WASHINGTON – Regulators from two continents are slowly inching toward more common ground when it comes to device approvals, a move that should strike a better balance between the time to approval and safety of the products.

It is no surprise that for devices to be approved in the United States, a much more rigorous evidence standard exists than it does in Europe, but the Food and Drug Administration is looking for ways to make changes to allow for quicker approval times without compromising safety.

Meanwhile, across the Atlantic, European regulators are looking for increased evidence requirements that will not stifle innovation.

Gregory Twachtman/Frontline Medical News

Gregory Twachtman/Frontline Medical News

[email protected]

WASHINGTON – Regulators from two continents are slowly inching toward more common ground when it comes to device approvals, a move that should strike a better balance between the time to approval and safety of the products.

It is no surprise that for devices to be approved in the United States, a much more rigorous evidence standard exists than it does in Europe, but the Food and Drug Administration is looking for ways to make changes to allow for quicker approval times without compromising safety.

Meanwhile, across the Atlantic, European regulators are looking for increased evidence requirements that will not stifle innovation.

Gregory Twachtman/Frontline Medical News

Gregory Twachtman/Frontline Medical News

[email protected]

WASHINGTON – Regulators from two continents are slowly inching toward more common ground when it comes to device approvals, a move that should strike a better balance between the time to approval and safety of the products.

It is no surprise that for devices to be approved in the United States, a much more rigorous evidence standard exists than it does in Europe, but the Food and Drug Administration is looking for ways to make changes to allow for quicker approval times without compromising safety.

Meanwhile, across the Atlantic, European regulators are looking for increased evidence requirements that will not stifle innovation.

Gregory Twachtman/Frontline Medical News

Gregory Twachtman/Frontline Medical News

[email protected]

Welcome to the 43rd annual Vascular & Endovascular, Issues, Techniques and Horizons Symposium (VEITHsymposium). This year’s program promises to be one of the best, most comprehensive, and most thought-provoking of any of our meetings. This year we celebrate our 43rd anniversary and have introduced several improvements.

Nearly 600 international clinician/educators have gathered to provide attendees with the latest topics and advances that are important to the global vascular community. These data span the breadth of vascular diseases, diagnostic procedures, medical treatments, interventional procedures and open surgical advances for treating vascular disease. As is the hallmark of the VEITHsymposium, the 5-day program will run from dawn to dusk daily and will be fully captured in our online library.

Welcome to the 43rd annual Vascular & Endovascular, Issues, Techniques and Horizons Symposium (VEITHsymposium). This year’s program promises to be one of the best, most comprehensive, and most thought-provoking of any of our meetings. This year we celebrate our 43rd anniversary and have introduced several improvements.

Nearly 600 international clinician/educators have gathered to provide attendees with the latest topics and advances that are important to the global vascular community. These data span the breadth of vascular diseases, diagnostic procedures, medical treatments, interventional procedures and open surgical advances for treating vascular disease. As is the hallmark of the VEITHsymposium, the 5-day program will run from dawn to dusk daily and will be fully captured in our online library.

Welcome to the 43rd annual Vascular & Endovascular, Issues, Techniques and Horizons Symposium (VEITHsymposium). This year’s program promises to be one of the best, most comprehensive, and most thought-provoking of any of our meetings. This year we celebrate our 43rd anniversary and have introduced several improvements.

Nearly 600 international clinician/educators have gathered to provide attendees with the latest topics and advances that are important to the global vascular community. These data span the breadth of vascular diseases, diagnostic procedures, medical treatments, interventional procedures and open surgical advances for treating vascular disease. As is the hallmark of the VEITHsymposium, the 5-day program will run from dawn to dusk daily and will be fully captured in our online library.

Diabetic men with erectile dysfunction might consider a prescription for a drug like Viagra to be a permanent cure for a temporary issue: Take a pill, problem solved. But the truth, a leading urologist says, is entirely different.

“If a diabetic patient has erectile dysfunction, it’s not enough to provide Viagra [sildenafil] or Cialis [tadalafil] and then send him on his merry way,” J. Francois Eid, MD, a New York City urologist, said at the annual meeting of the American Association of Diabetes Educators. “It’s important to let individuals know the drug has not cured the erectile dysfunction. If patients don’t take care of the diabetes, the erectile dysfunction progresses.”

In an interview, Dr. Eid shared several messages for medical professionals who treat men with diabetes and related erectile dysfunction:

• Diabetes has “devastating” effects on the penis, and may even cause it to shrink.

• Long-term uncontrolled diabetes can make ED permanent.

• While ED drugs often fail in men with diabetes, several other options exist; and penis implants may provide significant relief.

How big is the problem? An estimated 50%-75% of men with diabetes experience from some degree of ED, which is thought to be three times more common in diabetic men than other men, according to Dr. Eid.

“Diabetes has a devastating effect on the muscle tissue inside the penis,” he said. “All the tiny little arteries that feed blood to the muscle get occluded. Little by little, the muscle inside the penis shrinks.” Indeed, some diabetics with ED complain that their penises have shrunk, he said.

Diabetic damage doesn’t stop with these small vessels, he said. “You really have two parallel situations: You need blood flow that feeds the muscle of the penis, and you need an artery dedicated to bringing blood rapidly when a man becomes aroused and wants to be sexually active,” he said. “That artery is also affected by diabetes. They’ll say ‘I can get a partial erection, but I can’t maintain it.’ ”

What comes after an ED diagnosis in diabetic patients? Often, Dr. Eid will instantly refer these men to a cardiologist. “If a patient has diabetes and is newly diagnosed, a significant portion of these men are going to develop coronary artery disease in the next 2-3 years,” he said. “One of the things we do is recommend is that they see a cardiologist and perhaps have a stress test or some sort of evaluation.”

Dr. Eid also urges these patients to treat their diabetes in order to avoid developing ED for life. “They need to manage their diabetes and make sure they control it so the ED will not progress and will stabilize, as a result,” he said. “If the diabetes is controlled after the patient is first diagnosed, then the erections will come back. But if the patient has diabetes for many years, and suddenly decides it’s time to control it, they cannot prevent the damage that’s already been done.”

As for treatments, patients with diabetes and related ED should begin with medications like sildenafil and tadalafil, he recommended. But research findings suggest that the drugs will fail in half of men with type 2 diabetes, he said.

Other options include penile self-injections, vacuum devices, and penile implants.

The injections “can work well and are painless, but men detest having to inject themselves before sexual activity,” Dr. Eid said. And he said men rarely have success using vacuum devices, which are available over the counter.

By contrast, penis implants can successfully treat erectile dysfunction in many cases, Dr. Eid said. Men trigger erections by squeezing a pump that is implanted into the scrotum. Fluid then flows from an implanted reservoir into a cylinder implanted in the penis.

Men are often pleased by penis implants because they can have sex spontaneously without having to plan for it ahead of time, as required by medications. “They’re completely transformed,” Dr. Eid said. “They feel that they’re cured.”

Dr. Eid receives or has received research support/grants from American Medical Systems, Coloplast, Lilly ICOS, Bayer, Vivus, Pharmacia-Upjohn, and Pfizer. He is or was a consultant and on the speakers bureau for Coloplast, American Medical Systems, Lilly ICOS, Bayer and Pfizer.

Diabetic men with erectile dysfunction might consider a prescription for a drug like Viagra to be a permanent cure for a temporary issue: Take a pill, problem solved. But the truth, a leading urologist says, is entirely different.

“If a diabetic patient has erectile dysfunction, it’s not enough to provide Viagra [sildenafil] or Cialis [tadalafil] and then send him on his merry way,” J. Francois Eid, MD, a New York City urologist, said at the annual meeting of the American Association of Diabetes Educators. “It’s important to let individuals know the drug has not cured the erectile dysfunction. If patients don’t take care of the diabetes, the erectile dysfunction progresses.”

In an interview, Dr. Eid shared several messages for medical professionals who treat men with diabetes and related erectile dysfunction:

• Diabetes has “devastating” effects on the penis, and may even cause it to shrink.

• Long-term uncontrolled diabetes can make ED permanent.

• While ED drugs often fail in men with diabetes, several other options exist; and penis implants may provide significant relief.

How big is the problem? An estimated 50%-75% of men with diabetes experience from some degree of ED, which is thought to be three times more common in diabetic men than other men, according to Dr. Eid.

“Diabetes has a devastating effect on the muscle tissue inside the penis,” he said. “All the tiny little arteries that feed blood to the muscle get occluded. Little by little, the muscle inside the penis shrinks.” Indeed, some diabetics with ED complain that their penises have shrunk, he said.

Diabetic damage doesn’t stop with these small vessels, he said. “You really have two parallel situations: You need blood flow that feeds the muscle of the penis, and you need an artery dedicated to bringing blood rapidly when a man becomes aroused and wants to be sexually active,” he said. “That artery is also affected by diabetes. They’ll say ‘I can get a partial erection, but I can’t maintain it.’ ”

What comes after an ED diagnosis in diabetic patients? Often, Dr. Eid will instantly refer these men to a cardiologist. “If a patient has diabetes and is newly diagnosed, a significant portion of these men are going to develop coronary artery disease in the next 2-3 years,” he said. “One of the things we do is recommend is that they see a cardiologist and perhaps have a stress test or some sort of evaluation.”

Dr. Eid also urges these patients to treat their diabetes in order to avoid developing ED for life. “They need to manage their diabetes and make sure they control it so the ED will not progress and will stabilize, as a result,” he said. “If the diabetes is controlled after the patient is first diagnosed, then the erections will come back. But if the patient has diabetes for many years, and suddenly decides it’s time to control it, they cannot prevent the damage that’s already been done.”

As for treatments, patients with diabetes and related ED should begin with medications like sildenafil and tadalafil, he recommended. But research findings suggest that the drugs will fail in half of men with type 2 diabetes, he said.

Other options include penile self-injections, vacuum devices, and penile implants.

The injections “can work well and are painless, but men detest having to inject themselves before sexual activity,” Dr. Eid said. And he said men rarely have success using vacuum devices, which are available over the counter.

By contrast, penis implants can successfully treat erectile dysfunction in many cases, Dr. Eid said. Men trigger erections by squeezing a pump that is implanted into the scrotum. Fluid then flows from an implanted reservoir into a cylinder implanted in the penis.

Men are often pleased by penis implants because they can have sex spontaneously without having to plan for it ahead of time, as required by medications. “They’re completely transformed,” Dr. Eid said. “They feel that they’re cured.”

Dr. Eid receives or has received research support/grants from American Medical Systems, Coloplast, Lilly ICOS, Bayer, Vivus, Pharmacia-Upjohn, and Pfizer. He is or was a consultant and on the speakers bureau for Coloplast, American Medical Systems, Lilly ICOS, Bayer and Pfizer.

Diabetic men with erectile dysfunction might consider a prescription for a drug like Viagra to be a permanent cure for a temporary issue: Take a pill, problem solved. But the truth, a leading urologist says, is entirely different.

“If a diabetic patient has erectile dysfunction, it’s not enough to provide Viagra [sildenafil] or Cialis [tadalafil] and then send him on his merry way,” J. Francois Eid, MD, a New York City urologist, said at the annual meeting of the American Association of Diabetes Educators. “It’s important to let individuals know the drug has not cured the erectile dysfunction. If patients don’t take care of the diabetes, the erectile dysfunction progresses.”

In an interview, Dr. Eid shared several messages for medical professionals who treat men with diabetes and related erectile dysfunction:

• Diabetes has “devastating” effects on the penis, and may even cause it to shrink.

• Long-term uncontrolled diabetes can make ED permanent.

• While ED drugs often fail in men with diabetes, several other options exist; and penis implants may provide significant relief.

How big is the problem? An estimated 50%-75% of men with diabetes experience from some degree of ED, which is thought to be three times more common in diabetic men than other men, according to Dr. Eid.

“Diabetes has a devastating effect on the muscle tissue inside the penis,” he said. “All the tiny little arteries that feed blood to the muscle get occluded. Little by little, the muscle inside the penis shrinks.” Indeed, some diabetics with ED complain that their penises have shrunk, he said.

Diabetic damage doesn’t stop with these small vessels, he said. “You really have two parallel situations: You need blood flow that feeds the muscle of the penis, and you need an artery dedicated to bringing blood rapidly when a man becomes aroused and wants to be sexually active,” he said. “That artery is also affected by diabetes. They’ll say ‘I can get a partial erection, but I can’t maintain it.’ ”

What comes after an ED diagnosis in diabetic patients? Often, Dr. Eid will instantly refer these men to a cardiologist. “If a patient has diabetes and is newly diagnosed, a significant portion of these men are going to develop coronary artery disease in the next 2-3 years,” he said. “One of the things we do is recommend is that they see a cardiologist and perhaps have a stress test or some sort of evaluation.”

Dr. Eid also urges these patients to treat their diabetes in order to avoid developing ED for life. “They need to manage their diabetes and make sure they control it so the ED will not progress and will stabilize, as a result,” he said. “If the diabetes is controlled after the patient is first diagnosed, then the erections will come back. But if the patient has diabetes for many years, and suddenly decides it’s time to control it, they cannot prevent the damage that’s already been done.”

As for treatments, patients with diabetes and related ED should begin with medications like sildenafil and tadalafil, he recommended. But research findings suggest that the drugs will fail in half of men with type 2 diabetes, he said.

Other options include penile self-injections, vacuum devices, and penile implants.

The injections “can work well and are painless, but men detest having to inject themselves before sexual activity,” Dr. Eid said. And he said men rarely have success using vacuum devices, which are available over the counter.

By contrast, penis implants can successfully treat erectile dysfunction in many cases, Dr. Eid said. Men trigger erections by squeezing a pump that is implanted into the scrotum. Fluid then flows from an implanted reservoir into a cylinder implanted in the penis.

Men are often pleased by penis implants because they can have sex spontaneously without having to plan for it ahead of time, as required by medications. “They’re completely transformed,” Dr. Eid said. “They feel that they’re cured.”

Dr. Eid receives or has received research support/grants from American Medical Systems, Coloplast, Lilly ICOS, Bayer, Vivus, Pharmacia-Upjohn, and Pfizer. He is or was a consultant and on the speakers bureau for Coloplast, American Medical Systems, Lilly ICOS, Bayer and Pfizer.

NEW ORLEANS – Early weight loss on liraglutide – specifically, dropping at least 4% of body weight at 16 weeks – is a strong and clinically useful identifier of patients with a high likelihood of significant weight loss 13 months into treatment, with an accompanying improvement in cardiometabolic risk factors, according to Ken Fujioka, MD.

Conversely, patients who aren’t early responders to subcutaneous liraglutide at 3 mg/day are unlikely to achieve at least 5% weight loss after a full year on the drug, the regulatory benchmark for clinically meaningful weight loss, added Dr. Fujioka, an internist and director of the center for weight management at the Scripps Clinic in La Jolla, Calif.

“Using this early response criterion at week 16 to predict long-term weight loss is to me a very valuable tool. Obesity is an odd disease because it has so many different causes. Finding the right drug is tough, and how long to keep trying with a particular medication is something we haven’t known. So I think the biggest change in obesity medicine is the creation of stopping rules that allow you to say, ‘OK, maybe this isn’t going to work. There’s some other reason you’re gaining weight, so let’s move on to something else,’” Dr. Fujioka said at the meeting presented by the Obesity Society of America and the American Society for Metabolic and Bariatric Surgery.

“When you stop the medication, you improve the risk-benefit ratio by removing all risk. That’s a win-win to me, and I applaud the FDA for getting on the pharmaceutical companies to make sure they put stopping rules in their medication labels,” he added.

He presented a post hoc pooled analysis of two previously published large, double-blind phase III clinical trials of subcutaneous liraglutide at 3 mg/day (Saxenda) or placebo in combination with a diet and exercise intervention for weight loss: the 3,731-patient SCALE Obesity and Prediabetes trial and the 846-patient SCALE Diabetes trial. In both trials liraglutide was started at a dose of 0.6 mg and titrated to 3.0 mg by week 4. The lifestyle intervention entailed a 500-kcal/day deficit diet and a minimum of 150 minutes of physical activity per week.

The purpose of the pooled analysis was to identify the best early predictor of response status at 56 weeks by examining the impact of 3%, 4%, and 5% weight loss after 8, 12, and 16 weeks of treatment as cut points. This post hoc analysis was prespecified at the request of the Food and Drug Administration before the trials were completed.

The bottom line: The best predictor of long-term outcome on liraglutide, a glucagonlike peptide–1 analog, proved to be a weight loss of 4% or greater at 16 weeks. It had an 81% positive predictive value and a 76% negative predictive value for at least a 5% weight loss at 56 weeks. It correctly predicted weight outcomes at 56 weeks in 80.1% of patients, the highest success rate of all the combinations studied. This finding was the impetus for the current product labeling, which contains the stopping rule. Dr. Fujioka shared study data not included in the labeling; namely, the marked contrast in how early responders and early nonresponders fared at 56 weeks.

The mean weight loss at 56 weeks in nondiabetic early responders to liraglutide was 10.8%, compared with only 3% in early nondiabetic nonresponders. Diabetic early responders averaged an 8.5% weight loss at 56 weeks, while early nonresponders had a mean 3.1% weight loss.

In the SCALE Obesity and Prediabetes trial, 50% of early responders to liraglutide ended up with a greater than 10% weight loss at 56 weeks, and 21% had more than 15% weight loss, compared with rates of 6% and 2%, respectively, in early nonresponders.

In the SCALE Diabetes study, 38% of early responders had greater than 10% weight loss long term, a rate nearly fourfold higher than in early nonresponders. Moreover, 10% of early responder diabetic patients had greater than 15% weight loss, versus a mere 2% of early nonresponders, the internist continued.

The ratio of early responders to early nonresponders in the nondiabetic population was 77%:23%. In diabetic patients, it was 63%:37%.

Turning to cardiometabolic endpoints, Dr. Fujioka noted that early responders in the SCALE Obesity and Prediabetes trial went on to show a mean reduction in systolic blood pressure of 5.1 mm Hg at 56 weeks, compared with a 2–mm Hg decrease in early nonresponders. Early responders also averaged a 10.5-cm shrinkage in waist circumference from a baseline of 115 cm, which was more than twice that observed at 56 weeks in early nonresponders. HDL-cholesterol level rose by 3.9% in early responders but remained unchanged over time in early nonresponders.

Diabetic patients who were early responders to liraglutide 3.0 mg/day had a mean 44.2-mg/dL reduction in fasting plasma glucose at 56 weeks from a baseline of 158 mg/dL, compared with a 30.1-mg/dL decrease in early nonresponders.

“The drop in fasting blood glucose is very quick – within a matter of weeks – so if you already have diabetic patients on drugs that are going to bring their blood sugar down, you may have to back titrate those other drugs really quickly. You don’t want to make your patients hypoglycemic,” the physician said.

Mean hemoglobin A_1c values in early responder diabetic patients fell by 1.6% from a baseline of 7.9%, a full 0.5% greater reduction than in early nonresponders.

By far the most frequent adverse events in the two SCALE trials were gastrointestinal, with nausea leading the way. Rates were modestly higher in the early responders.

 

This analysis and the clinical trials on which it was based were sponsored by Novo Nordisk, which markets liraglutide under the brand names Saxenda and Voctoza. The presenter reported receiving research grants from and serving as a consultant to Novo Nordisk and other pharmaceutical companies.

NEW ORLEANS – Early weight loss on liraglutide – specifically, dropping at least 4% of body weight at 16 weeks – is a strong and clinically useful identifier of patients with a high likelihood of significant weight loss 13 months into treatment, with an accompanying improvement in cardiometabolic risk factors, according to Ken Fujioka, MD.

Conversely, patients who aren’t early responders to subcutaneous liraglutide at 3 mg/day are unlikely to achieve at least 5% weight loss after a full year on the drug, the regulatory benchmark for clinically meaningful weight loss, added Dr. Fujioka, an internist and director of the center for weight management at the Scripps Clinic in La Jolla, Calif.

“Using this early response criterion at week 16 to predict long-term weight loss is to me a very valuable tool. Obesity is an odd disease because it has so many different causes. Finding the right drug is tough, and how long to keep trying with a particular medication is something we haven’t known. So I think the biggest change in obesity medicine is the creation of stopping rules that allow you to say, ‘OK, maybe this isn’t going to work. There’s some other reason you’re gaining weight, so let’s move on to something else,’” Dr. Fujioka said at the meeting presented by the Obesity Society of America and the American Society for Metabolic and Bariatric Surgery.

“When you stop the medication, you improve the risk-benefit ratio by removing all risk. That’s a win-win to me, and I applaud the FDA for getting on the pharmaceutical companies to make sure they put stopping rules in their medication labels,” he added.

He presented a post hoc pooled analysis of two previously published large, double-blind phase III clinical trials of subcutaneous liraglutide at 3 mg/day (Saxenda) or placebo in combination with a diet and exercise intervention for weight loss: the 3,731-patient SCALE Obesity and Prediabetes trial and the 846-patient SCALE Diabetes trial. In both trials liraglutide was started at a dose of 0.6 mg and titrated to 3.0 mg by week 4. The lifestyle intervention entailed a 500-kcal/day deficit diet and a minimum of 150 minutes of physical activity per week.

The purpose of the pooled analysis was to identify the best early predictor of response status at 56 weeks by examining the impact of 3%, 4%, and 5% weight loss after 8, 12, and 16 weeks of treatment as cut points. This post hoc analysis was prespecified at the request of the Food and Drug Administration before the trials were completed.

The bottom line: The best predictor of long-term outcome on liraglutide, a glucagonlike peptide–1 analog, proved to be a weight loss of 4% or greater at 16 weeks. It had an 81% positive predictive value and a 76% negative predictive value for at least a 5% weight loss at 56 weeks. It correctly predicted weight outcomes at 56 weeks in 80.1% of patients, the highest success rate of all the combinations studied. This finding was the impetus for the current product labeling, which contains the stopping rule. Dr. Fujioka shared study data not included in the labeling; namely, the marked contrast in how early responders and early nonresponders fared at 56 weeks.

The mean weight loss at 56 weeks in nondiabetic early responders to liraglutide was 10.8%, compared with only 3% in early nondiabetic nonresponders. Diabetic early responders averaged an 8.5% weight loss at 56 weeks, while early nonresponders had a mean 3.1% weight loss.

In the SCALE Obesity and Prediabetes trial, 50% of early responders to liraglutide ended up with a greater than 10% weight loss at 56 weeks, and 21% had more than 15% weight loss, compared with rates of 6% and 2%, respectively, in early nonresponders.

In the SCALE Diabetes study, 38% of early responders had greater than 10% weight loss long term, a rate nearly fourfold higher than in early nonresponders. Moreover, 10% of early responder diabetic patients had greater than 15% weight loss, versus a mere 2% of early nonresponders, the internist continued.

The ratio of early responders to early nonresponders in the nondiabetic population was 77%:23%. In diabetic patients, it was 63%:37%.

Turning to cardiometabolic endpoints, Dr. Fujioka noted that early responders in the SCALE Obesity and Prediabetes trial went on to show a mean reduction in systolic blood pressure of 5.1 mm Hg at 56 weeks, compared with a 2–mm Hg decrease in early nonresponders. Early responders also averaged a 10.5-cm shrinkage in waist circumference from a baseline of 115 cm, which was more than twice that observed at 56 weeks in early nonresponders. HDL-cholesterol level rose by 3.9% in early responders but remained unchanged over time in early nonresponders.

Diabetic patients who were early responders to liraglutide 3.0 mg/day had a mean 44.2-mg/dL reduction in fasting plasma glucose at 56 weeks from a baseline of 158 mg/dL, compared with a 30.1-mg/dL decrease in early nonresponders.

“The drop in fasting blood glucose is very quick – within a matter of weeks – so if you already have diabetic patients on drugs that are going to bring their blood sugar down, you may have to back titrate those other drugs really quickly. You don’t want to make your patients hypoglycemic,” the physician said.

Mean hemoglobin A_1c values in early responder diabetic patients fell by 1.6% from a baseline of 7.9%, a full 0.5% greater reduction than in early nonresponders.

By far the most frequent adverse events in the two SCALE trials were gastrointestinal, with nausea leading the way. Rates were modestly higher in the early responders.

 

This analysis and the clinical trials on which it was based were sponsored by Novo Nordisk, which markets liraglutide under the brand names Saxenda and Voctoza. The presenter reported receiving research grants from and serving as a consultant to Novo Nordisk and other pharmaceutical companies.

NEW ORLEANS – Early weight loss on liraglutide – specifically, dropping at least 4% of body weight at 16 weeks – is a strong and clinically useful identifier of patients with a high likelihood of significant weight loss 13 months into treatment, with an accompanying improvement in cardiometabolic risk factors, according to Ken Fujioka, MD.

Conversely, patients who aren’t early responders to subcutaneous liraglutide at 3 mg/day are unlikely to achieve at least 5% weight loss after a full year on the drug, the regulatory benchmark for clinically meaningful weight loss, added Dr. Fujioka, an internist and director of the center for weight management at the Scripps Clinic in La Jolla, Calif.

“Using this early response criterion at week 16 to predict long-term weight loss is to me a very valuable tool. Obesity is an odd disease because it has so many different causes. Finding the right drug is tough, and how long to keep trying with a particular medication is something we haven’t known. So I think the biggest change in obesity medicine is the creation of stopping rules that allow you to say, ‘OK, maybe this isn’t going to work. There’s some other reason you’re gaining weight, so let’s move on to something else,’” Dr. Fujioka said at the meeting presented by the Obesity Society of America and the American Society for Metabolic and Bariatric Surgery.

“When you stop the medication, you improve the risk-benefit ratio by removing all risk. That’s a win-win to me, and I applaud the FDA for getting on the pharmaceutical companies to make sure they put stopping rules in their medication labels,” he added.

He presented a post hoc pooled analysis of two previously published large, double-blind phase III clinical trials of subcutaneous liraglutide at 3 mg/day (Saxenda) or placebo in combination with a diet and exercise intervention for weight loss: the 3,731-patient SCALE Obesity and Prediabetes trial and the 846-patient SCALE Diabetes trial. In both trials liraglutide was started at a dose of 0.6 mg and titrated to 3.0 mg by week 4. The lifestyle intervention entailed a 500-kcal/day deficit diet and a minimum of 150 minutes of physical activity per week.

The purpose of the pooled analysis was to identify the best early predictor of response status at 56 weeks by examining the impact of 3%, 4%, and 5% weight loss after 8, 12, and 16 weeks of treatment as cut points. This post hoc analysis was prespecified at the request of the Food and Drug Administration before the trials were completed.

The bottom line: The best predictor of long-term outcome on liraglutide, a glucagonlike peptide–1 analog, proved to be a weight loss of 4% or greater at 16 weeks. It had an 81% positive predictive value and a 76% negative predictive value for at least a 5% weight loss at 56 weeks. It correctly predicted weight outcomes at 56 weeks in 80.1% of patients, the highest success rate of all the combinations studied. This finding was the impetus for the current product labeling, which contains the stopping rule. Dr. Fujioka shared study data not included in the labeling; namely, the marked contrast in how early responders and early nonresponders fared at 56 weeks.

The mean weight loss at 56 weeks in nondiabetic early responders to liraglutide was 10.8%, compared with only 3% in early nondiabetic nonresponders. Diabetic early responders averaged an 8.5% weight loss at 56 weeks, while early nonresponders had a mean 3.1% weight loss.

In the SCALE Obesity and Prediabetes trial, 50% of early responders to liraglutide ended up with a greater than 10% weight loss at 56 weeks, and 21% had more than 15% weight loss, compared with rates of 6% and 2%, respectively, in early nonresponders.

In the SCALE Diabetes study, 38% of early responders had greater than 10% weight loss long term, a rate nearly fourfold higher than in early nonresponders. Moreover, 10% of early responder diabetic patients had greater than 15% weight loss, versus a mere 2% of early nonresponders, the internist continued.

The ratio of early responders to early nonresponders in the nondiabetic population was 77%:23%. In diabetic patients, it was 63%:37%.

Turning to cardiometabolic endpoints, Dr. Fujioka noted that early responders in the SCALE Obesity and Prediabetes trial went on to show a mean reduction in systolic blood pressure of 5.1 mm Hg at 56 weeks, compared with a 2–mm Hg decrease in early nonresponders. Early responders also averaged a 10.5-cm shrinkage in waist circumference from a baseline of 115 cm, which was more than twice that observed at 56 weeks in early nonresponders. HDL-cholesterol level rose by 3.9% in early responders but remained unchanged over time in early nonresponders.

Diabetic patients who were early responders to liraglutide 3.0 mg/day had a mean 44.2-mg/dL reduction in fasting plasma glucose at 56 weeks from a baseline of 158 mg/dL, compared with a 30.1-mg/dL decrease in early nonresponders.

“The drop in fasting blood glucose is very quick – within a matter of weeks – so if you already have diabetic patients on drugs that are going to bring their blood sugar down, you may have to back titrate those other drugs really quickly. You don’t want to make your patients hypoglycemic,” the physician said.

Mean hemoglobin A_1c values in early responder diabetic patients fell by 1.6% from a baseline of 7.9%, a full 0.5% greater reduction than in early nonresponders.

By far the most frequent adverse events in the two SCALE trials were gastrointestinal, with nausea leading the way. Rates were modestly higher in the early responders.

 

This analysis and the clinical trials on which it was based were sponsored by Novo Nordisk, which markets liraglutide under the brand names Saxenda and Voctoza. The presenter reported receiving research grants from and serving as a consultant to Novo Nordisk and other pharmaceutical companies.

SAN FRANCISCO – Body-size awareness was associated with a decrease in BMI among Latino children and teens, said Grace Lim, MD, a pediatrician in King City, Calif.

Awareness of body size, as a proxy for motivation to change behavior, was based on choices of sex-specific body silhouettes in comparison to actual body mass index (BMI) z-scores. Dr. Lim and her coauthor, Dr. Nazrat Mirza, conducted a study at Children’s National Medical Center in Washington of 80 overweight or obese Latino youths aged 7-15 years who were taking part in a 12-week, community-based weight management program: 68% of study participants demonstrated awareness of overweight or obese body sizes. They were more likely to be older (P less than .001) and with higher maternal age (P = .02). Body-size awareness in the child was positively associated with a decrease in BMI during the intervention period (P less than .001).

Catherine Cooper Nellist/Frontline Medical News

[email protected]

SAN FRANCISCO – Body-size awareness was associated with a decrease in BMI among Latino children and teens, said Grace Lim, MD, a pediatrician in King City, Calif.

Awareness of body size, as a proxy for motivation to change behavior, was based on choices of sex-specific body silhouettes in comparison to actual body mass index (BMI) z-scores. Dr. Lim and her coauthor, Dr. Nazrat Mirza, conducted a study at Children’s National Medical Center in Washington of 80 overweight or obese Latino youths aged 7-15 years who were taking part in a 12-week, community-based weight management program: 68% of study participants demonstrated awareness of overweight or obese body sizes. They were more likely to be older (P less than .001) and with higher maternal age (P = .02). Body-size awareness in the child was positively associated with a decrease in BMI during the intervention period (P less than .001).

Catherine Cooper Nellist/Frontline Medical News

[email protected]

SAN FRANCISCO – Body-size awareness was associated with a decrease in BMI among Latino children and teens, said Grace Lim, MD, a pediatrician in King City, Calif.

Awareness of body size, as a proxy for motivation to change behavior, was based on choices of sex-specific body silhouettes in comparison to actual body mass index (BMI) z-scores. Dr. Lim and her coauthor, Dr. Nazrat Mirza, conducted a study at Children’s National Medical Center in Washington of 80 overweight or obese Latino youths aged 7-15 years who were taking part in a 12-week, community-based weight management program: 68% of study participants demonstrated awareness of overweight or obese body sizes. They were more likely to be older (P less than .001) and with higher maternal age (P = .02). Body-size awareness in the child was positively associated with a decrease in BMI during the intervention period (P less than .001).

Catherine Cooper Nellist/Frontline Medical News

[email protected]

Inhaling He/O₂ did not result in a lower NIV failure rate than inhaling Air/O₂ in COPD patients requiring noninvasive ventilation, in a randomized, controlled study.

In the study, known as the E.C.H.O.ICU trial, patients either received He/0₂ (a 78%/22% mixture blended with 100% O₂) or a conventional Air/O₂ mixture for up to 72 hours, during both noninvasive ventilation (NIV) and spontaneous breathing.

Previous research had demonstrated that during hypercapnic COPD exacerbations, the He/O₂ mixture reduces airway resistance, partial pressure of carbon dioxide in arterial blood (PaCO₂₎, intrinsic positive end-expiratory pressure, and work of breathing during both spontaneous breathing and NIV, compared with Air/O₂, said Philippe Jolliet, MD, and his colleagues.

The two treatment groups in the E.C.H.O.^ICU trial had similar NIV failure rates – defined as endotracheal intubation or death without intubation. The rates were 14.7% for the patients who received He/O₂ and 14.5% for the patients who received Air/O₂. The NIV failures for 31 the patients in the He/O₂ group resulted in intubation; the remaining two patients who were classified as having NIV failure died. All 32 of the patients in the Air/O₂ group who had NIV failures were intubated.

The length of ICU stay was also comparable between the two groups. In the subgroups of patients with severe acidosis (having a pH of less than 7.30) from both the He/O₂ and Air/O₂ groups, the NIV failure rates were again nearly identical (AJRCCM. 2016 Oct 13; doi: 10.1164/rccm.201601-0083OC).

The average times to NIV failure were 93 hours in the He/O₂ group (N = 33) and 52 hours in the Air/O₂ group (N = 32, P = .12). The He/O₂ group achieved a significantly quicker improvement in respiratory acidosis, encephalopathy score, and respiratory rate.

Patients intubated following an NIV failure who had received He/O₂ had a shorter ventilation duration and a shorter ICU stay than did the intubated patients who had received Air/O₂ (7.4 days, vs. 13.6 days, P = .02, and 15.8 vs. 26.7 days, P = .01).

No significant differences appeared in the safety profile of the two groups, nor were significant differences seen in ICU, hospital, or 6-month mortality rates; or in 6-month hospital readmission rates.

“[The] study was stopped prematurely after a futility analysis due the low event rate identified by [an independent adjudication committee],” said Dr. Jolliet of the intensive care and burn unit at Le Centre Hospitalier Universitaire Vaudois (CHUV), in Lausanne, Switzerland, and his fellow researchers.

The study included 445 patients from ICUs or intermediate care units in six countries. The inclusion criteria were presenting with current COPD exacerbation with hypercapnic acute respiratory failure, a PaCO₂ of at least 45 mm Hg, an arterial pH of less than or equal to 7.35, and at least one of the following: respiration rate of at least 25 breaths per minute, a PaO₂ less than or equal to 50 mm Hg, and an arterial oxygen saturation of less than or equal to 90%.

Half of the patients in each group were already receiving NIV prior to enrollment in the study. Males constituted two thirds of all enrolled patients.

HeO₂ administration was limited to 72 hours for each patient and about a third of NIV failures occurred after the end of the HeO₂ administration, the researchers said.

“The main reason for the absence of observed benefit on outcome in the He/O₂ probably lies in the very low NIV failure rate now observed in both groups. One possible mechanism explaining the low intubation rate could be that some patients had received uncontrolled oxygen therapy prior to ICU admission, thereby worsening initial hypercapnia and acidosis, a problem that can easily be corrected by adequate titration,” the researchers said. “The 14.5% failure rate in the Air/O₂ group was much lower than the 25% rate used in designing the study,” which was based on previous research.

The trial’s sponsor, Air Liquide Healthcare, provided input into the design and conduct of the study; oversaw the collection, management, and statistical analysis of data; and contributed to the manuscript’s preparation and review.

Inhaling He/O₂ did not result in a lower NIV failure rate than inhaling Air/O₂ in COPD patients requiring noninvasive ventilation, in a randomized, controlled study.

In the study, known as the E.C.H.O.ICU trial, patients either received He/0₂ (a 78%/22% mixture blended with 100% O₂) or a conventional Air/O₂ mixture for up to 72 hours, during both noninvasive ventilation (NIV) and spontaneous breathing.

Previous research had demonstrated that during hypercapnic COPD exacerbations, the He/O₂ mixture reduces airway resistance, partial pressure of carbon dioxide in arterial blood (PaCO₂₎, intrinsic positive end-expiratory pressure, and work of breathing during both spontaneous breathing and NIV, compared with Air/O₂, said Philippe Jolliet, MD, and his colleagues.

The two treatment groups in the E.C.H.O.^ICU trial had similar NIV failure rates – defined as endotracheal intubation or death without intubation. The rates were 14.7% for the patients who received He/O₂ and 14.5% for the patients who received Air/O₂. The NIV failures for 31 the patients in the He/O₂ group resulted in intubation; the remaining two patients who were classified as having NIV failure died. All 32 of the patients in the Air/O₂ group who had NIV failures were intubated.

The length of ICU stay was also comparable between the two groups. In the subgroups of patients with severe acidosis (having a pH of less than 7.30) from both the He/O₂ and Air/O₂ groups, the NIV failure rates were again nearly identical (AJRCCM. 2016 Oct 13; doi: 10.1164/rccm.201601-0083OC).

The average times to NIV failure were 93 hours in the He/O₂ group (N = 33) and 52 hours in the Air/O₂ group (N = 32, P = .12). The He/O₂ group achieved a significantly quicker improvement in respiratory acidosis, encephalopathy score, and respiratory rate.

Patients intubated following an NIV failure who had received He/O₂ had a shorter ventilation duration and a shorter ICU stay than did the intubated patients who had received Air/O₂ (7.4 days, vs. 13.6 days, P = .02, and 15.8 vs. 26.7 days, P = .01).

No significant differences appeared in the safety profile of the two groups, nor were significant differences seen in ICU, hospital, or 6-month mortality rates; or in 6-month hospital readmission rates.

“[The] study was stopped prematurely after a futility analysis due the low event rate identified by [an independent adjudication committee],” said Dr. Jolliet of the intensive care and burn unit at Le Centre Hospitalier Universitaire Vaudois (CHUV), in Lausanne, Switzerland, and his fellow researchers.

The study included 445 patients from ICUs or intermediate care units in six countries. The inclusion criteria were presenting with current COPD exacerbation with hypercapnic acute respiratory failure, a PaCO₂ of at least 45 mm Hg, an arterial pH of less than or equal to 7.35, and at least one of the following: respiration rate of at least 25 breaths per minute, a PaO₂ less than or equal to 50 mm Hg, and an arterial oxygen saturation of less than or equal to 90%.

Half of the patients in each group were already receiving NIV prior to enrollment in the study. Males constituted two thirds of all enrolled patients.

HeO₂ administration was limited to 72 hours for each patient and about a third of NIV failures occurred after the end of the HeO₂ administration, the researchers said.

“The main reason for the absence of observed benefit on outcome in the He/O₂ probably lies in the very low NIV failure rate now observed in both groups. One possible mechanism explaining the low intubation rate could be that some patients had received uncontrolled oxygen therapy prior to ICU admission, thereby worsening initial hypercapnia and acidosis, a problem that can easily be corrected by adequate titration,” the researchers said. “The 14.5% failure rate in the Air/O₂ group was much lower than the 25% rate used in designing the study,” which was based on previous research.

The trial’s sponsor, Air Liquide Healthcare, provided input into the design and conduct of the study; oversaw the collection, management, and statistical analysis of data; and contributed to the manuscript’s preparation and review.

Inhaling He/O₂ did not result in a lower NIV failure rate than inhaling Air/O₂ in COPD patients requiring noninvasive ventilation, in a randomized, controlled study.

In the study, known as the E.C.H.O.ICU trial, patients either received He/0₂ (a 78%/22% mixture blended with 100% O₂) or a conventional Air/O₂ mixture for up to 72 hours, during both noninvasive ventilation (NIV) and spontaneous breathing.

Previous research had demonstrated that during hypercapnic COPD exacerbations, the He/O₂ mixture reduces airway resistance, partial pressure of carbon dioxide in arterial blood (PaCO₂₎, intrinsic positive end-expiratory pressure, and work of breathing during both spontaneous breathing and NIV, compared with Air/O₂, said Philippe Jolliet, MD, and his colleagues.

The two treatment groups in the E.C.H.O.^ICU trial had similar NIV failure rates – defined as endotracheal intubation or death without intubation. The rates were 14.7% for the patients who received He/O₂ and 14.5% for the patients who received Air/O₂. The NIV failures for 31 the patients in the He/O₂ group resulted in intubation; the remaining two patients who were classified as having NIV failure died. All 32 of the patients in the Air/O₂ group who had NIV failures were intubated.

The length of ICU stay was also comparable between the two groups. In the subgroups of patients with severe acidosis (having a pH of less than 7.30) from both the He/O₂ and Air/O₂ groups, the NIV failure rates were again nearly identical (AJRCCM. 2016 Oct 13; doi: 10.1164/rccm.201601-0083OC).

The average times to NIV failure were 93 hours in the He/O₂ group (N = 33) and 52 hours in the Air/O₂ group (N = 32, P = .12). The He/O₂ group achieved a significantly quicker improvement in respiratory acidosis, encephalopathy score, and respiratory rate.

Patients intubated following an NIV failure who had received He/O₂ had a shorter ventilation duration and a shorter ICU stay than did the intubated patients who had received Air/O₂ (7.4 days, vs. 13.6 days, P = .02, and 15.8 vs. 26.7 days, P = .01).

No significant differences appeared in the safety profile of the two groups, nor were significant differences seen in ICU, hospital, or 6-month mortality rates; or in 6-month hospital readmission rates.

“[The] study was stopped prematurely after a futility analysis due the low event rate identified by [an independent adjudication committee],” said Dr. Jolliet of the intensive care and burn unit at Le Centre Hospitalier Universitaire Vaudois (CHUV), in Lausanne, Switzerland, and his fellow researchers.

The study included 445 patients from ICUs or intermediate care units in six countries. The inclusion criteria were presenting with current COPD exacerbation with hypercapnic acute respiratory failure, a PaCO₂ of at least 45 mm Hg, an arterial pH of less than or equal to 7.35, and at least one of the following: respiration rate of at least 25 breaths per minute, a PaO₂ less than or equal to 50 mm Hg, and an arterial oxygen saturation of less than or equal to 90%.

Half of the patients in each group were already receiving NIV prior to enrollment in the study. Males constituted two thirds of all enrolled patients.

HeO₂ administration was limited to 72 hours for each patient and about a third of NIV failures occurred after the end of the HeO₂ administration, the researchers said.

“The main reason for the absence of observed benefit on outcome in the He/O₂ probably lies in the very low NIV failure rate now observed in both groups. One possible mechanism explaining the low intubation rate could be that some patients had received uncontrolled oxygen therapy prior to ICU admission, thereby worsening initial hypercapnia and acidosis, a problem that can easily be corrected by adequate titration,” the researchers said. “The 14.5% failure rate in the Air/O₂ group was much lower than the 25% rate used in designing the study,” which was based on previous research.

The trial’s sponsor, Air Liquide Healthcare, provided input into the design and conduct of the study; oversaw the collection, management, and statistical analysis of data; and contributed to the manuscript’s preparation and review.

LOS ANGELES – Comorbidities are common in patients with chronic obstructive pulmonary disease, especially cardiovascular disease, diabetes, anemia, and osteoporosis, results from a single-center analysis showed.

“These affect the course and outcome of COPD, so identification and treatment of these comorbidities is very important,” Hamdy Mohammadien, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians.

In an effort to estimate the presence of comorbidities in patients with COPD and to assess the relationship of comorbid diseases with age, sex, C-reactive protein, and COPD severity, Dr. Mohammadien and his associates at Sohag (Egypt) University, retrospectively evaluated 400 COPD patients who were at least 40 years of age. Those who presented with bronchial asthma or other lung diseases were excluded from the analysis. The mean age of patients was 62 years, 69% were male, and 36% were current smokers. Their mean FEV₁/FVC ratio (forced expiratory volume in 1 second/forced vital capacity) was 48%, and 57% had two or more exacerbations in the previous year.

Dr. Mohammadien reported that all patients had at least one comorbidity. The most common comorbidities were cardiovascular diseases (85%), diabetes (35%), dyslipidemia (23%), osteopenia (11%), anemia (10%), muscle wasting (9%), pneumonia (7%), osteoporosis (6%), GERD (2%), and lung cancer (2%). He also noted that the association between cardiovascular events, dyslipidemia, diabetes, osteoporosis, muscle wasting, and anemia was highly significant in COPD patients aged 60 years and older, in men, and in patients with stage III and IV COPD. In addition, a significant relationship was observed between a positive CRP level and each comorbidity, with the exception of gastroesophageal reflux disease and lung cancer. The three comorbidities with the greatest significance were ischemic heart disease (P = .0001), dyslipidemia (P = .0001), and pneumonia (P = .0003). Finally, frequent exacerbators were significantly more likely to have two or more comorbidities (odds ratio 2; P = .04) and to have more hospitalizations in the past year (P less than .01).

“Comorbidities are common in patients with COPD, and have a significant impact on health status and prognosis, thus justifying the need for a comprehensive and integrating therapeutic approach,” Dr. Mohammadien said at the meeting. “In the management of COPD all these conditions need to be carefully evaluated and treated.”

He acknowledged certain limitations of the study, including its relatively small sample size and the fact that bone density was measured by sonar and not by dual-energy x-ray absorptiometry. Dr. Mohammadien reported having no financial disclosures.

[email protected]

LOS ANGELES – Comorbidities are common in patients with chronic obstructive pulmonary disease, especially cardiovascular disease, diabetes, anemia, and osteoporosis, results from a single-center analysis showed.

“These affect the course and outcome of COPD, so identification and treatment of these comorbidities is very important,” Hamdy Mohammadien, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians.

In an effort to estimate the presence of comorbidities in patients with COPD and to assess the relationship of comorbid diseases with age, sex, C-reactive protein, and COPD severity, Dr. Mohammadien and his associates at Sohag (Egypt) University, retrospectively evaluated 400 COPD patients who were at least 40 years of age. Those who presented with bronchial asthma or other lung diseases were excluded from the analysis. The mean age of patients was 62 years, 69% were male, and 36% were current smokers. Their mean FEV₁/FVC ratio (forced expiratory volume in 1 second/forced vital capacity) was 48%, and 57% had two or more exacerbations in the previous year.

Dr. Mohammadien reported that all patients had at least one comorbidity. The most common comorbidities were cardiovascular diseases (85%), diabetes (35%), dyslipidemia (23%), osteopenia (11%), anemia (10%), muscle wasting (9%), pneumonia (7%), osteoporosis (6%), GERD (2%), and lung cancer (2%). He also noted that the association between cardiovascular events, dyslipidemia, diabetes, osteoporosis, muscle wasting, and anemia was highly significant in COPD patients aged 60 years and older, in men, and in patients with stage III and IV COPD. In addition, a significant relationship was observed between a positive CRP level and each comorbidity, with the exception of gastroesophageal reflux disease and lung cancer. The three comorbidities with the greatest significance were ischemic heart disease (P = .0001), dyslipidemia (P = .0001), and pneumonia (P = .0003). Finally, frequent exacerbators were significantly more likely to have two or more comorbidities (odds ratio 2; P = .04) and to have more hospitalizations in the past year (P less than .01).

“Comorbidities are common in patients with COPD, and have a significant impact on health status and prognosis, thus justifying the need for a comprehensive and integrating therapeutic approach,” Dr. Mohammadien said at the meeting. “In the management of COPD all these conditions need to be carefully evaluated and treated.”

He acknowledged certain limitations of the study, including its relatively small sample size and the fact that bone density was measured by sonar and not by dual-energy x-ray absorptiometry. Dr. Mohammadien reported having no financial disclosures.

[email protected]

LOS ANGELES – Comorbidities are common in patients with chronic obstructive pulmonary disease, especially cardiovascular disease, diabetes, anemia, and osteoporosis, results from a single-center analysis showed.

“These affect the course and outcome of COPD, so identification and treatment of these comorbidities is very important,” Hamdy Mohammadien, MD, said in an interview in advance of the annual meeting of the American College of Chest Physicians.

In an effort to estimate the presence of comorbidities in patients with COPD and to assess the relationship of comorbid diseases with age, sex, C-reactive protein, and COPD severity, Dr. Mohammadien and his associates at Sohag (Egypt) University, retrospectively evaluated 400 COPD patients who were at least 40 years of age. Those who presented with bronchial asthma or other lung diseases were excluded from the analysis. The mean age of patients was 62 years, 69% were male, and 36% were current smokers. Their mean FEV₁/FVC ratio (forced expiratory volume in 1 second/forced vital capacity) was 48%, and 57% had two or more exacerbations in the previous year.

Dr. Mohammadien reported that all patients had at least one comorbidity. The most common comorbidities were cardiovascular diseases (85%), diabetes (35%), dyslipidemia (23%), osteopenia (11%), anemia (10%), muscle wasting (9%), pneumonia (7%), osteoporosis (6%), GERD (2%), and lung cancer (2%). He also noted that the association between cardiovascular events, dyslipidemia, diabetes, osteoporosis, muscle wasting, and anemia was highly significant in COPD patients aged 60 years and older, in men, and in patients with stage III and IV COPD. In addition, a significant relationship was observed between a positive CRP level and each comorbidity, with the exception of gastroesophageal reflux disease and lung cancer. The three comorbidities with the greatest significance were ischemic heart disease (P = .0001), dyslipidemia (P = .0001), and pneumonia (P = .0003). Finally, frequent exacerbators were significantly more likely to have two or more comorbidities (odds ratio 2; P = .04) and to have more hospitalizations in the past year (P less than .01).

“Comorbidities are common in patients with COPD, and have a significant impact on health status and prognosis, thus justifying the need for a comprehensive and integrating therapeutic approach,” Dr. Mohammadien said at the meeting. “In the management of COPD all these conditions need to be carefully evaluated and treated.”

He acknowledged certain limitations of the study, including its relatively small sample size and the fact that bone density was measured by sonar and not by dual-energy x-ray absorptiometry. Dr. Mohammadien reported having no financial disclosures.

[email protected]

Concerns that Affordable Care Act (ACA) provisions implemented in 2014 would lead large numbers of employers to drop health insurance coverage appear to have been unfounded, according to a study published in the journal Health Affairs.

More than 95% of employers did not change their insurance coverage policy between 2013 and 2014: 46.4% offered coverage in 2013 and continued it in 2014 and 49.1% did not offer coverage either year. Of the 21,900 private-sector employers included in the analysis, 3.5% provided coverage in 2013 but not in 2014 and 1.1% did not offer it in 2013 but did in 2014, reported Jean Abraham, PhD, of the University of Minnesota, Minneapolis, and her associates (Health Aff. 2016 Oct 26;35[11]. doi: 10.1377/hlthaff.2016.0631).

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Concerns that Affordable Care Act (ACA) provisions implemented in 2014 would lead large numbers of employers to drop health insurance coverage appear to have been unfounded, according to a study published in the journal Health Affairs.

More than 95% of employers did not change their insurance coverage policy between 2013 and 2014: 46.4% offered coverage in 2013 and continued it in 2014 and 49.1% did not offer coverage either year. Of the 21,900 private-sector employers included in the analysis, 3.5% provided coverage in 2013 but not in 2014 and 1.1% did not offer it in 2013 but did in 2014, reported Jean Abraham, PhD, of the University of Minnesota, Minneapolis, and her associates (Health Aff. 2016 Oct 26;35[11]. doi: 10.1377/hlthaff.2016.0631).

[email protected]

Concerns that Affordable Care Act (ACA) provisions implemented in 2014 would lead large numbers of employers to drop health insurance coverage appear to have been unfounded, according to a study published in the journal Health Affairs.

More than 95% of employers did not change their insurance coverage policy between 2013 and 2014: 46.4% offered coverage in 2013 and continued it in 2014 and 49.1% did not offer coverage either year. Of the 21,900 private-sector employers included in the analysis, 3.5% provided coverage in 2013 but not in 2014 and 1.1% did not offer it in 2013 but did in 2014, reported Jean Abraham, PhD, of the University of Minnesota, Minneapolis, and her associates (Health Aff. 2016 Oct 26;35[11]. doi: 10.1377/hlthaff.2016.0631).

[email protected]

There will be 16% fewer Medicare part D prescription drug plans available in 2017, compared with 2016, according to an analysis by the Kaiser Family Foundation.

In 2017, there will be 746 stand-alone prescription drug plans available to Medicare beneficiaries in the 50 states and the District of Columbia, which is 140 (16%) less than were available in 2016 and 1,129 (60%) less than the peak in 2007, Kaiser reported.

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There will be 16% fewer Medicare part D prescription drug plans available in 2017, compared with 2016, according to an analysis by the Kaiser Family Foundation.

In 2017, there will be 746 stand-alone prescription drug plans available to Medicare beneficiaries in the 50 states and the District of Columbia, which is 140 (16%) less than were available in 2016 and 1,129 (60%) less than the peak in 2007, Kaiser reported.

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There will be 16% fewer Medicare part D prescription drug plans available in 2017, compared with 2016, according to an analysis by the Kaiser Family Foundation.

In 2017, there will be 746 stand-alone prescription drug plans available to Medicare beneficiaries in the 50 states and the District of Columbia, which is 140 (16%) less than were available in 2016 and 1,129 (60%) less than the peak in 2007, Kaiser reported.

[email protected]

The family physician (FP) suspected that the patient had tinea cruris, but hadn’t ever seen it spread so far from the inguinal area. The rash had central clearing, which is typical of tinea corporis, but is not seen as often with tinea cruris. The FP performed a potassium hydroxide (KOH) preparation, which was positive for branching septate hyphae. (See video on how to perform a KOH preparation here.)

The FP discussed the treatment options, which consisted of topical antifungal medicine vs oral antifungal medicine. The patient was willing to try the topical terbinafine and return for a follow-up appointment in a month. The FP told the patient that he would give her oral terbinafine if the topical terbinafine didn’t work. One month later, the skin had cleared and the patient was happy with the results.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Usatine R, Smith M. Tinea cruris. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:795-798.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com

The family physician (FP) suspected that the patient had tinea cruris, but hadn’t ever seen it spread so far from the inguinal area. The rash had central clearing, which is typical of tinea corporis, but is not seen as often with tinea cruris. The FP performed a potassium hydroxide (KOH) preparation, which was positive for branching septate hyphae. (See video on how to perform a KOH preparation here.)

The FP discussed the treatment options, which consisted of topical antifungal medicine vs oral antifungal medicine. The patient was willing to try the topical terbinafine and return for a follow-up appointment in a month. The FP told the patient that he would give her oral terbinafine if the topical terbinafine didn’t work. One month later, the skin had cleared and the patient was happy with the results.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Usatine R, Smith M. Tinea cruris. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:795-798.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com

The family physician (FP) suspected that the patient had tinea cruris, but hadn’t ever seen it spread so far from the inguinal area. The rash had central clearing, which is typical of tinea corporis, but is not seen as often with tinea cruris. The FP performed a potassium hydroxide (KOH) preparation, which was positive for branching septate hyphae. (See video on how to perform a KOH preparation here.)

The FP discussed the treatment options, which consisted of topical antifungal medicine vs oral antifungal medicine. The patient was willing to try the topical terbinafine and return for a follow-up appointment in a month. The FP told the patient that he would give her oral terbinafine if the topical terbinafine didn’t work. One month later, the skin had cleared and the patient was happy with the results.

Photos and text for Photo Rounds Friday courtesy of Richard P. Usatine, MD. This case was adapted from: Usatine R, Smith M. Tinea cruris. In: Usatine R, Smith M, Mayeaux EJ, et al, eds. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:795-798.

To learn more about the Color Atlas of Family Medicine, see: www.amazon.com/Color-Family-Medicine-Richard-Usatine/dp/0071769641/

You can now get the second edition of the Color Atlas of Family Medicine as an app by clicking on this link: usatinemedia.com