudes away from the calcium and towards the right coronary artery commisure, compressing the conduction system that we know lies there,” Dr. Abdelghani said.
Dr. Spaziano reported having no financial conflicts of interest regarding his study.
AT europcr 2016
Key clinical point: Aortomitral continuity calcification is associated with a markedly increased risk of new atrial fibrillation in patients undergoing transcatheter aortic valve replacement.
Major finding: The CT finding of aortomitral continuity calcification in patients undergoing transcatheter aortic valve replacement was associated with a 3.4-fold increased likelihood of new atrial fibrillation arising during the first 30 days post procedure.
Data source: A retrospective single-center study in 524 patients undergoing transcatheter aortic valve replacement, nearly 16% of whom were found to have aortomitral continuity calcification.
Disclosures: The presenter reported having no financial conflicts of interest regarding his study.
Extreme alcohol use worsens HIV disease
DURBAN, SOUTH AFRICA – A large, longitudinal study of alcohol consumption patterns among HIV-infected U.S. military veterans indicates that only the highest level of persistent heavy drinking is associated with more advanced HIV disease severity over time.
In this study of 3,539 veterans receiving care for HIV infection for 15,354 person-years of follow-up at 8 VA centers, only those scoring in the top 8% on a validated measure of unhealthy drinking showed significant worsening of HIV disease over the 8-year study period, Brandon D.L. Marshall, PhD, reported at the 21st International AIDS Conference.
“The relationship between persistent unhealthy alcohol use and greater HIV disease severity is perhaps not as strong as we would have hypothesized. This suggests that, given the relatively small number of people reporting consistent unhealthy alcohol use, targeted risk reduction and treatment strategies are needed only in those consistent unhealthy drinkers,” said Dr. Marshall, an epidemiologist at Brown University in Providence, R.I.
The subjects’ median age was 49 years; 98% were men, and 68% were African American.
Alcohol use patterns were evaluated annually using the Alcohol Use Disorders Identification Test (AUDIT-C), a validated 3-question screening tool measuring self-reported frequency, quantity, and binge alcohol use. Alcohol use trajectories were linear and relatively stable over time. Eight percent of subjects were classified as high-risk drinkers on the basis of an AUDIT-C score of 8-12; 24% were deemed at moderate risk, with a score of 6-7; the 44% with a score of 4-5 were categorized as lower risk; and 24% of participants were abstainers. The abstainers fell into two distinct groups: sick quitters with worsening HIV disease and healthy abstainers.
Of note, this was the first large study to utilize an objective biomarker in order to validate long-term self-reported alcohol use patterns as assessed by the AUDIT-C test. Nearly 1,500 subjects had a blood test for phosphatidylethanol, a reliable indicator of exposure to alcohol within the previous 21 days. The biomarker has high specificity for alcohol abstinence and showed good correlation with AUDIT-C results across the board, according to Dr. Marshall.
Subjects’ HIV disease severity trajectory was determined annually using the Veterans Aging Cohort Study (VACS) Index, a weighted score that estimates an individual’s risk of all-cause mortality based upon age, HIV RNA viral load, CD4 count, and general indicators of organ system injury including hemoglobin, platelets, glomerular filtration rate, and hepatitis C infection. As was the case for AUDIT-C scores, VACS scores remained relatively stable over 8 years of follow-up. The HIV disease trajectory was categorized as low risk in 2% of subjects, moderate in 46%, high risk in 36%, and extreme in 16%.
To plot the joint trajectories of alcohol use and HIV disease severity, the investigators employed a statistical technique called group-based finite mixture modeling and performed a multivariate logistic regression analysis in which the moderate-risk drinkers and moderate VACS subgroups served as reference standards. Only two significant associations emerged: the highest-risk subgroup of drinkers were at 1.83-fold increased risk of extremely poor VACS trajectory, and the abstainers were at 1.9-fold increased risk for both the most favorable VACS trajectory and an extremely-high-mortality VACS trajectory, reflecting the split in prognosis between the healthy abstainer and sick quitter subgroups. No high-risk drinkers were in the low VACS group.
Unhealthy alcohol use is hypothesized to accelerate HIV disease progression through two mechanisms: Heavy drinkers are less likely to adhere to antiretroviral therapy and remain in care, and the heavy drinking itself has direct negative immunologic effects, Dr. Marshall said.
He reported having no financial conflicts of interest regarding his study, funded by the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Allergy and Infectious Diseases.
DURBAN, SOUTH AFRICA – A large, longitudinal study of alcohol consumption patterns among HIV-infected U.S. military veterans indicates that only the highest level of persistent heavy drinking is associated with more advanced HIV disease severity over time.
In this study of 3,539 veterans receiving care for HIV infection for 15,354 person-years of follow-up at 8 VA centers, only those scoring in the top 8% on a validated measure of unhealthy drinking showed significant worsening of HIV disease over the 8-year study period, Brandon D.L. Marshall, PhD, reported at the 21st International AIDS Conference.
“The relationship between persistent unhealthy alcohol use and greater HIV disease severity is perhaps not as strong as we would have hypothesized. This suggests that, given the relatively small number of people reporting consistent unhealthy alcohol use, targeted risk reduction and treatment strategies are needed only in those consistent unhealthy drinkers,” said Dr. Marshall, an epidemiologist at Brown University in Providence, R.I.
The subjects’ median age was 49 years; 98% were men, and 68% were African American.
Alcohol use patterns were evaluated annually using the Alcohol Use Disorders Identification Test (AUDIT-C), a validated 3-question screening tool measuring self-reported frequency, quantity, and binge alcohol use. Alcohol use trajectories were linear and relatively stable over time. Eight percent of subjects were classified as high-risk drinkers on the basis of an AUDIT-C score of 8-12; 24% were deemed at moderate risk, with a score of 6-7; the 44% with a score of 4-5 were categorized as lower risk; and 24% of participants were abstainers. The abstainers fell into two distinct groups: sick quitters with worsening HIV disease and healthy abstainers.
Of note, this was the first large study to utilize an objective biomarker in order to validate long-term self-reported alcohol use patterns as assessed by the AUDIT-C test. Nearly 1,500 subjects had a blood test for phosphatidylethanol, a reliable indicator of exposure to alcohol within the previous 21 days. The biomarker has high specificity for alcohol abstinence and showed good correlation with AUDIT-C results across the board, according to Dr. Marshall.
Subjects’ HIV disease severity trajectory was determined annually using the Veterans Aging Cohort Study (VACS) Index, a weighted score that estimates an individual’s risk of all-cause mortality based upon age, HIV RNA viral load, CD4 count, and general indicators of organ system injury including hemoglobin, platelets, glomerular filtration rate, and hepatitis C infection. As was the case for AUDIT-C scores, VACS scores remained relatively stable over 8 years of follow-up. The HIV disease trajectory was categorized as low risk in 2% of subjects, moderate in 46%, high risk in 36%, and extreme in 16%.
To plot the joint trajectories of alcohol use and HIV disease severity, the investigators employed a statistical technique called group-based finite mixture modeling and performed a multivariate logistic regression analysis in which the moderate-risk drinkers and moderate VACS subgroups served as reference standards. Only two significant associations emerged: the highest-risk subgroup of drinkers were at 1.83-fold increased risk of extremely poor VACS trajectory, and the abstainers were at 1.9-fold increased risk for both the most favorable VACS trajectory and an extremely-high-mortality VACS trajectory, reflecting the split in prognosis between the healthy abstainer and sick quitter subgroups. No high-risk drinkers were in the low VACS group.
Unhealthy alcohol use is hypothesized to accelerate HIV disease progression through two mechanisms: Heavy drinkers are less likely to adhere to antiretroviral therapy and remain in care, and the heavy drinking itself has direct negative immunologic effects, Dr. Marshall said.
He reported having no financial conflicts of interest regarding his study, funded by the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Allergy and Infectious Diseases.
DURBAN, SOUTH AFRICA – A large, longitudinal study of alcohol consumption patterns among HIV-infected U.S. military veterans indicates that only the highest level of persistent heavy drinking is associated with more advanced HIV disease severity over time.
In this study of 3,539 veterans receiving care for HIV infection for 15,354 person-years of follow-up at 8 VA centers, only those scoring in the top 8% on a validated measure of unhealthy drinking showed significant worsening of HIV disease over the 8-year study period, Brandon D.L. Marshall, PhD, reported at the 21st International AIDS Conference.
“The relationship between persistent unhealthy alcohol use and greater HIV disease severity is perhaps not as strong as we would have hypothesized. This suggests that, given the relatively small number of people reporting consistent unhealthy alcohol use, targeted risk reduction and treatment strategies are needed only in those consistent unhealthy drinkers,” said Dr. Marshall, an epidemiologist at Brown University in Providence, R.I.
The subjects’ median age was 49 years; 98% were men, and 68% were African American.
Alcohol use patterns were evaluated annually using the Alcohol Use Disorders Identification Test (AUDIT-C), a validated 3-question screening tool measuring self-reported frequency, quantity, and binge alcohol use. Alcohol use trajectories were linear and relatively stable over time. Eight percent of subjects were classified as high-risk drinkers on the basis of an AUDIT-C score of 8-12; 24% were deemed at moderate risk, with a score of 6-7; the 44% with a score of 4-5 were categorized as lower risk; and 24% of participants were abstainers. The abstainers fell into two distinct groups: sick quitters with worsening HIV disease and healthy abstainers.
Of note, this was the first large study to utilize an objective biomarker in order to validate long-term self-reported alcohol use patterns as assessed by the AUDIT-C test. Nearly 1,500 subjects had a blood test for phosphatidylethanol, a reliable indicator of exposure to alcohol within the previous 21 days. The biomarker has high specificity for alcohol abstinence and showed good correlation with AUDIT-C results across the board, according to Dr. Marshall.
Subjects’ HIV disease severity trajectory was determined annually using the Veterans Aging Cohort Study (VACS) Index, a weighted score that estimates an individual’s risk of all-cause mortality based upon age, HIV RNA viral load, CD4 count, and general indicators of organ system injury including hemoglobin, platelets, glomerular filtration rate, and hepatitis C infection. As was the case for AUDIT-C scores, VACS scores remained relatively stable over 8 years of follow-up. The HIV disease trajectory was categorized as low risk in 2% of subjects, moderate in 46%, high risk in 36%, and extreme in 16%.
To plot the joint trajectories of alcohol use and HIV disease severity, the investigators employed a statistical technique called group-based finite mixture modeling and performed a multivariate logistic regression analysis in which the moderate-risk drinkers and moderate VACS subgroups served as reference standards. Only two significant associations emerged: the highest-risk subgroup of drinkers were at 1.83-fold increased risk of extremely poor VACS trajectory, and the abstainers were at 1.9-fold increased risk for both the most favorable VACS trajectory and an extremely-high-mortality VACS trajectory, reflecting the split in prognosis between the healthy abstainer and sick quitter subgroups. No high-risk drinkers were in the low VACS group.
Unhealthy alcohol use is hypothesized to accelerate HIV disease progression through two mechanisms: Heavy drinkers are less likely to adhere to antiretroviral therapy and remain in care, and the heavy drinking itself has direct negative immunologic effects, Dr. Marshall said.
He reported having no financial conflicts of interest regarding his study, funded by the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Allergy and Infectious Diseases.
AT AIDS 2016
Key clinical point: A pattern of heavy alcohol use over time in HIV-infected patients was associated with accelerated HIV disease progression.
Major finding: Long-term heavy alcohol use by middle-aged, HIV-infected military veterans was associated with a 1.83-fold increased likelihood of also being in the highest-risk group for accelerated progression of HIV disease.
Data source: This study included 3,539 U.S. military veterans receiving care for HIV infection at eight VA centers. The impact of their long-term pattern of alcohol use on HIV disease progression was assessed over an 8-year period by annual assessments using validated instruments.
Disclosures: The presenter reported having no financial conflicts of interest regarding the study, funded by the National Institute on Alcohol Abuse and Alcoholism and the National Institute of Allergy and Infectious Diseases.
Most physician practices unsure about joining ACOs
The majority of physician practices are uncertain about joining or starting an accountable care organization (ACO), according to a survey.
Of nearly 400 hospital-owned and freestanding outpatient practices, 65% were unsure how to approach accountable care, a survey by Healthcare Information and Management Systems Society (HIMSS) Analytics found. About 13% of health providers said they expected to join an established ACO, while 14% planned to form an ACO, and 8% planned to create an ACO with a neighboring provider.
HIMSS Analytics director of research Brendan FitzGeraldand his team surveyed 436 health providers during June 23–July 12, 2016, regarding electronic health record (EHR) adoption, accountable care, and health information exchanges, among other subjects. The respondents included physicians, practice managers/administrators, physician assistants, nurse practitioners, and practice IT directors. Investigators also analyzed the HIMSS Analytics LOGIC database, which includes 47,084 hospital-owned practices and 57,909 freestanding practices.
Respondents also reported a high level of uncertainty around plans to join a health information exchange (HIE): 48% of health providers were unsure about whether to join an HIE, compared with 46% who were uncertain in 2015. Of respondents who plan to join an HIE, 10% plan to enter a hospital or health system HIE, 7% plan to enter a regional HIE, and 17% plan to join a state health information exchange.
As far as EHR adoption, nearly 78% of respondents representing a free standing outpatient facility (228 practices) reported having an EHR, a 30% increase since 2010. Data from the LOGIC database found 92% of hospital-owned outpatient facilities had a live and operational EHR. Of all survey respondents, 66% did not have plans to replace or upgrade their current outpatient solution, or purchase a new solution. Of health providers that planned to purchase a new EHR, 18% said they would be upgrading, 9% would be purchasing a new solution, and 7% would be replacing a their current EHR.
The survey shows that most doctors appear to be content with the EHR solutions they have adopted with no plans to change systems, said Mr. FitzGerald.
“The level of universal adoption is great, and it seems that physicians for the most part, are satisfied with the work they’ve done to implement and utilize these solutions the first time around,” he said in an interview. “While there may be some getting used to the process of using these particular solutions or even some functionality shortcomings, it seems likes physicians are moving forward with the solutions they have on hand.”
On Twitter @legal_med
The majority of physician practices are uncertain about joining or starting an accountable care organization (ACO), according to a survey.
Of nearly 400 hospital-owned and freestanding outpatient practices, 65% were unsure how to approach accountable care, a survey by Healthcare Information and Management Systems Society (HIMSS) Analytics found. About 13% of health providers said they expected to join an established ACO, while 14% planned to form an ACO, and 8% planned to create an ACO with a neighboring provider.
HIMSS Analytics director of research Brendan FitzGeraldand his team surveyed 436 health providers during June 23–July 12, 2016, regarding electronic health record (EHR) adoption, accountable care, and health information exchanges, among other subjects. The respondents included physicians, practice managers/administrators, physician assistants, nurse practitioners, and practice IT directors. Investigators also analyzed the HIMSS Analytics LOGIC database, which includes 47,084 hospital-owned practices and 57,909 freestanding practices.
Respondents also reported a high level of uncertainty around plans to join a health information exchange (HIE): 48% of health providers were unsure about whether to join an HIE, compared with 46% who were uncertain in 2015. Of respondents who plan to join an HIE, 10% plan to enter a hospital or health system HIE, 7% plan to enter a regional HIE, and 17% plan to join a state health information exchange.
As far as EHR adoption, nearly 78% of respondents representing a free standing outpatient facility (228 practices) reported having an EHR, a 30% increase since 2010. Data from the LOGIC database found 92% of hospital-owned outpatient facilities had a live and operational EHR. Of all survey respondents, 66% did not have plans to replace or upgrade their current outpatient solution, or purchase a new solution. Of health providers that planned to purchase a new EHR, 18% said they would be upgrading, 9% would be purchasing a new solution, and 7% would be replacing a their current EHR.
The survey shows that most doctors appear to be content with the EHR solutions they have adopted with no plans to change systems, said Mr. FitzGerald.
“The level of universal adoption is great, and it seems that physicians for the most part, are satisfied with the work they’ve done to implement and utilize these solutions the first time around,” he said in an interview. “While there may be some getting used to the process of using these particular solutions or even some functionality shortcomings, it seems likes physicians are moving forward with the solutions they have on hand.”
On Twitter @legal_med
The majority of physician practices are uncertain about joining or starting an accountable care organization (ACO), according to a survey.
Of nearly 400 hospital-owned and freestanding outpatient practices, 65% were unsure how to approach accountable care, a survey by Healthcare Information and Management Systems Society (HIMSS) Analytics found. About 13% of health providers said they expected to join an established ACO, while 14% planned to form an ACO, and 8% planned to create an ACO with a neighboring provider.
HIMSS Analytics director of research Brendan FitzGeraldand his team surveyed 436 health providers during June 23–July 12, 2016, regarding electronic health record (EHR) adoption, accountable care, and health information exchanges, among other subjects. The respondents included physicians, practice managers/administrators, physician assistants, nurse practitioners, and practice IT directors. Investigators also analyzed the HIMSS Analytics LOGIC database, which includes 47,084 hospital-owned practices and 57,909 freestanding practices.
Respondents also reported a high level of uncertainty around plans to join a health information exchange (HIE): 48% of health providers were unsure about whether to join an HIE, compared with 46% who were uncertain in 2015. Of respondents who plan to join an HIE, 10% plan to enter a hospital or health system HIE, 7% plan to enter a regional HIE, and 17% plan to join a state health information exchange.
As far as EHR adoption, nearly 78% of respondents representing a free standing outpatient facility (228 practices) reported having an EHR, a 30% increase since 2010. Data from the LOGIC database found 92% of hospital-owned outpatient facilities had a live and operational EHR. Of all survey respondents, 66% did not have plans to replace or upgrade their current outpatient solution, or purchase a new solution. Of health providers that planned to purchase a new EHR, 18% said they would be upgrading, 9% would be purchasing a new solution, and 7% would be replacing a their current EHR.
The survey shows that most doctors appear to be content with the EHR solutions they have adopted with no plans to change systems, said Mr. FitzGerald.
“The level of universal adoption is great, and it seems that physicians for the most part, are satisfied with the work they’ve done to implement and utilize these solutions the first time around,” he said in an interview. “While there may be some getting used to the process of using these particular solutions or even some functionality shortcomings, it seems likes physicians are moving forward with the solutions they have on hand.”
On Twitter @legal_med
Key clinical point: Most health providers don’t know how to go about joining or creating an accountable care organization.
Major finding: Sixty-five percent of health providers reported being unsure as how to approach accountable care.
Data source: A survey of 436 health providers.
Disclosures: The survey was conducted by HIMSS Analytics, of which Mr. FitzGerald is an employee.
MRI now anchors spondyloarthritis diagnosis
DENVER – MRI of the sacroiliac joint now serves as the primary imaging driver for a diagnosis of spondyloarthritis, especially early spondyloarthritis, and has largely supplanted radiographic assessment, Walter P. Maksymowych, MD, said at an educational symposium organized by the Spondyloarthritis Research and Treatment Network.
“MRI is reliable for early diagnosis; radiographic assessment of early spondyloarthritis is problematic,” said Dr. Maksymowych, a rheumatologist and professor of medicine at the University of Alberta in Edmonton. “The EULAR recommendations now say that early diagnosis of spondyloarthritis needs to focus on MRI.”
While the recommendations from the European League Against Rheumatism (EULAR) that came out last year on using imaging for diagnosing and managing spondyloarthritis (SpA) cite radiography of the patient’s sacroiliac joint as the recommended first imaging method to use to diagnose sacroiliitis as part of a diagnosis of axial SpA, the EULAR recommendations place MRI very close behind.
The recommendations list MRI as an “alternative” first-line approach for diagnostic imaging. For patients who appear negative for axial SpA on radiographic imaging but who remain suspected of having SpA the EULAR panel “recommended” MRI of the sacroiliac joints as a backup method for imaging assessment and to definitively rule out SpA. No other imaging method received EULAR’s endorsement for SpA diagnosis aside from these two approaches.
The recommendations direct the MRI examination to include assessment of inflammation based on bone marrow edema, and also structural abnormalities including bone erosion, new bone formation, sclerosis and fat infiltration. The 2015 EULAR recommendations also cite roles for MRI in diagnosing peripheral SpA, monitoring disease activity in axial and peripheral SpA, monioring structural changes in axial and peripheral SpA, predicting outcome and treatment effect in axial SpA, assessing spinal fracture in patients with axial SpA and to assess osteoporosis in selected axial SpA patients.
The MRI imaging sequences particularly useful for SpA diagnosis are “short tau inversion recovery” (STIR), a “water sensitive” sequence that involves suppression of the fat MRI signal, and a T1 weighted sequence that is a “fat sensitive” scan, explained Dr. Maksymowych at the symposium, also organized by the Group for the Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). He strongly encouraged clinicians to apply a standardized approach to imaging in every patient suspected of having axial SpA.
The definition of an MRI imaging result that is positive for SpA remains a consensus of expert opinion without a firm evidence base. The currently accepted MRI marker of SpA involves identifying several areas of bone marrow edema in a single T1 and STIR MRI image-slice through the sacroiliac joint, or focal bone marrow edema visible in at least two consecutive sacroiliac joint T1 and STIR image slices.
The confluence of a structural lesion at the same site as bone marrow edema provides further confirmatory information, he said. “A structural lesions at the site of bone marrow edema enhances your confidence in the diagnosis,” he said.
“The specificity of MRI for SpA is quite high,” Dr. Maksymowych noted, with specificity rates often in the range of 85%-95%. Sensitivity rates are lower, often 50%-70%. Sensitivity further improves by factoring in the presence of bone erosions. Diagnostic confidence also increases as the number of lesions visualized increases.
MRI has become so integral to the assessment of SpA that “to understand SpA you need to understand the language of MRI,” Dr. Maksymowych concluded.
Dr. Maksymowych has received honoraria from eight drug companies and research grant support from Abbvie and Pfizer.
On Twitter @mitchelzoler
DENVER – MRI of the sacroiliac joint now serves as the primary imaging driver for a diagnosis of spondyloarthritis, especially early spondyloarthritis, and has largely supplanted radiographic assessment, Walter P. Maksymowych, MD, said at an educational symposium organized by the Spondyloarthritis Research and Treatment Network.
“MRI is reliable for early diagnosis; radiographic assessment of early spondyloarthritis is problematic,” said Dr. Maksymowych, a rheumatologist and professor of medicine at the University of Alberta in Edmonton. “The EULAR recommendations now say that early diagnosis of spondyloarthritis needs to focus on MRI.”
While the recommendations from the European League Against Rheumatism (EULAR) that came out last year on using imaging for diagnosing and managing spondyloarthritis (SpA) cite radiography of the patient’s sacroiliac joint as the recommended first imaging method to use to diagnose sacroiliitis as part of a diagnosis of axial SpA, the EULAR recommendations place MRI very close behind.
The recommendations list MRI as an “alternative” first-line approach for diagnostic imaging. For patients who appear negative for axial SpA on radiographic imaging but who remain suspected of having SpA the EULAR panel “recommended” MRI of the sacroiliac joints as a backup method for imaging assessment and to definitively rule out SpA. No other imaging method received EULAR’s endorsement for SpA diagnosis aside from these two approaches.
The recommendations direct the MRI examination to include assessment of inflammation based on bone marrow edema, and also structural abnormalities including bone erosion, new bone formation, sclerosis and fat infiltration. The 2015 EULAR recommendations also cite roles for MRI in diagnosing peripheral SpA, monitoring disease activity in axial and peripheral SpA, monioring structural changes in axial and peripheral SpA, predicting outcome and treatment effect in axial SpA, assessing spinal fracture in patients with axial SpA and to assess osteoporosis in selected axial SpA patients.
The MRI imaging sequences particularly useful for SpA diagnosis are “short tau inversion recovery” (STIR), a “water sensitive” sequence that involves suppression of the fat MRI signal, and a T1 weighted sequence that is a “fat sensitive” scan, explained Dr. Maksymowych at the symposium, also organized by the Group for the Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). He strongly encouraged clinicians to apply a standardized approach to imaging in every patient suspected of having axial SpA.
The definition of an MRI imaging result that is positive for SpA remains a consensus of expert opinion without a firm evidence base. The currently accepted MRI marker of SpA involves identifying several areas of bone marrow edema in a single T1 and STIR MRI image-slice through the sacroiliac joint, or focal bone marrow edema visible in at least two consecutive sacroiliac joint T1 and STIR image slices.
The confluence of a structural lesion at the same site as bone marrow edema provides further confirmatory information, he said. “A structural lesions at the site of bone marrow edema enhances your confidence in the diagnosis,” he said.
“The specificity of MRI for SpA is quite high,” Dr. Maksymowych noted, with specificity rates often in the range of 85%-95%. Sensitivity rates are lower, often 50%-70%. Sensitivity further improves by factoring in the presence of bone erosions. Diagnostic confidence also increases as the number of lesions visualized increases.
MRI has become so integral to the assessment of SpA that “to understand SpA you need to understand the language of MRI,” Dr. Maksymowych concluded.
Dr. Maksymowych has received honoraria from eight drug companies and research grant support from Abbvie and Pfizer.
On Twitter @mitchelzoler
DENVER – MRI of the sacroiliac joint now serves as the primary imaging driver for a diagnosis of spondyloarthritis, especially early spondyloarthritis, and has largely supplanted radiographic assessment, Walter P. Maksymowych, MD, said at an educational symposium organized by the Spondyloarthritis Research and Treatment Network.
“MRI is reliable for early diagnosis; radiographic assessment of early spondyloarthritis is problematic,” said Dr. Maksymowych, a rheumatologist and professor of medicine at the University of Alberta in Edmonton. “The EULAR recommendations now say that early diagnosis of spondyloarthritis needs to focus on MRI.”
While the recommendations from the European League Against Rheumatism (EULAR) that came out last year on using imaging for diagnosing and managing spondyloarthritis (SpA) cite radiography of the patient’s sacroiliac joint as the recommended first imaging method to use to diagnose sacroiliitis as part of a diagnosis of axial SpA, the EULAR recommendations place MRI very close behind.
The recommendations list MRI as an “alternative” first-line approach for diagnostic imaging. For patients who appear negative for axial SpA on radiographic imaging but who remain suspected of having SpA the EULAR panel “recommended” MRI of the sacroiliac joints as a backup method for imaging assessment and to definitively rule out SpA. No other imaging method received EULAR’s endorsement for SpA diagnosis aside from these two approaches.
The recommendations direct the MRI examination to include assessment of inflammation based on bone marrow edema, and also structural abnormalities including bone erosion, new bone formation, sclerosis and fat infiltration. The 2015 EULAR recommendations also cite roles for MRI in diagnosing peripheral SpA, monitoring disease activity in axial and peripheral SpA, monioring structural changes in axial and peripheral SpA, predicting outcome and treatment effect in axial SpA, assessing spinal fracture in patients with axial SpA and to assess osteoporosis in selected axial SpA patients.
The MRI imaging sequences particularly useful for SpA diagnosis are “short tau inversion recovery” (STIR), a “water sensitive” sequence that involves suppression of the fat MRI signal, and a T1 weighted sequence that is a “fat sensitive” scan, explained Dr. Maksymowych at the symposium, also organized by the Group for the Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). He strongly encouraged clinicians to apply a standardized approach to imaging in every patient suspected of having axial SpA.
The definition of an MRI imaging result that is positive for SpA remains a consensus of expert opinion without a firm evidence base. The currently accepted MRI marker of SpA involves identifying several areas of bone marrow edema in a single T1 and STIR MRI image-slice through the sacroiliac joint, or focal bone marrow edema visible in at least two consecutive sacroiliac joint T1 and STIR image slices.
The confluence of a structural lesion at the same site as bone marrow edema provides further confirmatory information, he said. “A structural lesions at the site of bone marrow edema enhances your confidence in the diagnosis,” he said.
“The specificity of MRI for SpA is quite high,” Dr. Maksymowych noted, with specificity rates often in the range of 85%-95%. Sensitivity rates are lower, often 50%-70%. Sensitivity further improves by factoring in the presence of bone erosions. Diagnostic confidence also increases as the number of lesions visualized increases.
MRI has become so integral to the assessment of SpA that “to understand SpA you need to understand the language of MRI,” Dr. Maksymowych concluded.
Dr. Maksymowych has received honoraria from eight drug companies and research grant support from Abbvie and Pfizer.
On Twitter @mitchelzoler
EXPERT ANALYSIS FROM A SPARTAN-GRAPPA SYMPOSIUM
NICE recommending long-term ticagrelor
Photo from AstraZeneca
The National Institute for Health and Care Excellence (NICE) has published a draft guidance recommending the antiplatelet agent ticagrelor (Brilique, AstraZeneca) be made available on the National Health Service (NHS) at a lower dose that can be used for a longer duration.
NICE previously decided ticagrelor should be available on the NHS as a treatment option for certain patients with acute coronary syndromes.
For these patients, the drug could be given at a dose of 90 mg, in combination with low-dose aspirin, for up to a year to prevent atherothrombotic events.
Now, NICE is recommending an additional option.
The agency’s new draft guidance recommends ticagrelor at 60 mg, to be given twice a day in combination with aspirin at 75 mg to 150 mg daily, as a continuation therapy for the prevention of atherothrombotic events in certain patients with a history of myocardial infarction and a high risk of developing atherothrombotic events.
Patients must have had a myocardial infarction at least a year ago and have already taken ticagrelor at 90 mg (or another adenosine diphosphate receptor inhibitor therapy), in combination with aspirin, for 1 year.
Ticagrelor at 60 mg, plus aspirin, must be continued without interruption. And the treatment must be stopped when clinically indicated or after a maximum of 3 years.
“The evidence shows that ticagrelor, in combination with aspirin, is effective at reducing the risk of further heart attacks and strokes in people who have already had a heart attack,” said Carole Longson, director of the Centre for Health Technology Evaluation at NICE.
“In provisionally recommending ticagrelor, we are pleased to be able to increase the treatment options available to the many thousands of people who stand to benefit from it.”
NICE’s new draft guidance is not intended to affect the position of patients whose treatment with ticagrelor at 60 mg, in combination with aspirin, as a continuation therapy was started within the NHS before this guidance was published.
Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.
NICE’s draft guidance is open for comments until 5 pm (GMT) on September 5, 2016. 
Photo from AstraZeneca
The National Institute for Health and Care Excellence (NICE) has published a draft guidance recommending the antiplatelet agent ticagrelor (Brilique, AstraZeneca) be made available on the National Health Service (NHS) at a lower dose that can be used for a longer duration.
NICE previously decided ticagrelor should be available on the NHS as a treatment option for certain patients with acute coronary syndromes.
For these patients, the drug could be given at a dose of 90 mg, in combination with low-dose aspirin, for up to a year to prevent atherothrombotic events.
Now, NICE is recommending an additional option.
The agency’s new draft guidance recommends ticagrelor at 60 mg, to be given twice a day in combination with aspirin at 75 mg to 150 mg daily, as a continuation therapy for the prevention of atherothrombotic events in certain patients with a history of myocardial infarction and a high risk of developing atherothrombotic events.
Patients must have had a myocardial infarction at least a year ago and have already taken ticagrelor at 90 mg (or another adenosine diphosphate receptor inhibitor therapy), in combination with aspirin, for 1 year.
Ticagrelor at 60 mg, plus aspirin, must be continued without interruption. And the treatment must be stopped when clinically indicated or after a maximum of 3 years.
“The evidence shows that ticagrelor, in combination with aspirin, is effective at reducing the risk of further heart attacks and strokes in people who have already had a heart attack,” said Carole Longson, director of the Centre for Health Technology Evaluation at NICE.
“In provisionally recommending ticagrelor, we are pleased to be able to increase the treatment options available to the many thousands of people who stand to benefit from it.”
NICE’s new draft guidance is not intended to affect the position of patients whose treatment with ticagrelor at 60 mg, in combination with aspirin, as a continuation therapy was started within the NHS before this guidance was published.
Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.
NICE’s draft guidance is open for comments until 5 pm (GMT) on September 5, 2016.
Photo from AstraZeneca
The National Institute for Health and Care Excellence (NICE) has published a draft guidance recommending the antiplatelet agent ticagrelor (Brilique, AstraZeneca) be made available on the National Health Service (NHS) at a lower dose that can be used for a longer duration.
NICE previously decided ticagrelor should be available on the NHS as a treatment option for certain patients with acute coronary syndromes.
For these patients, the drug could be given at a dose of 90 mg, in combination with low-dose aspirin, for up to a year to prevent atherothrombotic events.
Now, NICE is recommending an additional option.
The agency’s new draft guidance recommends ticagrelor at 60 mg, to be given twice a day in combination with aspirin at 75 mg to 150 mg daily, as a continuation therapy for the prevention of atherothrombotic events in certain patients with a history of myocardial infarction and a high risk of developing atherothrombotic events.
Patients must have had a myocardial infarction at least a year ago and have already taken ticagrelor at 90 mg (or another adenosine diphosphate receptor inhibitor therapy), in combination with aspirin, for 1 year.
Ticagrelor at 60 mg, plus aspirin, must be continued without interruption. And the treatment must be stopped when clinically indicated or after a maximum of 3 years.
“The evidence shows that ticagrelor, in combination with aspirin, is effective at reducing the risk of further heart attacks and strokes in people who have already had a heart attack,” said Carole Longson, director of the Centre for Health Technology Evaluation at NICE.
“In provisionally recommending ticagrelor, we are pleased to be able to increase the treatment options available to the many thousands of people who stand to benefit from it.”
NICE’s new draft guidance is not intended to affect the position of patients whose treatment with ticagrelor at 60 mg, in combination with aspirin, as a continuation therapy was started within the NHS before this guidance was published.
Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.
NICE’s draft guidance is open for comments until 5 pm (GMT) on September 5, 2016.
RISE registry stockpiles U.S. rheumatology data
DENVER – During early 2015, exactly a quarter of all patients seen in U.S. rheumatology practices were diagnosed with rheumatoid arthritis, and among them two-thirds received treatment with a disease modifying nonbiologic drug, based on data from more than 200,000 patients who enrolled in an American College of Rheumatology registry during that time.
That’s an example of some of the data now available in an EHR-based registry run by the ACR and open to participation by any U.S.-based rheumatologist, Kaleb Michaud, PhD, said at the annual meeting of the Spondyloarthritis Research and Treatment Network.
The ACR’s Rheumatology Informatics System for Effectiveness (RISE) is an EHR-based registry of passive reporting that as of July 2016 had enrolled 614,738 U.S. patients treated by 1,284 providers in 213 practices, said Dr. Michaud, codirector of the National Data Bank for Rheumatic Diseases in Wichita, Kan., who works with the ACR on RISE as a volunteer.
Patient participation in RISE more than doubled during the past year, rising from 302,000 participating patients in September 2015. In addition to enrolling even more providers with more patients to participate, RISE’s organizers is also now seeking investigators who can use the data collected in RISE to address useful research questions, he said.
RISE has been designated a qualified clinical data registry (QCDR) by the Centers for Medicare & Medicaid Services. If providers using RISE sign an agreement stating that they want to participate for quality reporting purposes, it then happens automatically. Participating practices also meet Medicare’s meaningful use measure of reporting to a specialty registry. Although most rheumatologists with academic positions already have these opportunities, for community rheumatologists this access is “a perq,” Dr. Michaud said.
As just an example of the data trove accumulating in RISE, Dr, Michaud rattled off some quick figures culled from analysis of the 239,302 RISE patients in 55 U.S. practices who entered the registry during October 2014-September 2015. The patients averaged 59 years of age, three quarters were women, 61% were white, 48% had commercial insurance and 30% were covered through Medicare.
Their most recent diagnosis was rheumatoid arthritis in 25%, unspecified myalgia or myositis in 21%, Sjögren’s syndrome in 7%, systemic lupus erythematosus in 6%, psoriatic arthritis in 6%, spondyloarthritides in 4%, gout in 4%, and several other disorders at rates of 1% or less.
Among the rheumatoid arthritis patients, two-thirds were on a nonbiologic disease modifying drug, led by methotrexate in 65% of this subgroup and hydroxychloroquine in a third of the subgroup. A third of the entire study group was on treatment with a biologic or small-molecule drug. Etanercept (Enbrel) and adalimumab (Humira) led in this category with 8% of patients on each of these two drugs, followed by infliximab (Remicade) in 6%. Other usage rates in this category included abatacept (Orencia) in 4%, and tocilizumab (Actemra) and tofacitinib (Xeljanz) each used in about 2% of rheumatoid arthritis patients.
On Twitter @mitchelzoler
DENVER – During early 2015, exactly a quarter of all patients seen in U.S. rheumatology practices were diagnosed with rheumatoid arthritis, and among them two-thirds received treatment with a disease modifying nonbiologic drug, based on data from more than 200,000 patients who enrolled in an American College of Rheumatology registry during that time.
That’s an example of some of the data now available in an EHR-based registry run by the ACR and open to participation by any U.S.-based rheumatologist, Kaleb Michaud, PhD, said at the annual meeting of the Spondyloarthritis Research and Treatment Network.
The ACR’s Rheumatology Informatics System for Effectiveness (RISE) is an EHR-based registry of passive reporting that as of July 2016 had enrolled 614,738 U.S. patients treated by 1,284 providers in 213 practices, said Dr. Michaud, codirector of the National Data Bank for Rheumatic Diseases in Wichita, Kan., who works with the ACR on RISE as a volunteer.
Patient participation in RISE more than doubled during the past year, rising from 302,000 participating patients in September 2015. In addition to enrolling even more providers with more patients to participate, RISE’s organizers is also now seeking investigators who can use the data collected in RISE to address useful research questions, he said.
RISE has been designated a qualified clinical data registry (QCDR) by the Centers for Medicare & Medicaid Services. If providers using RISE sign an agreement stating that they want to participate for quality reporting purposes, it then happens automatically. Participating practices also meet Medicare’s meaningful use measure of reporting to a specialty registry. Although most rheumatologists with academic positions already have these opportunities, for community rheumatologists this access is “a perq,” Dr. Michaud said.
As just an example of the data trove accumulating in RISE, Dr, Michaud rattled off some quick figures culled from analysis of the 239,302 RISE patients in 55 U.S. practices who entered the registry during October 2014-September 2015. The patients averaged 59 years of age, three quarters were women, 61% were white, 48% had commercial insurance and 30% were covered through Medicare.
Their most recent diagnosis was rheumatoid arthritis in 25%, unspecified myalgia or myositis in 21%, Sjögren’s syndrome in 7%, systemic lupus erythematosus in 6%, psoriatic arthritis in 6%, spondyloarthritides in 4%, gout in 4%, and several other disorders at rates of 1% or less.
Among the rheumatoid arthritis patients, two-thirds were on a nonbiologic disease modifying drug, led by methotrexate in 65% of this subgroup and hydroxychloroquine in a third of the subgroup. A third of the entire study group was on treatment with a biologic or small-molecule drug. Etanercept (Enbrel) and adalimumab (Humira) led in this category with 8% of patients on each of these two drugs, followed by infliximab (Remicade) in 6%. Other usage rates in this category included abatacept (Orencia) in 4%, and tocilizumab (Actemra) and tofacitinib (Xeljanz) each used in about 2% of rheumatoid arthritis patients.
On Twitter @mitchelzoler
DENVER – During early 2015, exactly a quarter of all patients seen in U.S. rheumatology practices were diagnosed with rheumatoid arthritis, and among them two-thirds received treatment with a disease modifying nonbiologic drug, based on data from more than 200,000 patients who enrolled in an American College of Rheumatology registry during that time.
That’s an example of some of the data now available in an EHR-based registry run by the ACR and open to participation by any U.S.-based rheumatologist, Kaleb Michaud, PhD, said at the annual meeting of the Spondyloarthritis Research and Treatment Network.
The ACR’s Rheumatology Informatics System for Effectiveness (RISE) is an EHR-based registry of passive reporting that as of July 2016 had enrolled 614,738 U.S. patients treated by 1,284 providers in 213 practices, said Dr. Michaud, codirector of the National Data Bank for Rheumatic Diseases in Wichita, Kan., who works with the ACR on RISE as a volunteer.
Patient participation in RISE more than doubled during the past year, rising from 302,000 participating patients in September 2015. In addition to enrolling even more providers with more patients to participate, RISE’s organizers is also now seeking investigators who can use the data collected in RISE to address useful research questions, he said.
RISE has been designated a qualified clinical data registry (QCDR) by the Centers for Medicare & Medicaid Services. If providers using RISE sign an agreement stating that they want to participate for quality reporting purposes, it then happens automatically. Participating practices also meet Medicare’s meaningful use measure of reporting to a specialty registry. Although most rheumatologists with academic positions already have these opportunities, for community rheumatologists this access is “a perq,” Dr. Michaud said.
As just an example of the data trove accumulating in RISE, Dr, Michaud rattled off some quick figures culled from analysis of the 239,302 RISE patients in 55 U.S. practices who entered the registry during October 2014-September 2015. The patients averaged 59 years of age, three quarters were women, 61% were white, 48% had commercial insurance and 30% were covered through Medicare.
Their most recent diagnosis was rheumatoid arthritis in 25%, unspecified myalgia or myositis in 21%, Sjögren’s syndrome in 7%, systemic lupus erythematosus in 6%, psoriatic arthritis in 6%, spondyloarthritides in 4%, gout in 4%, and several other disorders at rates of 1% or less.
Among the rheumatoid arthritis patients, two-thirds were on a nonbiologic disease modifying drug, led by methotrexate in 65% of this subgroup and hydroxychloroquine in a third of the subgroup. A third of the entire study group was on treatment with a biologic or small-molecule drug. Etanercept (Enbrel) and adalimumab (Humira) led in this category with 8% of patients on each of these two drugs, followed by infliximab (Remicade) in 6%. Other usage rates in this category included abatacept (Orencia) in 4%, and tocilizumab (Actemra) and tofacitinib (Xeljanz) each used in about 2% of rheumatoid arthritis patients.
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EXPERT ANALYSIS FROM THE 2016 SPARTAN ANNUAL MEETING
Model estimates risk of pneumonia after CABG
A model incorporating 17 easily obtainable preoperative variables may help clinicians estimate patients’ risk of developing pneumonia after undergoing coronary artery bypass graft surgery, according to a report published in Annals of Thoracic Surgery.
“This model may be used to inform clinician-patient decision making and to identify opportunities for mitigating a patient’s risk,” said Raymond J. Strobel, a medical student at the University of Michigan, Ann Arbor, and his associates.
Postoperative pneumonia is the most common hospital-acquired infection following CABG, and it raises mortality risk fourfold and increases length of stay threefold. But reliable estimation of patient risk of post-CABG pneumonia has been difficult because of its low relative incidence – roughly 3% – and because most studies of the disorder are nearly a decade out of date.
To devise a predictive model using current data, Mr. Strobel and his associates assessed numerous potential risk factors and outcomes for 16,084 consecutive patients undergoing CABG at all 33 cardiac centers across Michigan during a 3-year period. They identified 531 cases of post-CABG pneumonia (3.3%) in this cohort.
The investigators performed a univariate analysis to test the associations between pneumonia and numerous factors related to patient demographics, medical history, comorbid diseases, laboratory values, cardiac anatomy, cardiac function, pulmonary function, the CABG procedure, and the institution where the procedure was performed. Variables that were found to be significantly associated with pneumonia (though usually with small absolute magnitudes) were then assessed in a multivariate analysis, which was further refined to create the final model.
The final model includes 17 factors that clearly raise the risk of post-CABG pneumonia. These include an elevated leukocyte count; a decreased hematocrit; older patient age; comorbidities such as peripheral vascular disease, diabetes, and liver disease; markers of pulmonary impairment such as cigarette smoking, the need for home oxygen therapy, and chronic lung disease; markers of cardiac dysfunction such as a recent history of arrhythmia and decreased ejection fraction; and emergency or urgent rather than elective operative status.
“This model performs well and demonstrates robustness across important clinical subgroups and centers,” the investigators said (Ann Thorac Surg. 2016 Jun 1; doi: 10.1016/j.athoracsur.2016.03.074).
In particular, this study identified preoperative leukocytosis to be a significant predictor of post-CABG pneumonia across several subgroups of patients. “We speculate that patients presenting with an elevated white blood cell count before surgery may be mounting an immune response against a pathogen and that the insult of CABG significantly increases their odds of postoperative pneumonia. ... It may be prudent to delay surgery until the source of leukocytosis is satisfactorily investigated, if not identified and treated, or the leukocytosis has otherwise resolved,” Mr. Strobel and his associates noted.
A model incorporating 17 easily obtainable preoperative variables may help clinicians estimate patients’ risk of developing pneumonia after undergoing coronary artery bypass graft surgery, according to a report published in Annals of Thoracic Surgery.
“This model may be used to inform clinician-patient decision making and to identify opportunities for mitigating a patient’s risk,” said Raymond J. Strobel, a medical student at the University of Michigan, Ann Arbor, and his associates.
Postoperative pneumonia is the most common hospital-acquired infection following CABG, and it raises mortality risk fourfold and increases length of stay threefold. But reliable estimation of patient risk of post-CABG pneumonia has been difficult because of its low relative incidence – roughly 3% – and because most studies of the disorder are nearly a decade out of date.
To devise a predictive model using current data, Mr. Strobel and his associates assessed numerous potential risk factors and outcomes for 16,084 consecutive patients undergoing CABG at all 33 cardiac centers across Michigan during a 3-year period. They identified 531 cases of post-CABG pneumonia (3.3%) in this cohort.
The investigators performed a univariate analysis to test the associations between pneumonia and numerous factors related to patient demographics, medical history, comorbid diseases, laboratory values, cardiac anatomy, cardiac function, pulmonary function, the CABG procedure, and the institution where the procedure was performed. Variables that were found to be significantly associated with pneumonia (though usually with small absolute magnitudes) were then assessed in a multivariate analysis, which was further refined to create the final model.
The final model includes 17 factors that clearly raise the risk of post-CABG pneumonia. These include an elevated leukocyte count; a decreased hematocrit; older patient age; comorbidities such as peripheral vascular disease, diabetes, and liver disease; markers of pulmonary impairment such as cigarette smoking, the need for home oxygen therapy, and chronic lung disease; markers of cardiac dysfunction such as a recent history of arrhythmia and decreased ejection fraction; and emergency or urgent rather than elective operative status.
“This model performs well and demonstrates robustness across important clinical subgroups and centers,” the investigators said (Ann Thorac Surg. 2016 Jun 1; doi: 10.1016/j.athoracsur.2016.03.074).
In particular, this study identified preoperative leukocytosis to be a significant predictor of post-CABG pneumonia across several subgroups of patients. “We speculate that patients presenting with an elevated white blood cell count before surgery may be mounting an immune response against a pathogen and that the insult of CABG significantly increases their odds of postoperative pneumonia. ... It may be prudent to delay surgery until the source of leukocytosis is satisfactorily investigated, if not identified and treated, or the leukocytosis has otherwise resolved,” Mr. Strobel and his associates noted.
A model incorporating 17 easily obtainable preoperative variables may help clinicians estimate patients’ risk of developing pneumonia after undergoing coronary artery bypass graft surgery, according to a report published in Annals of Thoracic Surgery.
“This model may be used to inform clinician-patient decision making and to identify opportunities for mitigating a patient’s risk,” said Raymond J. Strobel, a medical student at the University of Michigan, Ann Arbor, and his associates.
Postoperative pneumonia is the most common hospital-acquired infection following CABG, and it raises mortality risk fourfold and increases length of stay threefold. But reliable estimation of patient risk of post-CABG pneumonia has been difficult because of its low relative incidence – roughly 3% – and because most studies of the disorder are nearly a decade out of date.
To devise a predictive model using current data, Mr. Strobel and his associates assessed numerous potential risk factors and outcomes for 16,084 consecutive patients undergoing CABG at all 33 cardiac centers across Michigan during a 3-year period. They identified 531 cases of post-CABG pneumonia (3.3%) in this cohort.
The investigators performed a univariate analysis to test the associations between pneumonia and numerous factors related to patient demographics, medical history, comorbid diseases, laboratory values, cardiac anatomy, cardiac function, pulmonary function, the CABG procedure, and the institution where the procedure was performed. Variables that were found to be significantly associated with pneumonia (though usually with small absolute magnitudes) were then assessed in a multivariate analysis, which was further refined to create the final model.
The final model includes 17 factors that clearly raise the risk of post-CABG pneumonia. These include an elevated leukocyte count; a decreased hematocrit; older patient age; comorbidities such as peripheral vascular disease, diabetes, and liver disease; markers of pulmonary impairment such as cigarette smoking, the need for home oxygen therapy, and chronic lung disease; markers of cardiac dysfunction such as a recent history of arrhythmia and decreased ejection fraction; and emergency or urgent rather than elective operative status.
“This model performs well and demonstrates robustness across important clinical subgroups and centers,” the investigators said (Ann Thorac Surg. 2016 Jun 1; doi: 10.1016/j.athoracsur.2016.03.074).
In particular, this study identified preoperative leukocytosis to be a significant predictor of post-CABG pneumonia across several subgroups of patients. “We speculate that patients presenting with an elevated white blood cell count before surgery may be mounting an immune response against a pathogen and that the insult of CABG significantly increases their odds of postoperative pneumonia. ... It may be prudent to delay surgery until the source of leukocytosis is satisfactorily investigated, if not identified and treated, or the leukocytosis has otherwise resolved,” Mr. Strobel and his associates noted.
FROM ANNALS OF THORACIC SURGERY
Key clinical point: A model incorporating 17 easily obtainable preoperative variables helps estimate patients’ risk of developing pneumonia after coronary artery bypass surgery.
Major finding: Seventeen factors clearly raise the risk of post-CABG pneumonia, including an elevated leukocyte count, a decreased hematocrit, cigarette smoking, and the need for home oxygen therapy.
Data source: A prospective observational cohort study assessing numerous risk factors in 16,084 CABG patients.
Disclosures: This study was funded in part by the U.S. Agency for Healthcare Research and Quality, Blue Cross and Blue Shield of Michigan, and Blue Care Network. The authors’ financial disclosures were not provided.
Hematuria a common finding in pediatric hemophilia
ORLANDO – Screening urinalysis should be a part of routine care for children and young adults with hemophilia, although the clinical significance of the finding is still unclear, investigators say.
Among 93 boys and young men with hemophilia A or B followed at a hemophilia treatment center, nearly half were found to have hematuria on routine screening, a possible indicator for future renal problems, said Kyle Davis, MD, and Amy Dunn, MD, from the division of hematology at Nationwide Children’s Hospital in Columbus, Ohio.
“It’s not routine for all centers to screen for hematuria, so there is likely a large number of patients that are underrecognized, who have hematuria but we don’t even know it,” Dr. Davis said in an interview at the World Federation of Hemophilia World Congress.
Hematuria is a recognized complication in patients with hemophilia A and B, second only to joint damage in frequency. In addition, adults with hemophilia have been shown to have a higher prevalence of renal disease than the general population, suggesting that hematuria might be a marker or harbinger of later renal disease, the authors proposed in a scientific poster.
The investigators conducted their study as part of a quality improvement program at their center aimed at increasing the frequency of urine screening in patients with hemophilia during annual comprehensive visits.
They looked at urinalysis results collected from all male patients older than 2 years with hemophilia A or B seen at their center from August 2011 through September 2015. They defined hematuria as the presence of three or more red blood cells on at least one urinalysis sample.
They also performed univariate logistic regression to evaluate the association of hematuria with patient age, race, hemophilia type and severity, treatment regimen, and history of inhibitory antibodies.
A total of 93 patients, 67 with hemophilia A and 26 with hemophilia B, were included. In all, 43 patients (47%) were identified as having hematuria, with a median of seven red cells. Hematuria was seen in 37 patients with hemophilia A (55%), and in 6 patients with hemophilia B (23%).
Characteristics associated with risk for hematuria included older age and hemophilia A.
Imaging studies available on 24 of the 93 patients showed renal calculi in 3 patients, minor pelviectasis in 1, and congenital dysplastic left kidney, ureterocele, and right hydroureter in 1 patient.
Dr. Davis and Dr. Dunn said that while screening urinalysis could be considered as a part of routine hemophilia, additional studies are needed to replicate the finding in other treatment centers and to determine whether urinalysis results can be predictive of future renal disease, and if so, whether interventions might help.
“For example, there is the potential that if you recognize hematuria in a patient and that patient is currently on an on-demand treatment process, should we switch to prophylaxis?” Dr Davis said.
Dr. Dunn noted that “certainly there are high-risk populations who should be screened, like our patients who have an active inhibitor or even a tolerized inhibitor. Our data suggest that we ought to be looking a bit more closely at those patients, and perhaps that will help us tease out the cause of this. Can we blame it all on hemophilia, or is there something else going on?”
The study was internally funded. Dr. Davis and Dr. Dunn reported no relevant disclosures.
ORLANDO – Screening urinalysis should be a part of routine care for children and young adults with hemophilia, although the clinical significance of the finding is still unclear, investigators say.
Among 93 boys and young men with hemophilia A or B followed at a hemophilia treatment center, nearly half were found to have hematuria on routine screening, a possible indicator for future renal problems, said Kyle Davis, MD, and Amy Dunn, MD, from the division of hematology at Nationwide Children’s Hospital in Columbus, Ohio.
“It’s not routine for all centers to screen for hematuria, so there is likely a large number of patients that are underrecognized, who have hematuria but we don’t even know it,” Dr. Davis said in an interview at the World Federation of Hemophilia World Congress.
Hematuria is a recognized complication in patients with hemophilia A and B, second only to joint damage in frequency. In addition, adults with hemophilia have been shown to have a higher prevalence of renal disease than the general population, suggesting that hematuria might be a marker or harbinger of later renal disease, the authors proposed in a scientific poster.
The investigators conducted their study as part of a quality improvement program at their center aimed at increasing the frequency of urine screening in patients with hemophilia during annual comprehensive visits.
They looked at urinalysis results collected from all male patients older than 2 years with hemophilia A or B seen at their center from August 2011 through September 2015. They defined hematuria as the presence of three or more red blood cells on at least one urinalysis sample.
They also performed univariate logistic regression to evaluate the association of hematuria with patient age, race, hemophilia type and severity, treatment regimen, and history of inhibitory antibodies.
A total of 93 patients, 67 with hemophilia A and 26 with hemophilia B, were included. In all, 43 patients (47%) were identified as having hematuria, with a median of seven red cells. Hematuria was seen in 37 patients with hemophilia A (55%), and in 6 patients with hemophilia B (23%).
Characteristics associated with risk for hematuria included older age and hemophilia A.
Imaging studies available on 24 of the 93 patients showed renal calculi in 3 patients, minor pelviectasis in 1, and congenital dysplastic left kidney, ureterocele, and right hydroureter in 1 patient.
Dr. Davis and Dr. Dunn said that while screening urinalysis could be considered as a part of routine hemophilia, additional studies are needed to replicate the finding in other treatment centers and to determine whether urinalysis results can be predictive of future renal disease, and if so, whether interventions might help.
“For example, there is the potential that if you recognize hematuria in a patient and that patient is currently on an on-demand treatment process, should we switch to prophylaxis?” Dr Davis said.
Dr. Dunn noted that “certainly there are high-risk populations who should be screened, like our patients who have an active inhibitor or even a tolerized inhibitor. Our data suggest that we ought to be looking a bit more closely at those patients, and perhaps that will help us tease out the cause of this. Can we blame it all on hemophilia, or is there something else going on?”
The study was internally funded. Dr. Davis and Dr. Dunn reported no relevant disclosures.
ORLANDO – Screening urinalysis should be a part of routine care for children and young adults with hemophilia, although the clinical significance of the finding is still unclear, investigators say.
Among 93 boys and young men with hemophilia A or B followed at a hemophilia treatment center, nearly half were found to have hematuria on routine screening, a possible indicator for future renal problems, said Kyle Davis, MD, and Amy Dunn, MD, from the division of hematology at Nationwide Children’s Hospital in Columbus, Ohio.
“It’s not routine for all centers to screen for hematuria, so there is likely a large number of patients that are underrecognized, who have hematuria but we don’t even know it,” Dr. Davis said in an interview at the World Federation of Hemophilia World Congress.
Hematuria is a recognized complication in patients with hemophilia A and B, second only to joint damage in frequency. In addition, adults with hemophilia have been shown to have a higher prevalence of renal disease than the general population, suggesting that hematuria might be a marker or harbinger of later renal disease, the authors proposed in a scientific poster.
The investigators conducted their study as part of a quality improvement program at their center aimed at increasing the frequency of urine screening in patients with hemophilia during annual comprehensive visits.
They looked at urinalysis results collected from all male patients older than 2 years with hemophilia A or B seen at their center from August 2011 through September 2015. They defined hematuria as the presence of three or more red blood cells on at least one urinalysis sample.
They also performed univariate logistic regression to evaluate the association of hematuria with patient age, race, hemophilia type and severity, treatment regimen, and history of inhibitory antibodies.
A total of 93 patients, 67 with hemophilia A and 26 with hemophilia B, were included. In all, 43 patients (47%) were identified as having hematuria, with a median of seven red cells. Hematuria was seen in 37 patients with hemophilia A (55%), and in 6 patients with hemophilia B (23%).
Characteristics associated with risk for hematuria included older age and hemophilia A.
Imaging studies available on 24 of the 93 patients showed renal calculi in 3 patients, minor pelviectasis in 1, and congenital dysplastic left kidney, ureterocele, and right hydroureter in 1 patient.
Dr. Davis and Dr. Dunn said that while screening urinalysis could be considered as a part of routine hemophilia, additional studies are needed to replicate the finding in other treatment centers and to determine whether urinalysis results can be predictive of future renal disease, and if so, whether interventions might help.
“For example, there is the potential that if you recognize hematuria in a patient and that patient is currently on an on-demand treatment process, should we switch to prophylaxis?” Dr Davis said.
Dr. Dunn noted that “certainly there are high-risk populations who should be screened, like our patients who have an active inhibitor or even a tolerized inhibitor. Our data suggest that we ought to be looking a bit more closely at those patients, and perhaps that will help us tease out the cause of this. Can we blame it all on hemophilia, or is there something else going on?”
The study was internally funded. Dr. Davis and Dr. Dunn reported no relevant disclosures.
AT WFH 2016 WORLD CONGRESS
Key clinical point:. Hematuria is a common finding in children with hemophilia A or B.
Major finding: Of 93 patients with hemophilia, 43 (47%) had hematuria findings on routine urinalysis.
Data source:. Prospective study in 67 patients with hemophilia A and 26 with hemophilia B.
Disclosures: The study was internally funded. Dr. Davis and Dr. Dunn reported no relevant disclosures
Antiretroviral efavirenz linked to increased suicidality
DURBAN, SOUTH AFRICA – The use of efavirenz in HIV-infected participants in the landmark START trial was associated with significantly increased risk of suicidal behavior, Alejandro Arenas-Pinto, MD, reported at the 21st International AIDS Conference.
“The impact of efavirenz exposure was particularly high in those with a prior psychiatric diagnosis,” according to the infectious diseases specialist. “The message here is that it’s probably just those patients with preexisting neuropsychiatric conditions who are at higher risk of suicidal behavior, according to our data. This supports a recommendation to screen for preexisting depression and other neuropsychiatric conditions before efavirenz initiation.”
START was a clinical practice-transforming randomized trial that established a clear clinical benefit for a strategy of initiating antiretroviral therapy immediately upon diagnosis of HIV infection in asymptomatic adults instead of waiting until their CD4+ count drops below the level of 350 cells/mm3 (N Engl J Med. 2015 Aug 27;373[9]:795-807). Immediate antiretroviral therapy (ART) was associated with a 57% reduction in the risk of the primary outcome, a composite comprised of serious AIDS-defining events, serious non-AIDS adverse events, and all-cause mortality.
Once the results were in, however, Dr. Arenas-Pinto and the other START investigators quickly noticed that suicidal behavior was the second-most-common serious non-AIDS event observed in the study. A total of 57 patients were affected, for a rate of 0.36 events per 100 person-years of follow-up. There were 30 suicide attempts, 16 cases of suicidal ideation, 3 completed suicides, and 1 case each classified as intentional self-injury or self-injurious ideation. A closer look was warranted, said Dr. Arenas-Pinto of University College London.
The investigators next determined that the risk of suicidal behavior was significantly higher in the 3,516 START participants on efavirenz than in the 1,169 subjects on other ART drugs. The risk was 4.2-fold greater in patients who started on efavirenz immediately than in those randomized to begin the drug on a deferred basis. In contrast, suicidal behavior was no more frequent in patients who started on other ART medications immediately than if treatment was deferred.
In a multivariate Cox proportional hazards analysis of predictors of suicidal behavior in patients on efavirenz, the stand-out predictor was prior diagnosis of major depression, bipolar disorder, or schizophrenia or another psychotic disorder, with an associated 12.8-fold increased risk. Heavy alcohol use was associated with a 6.1-fold increased risk and ever having used recreational drugs conferred a 2.9-fold increased risk. In contrast, the risk of suicidal behavior in patients on efavirenz dropped sharply with advancing age.
Efavirenz is a non-nucleoside transcriptase inhibitor marketed as Sustiva, or when incorporated into once-daily, fixed-dose, triple-drug therapy with tenofovir/emtricitabine, as Atripla.
The labeling for efavirenz states that many of the drug’s more common side effects involve the brain. They include dizziness, insomnia, depression, anxiety, nightmares, hallucinations, delusions, and confusion.
The START study was funded by the National Institutes of Health. Dr. Arenas-Pinto reported having no financial conflicts of interest.
DURBAN, SOUTH AFRICA – The use of efavirenz in HIV-infected participants in the landmark START trial was associated with significantly increased risk of suicidal behavior, Alejandro Arenas-Pinto, MD, reported at the 21st International AIDS Conference.
“The impact of efavirenz exposure was particularly high in those with a prior psychiatric diagnosis,” according to the infectious diseases specialist. “The message here is that it’s probably just those patients with preexisting neuropsychiatric conditions who are at higher risk of suicidal behavior, according to our data. This supports a recommendation to screen for preexisting depression and other neuropsychiatric conditions before efavirenz initiation.”
START was a clinical practice-transforming randomized trial that established a clear clinical benefit for a strategy of initiating antiretroviral therapy immediately upon diagnosis of HIV infection in asymptomatic adults instead of waiting until their CD4+ count drops below the level of 350 cells/mm3 (N Engl J Med. 2015 Aug 27;373[9]:795-807). Immediate antiretroviral therapy (ART) was associated with a 57% reduction in the risk of the primary outcome, a composite comprised of serious AIDS-defining events, serious non-AIDS adverse events, and all-cause mortality.
Once the results were in, however, Dr. Arenas-Pinto and the other START investigators quickly noticed that suicidal behavior was the second-most-common serious non-AIDS event observed in the study. A total of 57 patients were affected, for a rate of 0.36 events per 100 person-years of follow-up. There were 30 suicide attempts, 16 cases of suicidal ideation, 3 completed suicides, and 1 case each classified as intentional self-injury or self-injurious ideation. A closer look was warranted, said Dr. Arenas-Pinto of University College London.
The investigators next determined that the risk of suicidal behavior was significantly higher in the 3,516 START participants on efavirenz than in the 1,169 subjects on other ART drugs. The risk was 4.2-fold greater in patients who started on efavirenz immediately than in those randomized to begin the drug on a deferred basis. In contrast, suicidal behavior was no more frequent in patients who started on other ART medications immediately than if treatment was deferred.
In a multivariate Cox proportional hazards analysis of predictors of suicidal behavior in patients on efavirenz, the stand-out predictor was prior diagnosis of major depression, bipolar disorder, or schizophrenia or another psychotic disorder, with an associated 12.8-fold increased risk. Heavy alcohol use was associated with a 6.1-fold increased risk and ever having used recreational drugs conferred a 2.9-fold increased risk. In contrast, the risk of suicidal behavior in patients on efavirenz dropped sharply with advancing age.
Efavirenz is a non-nucleoside transcriptase inhibitor marketed as Sustiva, or when incorporated into once-daily, fixed-dose, triple-drug therapy with tenofovir/emtricitabine, as Atripla.
The labeling for efavirenz states that many of the drug’s more common side effects involve the brain. They include dizziness, insomnia, depression, anxiety, nightmares, hallucinations, delusions, and confusion.
The START study was funded by the National Institutes of Health. Dr. Arenas-Pinto reported having no financial conflicts of interest.
DURBAN, SOUTH AFRICA – The use of efavirenz in HIV-infected participants in the landmark START trial was associated with significantly increased risk of suicidal behavior, Alejandro Arenas-Pinto, MD, reported at the 21st International AIDS Conference.
“The impact of efavirenz exposure was particularly high in those with a prior psychiatric diagnosis,” according to the infectious diseases specialist. “The message here is that it’s probably just those patients with preexisting neuropsychiatric conditions who are at higher risk of suicidal behavior, according to our data. This supports a recommendation to screen for preexisting depression and other neuropsychiatric conditions before efavirenz initiation.”
START was a clinical practice-transforming randomized trial that established a clear clinical benefit for a strategy of initiating antiretroviral therapy immediately upon diagnosis of HIV infection in asymptomatic adults instead of waiting until their CD4+ count drops below the level of 350 cells/mm3 (N Engl J Med. 2015 Aug 27;373[9]:795-807). Immediate antiretroviral therapy (ART) was associated with a 57% reduction in the risk of the primary outcome, a composite comprised of serious AIDS-defining events, serious non-AIDS adverse events, and all-cause mortality.
Once the results were in, however, Dr. Arenas-Pinto and the other START investigators quickly noticed that suicidal behavior was the second-most-common serious non-AIDS event observed in the study. A total of 57 patients were affected, for a rate of 0.36 events per 100 person-years of follow-up. There were 30 suicide attempts, 16 cases of suicidal ideation, 3 completed suicides, and 1 case each classified as intentional self-injury or self-injurious ideation. A closer look was warranted, said Dr. Arenas-Pinto of University College London.
The investigators next determined that the risk of suicidal behavior was significantly higher in the 3,516 START participants on efavirenz than in the 1,169 subjects on other ART drugs. The risk was 4.2-fold greater in patients who started on efavirenz immediately than in those randomized to begin the drug on a deferred basis. In contrast, suicidal behavior was no more frequent in patients who started on other ART medications immediately than if treatment was deferred.
In a multivariate Cox proportional hazards analysis of predictors of suicidal behavior in patients on efavirenz, the stand-out predictor was prior diagnosis of major depression, bipolar disorder, or schizophrenia or another psychotic disorder, with an associated 12.8-fold increased risk. Heavy alcohol use was associated with a 6.1-fold increased risk and ever having used recreational drugs conferred a 2.9-fold increased risk. In contrast, the risk of suicidal behavior in patients on efavirenz dropped sharply with advancing age.
Efavirenz is a non-nucleoside transcriptase inhibitor marketed as Sustiva, or when incorporated into once-daily, fixed-dose, triple-drug therapy with tenofovir/emtricitabine, as Atripla.
The labeling for efavirenz states that many of the drug’s more common side effects involve the brain. They include dizziness, insomnia, depression, anxiety, nightmares, hallucinations, delusions, and confusion.
The START study was funded by the National Institutes of Health. Dr. Arenas-Pinto reported having no financial conflicts of interest.
AT AIDS 2016
Key clinical point: Screen for depression and other psychiatric disorders before placing an HIV-positive patient on efavirenz.
Major finding: The risk of suicidal behavior was increased 12.8-fold in HIV-infected patients on efavirenz who had a prior psychiatric diagnosis.
Data source: This was a secondary analysis of suicidal behavior in 4,685 HIV-infected participants in the randomized START trial.
Disclosures: The National Institutes of Health sponsored the study. The presenter reported having no financial conflicts of interest.
