Sherry Boschert

LONG BEACH, CALIF. — Creation of a subacute care service at a university medical center decreased hospital readmissions from nursing homes, reduced the average length of hospitalization, freed up inpatient beds, cut hospital costs by $600,000 a year, and provided the opportunity for an additional $1.6 million in hospital revenues, representatives of the center said.

How? By financially rewarding the University of Michigan's subacute service's faculty for reducing hospital stays and readmissions. The university pays these physicians' salaries at hospitalist levels (30% higher than standard salary rates) and covers half of the nurse practitioners' salaries. And knowing that a university colleague will be managing the transition makes other physicians comfortable with the idea of discharging patients earlier to nonuniversity skilled nursing facilities (SNFs).

“It's a new model of care,” Dr. Caroline S. Blaum said in a presentation at the annual meeting of the American Medical Directors Association. In this approach, “SNF-ists” combine the expertise of geriatricians and hospitalists, she explained.

Physicians at the medical center started the subacute service after realizing that the patients with the most difficult hospital discharges and highest readmission rates were those discharged to SNFs, said Dr. Blaum, professor of medicine and geriatrics at the university in Ann Arbor.

The Sub-Acute Care Service began in 2006, working with two local SNFs, and has since grown to include five SNFs. “The University of Michigan does not own any of these facilities. They are all independently owned,” Dr. Darius K. Joshi said in the same meeting session. The SNFs have been happy to work with the subacute service, and have increased nurse-to-patient ratios higher than the state average in order to meet the university's standards, he said.

Three full-time geriatrician physicians (the SNF-ists) in the service work closely with four nurse practitioners. “In my experience, a nurse practitioner who has a medical-surgical background is an excellent fit for a subacute service” because of comfort with high acuity, said Dr. Joshi, director of the Sub-Acute Care Service at the university.

The salary guarantee liberates the service from having to bill using Medicare relative value units (RVUs), allowing physicians to spend more time with patients and focus on the transitions of care. “If this was a pure RVU service, we wouldn't survive,” said Dr. Joshi, who said he sees 10-12 patients per day.

Hospital executives were skeptical when the subacute service was proposed, but ultimately they were won over by the promise of shorter hospital stays.

Data from the first 2 years of the program show that the average length of hospital stay for patients discharged to SNFs decreased from 9.7 days before the service started to 9.2 days. Readmissions within 15 days of discharge to SNFs declined from 12.7% of patients to 11.6%, and 30-day readmissions declined from 17.5% to 15.8%, Dr. Blaum reported. Each difference was of borderline statistical significance.

The service handled 42% of all patients discharged to subacute care during its first 2 years.

Data for its first 3 years suggest that the subacute service saved the hospital 939 days of care, which avoided $600,000 in costs per year and gave the hospital the opportunity to fill those beds with new patients and generate an additional $1.6 million/year in revenue, reported Rick Bluhm, J.D., also of the university.

The university's hospital is always full, so from the perspective of hospital administrators, freeing up beds is an important benefit of the subacute service, according to the presenters. All professional revenue from the service is kept by the division of geriatrics, they added.

One key to clinical success is good transfer of information involving the Sub-Acute Care Service, Dr. Joshi said. All notes, medication changes, new diagnoses or allergies, and changes in advance directives are recorded in the university's electronic medical records system, which can be accessed at each SNF via the Internet. The notes also are printed and placed in SNF paper charts. University laboratories handle lab testing at three of the five SNFs and record results in the electronic system.

“Our goal is to get you to the highest functioning level and preferably back to your home,” Dr. Joshi said. Elderly patients with complex medical and psychosocial needs who are discharged from SNFs and can't see their nonuniversity primary physicians within a few days may come to the university's Geriatric Transitional Care Clinic.

Over time, the Sub-Acute Care Service has expanded to handle patients needing specialized care, including some with left ventricular assist devices and patients who underwent liver or bone marrow transplantation. “Some of the highest [rehospitalization rates] we have are these patients,” which may skew the service's data on readmissions, Dr. Joshi added.

“We have developed a comfort level,” he said. “They have to trust us, and discharge sooner.”

Disclosures: The speakers reported having no relevant financial relationships.

'Our goal is to get you to the highest functioning level and preferably back to your home.'

Source DR. JOSHI

LONG BEACH, CALIF. — Creation of a subacute care service at a university medical center decreased hospital readmissions from nursing homes, reduced the average length of hospitalization, freed up inpatient beds, cut hospital costs by $600,000 a year, and provided the opportunity for an additional $1.6 million in hospital revenues, representatives of the center said.

How? By financially rewarding the University of Michigan's subacute service's faculty for reducing hospital stays and readmissions. The university pays these physicians' salaries at hospitalist levels (30% higher than standard salary rates) and covers half of the nurse practitioners' salaries. And knowing that a university colleague will be managing the transition makes other physicians comfortable with the idea of discharging patients earlier to nonuniversity skilled nursing facilities (SNFs).

“It's a new model of care,” Dr. Caroline S. Blaum said in a presentation at the annual meeting of the American Medical Directors Association. In this approach, “SNF-ists” combine the expertise of geriatricians and hospitalists, she explained.

Physicians at the medical center started the subacute service after realizing that the patients with the most difficult hospital discharges and highest readmission rates were those discharged to SNFs, said Dr. Blaum, professor of medicine and geriatrics at the university in Ann Arbor.

The Sub-Acute Care Service began in 2006, working with two local SNFs, and has since grown to include five SNFs. “The University of Michigan does not own any of these facilities. They are all independently owned,” Dr. Darius K. Joshi said in the same meeting session. The SNFs have been happy to work with the subacute service, and have increased nurse-to-patient ratios higher than the state average in order to meet the university's standards, he said.

Three full-time geriatrician physicians (the SNF-ists) in the service work closely with four nurse practitioners. “In my experience, a nurse practitioner who has a medical-surgical background is an excellent fit for a subacute service” because of comfort with high acuity, said Dr. Joshi, director of the Sub-Acute Care Service at the university.

The salary guarantee liberates the service from having to bill using Medicare relative value units (RVUs), allowing physicians to spend more time with patients and focus on the transitions of care. “If this was a pure RVU service, we wouldn't survive,” said Dr. Joshi, who said he sees 10-12 patients per day.

Hospital executives were skeptical when the subacute service was proposed, but ultimately they were won over by the promise of shorter hospital stays.

Data from the first 2 years of the program show that the average length of hospital stay for patients discharged to SNFs decreased from 9.7 days before the service started to 9.2 days. Readmissions within 15 days of discharge to SNFs declined from 12.7% of patients to 11.6%, and 30-day readmissions declined from 17.5% to 15.8%, Dr. Blaum reported. Each difference was of borderline statistical significance.

The service handled 42% of all patients discharged to subacute care during its first 2 years.

Data for its first 3 years suggest that the subacute service saved the hospital 939 days of care, which avoided $600,000 in costs per year and gave the hospital the opportunity to fill those beds with new patients and generate an additional $1.6 million/year in revenue, reported Rick Bluhm, J.D., also of the university.

The university's hospital is always full, so from the perspective of hospital administrators, freeing up beds is an important benefit of the subacute service, according to the presenters. All professional revenue from the service is kept by the division of geriatrics, they added.

One key to clinical success is good transfer of information involving the Sub-Acute Care Service, Dr. Joshi said. All notes, medication changes, new diagnoses or allergies, and changes in advance directives are recorded in the university's electronic medical records system, which can be accessed at each SNF via the Internet. The notes also are printed and placed in SNF paper charts. University laboratories handle lab testing at three of the five SNFs and record results in the electronic system.

“Our goal is to get you to the highest functioning level and preferably back to your home,” Dr. Joshi said. Elderly patients with complex medical and psychosocial needs who are discharged from SNFs and can't see their nonuniversity primary physicians within a few days may come to the university's Geriatric Transitional Care Clinic.

Over time, the Sub-Acute Care Service has expanded to handle patients needing specialized care, including some with left ventricular assist devices and patients who underwent liver or bone marrow transplantation. “Some of the highest [rehospitalization rates] we have are these patients,” which may skew the service's data on readmissions, Dr. Joshi added.

“We have developed a comfort level,” he said. “They have to trust us, and discharge sooner.”

Disclosures: The speakers reported having no relevant financial relationships.

'Our goal is to get you to the highest functioning level and preferably back to your home.'

Source DR. JOSHI

LONG BEACH, CALIF. — Creation of a subacute care service at a university medical center decreased hospital readmissions from nursing homes, reduced the average length of hospitalization, freed up inpatient beds, cut hospital costs by $600,000 a year, and provided the opportunity for an additional $1.6 million in hospital revenues, representatives of the center said.

How? By financially rewarding the University of Michigan's subacute service's faculty for reducing hospital stays and readmissions. The university pays these physicians' salaries at hospitalist levels (30% higher than standard salary rates) and covers half of the nurse practitioners' salaries. And knowing that a university colleague will be managing the transition makes other physicians comfortable with the idea of discharging patients earlier to nonuniversity skilled nursing facilities (SNFs).

“It's a new model of care,” Dr. Caroline S. Blaum said in a presentation at the annual meeting of the American Medical Directors Association. In this approach, “SNF-ists” combine the expertise of geriatricians and hospitalists, she explained.

Physicians at the medical center started the subacute service after realizing that the patients with the most difficult hospital discharges and highest readmission rates were those discharged to SNFs, said Dr. Blaum, professor of medicine and geriatrics at the university in Ann Arbor.

The Sub-Acute Care Service began in 2006, working with two local SNFs, and has since grown to include five SNFs. “The University of Michigan does not own any of these facilities. They are all independently owned,” Dr. Darius K. Joshi said in the same meeting session. The SNFs have been happy to work with the subacute service, and have increased nurse-to-patient ratios higher than the state average in order to meet the university's standards, he said.

Three full-time geriatrician physicians (the SNF-ists) in the service work closely with four nurse practitioners. “In my experience, a nurse practitioner who has a medical-surgical background is an excellent fit for a subacute service” because of comfort with high acuity, said Dr. Joshi, director of the Sub-Acute Care Service at the university.

The salary guarantee liberates the service from having to bill using Medicare relative value units (RVUs), allowing physicians to spend more time with patients and focus on the transitions of care. “If this was a pure RVU service, we wouldn't survive,” said Dr. Joshi, who said he sees 10-12 patients per day.

Hospital executives were skeptical when the subacute service was proposed, but ultimately they were won over by the promise of shorter hospital stays.

Data from the first 2 years of the program show that the average length of hospital stay for patients discharged to SNFs decreased from 9.7 days before the service started to 9.2 days. Readmissions within 15 days of discharge to SNFs declined from 12.7% of patients to 11.6%, and 30-day readmissions declined from 17.5% to 15.8%, Dr. Blaum reported. Each difference was of borderline statistical significance.

The service handled 42% of all patients discharged to subacute care during its first 2 years.

Data for its first 3 years suggest that the subacute service saved the hospital 939 days of care, which avoided $600,000 in costs per year and gave the hospital the opportunity to fill those beds with new patients and generate an additional $1.6 million/year in revenue, reported Rick Bluhm, J.D., also of the university.

The university's hospital is always full, so from the perspective of hospital administrators, freeing up beds is an important benefit of the subacute service, according to the presenters. All professional revenue from the service is kept by the division of geriatrics, they added.

One key to clinical success is good transfer of information involving the Sub-Acute Care Service, Dr. Joshi said. All notes, medication changes, new diagnoses or allergies, and changes in advance directives are recorded in the university's electronic medical records system, which can be accessed at each SNF via the Internet. The notes also are printed and placed in SNF paper charts. University laboratories handle lab testing at three of the five SNFs and record results in the electronic system.

“Our goal is to get you to the highest functioning level and preferably back to your home,” Dr. Joshi said. Elderly patients with complex medical and psychosocial needs who are discharged from SNFs and can't see their nonuniversity primary physicians within a few days may come to the university's Geriatric Transitional Care Clinic.

Over time, the Sub-Acute Care Service has expanded to handle patients needing specialized care, including some with left ventricular assist devices and patients who underwent liver or bone marrow transplantation. “Some of the highest [rehospitalization rates] we have are these patients,” which may skew the service's data on readmissions, Dr. Joshi added.

“We have developed a comfort level,” he said. “They have to trust us, and discharge sooner.”

Disclosures: The speakers reported having no relevant financial relationships.

'Our goal is to get you to the highest functioning level and preferably back to your home.'

Source DR. JOSHI

SAN FRANCISCO — The traditional pathway to market for new anti-HIV medications is to win approval first for use in treatment-experienced patients who may have developed drug resistance, and perhaps later be considered for first-line therapy.

That may be changing.

“We now have such a robust armamentarium of regimens for our treatment-resistant patients,” Dr. C. Bradley Hare said, that “our pipeline is really looking at first-line therapy, which I think is really a change in how drugs are being developed and how we analyze these drugs.”

He gave three examples in the development pipeline—rilpivirine, elvitegravir, and S/GSK1349572—in a presentation at a meeting on HIV management sponsored by the University of California, San Francisco.

Follow-up data out to 96 weeks in a phase II clinical trial of 368 treatment-naive patients support 48-week data showing equivalent potency between rilpivirine and efavirenz, said Dr. Hare, medical director of the university's HIV/AIDS clinic at San Francisco General Hospital. Patients were randomized to receive 25, 75, or 150 mg/day of rilpivirine or 600 mg/day of efavirenz, along with backbone therapy consisting of two NRTI drugs.

A virologic response was seen in 71%-76% of patients, which was not significantly different between groups. Overall rates of side effects did not differ significantly.

Patients in every group developed prolongations in QTc interval, though less so with the 25-mg/day dose of rilpivirine. That dose has been selected for further study in a phase III clinical trial, Dr. Hare said.

The pattern of emergence of resistant mutations differed for rilpivirine and efavirenz. Tibotec Pharmaceuticals, which is developing rilpivirine, may coformulate the once-a-day drug with tenofovir and emtricitabine into a single, once-daily pill for triple-drug therapy, he said.

Elvitegravir, a second-generation integrase inhibitor, is being developed by Gilead Sciences. Because preliminary laboratory data look promising, elvitegravir is also being considered for development as a “quad” pill in combination with GS-9350, tenofovir, and emtricitabine, he said.

S/GSK1349572, which is being developed by GlaxoSmithKline, is another second-generation integrase inhibitor that may be headed to phase II/III clinical trials. Unpublished data from a 10-day trial of various doses or placebo in 30 patients suggested that 50 mg taken once daily reduced HIV RNA levels without need for a booster agent.

Disclosures: Dr. Hare has received funding from or been a consultant, adviser, or speaker for Tibotec (which is developing rilpivirine), Gilead (which is developing elvitegravir and a rilpivirine dual formulation), GlaxoSmithKline, Roche, Merck, Bristol-Myers Squibb, Abbott, Pfizer, and Schering-Plough.

SAN FRANCISCO — The traditional pathway to market for new anti-HIV medications is to win approval first for use in treatment-experienced patients who may have developed drug resistance, and perhaps later be considered for first-line therapy.

That may be changing.

“We now have such a robust armamentarium of regimens for our treatment-resistant patients,” Dr. C. Bradley Hare said, that “our pipeline is really looking at first-line therapy, which I think is really a change in how drugs are being developed and how we analyze these drugs.”

He gave three examples in the development pipeline—rilpivirine, elvitegravir, and S/GSK1349572—in a presentation at a meeting on HIV management sponsored by the University of California, San Francisco.

Follow-up data out to 96 weeks in a phase II clinical trial of 368 treatment-naive patients support 48-week data showing equivalent potency between rilpivirine and efavirenz, said Dr. Hare, medical director of the university's HIV/AIDS clinic at San Francisco General Hospital. Patients were randomized to receive 25, 75, or 150 mg/day of rilpivirine or 600 mg/day of efavirenz, along with backbone therapy consisting of two NRTI drugs.

A virologic response was seen in 71%-76% of patients, which was not significantly different between groups. Overall rates of side effects did not differ significantly.

Patients in every group developed prolongations in QTc interval, though less so with the 25-mg/day dose of rilpivirine. That dose has been selected for further study in a phase III clinical trial, Dr. Hare said.

The pattern of emergence of resistant mutations differed for rilpivirine and efavirenz. Tibotec Pharmaceuticals, which is developing rilpivirine, may coformulate the once-a-day drug with tenofovir and emtricitabine into a single, once-daily pill for triple-drug therapy, he said.

Elvitegravir, a second-generation integrase inhibitor, is being developed by Gilead Sciences. Because preliminary laboratory data look promising, elvitegravir is also being considered for development as a “quad” pill in combination with GS-9350, tenofovir, and emtricitabine, he said.

S/GSK1349572, which is being developed by GlaxoSmithKline, is another second-generation integrase inhibitor that may be headed to phase II/III clinical trials. Unpublished data from a 10-day trial of various doses or placebo in 30 patients suggested that 50 mg taken once daily reduced HIV RNA levels without need for a booster agent.

Disclosures: Dr. Hare has received funding from or been a consultant, adviser, or speaker for Tibotec (which is developing rilpivirine), Gilead (which is developing elvitegravir and a rilpivirine dual formulation), GlaxoSmithKline, Roche, Merck, Bristol-Myers Squibb, Abbott, Pfizer, and Schering-Plough.

SAN FRANCISCO — The traditional pathway to market for new anti-HIV medications is to win approval first for use in treatment-experienced patients who may have developed drug resistance, and perhaps later be considered for first-line therapy.

That may be changing.

“We now have such a robust armamentarium of regimens for our treatment-resistant patients,” Dr. C. Bradley Hare said, that “our pipeline is really looking at first-line therapy, which I think is really a change in how drugs are being developed and how we analyze these drugs.”

He gave three examples in the development pipeline—rilpivirine, elvitegravir, and S/GSK1349572—in a presentation at a meeting on HIV management sponsored by the University of California, San Francisco.

Follow-up data out to 96 weeks in a phase II clinical trial of 368 treatment-naive patients support 48-week data showing equivalent potency between rilpivirine and efavirenz, said Dr. Hare, medical director of the university's HIV/AIDS clinic at San Francisco General Hospital. Patients were randomized to receive 25, 75, or 150 mg/day of rilpivirine or 600 mg/day of efavirenz, along with backbone therapy consisting of two NRTI drugs.

A virologic response was seen in 71%-76% of patients, which was not significantly different between groups. Overall rates of side effects did not differ significantly.

Patients in every group developed prolongations in QTc interval, though less so with the 25-mg/day dose of rilpivirine. That dose has been selected for further study in a phase III clinical trial, Dr. Hare said.

The pattern of emergence of resistant mutations differed for rilpivirine and efavirenz. Tibotec Pharmaceuticals, which is developing rilpivirine, may coformulate the once-a-day drug with tenofovir and emtricitabine into a single, once-daily pill for triple-drug therapy, he said.

Elvitegravir, a second-generation integrase inhibitor, is being developed by Gilead Sciences. Because preliminary laboratory data look promising, elvitegravir is also being considered for development as a “quad” pill in combination with GS-9350, tenofovir, and emtricitabine, he said.

S/GSK1349572, which is being developed by GlaxoSmithKline, is another second-generation integrase inhibitor that may be headed to phase II/III clinical trials. Unpublished data from a 10-day trial of various doses or placebo in 30 patients suggested that 50 mg taken once daily reduced HIV RNA levels without need for a booster agent.

Disclosures: Dr. Hare has received funding from or been a consultant, adviser, or speaker for Tibotec (which is developing rilpivirine), Gilead (which is developing elvitegravir and a rilpivirine dual formulation), GlaxoSmithKline, Roche, Merck, Bristol-Myers Squibb, Abbott, Pfizer, and Schering-Plough.

Postmenopausal women improved their physical fitness and reported reductions in the severity of menopausal symptoms after 12–24 weeks of aerobic exercise in three 70-minute sessions per week.

The 65 women (mean age 50 years) rated the severity of menopausal symptoms on the self-administered Menopause Rating Scale questionnaire at baseline, 12 weeks, and 24 weeks in the uncontrolled study. The program of aerobic and calisthenic exercise aimed for 75%–80% of maximal heart rate according to the Karvonen method and consisted of 10 minutes of warm-up exercises; 40 minutes of aerobics; 15 minutes of exercise targeting the abdomen, hip, and leg muscles; and 5 minutes for cool-down and stretching.

Participants reported significant decreases in the severity of hot flushes, night sweats, cardiac symptoms, muscle and joint pain, sleeping disorder symptoms, depressive mood, irritability, anxiety, exhaustion, sexual problems, and urinary symptoms between the start and the end of the study, Dr. Selma Karacan of Selcuk University in Konya, Turkey, reported.

Some of the symptoms showed improvement by 12 weeks and further significant improvements by 24 weeks, including vasomotor symptoms, muscle and joint pain, psychological symptoms, and sexual problems. The women reported no significant change in vaginal dryness (Sci. Sports 2010;25:39-46).

Significant improvements also were seen in resting heart rate, systolic and diastolic blood pressures, flexibility, aerobic power, and the ability to perform sit-ups, push-ups, and right or left hand grips. Body weight, body mass index, body fat percentage, and fat weight decreased significantly, with no change in lean body mass.

The findings support results from previous observational studies of physically active postmenopausal women compared with age-matched, sedentary control women. No randomized controlled trials have looked at the efficacy of exercise in managing hot flushes.

Disclosures: Dr. Karacan reported having no conflicts of interest.

Postmenopausal women improved their physical fitness and reported reductions in the severity of menopausal symptoms after 12–24 weeks of aerobic exercise in three 70-minute sessions per week.

The 65 women (mean age 50 years) rated the severity of menopausal symptoms on the self-administered Menopause Rating Scale questionnaire at baseline, 12 weeks, and 24 weeks in the uncontrolled study. The program of aerobic and calisthenic exercise aimed for 75%–80% of maximal heart rate according to the Karvonen method and consisted of 10 minutes of warm-up exercises; 40 minutes of aerobics; 15 minutes of exercise targeting the abdomen, hip, and leg muscles; and 5 minutes for cool-down and stretching.

Participants reported significant decreases in the severity of hot flushes, night sweats, cardiac symptoms, muscle and joint pain, sleeping disorder symptoms, depressive mood, irritability, anxiety, exhaustion, sexual problems, and urinary symptoms between the start and the end of the study, Dr. Selma Karacan of Selcuk University in Konya, Turkey, reported.

Some of the symptoms showed improvement by 12 weeks and further significant improvements by 24 weeks, including vasomotor symptoms, muscle and joint pain, psychological symptoms, and sexual problems. The women reported no significant change in vaginal dryness (Sci. Sports 2010;25:39-46).

Significant improvements also were seen in resting heart rate, systolic and diastolic blood pressures, flexibility, aerobic power, and the ability to perform sit-ups, push-ups, and right or left hand grips. Body weight, body mass index, body fat percentage, and fat weight decreased significantly, with no change in lean body mass.

The findings support results from previous observational studies of physically active postmenopausal women compared with age-matched, sedentary control women. No randomized controlled trials have looked at the efficacy of exercise in managing hot flushes.

Disclosures: Dr. Karacan reported having no conflicts of interest.

Postmenopausal women improved their physical fitness and reported reductions in the severity of menopausal symptoms after 12–24 weeks of aerobic exercise in three 70-minute sessions per week.

The 65 women (mean age 50 years) rated the severity of menopausal symptoms on the self-administered Menopause Rating Scale questionnaire at baseline, 12 weeks, and 24 weeks in the uncontrolled study. The program of aerobic and calisthenic exercise aimed for 75%–80% of maximal heart rate according to the Karvonen method and consisted of 10 minutes of warm-up exercises; 40 minutes of aerobics; 15 minutes of exercise targeting the abdomen, hip, and leg muscles; and 5 minutes for cool-down and stretching.

Participants reported significant decreases in the severity of hot flushes, night sweats, cardiac symptoms, muscle and joint pain, sleeping disorder symptoms, depressive mood, irritability, anxiety, exhaustion, sexual problems, and urinary symptoms between the start and the end of the study, Dr. Selma Karacan of Selcuk University in Konya, Turkey, reported.

Some of the symptoms showed improvement by 12 weeks and further significant improvements by 24 weeks, including vasomotor symptoms, muscle and joint pain, psychological symptoms, and sexual problems. The women reported no significant change in vaginal dryness (Sci. Sports 2010;25:39-46).

Significant improvements also were seen in resting heart rate, systolic and diastolic blood pressures, flexibility, aerobic power, and the ability to perform sit-ups, push-ups, and right or left hand grips. Body weight, body mass index, body fat percentage, and fat weight decreased significantly, with no change in lean body mass.

The findings support results from previous observational studies of physically active postmenopausal women compared with age-matched, sedentary control women. No randomized controlled trials have looked at the efficacy of exercise in managing hot flushes.

Disclosures: Dr. Karacan reported having no conflicts of interest.

SAN FRANCISCO — The once-daily drug liraglutide may work better than other diabetes medications to help patients reach a combination of goals, a secondary analysis of data from pivotal liraglutide studies suggests.

The Food and Drug Administration approved use of liraglutide (Victoza) in January for adults with type 2 diabetes who fail first-line drug therapy, based on data from the pivotal Liraglutide Effect and Action in Diabetes (LEAD) studies. Liraglutide is an injectable human glucagonlike peptide–1 (GLP-1) analogue.

The LEAD trials were “truly heroic” in their number, breadth, and head-to-head comparisons with existing diabetes medications, and in most of those trials liraglutide was more effective at lowering hemoglobin A_1c levels, Dr. John B. Buse said at a meeting sponsored by the American Diabetes Association.

He reported on an analysis that combined data from the more than 3,900 patients in the LEAD studies to compare the effectiveness of various therapies at achieving a composite end point known among diabetologists as a “Zindex” (because the idea was first proposed by Dr. Bernard Zinman, professor of medicine at the University of Toronto).

The analysis assessed the proportion of patients achieving the Zindex of an HbA_1c level below 7% with no weight gain and no confirmed hypoglycemia (minor or severe) by the end of the 26- to 52-week studies. A significantly greater proportion of patients on 1.8 mg/day of liraglutide achieved this Zindex (39%), compared with those on twice-daily injections of the GLP-1 agonist exenatide (24%) or patients treated with glargine (15%), a sulfonylurea (8%), placebo (8%), or a thiazolidinedione (6%).

“An A_1c less than 7% without weight gain or hypoglycemia is something that's of substantial interest to patients and clinicians,” said Dr. Buse, chief of endocrinology and director of the diabetes care center at the University of North Carolina at Chapel Hill.

A second analysis compared the data with a second Zindex that combines three goals identified as standards of care by the American Diabetes Association in 2008: an HbA_1c less than 7%, no weight gain, and a systolic blood pressure less than 130 mm Hg. The GLP-1 therapies in general have modest effects on blood pressure and lipids, with potentially greater changes in blood pressure on long-acting GLP-1 agonists, Dr. Buse noted.

Again, a significantly greater proportion of patients on 1.8 mg/day of liraglutide (25%) achieved the second Zindex, compared with patients on exenatide (14%), a sulfonylurea (7%), glargine or placebo (5% each), or a thiazolidinedione (3%). “This is of considerable interest, particularly in our pay-for-performance kind of world,” he said.

Disclosures: Dr. Buse has been a consultant for, or received research support from, Novo Nordisk (which markets liraglutide), and Amylin Pharmaceuticals and Eli Lilly (which together are marketing the long-acting version of Amylin's exenatide). He has held stock in Insulet, which makes an insulin pump.

SAN FRANCISCO — The once-daily drug liraglutide may work better than other diabetes medications to help patients reach a combination of goals, a secondary analysis of data from pivotal liraglutide studies suggests.

The Food and Drug Administration approved use of liraglutide (Victoza) in January for adults with type 2 diabetes who fail first-line drug therapy, based on data from the pivotal Liraglutide Effect and Action in Diabetes (LEAD) studies. Liraglutide is an injectable human glucagonlike peptide–1 (GLP-1) analogue.

The LEAD trials were “truly heroic” in their number, breadth, and head-to-head comparisons with existing diabetes medications, and in most of those trials liraglutide was more effective at lowering hemoglobin A_1c levels, Dr. John B. Buse said at a meeting sponsored by the American Diabetes Association.

He reported on an analysis that combined data from the more than 3,900 patients in the LEAD studies to compare the effectiveness of various therapies at achieving a composite end point known among diabetologists as a “Zindex” (because the idea was first proposed by Dr. Bernard Zinman, professor of medicine at the University of Toronto).

The analysis assessed the proportion of patients achieving the Zindex of an HbA_1c level below 7% with no weight gain and no confirmed hypoglycemia (minor or severe) by the end of the 26- to 52-week studies. A significantly greater proportion of patients on 1.8 mg/day of liraglutide achieved this Zindex (39%), compared with those on twice-daily injections of the GLP-1 agonist exenatide (24%) or patients treated with glargine (15%), a sulfonylurea (8%), placebo (8%), or a thiazolidinedione (6%).

“An A_1c less than 7% without weight gain or hypoglycemia is something that's of substantial interest to patients and clinicians,” said Dr. Buse, chief of endocrinology and director of the diabetes care center at the University of North Carolina at Chapel Hill.

A second analysis compared the data with a second Zindex that combines three goals identified as standards of care by the American Diabetes Association in 2008: an HbA_1c less than 7%, no weight gain, and a systolic blood pressure less than 130 mm Hg. The GLP-1 therapies in general have modest effects on blood pressure and lipids, with potentially greater changes in blood pressure on long-acting GLP-1 agonists, Dr. Buse noted.

Again, a significantly greater proportion of patients on 1.8 mg/day of liraglutide (25%) achieved the second Zindex, compared with patients on exenatide (14%), a sulfonylurea (7%), glargine or placebo (5% each), or a thiazolidinedione (3%). “This is of considerable interest, particularly in our pay-for-performance kind of world,” he said.

Disclosures: Dr. Buse has been a consultant for, or received research support from, Novo Nordisk (which markets liraglutide), and Amylin Pharmaceuticals and Eli Lilly (which together are marketing the long-acting version of Amylin's exenatide). He has held stock in Insulet, which makes an insulin pump.

SAN FRANCISCO — The once-daily drug liraglutide may work better than other diabetes medications to help patients reach a combination of goals, a secondary analysis of data from pivotal liraglutide studies suggests.

The Food and Drug Administration approved use of liraglutide (Victoza) in January for adults with type 2 diabetes who fail first-line drug therapy, based on data from the pivotal Liraglutide Effect and Action in Diabetes (LEAD) studies. Liraglutide is an injectable human glucagonlike peptide–1 (GLP-1) analogue.

The LEAD trials were “truly heroic” in their number, breadth, and head-to-head comparisons with existing diabetes medications, and in most of those trials liraglutide was more effective at lowering hemoglobin A_1c levels, Dr. John B. Buse said at a meeting sponsored by the American Diabetes Association.

He reported on an analysis that combined data from the more than 3,900 patients in the LEAD studies to compare the effectiveness of various therapies at achieving a composite end point known among diabetologists as a “Zindex” (because the idea was first proposed by Dr. Bernard Zinman, professor of medicine at the University of Toronto).

The analysis assessed the proportion of patients achieving the Zindex of an HbA_1c level below 7% with no weight gain and no confirmed hypoglycemia (minor or severe) by the end of the 26- to 52-week studies. A significantly greater proportion of patients on 1.8 mg/day of liraglutide achieved this Zindex (39%), compared with those on twice-daily injections of the GLP-1 agonist exenatide (24%) or patients treated with glargine (15%), a sulfonylurea (8%), placebo (8%), or a thiazolidinedione (6%).

“An A_1c less than 7% without weight gain or hypoglycemia is something that's of substantial interest to patients and clinicians,” said Dr. Buse, chief of endocrinology and director of the diabetes care center at the University of North Carolina at Chapel Hill.

A second analysis compared the data with a second Zindex that combines three goals identified as standards of care by the American Diabetes Association in 2008: an HbA_1c less than 7%, no weight gain, and a systolic blood pressure less than 130 mm Hg. The GLP-1 therapies in general have modest effects on blood pressure and lipids, with potentially greater changes in blood pressure on long-acting GLP-1 agonists, Dr. Buse noted.

Again, a significantly greater proportion of patients on 1.8 mg/day of liraglutide (25%) achieved the second Zindex, compared with patients on exenatide (14%), a sulfonylurea (7%), glargine or placebo (5% each), or a thiazolidinedione (3%). “This is of considerable interest, particularly in our pay-for-performance kind of world,” he said.

Disclosures: Dr. Buse has been a consultant for, or received research support from, Novo Nordisk (which markets liraglutide), and Amylin Pharmaceuticals and Eli Lilly (which together are marketing the long-acting version of Amylin's exenatide). He has held stock in Insulet, which makes an insulin pump.

SAN FRANCISCO — Although three recent major trials found that the potential harms of intensive glycemic control in patients with diabetes generally outweigh potential benefits, substudies of the data may help identify patients who could benefit from intensive therapy.

“Improvement in picking individuals for intensive glycemic control may be the right approach,” Dr. Peter D. Reaven said at a meeting sponsored by the American Diabetes Association.

The substudies and other recent analyses suggest that clinicians should avoid aggressive glycemic management (that is, trying to get hemoglobin A_1c values down to 6.5% or lower) in patients who are older and who have a longer duration of diabetes, more extensive calcified coronary atherosclerosis, or a higher burden of comorbidities, said Dr. Reaven, professor of clinical medicine at the University of Arizona, Phoenix.

Cardiovascular outcomes did not differ significantly between the intensive-control and usual-control groups in the three major recent studies—the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial (N. Engl. J. Med. 2008;358:2545-59), the ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation) trial (N. Engl. J. Med. 2008;358:2560-72), and the VADT (Veterans Affairs Diabetes Trial) (N. Engl. J. Med. 2009;360:129-39). The ACCORD trial was stopped early because of increased mortality in the intensive-control group. In the VADT, intensive glycemic control was associated with a tripled risk for hypoglycemia, which was a strong predictor of cardiovascular death.

However, a subanalysis within the ACCORD trial of prespecified subgroups found less risk of mortality in the intensive-control group if patients entered the study with no history of a cardiovascular event or if they entered the study with an HbA_1c level below 8%, he noted.

In the VADT, in which Dr. Reaven participated, a subanalysis found that patients with a shorter duration of diabetes in the intensive-control group appeared to have improved cardiovascular outcomes, compared with the usual-control group. Patients in the intensive group who had diabetes for 15 years or less had a 26% reduction in cardiovascular risk, compared with the usual-care group, but intensive glycemic control appeared to become harmful in patients with longer durations of diabetes.

A separate meta-analysis found a significant 10% reduction in cardiovascular events with intensive glycemic control when data from the ACCORD trial, ADVANCE trial, VADT, and the UKPDS (United Kingdom Prospective Diabetes Study) (Lancet 1998;352:837-53) were combined. Mortality rates did not differ significantly among treatment groups in this meta-analysis (Diabetologia 2009;52:2288-98), which was “somewhat reassuring,” though heterogeneity in the individual study results leaves uncertainty about the safety of intensive glycemic control, Dr. Reaven said.

A substudy by Dr. Reaven and associates of 301 patients in the VADT who had baseline CT scans to measure coronary artery calcium in the assessment of coronary atherosclerosis found that intensive glycemic control significantly reduced the risk of cardiovascular events if patients entered the study with lower levels of calcium in their coronary arteries. In the intensive-control group, the risk for cardiovascular events was nearly 10-fold higher in patients with higher coronary artery calcium levels at baseline (Diabetes 2009;58:2642-8).

Nearly 60% of VADT participants had higher levels of coronary artery calcium, he estimated, and the ACCORD and ADVANCE cohorts had a high prevalence of cardiovascular disease, which may help explain why the studies overall did not report cardiovascular benefits from tight glycemic control.

“Perhaps some imaging method may be reasonable to try to assess vascular risk” when considering intensive glycemic therapy, Dr. Reaven said.

The TIBI (Total Illness Burden Index) was assessed in a separate longitudinal observational study of 2,613 patients with diabetes. Cardiovascular risk was significantly reduced with intensive glycemic control in patients who had a lower baseline level of comorbidity, but not in patients who had low TIBI scores and higher HbA_1c levels or in patients who had higher TIBI scores (Ann. Int. Med. 2009;151:854-60).

“Intensive glucose lowering may have a cardiovascular benefit that is most useful in certain subgroups and may be harmful in some individuals,” he said.

Disclosures: Dr. Reaven has been a board member or adviser for AstraZeneca and Bristol-Myers Squibb, a stockholder in Pfizer and Merck, a speaker for Merck, and a consultant to Takeda. He has received research support from Amylin and Takeda.

SAN FRANCISCO — Although three recent major trials found that the potential harms of intensive glycemic control in patients with diabetes generally outweigh potential benefits, substudies of the data may help identify patients who could benefit from intensive therapy.

“Improvement in picking individuals for intensive glycemic control may be the right approach,” Dr. Peter D. Reaven said at a meeting sponsored by the American Diabetes Association.

The substudies and other recent analyses suggest that clinicians should avoid aggressive glycemic management (that is, trying to get hemoglobin A_1c values down to 6.5% or lower) in patients who are older and who have a longer duration of diabetes, more extensive calcified coronary atherosclerosis, or a higher burden of comorbidities, said Dr. Reaven, professor of clinical medicine at the University of Arizona, Phoenix.

Cardiovascular outcomes did not differ significantly between the intensive-control and usual-control groups in the three major recent studies—the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial (N. Engl. J. Med. 2008;358:2545-59), the ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation) trial (N. Engl. J. Med. 2008;358:2560-72), and the VADT (Veterans Affairs Diabetes Trial) (N. Engl. J. Med. 2009;360:129-39). The ACCORD trial was stopped early because of increased mortality in the intensive-control group. In the VADT, intensive glycemic control was associated with a tripled risk for hypoglycemia, which was a strong predictor of cardiovascular death.

However, a subanalysis within the ACCORD trial of prespecified subgroups found less risk of mortality in the intensive-control group if patients entered the study with no history of a cardiovascular event or if they entered the study with an HbA_1c level below 8%, he noted.

In the VADT, in which Dr. Reaven participated, a subanalysis found that patients with a shorter duration of diabetes in the intensive-control group appeared to have improved cardiovascular outcomes, compared with the usual-control group. Patients in the intensive group who had diabetes for 15 years or less had a 26% reduction in cardiovascular risk, compared with the usual-care group, but intensive glycemic control appeared to become harmful in patients with longer durations of diabetes.

A separate meta-analysis found a significant 10% reduction in cardiovascular events with intensive glycemic control when data from the ACCORD trial, ADVANCE trial, VADT, and the UKPDS (United Kingdom Prospective Diabetes Study) (Lancet 1998;352:837-53) were combined. Mortality rates did not differ significantly among treatment groups in this meta-analysis (Diabetologia 2009;52:2288-98), which was “somewhat reassuring,” though heterogeneity in the individual study results leaves uncertainty about the safety of intensive glycemic control, Dr. Reaven said.

A substudy by Dr. Reaven and associates of 301 patients in the VADT who had baseline CT scans to measure coronary artery calcium in the assessment of coronary atherosclerosis found that intensive glycemic control significantly reduced the risk of cardiovascular events if patients entered the study with lower levels of calcium in their coronary arteries. In the intensive-control group, the risk for cardiovascular events was nearly 10-fold higher in patients with higher coronary artery calcium levels at baseline (Diabetes 2009;58:2642-8).

Nearly 60% of VADT participants had higher levels of coronary artery calcium, he estimated, and the ACCORD and ADVANCE cohorts had a high prevalence of cardiovascular disease, which may help explain why the studies overall did not report cardiovascular benefits from tight glycemic control.

“Perhaps some imaging method may be reasonable to try to assess vascular risk” when considering intensive glycemic therapy, Dr. Reaven said.

The TIBI (Total Illness Burden Index) was assessed in a separate longitudinal observational study of 2,613 patients with diabetes. Cardiovascular risk was significantly reduced with intensive glycemic control in patients who had a lower baseline level of comorbidity, but not in patients who had low TIBI scores and higher HbA_1c levels or in patients who had higher TIBI scores (Ann. Int. Med. 2009;151:854-60).

“Intensive glucose lowering may have a cardiovascular benefit that is most useful in certain subgroups and may be harmful in some individuals,” he said.

Disclosures: Dr. Reaven has been a board member or adviser for AstraZeneca and Bristol-Myers Squibb, a stockholder in Pfizer and Merck, a speaker for Merck, and a consultant to Takeda. He has received research support from Amylin and Takeda.

SAN FRANCISCO — Although three recent major trials found that the potential harms of intensive glycemic control in patients with diabetes generally outweigh potential benefits, substudies of the data may help identify patients who could benefit from intensive therapy.

“Improvement in picking individuals for intensive glycemic control may be the right approach,” Dr. Peter D. Reaven said at a meeting sponsored by the American Diabetes Association.

The substudies and other recent analyses suggest that clinicians should avoid aggressive glycemic management (that is, trying to get hemoglobin A_1c values down to 6.5% or lower) in patients who are older and who have a longer duration of diabetes, more extensive calcified coronary atherosclerosis, or a higher burden of comorbidities, said Dr. Reaven, professor of clinical medicine at the University of Arizona, Phoenix.

Cardiovascular outcomes did not differ significantly between the intensive-control and usual-control groups in the three major recent studies—the ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial (N. Engl. J. Med. 2008;358:2545-59), the ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation) trial (N. Engl. J. Med. 2008;358:2560-72), and the VADT (Veterans Affairs Diabetes Trial) (N. Engl. J. Med. 2009;360:129-39). The ACCORD trial was stopped early because of increased mortality in the intensive-control group. In the VADT, intensive glycemic control was associated with a tripled risk for hypoglycemia, which was a strong predictor of cardiovascular death.

However, a subanalysis within the ACCORD trial of prespecified subgroups found less risk of mortality in the intensive-control group if patients entered the study with no history of a cardiovascular event or if they entered the study with an HbA_1c level below 8%, he noted.

In the VADT, in which Dr. Reaven participated, a subanalysis found that patients with a shorter duration of diabetes in the intensive-control group appeared to have improved cardiovascular outcomes, compared with the usual-control group. Patients in the intensive group who had diabetes for 15 years or less had a 26% reduction in cardiovascular risk, compared with the usual-care group, but intensive glycemic control appeared to become harmful in patients with longer durations of diabetes.

A separate meta-analysis found a significant 10% reduction in cardiovascular events with intensive glycemic control when data from the ACCORD trial, ADVANCE trial, VADT, and the UKPDS (United Kingdom Prospective Diabetes Study) (Lancet 1998;352:837-53) were combined. Mortality rates did not differ significantly among treatment groups in this meta-analysis (Diabetologia 2009;52:2288-98), which was “somewhat reassuring,” though heterogeneity in the individual study results leaves uncertainty about the safety of intensive glycemic control, Dr. Reaven said.

A substudy by Dr. Reaven and associates of 301 patients in the VADT who had baseline CT scans to measure coronary artery calcium in the assessment of coronary atherosclerosis found that intensive glycemic control significantly reduced the risk of cardiovascular events if patients entered the study with lower levels of calcium in their coronary arteries. In the intensive-control group, the risk for cardiovascular events was nearly 10-fold higher in patients with higher coronary artery calcium levels at baseline (Diabetes 2009;58:2642-8).

Nearly 60% of VADT participants had higher levels of coronary artery calcium, he estimated, and the ACCORD and ADVANCE cohorts had a high prevalence of cardiovascular disease, which may help explain why the studies overall did not report cardiovascular benefits from tight glycemic control.

“Perhaps some imaging method may be reasonable to try to assess vascular risk” when considering intensive glycemic therapy, Dr. Reaven said.

The TIBI (Total Illness Burden Index) was assessed in a separate longitudinal observational study of 2,613 patients with diabetes. Cardiovascular risk was significantly reduced with intensive glycemic control in patients who had a lower baseline level of comorbidity, but not in patients who had low TIBI scores and higher HbA_1c levels or in patients who had higher TIBI scores (Ann. Int. Med. 2009;151:854-60).

“Intensive glucose lowering may have a cardiovascular benefit that is most useful in certain subgroups and may be harmful in some individuals,” he said.

Disclosures: Dr. Reaven has been a board member or adviser for AstraZeneca and Bristol-Myers Squibb, a stockholder in Pfizer and Merck, a speaker for Merck, and a consultant to Takeda. He has received research support from Amylin and Takeda.

SAN FRANCISCO — The first update in recommendations for dietary intake of vitamin D since 1997 is expected in May and probably will comprise a conservative change from the status quo, according to one expert.

The Institute of Medicine's Food and Nutrition Board has been reviewing the literature, including consideration of associations between serum vitamin D levels and disease indicators. “The grapevine says they are going to come in very conservative. They are going to require evidence from randomized, controlled trials, and those don't really exist today,” Dr. Neil Binkley said at a meeting sponsored by the American Diabetes Association.

The current Dietary Reference Intake (or Recommended Dietary Allowance) describes “adequate” intake as 200 IU/day for people up to age 50 years, 400 IU/day for those aged 51–70 years, and 600 IU/day for people older than 70 years.

Dr. Binkley of the University of Wisconsin, Madison, expects the new intake recommendation for older adults to roughly double from 400 IU/day to 800 or maybe 1,000 IU/day.

“This will be an evolution,” he said. “I think the next iteration coming out in May is going to be a step up, but it's probably not going to get us all the way there.”

Recent data suggest that much higher levels should be consumed daily to keep serum 25-hydroxyvitamin D levels (25[OH]D) in desired ranges, he explained. Generally, levels lower than 10 ng/mL indicate vitamin D deficiency, 10–30 ng/mL reflects vitamin D insufficiency, and a 25(OH)D level above 30 ng/mL is considered optimal.

Optimal levels may differ by bodily system, he noted. Serum 25(OH)D levels greater than 40 ng/mL may be best for bone health, while leg function appears to be better with levels above 38 ng/mL. But a level above 36 ng/mL has been associated with reduced risk for colorectal cancer, and levels of 36–40 ng/mL have been associated with lower risk for periodontal disease.

One study calculated that 2,600 IU/day of vitamin D supplementation would be needed to ensure that 97.5% of older women have 25(OH)D levels at or above desirable levels (J. Nutr. 2006;136:1123–26). Other experts recommend that between 2,000 and 4,000 IU/day be consumed to reduce risks for cancer and autoimmune disease, Dr. Binkley said.

He aims for levels above 40 ng/mL in his patients to consistently hit targets above 30 ng/mL, he said. As a general rule of thumb, for every 1,000 IU of supplemental vitamin D₃ ingested, circulating 25(OH)D goes up by roughly 6 ng/mL, he said.

For a patient with a serum 25(OH)D level of 20 ng/mL, taking 2,000 IU/day of vitamin D₃would boost serum levels to about 32 ng/mL, and more than 3,000 IU/day would be needed to reach 40 ng/mL. People are unlikely to get adequate vitamin D from sunlight, and fortified foods contain roughly 40–100 IU per serving. “If we truly do need 1,000, 2,000 or 4,000 IU/day, that means you'd need to drink between 10 and 40 glasses of milk per day to get your vitamin D requirement” at current levels of food fortification, he said.

“I'm hopeful that after the Institute of Medicine meets, food fortification will go up,” he added.

The American Academy of Pediatrics in 2008 recommended that children and adolescents get 400 IU/day of vitamin D, double the current Dietary Reference Intake. The National Osteoporosis Foundation recommends that people up to age 50 ingest 400–800 IU/day, and that adults aged 50 or older get 800–1,000 IU/day.

Observational studies suggest that low vitamin D levels are associated with increased risk for diabetes. Several studies found that children who received vitamin D supplementation had a lower risk for developing type 1 diabetes, and the Nurses Health Study found an association between low vitamin D status and higher risk for type 2 diabetes over 20 years of follow-up.

Two prospective studies with 36 patients each found no significant effect of vitamin D supplementation on diabetes risk, but these studies were too small, Dr. Binkley said. A post hoc analysis of a randomized, controlled trial of 800 IU/day of vitamin D for fracture prevention in 3,314 women over age 70 found no protective effect against development of type 2 diabetes, but compliance with vitamin D supplements was poor, he noted (Age Ageing 2009;38:606–9).

Dr. Binkley said he has no conflicts of interest related to these topics.

The IOM's intake recommendation could go to 800 or 1,000 IU/day.

Source ©Joss/Fotolia.com

SAN FRANCISCO — The first update in recommendations for dietary intake of vitamin D since 1997 is expected in May and probably will comprise a conservative change from the status quo, according to one expert.

The Institute of Medicine's Food and Nutrition Board has been reviewing the literature, including consideration of associations between serum vitamin D levels and disease indicators. “The grapevine says they are going to come in very conservative. They are going to require evidence from randomized, controlled trials, and those don't really exist today,” Dr. Neil Binkley said at a meeting sponsored by the American Diabetes Association.

The current Dietary Reference Intake (or Recommended Dietary Allowance) describes “adequate” intake as 200 IU/day for people up to age 50 years, 400 IU/day for those aged 51–70 years, and 600 IU/day for people older than 70 years.

Dr. Binkley of the University of Wisconsin, Madison, expects the new intake recommendation for older adults to roughly double from 400 IU/day to 800 or maybe 1,000 IU/day.

“This will be an evolution,” he said. “I think the next iteration coming out in May is going to be a step up, but it's probably not going to get us all the way there.”

Recent data suggest that much higher levels should be consumed daily to keep serum 25-hydroxyvitamin D levels (25[OH]D) in desired ranges, he explained. Generally, levels lower than 10 ng/mL indicate vitamin D deficiency, 10–30 ng/mL reflects vitamin D insufficiency, and a 25(OH)D level above 30 ng/mL is considered optimal.

Optimal levels may differ by bodily system, he noted. Serum 25(OH)D levels greater than 40 ng/mL may be best for bone health, while leg function appears to be better with levels above 38 ng/mL. But a level above 36 ng/mL has been associated with reduced risk for colorectal cancer, and levels of 36–40 ng/mL have been associated with lower risk for periodontal disease.

One study calculated that 2,600 IU/day of vitamin D supplementation would be needed to ensure that 97.5% of older women have 25(OH)D levels at or above desirable levels (J. Nutr. 2006;136:1123–26). Other experts recommend that between 2,000 and 4,000 IU/day be consumed to reduce risks for cancer and autoimmune disease, Dr. Binkley said.

He aims for levels above 40 ng/mL in his patients to consistently hit targets above 30 ng/mL, he said. As a general rule of thumb, for every 1,000 IU of supplemental vitamin D₃ ingested, circulating 25(OH)D goes up by roughly 6 ng/mL, he said.

For a patient with a serum 25(OH)D level of 20 ng/mL, taking 2,000 IU/day of vitamin D₃would boost serum levels to about 32 ng/mL, and more than 3,000 IU/day would be needed to reach 40 ng/mL. People are unlikely to get adequate vitamin D from sunlight, and fortified foods contain roughly 40–100 IU per serving. “If we truly do need 1,000, 2,000 or 4,000 IU/day, that means you'd need to drink between 10 and 40 glasses of milk per day to get your vitamin D requirement” at current levels of food fortification, he said.

“I'm hopeful that after the Institute of Medicine meets, food fortification will go up,” he added.

The American Academy of Pediatrics in 2008 recommended that children and adolescents get 400 IU/day of vitamin D, double the current Dietary Reference Intake. The National Osteoporosis Foundation recommends that people up to age 50 ingest 400–800 IU/day, and that adults aged 50 or older get 800–1,000 IU/day.

Observational studies suggest that low vitamin D levels are associated with increased risk for diabetes. Several studies found that children who received vitamin D supplementation had a lower risk for developing type 1 diabetes, and the Nurses Health Study found an association between low vitamin D status and higher risk for type 2 diabetes over 20 years of follow-up.

Two prospective studies with 36 patients each found no significant effect of vitamin D supplementation on diabetes risk, but these studies were too small, Dr. Binkley said. A post hoc analysis of a randomized, controlled trial of 800 IU/day of vitamin D for fracture prevention in 3,314 women over age 70 found no protective effect against development of type 2 diabetes, but compliance with vitamin D supplements was poor, he noted (Age Ageing 2009;38:606–9).

Dr. Binkley said he has no conflicts of interest related to these topics.

The IOM's intake recommendation could go to 800 or 1,000 IU/day.

Source ©Joss/Fotolia.com

SAN FRANCISCO — The first update in recommendations for dietary intake of vitamin D since 1997 is expected in May and probably will comprise a conservative change from the status quo, according to one expert.

The Institute of Medicine's Food and Nutrition Board has been reviewing the literature, including consideration of associations between serum vitamin D levels and disease indicators. “The grapevine says they are going to come in very conservative. They are going to require evidence from randomized, controlled trials, and those don't really exist today,” Dr. Neil Binkley said at a meeting sponsored by the American Diabetes Association.

The current Dietary Reference Intake (or Recommended Dietary Allowance) describes “adequate” intake as 200 IU/day for people up to age 50 years, 400 IU/day for those aged 51–70 years, and 600 IU/day for people older than 70 years.

Dr. Binkley of the University of Wisconsin, Madison, expects the new intake recommendation for older adults to roughly double from 400 IU/day to 800 or maybe 1,000 IU/day.

“This will be an evolution,” he said. “I think the next iteration coming out in May is going to be a step up, but it's probably not going to get us all the way there.”

Recent data suggest that much higher levels should be consumed daily to keep serum 25-hydroxyvitamin D levels (25[OH]D) in desired ranges, he explained. Generally, levels lower than 10 ng/mL indicate vitamin D deficiency, 10–30 ng/mL reflects vitamin D insufficiency, and a 25(OH)D level above 30 ng/mL is considered optimal.

Optimal levels may differ by bodily system, he noted. Serum 25(OH)D levels greater than 40 ng/mL may be best for bone health, while leg function appears to be better with levels above 38 ng/mL. But a level above 36 ng/mL has been associated with reduced risk for colorectal cancer, and levels of 36–40 ng/mL have been associated with lower risk for periodontal disease.

One study calculated that 2,600 IU/day of vitamin D supplementation would be needed to ensure that 97.5% of older women have 25(OH)D levels at or above desirable levels (J. Nutr. 2006;136:1123–26). Other experts recommend that between 2,000 and 4,000 IU/day be consumed to reduce risks for cancer and autoimmune disease, Dr. Binkley said.

He aims for levels above 40 ng/mL in his patients to consistently hit targets above 30 ng/mL, he said. As a general rule of thumb, for every 1,000 IU of supplemental vitamin D₃ ingested, circulating 25(OH)D goes up by roughly 6 ng/mL, he said.

For a patient with a serum 25(OH)D level of 20 ng/mL, taking 2,000 IU/day of vitamin D₃would boost serum levels to about 32 ng/mL, and more than 3,000 IU/day would be needed to reach 40 ng/mL. People are unlikely to get adequate vitamin D from sunlight, and fortified foods contain roughly 40–100 IU per serving. “If we truly do need 1,000, 2,000 or 4,000 IU/day, that means you'd need to drink between 10 and 40 glasses of milk per day to get your vitamin D requirement” at current levels of food fortification, he said.

“I'm hopeful that after the Institute of Medicine meets, food fortification will go up,” he added.

The American Academy of Pediatrics in 2008 recommended that children and adolescents get 400 IU/day of vitamin D, double the current Dietary Reference Intake. The National Osteoporosis Foundation recommends that people up to age 50 ingest 400–800 IU/day, and that adults aged 50 or older get 800–1,000 IU/day.

Observational studies suggest that low vitamin D levels are associated with increased risk for diabetes. Several studies found that children who received vitamin D supplementation had a lower risk for developing type 1 diabetes, and the Nurses Health Study found an association between low vitamin D status and higher risk for type 2 diabetes over 20 years of follow-up.

Two prospective studies with 36 patients each found no significant effect of vitamin D supplementation on diabetes risk, but these studies were too small, Dr. Binkley said. A post hoc analysis of a randomized, controlled trial of 800 IU/day of vitamin D for fracture prevention in 3,314 women over age 70 found no protective effect against development of type 2 diabetes, but compliance with vitamin D supplements was poor, he noted (Age Ageing 2009;38:606–9).

Dr. Binkley said he has no conflicts of interest related to these topics.

The IOM's intake recommendation could go to 800 or 1,000 IU/day.

Source ©Joss/Fotolia.com

SAN FRANCISCO — It's okay to push for a rapid drop in high hemoglobin A_1c levels and tight glycemic control in patients with diabetes, but it's probably smart to ease up if there's no response within a year.

That's the key message from the recent major trials of aggressive glycemic control, Dr. Richard M. Bergenstal said at a meeting sponsored by the American Diabetes Association.

Many patients—but not all—can get their HbA_1c level below 7% and help prevent microvascular disease, if that's a goal the patient embraces and the physician provides the right therapies.

“Push hard, work with a team, make good choices, and if there's no response, be careful. Don't keep pushing, pushing, pushing,” said Dr. Bergenstal, president of medicine and science for the ADA and executive director of the International Diabetes Center in Saint Louis Park, Minn.

HbA_1c levels plummeted in the first year of intensive treatment in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial (N. Engl. J. Med. 2008;358:2545–59) but decreased more gradually in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial (N. Engl. J. Med. 2008;358:2560–72).

Contrary to what many have presumed, however, the increased risk of death in ACCORD in the intensive-therapy group compared with the standard-therapy group was not associated with fast decrease in HbA_1c, he said.

In a yet-to-be-published analysis, there was no increased mortality in ACCORD patients whose HbA_1c declined in the first year, and there was increased mortality if the HbA_1c did not drop. “It's just the opposite of what you might think. If you drop rapidly, you do fine. If you don't drop, you are at risk of dying,” probably because “there's something going on in your life or in your physiology” that increases risk, Dr. Bergenstal said.

Pushing hard to get the HbA_1c level below 6% may be overkill if the patient is not responding, he added.

This was the goal of intensive therapy in the ACCORD trial, which was associated with increased cardiovascular risk. The unpublished analysis, however, showed that patients on intensive therapy who achieved lower HbA_1c levels were less likely to die.

“So, yes, the ACCORD intensive group had higher mortality” compared with the standard-therapy group “but it was people who could not get to goal,” Dr. Bergenstal explained. “If you are working hard, hard, hard and not getting a response, that is the person you back off on. They're not going to get to goal, and you're probably going to cause more harm than benefit.” This shouldn't be an excuse for not trying to get HbA_1c down initially, however, at least to less than 7%, he added.

Lessons to be learned from these studies and the other recent major trial of tight glucose control, the Veterans Affairs Diabetes Trial (VADT), go far beyond management of HbA_1c, Dr. Bergenstal said. “I think relying on the A_1c alone is causing part of the problem” in getting too few patients to glycemic goals, he said.

Organizing a clinical practice for success is a team effort that should include a nurse, educator, and/or pharmacist who can help monitor patients between physician visits and initiate a change in therapy according to an agreed-upon algorithm that serves as a checklist, not a cookbook, he suggested. A team helps motivate patient lifestyle changes and helps patients cope with pain or depression.

It's very important that patients and physicians agree on the goals of therapy, and that the right therapies are chosen to meet those goals, he added. Some patients, for example, may be more afraid of increasing their risk for hypoglycemic episodes with intensive therapy than of the risk for complications from higher HbA_1c levels. Others may be more concerned about avoiding the weight gain associated with some medications than about lowering HbA_1c levels.

Disclosures for both stories: Dr. Bergenstal has held stock in Merck & Co. and participated in research or been a consultant for that company as well as Abbott Diabetes Care, Amylin Pharmaceuticals, Bayer, Eli Lilly and Co., Intuity Medical, LifeScan (Johnson & Johnson), Mannkind Corp., Medtronic, Novo Nordisk, ResMed, Roche Diagnostics Corp., Sanofi-Aventis, Pfizer, and Takeda Pharmaceuticals.

SAN FRANCISCO — It's okay to push for a rapid drop in high hemoglobin A_1c levels and tight glycemic control in patients with diabetes, but it's probably smart to ease up if there's no response within a year.

That's the key message from the recent major trials of aggressive glycemic control, Dr. Richard M. Bergenstal said at a meeting sponsored by the American Diabetes Association.

Many patients—but not all—can get their HbA_1c level below 7% and help prevent microvascular disease, if that's a goal the patient embraces and the physician provides the right therapies.

“Push hard, work with a team, make good choices, and if there's no response, be careful. Don't keep pushing, pushing, pushing,” said Dr. Bergenstal, president of medicine and science for the ADA and executive director of the International Diabetes Center in Saint Louis Park, Minn.

HbA_1c levels plummeted in the first year of intensive treatment in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial (N. Engl. J. Med. 2008;358:2545–59) but decreased more gradually in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial (N. Engl. J. Med. 2008;358:2560–72).

Contrary to what many have presumed, however, the increased risk of death in ACCORD in the intensive-therapy group compared with the standard-therapy group was not associated with fast decrease in HbA_1c, he said.

In a yet-to-be-published analysis, there was no increased mortality in ACCORD patients whose HbA_1c declined in the first year, and there was increased mortality if the HbA_1c did not drop. “It's just the opposite of what you might think. If you drop rapidly, you do fine. If you don't drop, you are at risk of dying,” probably because “there's something going on in your life or in your physiology” that increases risk, Dr. Bergenstal said.

Pushing hard to get the HbA_1c level below 6% may be overkill if the patient is not responding, he added.

This was the goal of intensive therapy in the ACCORD trial, which was associated with increased cardiovascular risk. The unpublished analysis, however, showed that patients on intensive therapy who achieved lower HbA_1c levels were less likely to die.

“So, yes, the ACCORD intensive group had higher mortality” compared with the standard-therapy group “but it was people who could not get to goal,” Dr. Bergenstal explained. “If you are working hard, hard, hard and not getting a response, that is the person you back off on. They're not going to get to goal, and you're probably going to cause more harm than benefit.” This shouldn't be an excuse for not trying to get HbA_1c down initially, however, at least to less than 7%, he added.

Lessons to be learned from these studies and the other recent major trial of tight glucose control, the Veterans Affairs Diabetes Trial (VADT), go far beyond management of HbA_1c, Dr. Bergenstal said. “I think relying on the A_1c alone is causing part of the problem” in getting too few patients to glycemic goals, he said.

Organizing a clinical practice for success is a team effort that should include a nurse, educator, and/or pharmacist who can help monitor patients between physician visits and initiate a change in therapy according to an agreed-upon algorithm that serves as a checklist, not a cookbook, he suggested. A team helps motivate patient lifestyle changes and helps patients cope with pain or depression.

It's very important that patients and physicians agree on the goals of therapy, and that the right therapies are chosen to meet those goals, he added. Some patients, for example, may be more afraid of increasing their risk for hypoglycemic episodes with intensive therapy than of the risk for complications from higher HbA_1c levels. Others may be more concerned about avoiding the weight gain associated with some medications than about lowering HbA_1c levels.

Disclosures for both stories: Dr. Bergenstal has held stock in Merck & Co. and participated in research or been a consultant for that company as well as Abbott Diabetes Care, Amylin Pharmaceuticals, Bayer, Eli Lilly and Co., Intuity Medical, LifeScan (Johnson & Johnson), Mannkind Corp., Medtronic, Novo Nordisk, ResMed, Roche Diagnostics Corp., Sanofi-Aventis, Pfizer, and Takeda Pharmaceuticals.

SAN FRANCISCO — It's okay to push for a rapid drop in high hemoglobin A_1c levels and tight glycemic control in patients with diabetes, but it's probably smart to ease up if there's no response within a year.

That's the key message from the recent major trials of aggressive glycemic control, Dr. Richard M. Bergenstal said at a meeting sponsored by the American Diabetes Association.

Many patients—but not all—can get their HbA_1c level below 7% and help prevent microvascular disease, if that's a goal the patient embraces and the physician provides the right therapies.

“Push hard, work with a team, make good choices, and if there's no response, be careful. Don't keep pushing, pushing, pushing,” said Dr. Bergenstal, president of medicine and science for the ADA and executive director of the International Diabetes Center in Saint Louis Park, Minn.

HbA_1c levels plummeted in the first year of intensive treatment in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial (N. Engl. J. Med. 2008;358:2545–59) but decreased more gradually in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial (N. Engl. J. Med. 2008;358:2560–72).

Contrary to what many have presumed, however, the increased risk of death in ACCORD in the intensive-therapy group compared with the standard-therapy group was not associated with fast decrease in HbA_1c, he said.

In a yet-to-be-published analysis, there was no increased mortality in ACCORD patients whose HbA_1c declined in the first year, and there was increased mortality if the HbA_1c did not drop. “It's just the opposite of what you might think. If you drop rapidly, you do fine. If you don't drop, you are at risk of dying,” probably because “there's something going on in your life or in your physiology” that increases risk, Dr. Bergenstal said.

Pushing hard to get the HbA_1c level below 6% may be overkill if the patient is not responding, he added.

This was the goal of intensive therapy in the ACCORD trial, which was associated with increased cardiovascular risk. The unpublished analysis, however, showed that patients on intensive therapy who achieved lower HbA_1c levels were less likely to die.

“So, yes, the ACCORD intensive group had higher mortality” compared with the standard-therapy group “but it was people who could not get to goal,” Dr. Bergenstal explained. “If you are working hard, hard, hard and not getting a response, that is the person you back off on. They're not going to get to goal, and you're probably going to cause more harm than benefit.” This shouldn't be an excuse for not trying to get HbA_1c down initially, however, at least to less than 7%, he added.

Lessons to be learned from these studies and the other recent major trial of tight glucose control, the Veterans Affairs Diabetes Trial (VADT), go far beyond management of HbA_1c, Dr. Bergenstal said. “I think relying on the A_1c alone is causing part of the problem” in getting too few patients to glycemic goals, he said.

Organizing a clinical practice for success is a team effort that should include a nurse, educator, and/or pharmacist who can help monitor patients between physician visits and initiate a change in therapy according to an agreed-upon algorithm that serves as a checklist, not a cookbook, he suggested. A team helps motivate patient lifestyle changes and helps patients cope with pain or depression.

It's very important that patients and physicians agree on the goals of therapy, and that the right therapies are chosen to meet those goals, he added. Some patients, for example, may be more afraid of increasing their risk for hypoglycemic episodes with intensive therapy than of the risk for complications from higher HbA_1c levels. Others may be more concerned about avoiding the weight gain associated with some medications than about lowering HbA_1c levels.

Disclosures for both stories: Dr. Bergenstal has held stock in Merck & Co. and participated in research or been a consultant for that company as well as Abbott Diabetes Care, Amylin Pharmaceuticals, Bayer, Eli Lilly and Co., Intuity Medical, LifeScan (Johnson & Johnson), Mannkind Corp., Medtronic, Novo Nordisk, ResMed, Roche Diagnostics Corp., Sanofi-Aventis, Pfizer, and Takeda Pharmaceuticals.

SAN FRANCISCO — The use of a hemoglobin A_1c level of 6.5% or higher to diagnose type 2 diabetes should now be mainstream, given formal endorsements from three major U.S. medical associations in 2010 supporting an International Expert Committee's 2009 consensus recommendations.

The World Health Organization and other groups are likely to follow suit, though with greater emphasis on this as an alternative to conventional means of diagnosing diabetes in regions that don't have easy access to standardized assays for HbA_1c, Dr. Richard M. Bergenstal said at a meeting sponsored by the American Diabetes Association.

He welcomed the change, and the rationale for using HbA_1c to diagnose diabetes. “Why do we follow it so closely once you're diagnosed, but pay no attention to it before you're diagnosed?” asked Dr. Bergenstal, president of medicine and science for the ADA and executive director of the International Diabetes Center, Saint Louis Park, Minn.

The International Expert Committee, with members appointed by the ADA, the European Association for the Study of Diabetes, and the International Diabetes Federation, got the ball rolling by publishing a consensus opinion in July 2009 to make HbA_1c the preferred test for diagnosing type 2 diabetes (Diabetes Care 2009;32:1327–34).

The ADA translated the international consensus into clinical practice recommendations that were published in its annual update on standards of care in January 2010 (Diabetes Care 2010;33:S11–61). The ADA backed away from calling HbA1_cthe preferred test, instead saying it's one of four diagnostic options, but acknowledged that it may become the most popular diagnostic test for type 2 diabetes.

The other, conventional diagnostic criteria are a fasting plasma glucose level of at least 126 mg/dL, an oral glucose tolerance test result of 200 mg/dL or higher, or classic symptoms of hyperglycemia plus a randomly obtained glucose level of at least 200 mg/dL.

The Endocrine Society endorsed the ADA clinical practice recommendations in a separate statement issued Jan. 20, 2010. The American Association of Clinical Endocrinologists then followed with its own supportive statement on Feb. 1, 2010.<

Inevitably, clinicians will have patients whose HbA_1c and glucose results conflict, Dr. Bergenstal noted. If one is abnormal and the other is not, repeat the abnormal test, the ADA recommendations say. “If that is still abnormal, you've made the diagnosis,” he said. If, instead, a third test method is used for confirmation and the result meets diagnostic criteria, diabetes is confirmed, he added.

Results are less clear when a patient has one normal and one abnormal test result, and repeating the abnormal test produces a normal result. “Then you have someone who is obviously on the edge” and who should be retested again in 3–6 months, he said.

Another gray area is the use of HbA_1c to define prediabetes (patients at high risk for developing diabetes or cardiovascular disease). The statements from the various groups differ somewhat in how they address this. “I think everyone agrees that for at-risk patients, that's a little bit more of a judgment call,” Dr. Bergenstal said.

The International Expert Committee suggested avoiding the concept of prediabetes because the risk is a continuum with a fairly steady rise in risk as HbA_1c levels increase. They identified HbA_1c levels of 6.0%-6.4% as “very high risk” while noting that people with lower HbA_1c levels also may have increased risk for diabetes if other risk factors are present. The committee recommended starting preventive strategies depending on the intensity with which a clinician wants to deploy any available resources, he said.

The ADA's 2010 clinical practice recommendations declare HbA_1c levels of 5.7%-6.4% to be indicative of high risk, and state that patients with these levels may be referred to as having prediabetes, Dr. Bergenstal said. “At 5.7% we thought the risk was really quite high, and that people deserved to have some kind of program” to prevent diabetes.

The American Association of Clinical Endocrinologists suggested that a HbA_1c level of 5.5%-6.4% may be a better cut-off to identify higher-risk patients.

Unlike the glucose tests, HbA_1c testing does not require patients to fast before testing, and carries several other advantages. Each of the statements supporting HbA_1c testing for diabetes diagnosis acknowledged a number of caveats, however, such as recognition that marginally elevated HbA_1c values in certain ethnic groups do not necessarily indicate diabetes. HbA_1c testing should not be used for diabetes diagnosis in patients with conditions that impair the correlation between HbA_1c and average blood glucose, such as iron deficiency or renal disease.

Only standardized, validated laboratory assays for HbA_1c were endorsed. Some of the newer point-of-care tests may be sufficiently accurate, but others are not, and more testing is needed before these can be endorsed for diabetes diagnosis, he said.

Why do we follow HbA_1c so closely once you're diagnosed, but pay no attention to it before diagnosis?

Source DR. BERGENSTAL

SAN FRANCISCO — The use of a hemoglobin A_1c level of 6.5% or higher to diagnose type 2 diabetes should now be mainstream, given formal endorsements from three major U.S. medical associations in 2010 supporting an International Expert Committee's 2009 consensus recommendations.

The World Health Organization and other groups are likely to follow suit, though with greater emphasis on this as an alternative to conventional means of diagnosing diabetes in regions that don't have easy access to standardized assays for HbA_1c, Dr. Richard M. Bergenstal said at a meeting sponsored by the American Diabetes Association.

He welcomed the change, and the rationale for using HbA_1c to diagnose diabetes. “Why do we follow it so closely once you're diagnosed, but pay no attention to it before you're diagnosed?” asked Dr. Bergenstal, president of medicine and science for the ADA and executive director of the International Diabetes Center, Saint Louis Park, Minn.

The International Expert Committee, with members appointed by the ADA, the European Association for the Study of Diabetes, and the International Diabetes Federation, got the ball rolling by publishing a consensus opinion in July 2009 to make HbA_1c the preferred test for diagnosing type 2 diabetes (Diabetes Care 2009;32:1327–34).

The ADA translated the international consensus into clinical practice recommendations that were published in its annual update on standards of care in January 2010 (Diabetes Care 2010;33:S11–61). The ADA backed away from calling HbA1_cthe preferred test, instead saying it's one of four diagnostic options, but acknowledged that it may become the most popular diagnostic test for type 2 diabetes.

The other, conventional diagnostic criteria are a fasting plasma glucose level of at least 126 mg/dL, an oral glucose tolerance test result of 200 mg/dL or higher, or classic symptoms of hyperglycemia plus a randomly obtained glucose level of at least 200 mg/dL.

The Endocrine Society endorsed the ADA clinical practice recommendations in a separate statement issued Jan. 20, 2010. The American Association of Clinical Endocrinologists then followed with its own supportive statement on Feb. 1, 2010.<

Inevitably, clinicians will have patients whose HbA_1c and glucose results conflict, Dr. Bergenstal noted. If one is abnormal and the other is not, repeat the abnormal test, the ADA recommendations say. “If that is still abnormal, you've made the diagnosis,” he said. If, instead, a third test method is used for confirmation and the result meets diagnostic criteria, diabetes is confirmed, he added.

Results are less clear when a patient has one normal and one abnormal test result, and repeating the abnormal test produces a normal result. “Then you have someone who is obviously on the edge” and who should be retested again in 3–6 months, he said.

Another gray area is the use of HbA_1c to define prediabetes (patients at high risk for developing diabetes or cardiovascular disease). The statements from the various groups differ somewhat in how they address this. “I think everyone agrees that for at-risk patients, that's a little bit more of a judgment call,” Dr. Bergenstal said.

The International Expert Committee suggested avoiding the concept of prediabetes because the risk is a continuum with a fairly steady rise in risk as HbA_1c levels increase. They identified HbA_1c levels of 6.0%-6.4% as “very high risk” while noting that people with lower HbA_1c levels also may have increased risk for diabetes if other risk factors are present. The committee recommended starting preventive strategies depending on the intensity with which a clinician wants to deploy any available resources, he said.

The ADA's 2010 clinical practice recommendations declare HbA_1c levels of 5.7%-6.4% to be indicative of high risk, and state that patients with these levels may be referred to as having prediabetes, Dr. Bergenstal said. “At 5.7% we thought the risk was really quite high, and that people deserved to have some kind of program” to prevent diabetes.

The American Association of Clinical Endocrinologists suggested that a HbA_1c level of 5.5%-6.4% may be a better cut-off to identify higher-risk patients.

Unlike the glucose tests, HbA_1c testing does not require patients to fast before testing, and carries several other advantages. Each of the statements supporting HbA_1c testing for diabetes diagnosis acknowledged a number of caveats, however, such as recognition that marginally elevated HbA_1c values in certain ethnic groups do not necessarily indicate diabetes. HbA_1c testing should not be used for diabetes diagnosis in patients with conditions that impair the correlation between HbA_1c and average blood glucose, such as iron deficiency or renal disease.

Only standardized, validated laboratory assays for HbA_1c were endorsed. Some of the newer point-of-care tests may be sufficiently accurate, but others are not, and more testing is needed before these can be endorsed for diabetes diagnosis, he said.

Why do we follow HbA_1c so closely once you're diagnosed, but pay no attention to it before diagnosis?

Source DR. BERGENSTAL

SAN FRANCISCO — The use of a hemoglobin A_1c level of 6.5% or higher to diagnose type 2 diabetes should now be mainstream, given formal endorsements from three major U.S. medical associations in 2010 supporting an International Expert Committee's 2009 consensus recommendations.

The World Health Organization and other groups are likely to follow suit, though with greater emphasis on this as an alternative to conventional means of diagnosing diabetes in regions that don't have easy access to standardized assays for HbA_1c, Dr. Richard M. Bergenstal said at a meeting sponsored by the American Diabetes Association.

He welcomed the change, and the rationale for using HbA_1c to diagnose diabetes. “Why do we follow it so closely once you're diagnosed, but pay no attention to it before you're diagnosed?” asked Dr. Bergenstal, president of medicine and science for the ADA and executive director of the International Diabetes Center, Saint Louis Park, Minn.

The International Expert Committee, with members appointed by the ADA, the European Association for the Study of Diabetes, and the International Diabetes Federation, got the ball rolling by publishing a consensus opinion in July 2009 to make HbA_1c the preferred test for diagnosing type 2 diabetes (Diabetes Care 2009;32:1327–34).

The ADA translated the international consensus into clinical practice recommendations that were published in its annual update on standards of care in January 2010 (Diabetes Care 2010;33:S11–61). The ADA backed away from calling HbA1_cthe preferred test, instead saying it's one of four diagnostic options, but acknowledged that it may become the most popular diagnostic test for type 2 diabetes.

The other, conventional diagnostic criteria are a fasting plasma glucose level of at least 126 mg/dL, an oral glucose tolerance test result of 200 mg/dL or higher, or classic symptoms of hyperglycemia plus a randomly obtained glucose level of at least 200 mg/dL.

The Endocrine Society endorsed the ADA clinical practice recommendations in a separate statement issued Jan. 20, 2010. The American Association of Clinical Endocrinologists then followed with its own supportive statement on Feb. 1, 2010.<

Inevitably, clinicians will have patients whose HbA_1c and glucose results conflict, Dr. Bergenstal noted. If one is abnormal and the other is not, repeat the abnormal test, the ADA recommendations say. “If that is still abnormal, you've made the diagnosis,” he said. If, instead, a third test method is used for confirmation and the result meets diagnostic criteria, diabetes is confirmed, he added.

Results are less clear when a patient has one normal and one abnormal test result, and repeating the abnormal test produces a normal result. “Then you have someone who is obviously on the edge” and who should be retested again in 3–6 months, he said.

Another gray area is the use of HbA_1c to define prediabetes (patients at high risk for developing diabetes or cardiovascular disease). The statements from the various groups differ somewhat in how they address this. “I think everyone agrees that for at-risk patients, that's a little bit more of a judgment call,” Dr. Bergenstal said.

The International Expert Committee suggested avoiding the concept of prediabetes because the risk is a continuum with a fairly steady rise in risk as HbA_1c levels increase. They identified HbA_1c levels of 6.0%-6.4% as “very high risk” while noting that people with lower HbA_1c levels also may have increased risk for diabetes if other risk factors are present. The committee recommended starting preventive strategies depending on the intensity with which a clinician wants to deploy any available resources, he said.

The ADA's 2010 clinical practice recommendations declare HbA_1c levels of 5.7%-6.4% to be indicative of high risk, and state that patients with these levels may be referred to as having prediabetes, Dr. Bergenstal said. “At 5.7% we thought the risk was really quite high, and that people deserved to have some kind of program” to prevent diabetes.

The American Association of Clinical Endocrinologists suggested that a HbA_1c level of 5.5%-6.4% may be a better cut-off to identify higher-risk patients.

Unlike the glucose tests, HbA_1c testing does not require patients to fast before testing, and carries several other advantages. Each of the statements supporting HbA_1c testing for diabetes diagnosis acknowledged a number of caveats, however, such as recognition that marginally elevated HbA_1c values in certain ethnic groups do not necessarily indicate diabetes. HbA_1c testing should not be used for diabetes diagnosis in patients with conditions that impair the correlation between HbA_1c and average blood glucose, such as iron deficiency or renal disease.

Only standardized, validated laboratory assays for HbA_1c were endorsed. Some of the newer point-of-care tests may be sufficiently accurate, but others are not, and more testing is needed before these can be endorsed for diabetes diagnosis, he said.

Why do we follow HbA_1c so closely once you're diagnosed, but pay no attention to it before diagnosis?

Source DR. BERGENSTAL

SAN DIEGO — Workers who responded to the scene and cleaned up after the Sept. 11, 2001, attack on New York's World Trade Center continued to have high rates of gastroesophageal reflux disease and mental health disorders 4-6 years later, a study of 697 patients has shown.

The findings suggest that mental health disorders may play an important role in the development and persistence of gastroesophageal reflux disease (GERD) after a highly stressful and toxic exposure such as the environs of the World Trade Center attack, Dr. Yvette Lam said at the annual meeting of the American College of Gastroenterology.

A multidisciplinary approach to care that includes treatment of mental health disorders may be needed to resolve GERD symptoms, suggested Dr. Lam of the State University of New York, Stony Brook.

Among the 697 patients studied, 55% had responded to the disaster scene on Sept. 11, and 97% had responded by the end of that month. The patients worked at the site for an average of 4 months. More time spent at the site correlated with a higher prevalence of GERD and posttraumatic stress disorder (PTSD).

The workers encountered toxic conditions: 63% were exposed to blood or bodily fluids, 80% to human remains, and 99.5% to dust. There was no association between the type of exposure and the prevalence of GERD.

The cohort was nearly all male (92%) and ranged in age from 34 to 50 years.

Data on these patients, seen between July 2005 and September 2006, were compared with data from the general population, serving as a control group in this retrospective study. The prevalence of GERD was 41% in the World Trade Center workers and 20% in the control group. PTSD was seen in 28% of the workers and 4% of the control group. Major depressive disorders affected 31% of the workers and 7% of the control group, and anxiety was diagnosed in 46% of the workers and 3% of the control group.

In addition, the 41% of workers who had GERD were significantly more likely than workers without GERD to have PTSD (21% vs. 7%), major depression (22% vs. 9%), and anxiety (30% vs. 16%), Dr. Lam and her associates reported.

Among 413 of the workers who came in for a follow-up visit 19-31 months after the first visit, those who had GERD at the second visit were significantly more likely than those without GERD to have PTSD (21% vs. 10%) and depression (33% vs. 12%).

Patients with more mental health disorders had a higher risk for GERD. The analysis showed that the prevalence of GERD increased to 72% among the patients with four mental health disorders.

More than 40,000 police, fire fighters, contract workers, and volunteers participated in the massive rescue and cleanup efforts at Ground Zero, recovering human remains and cleaning up debris over a 9-month period. A previous study of conditions in the World Trade Center workers found a 58% prevalence of GERD, among other disorders (Int. Arch. Occup. Environ. Health 2008;81:479-85).

In another previous study, people with anxiety disorders were three times more likely to have GERD, and people with depression were twice as likely to have GERD, compared with those without those mental health diagnoses (Aliment. Pharmacol. Ther. 2007;26:683-91).

SAN DIEGO — Workers who responded to the scene and cleaned up after the Sept. 11, 2001, attack on New York's World Trade Center continued to have high rates of gastroesophageal reflux disease and mental health disorders 4-6 years later, a study of 697 patients has shown.

The findings suggest that mental health disorders may play an important role in the development and persistence of gastroesophageal reflux disease (GERD) after a highly stressful and toxic exposure such as the environs of the World Trade Center attack, Dr. Yvette Lam said at the annual meeting of the American College of Gastroenterology.

A multidisciplinary approach to care that includes treatment of mental health disorders may be needed to resolve GERD symptoms, suggested Dr. Lam of the State University of New York, Stony Brook.

Among the 697 patients studied, 55% had responded to the disaster scene on Sept. 11, and 97% had responded by the end of that month. The patients worked at the site for an average of 4 months. More time spent at the site correlated with a higher prevalence of GERD and posttraumatic stress disorder (PTSD).

The workers encountered toxic conditions: 63% were exposed to blood or bodily fluids, 80% to human remains, and 99.5% to dust. There was no association between the type of exposure and the prevalence of GERD.

The cohort was nearly all male (92%) and ranged in age from 34 to 50 years.

Data on these patients, seen between July 2005 and September 2006, were compared with data from the general population, serving as a control group in this retrospective study. The prevalence of GERD was 41% in the World Trade Center workers and 20% in the control group. PTSD was seen in 28% of the workers and 4% of the control group. Major depressive disorders affected 31% of the workers and 7% of the control group, and anxiety was diagnosed in 46% of the workers and 3% of the control group.

In addition, the 41% of workers who had GERD were significantly more likely than workers without GERD to have PTSD (21% vs. 7%), major depression (22% vs. 9%), and anxiety (30% vs. 16%), Dr. Lam and her associates reported.

Among 413 of the workers who came in for a follow-up visit 19-31 months after the first visit, those who had GERD at the second visit were significantly more likely than those without GERD to have PTSD (21% vs. 10%) and depression (33% vs. 12%).

Patients with more mental health disorders had a higher risk for GERD. The analysis showed that the prevalence of GERD increased to 72% among the patients with four mental health disorders.

More than 40,000 police, fire fighters, contract workers, and volunteers participated in the massive rescue and cleanup efforts at Ground Zero, recovering human remains and cleaning up debris over a 9-month period. A previous study of conditions in the World Trade Center workers found a 58% prevalence of GERD, among other disorders (Int. Arch. Occup. Environ. Health 2008;81:479-85).

In another previous study, people with anxiety disorders were three times more likely to have GERD, and people with depression were twice as likely to have GERD, compared with those without those mental health diagnoses (Aliment. Pharmacol. Ther. 2007;26:683-91).

SAN DIEGO — Workers who responded to the scene and cleaned up after the Sept. 11, 2001, attack on New York's World Trade Center continued to have high rates of gastroesophageal reflux disease and mental health disorders 4-6 years later, a study of 697 patients has shown.

The findings suggest that mental health disorders may play an important role in the development and persistence of gastroesophageal reflux disease (GERD) after a highly stressful and toxic exposure such as the environs of the World Trade Center attack, Dr. Yvette Lam said at the annual meeting of the American College of Gastroenterology.

A multidisciplinary approach to care that includes treatment of mental health disorders may be needed to resolve GERD symptoms, suggested Dr. Lam of the State University of New York, Stony Brook.

Among the 697 patients studied, 55% had responded to the disaster scene on Sept. 11, and 97% had responded by the end of that month. The patients worked at the site for an average of 4 months. More time spent at the site correlated with a higher prevalence of GERD and posttraumatic stress disorder (PTSD).

The workers encountered toxic conditions: 63% were exposed to blood or bodily fluids, 80% to human remains, and 99.5% to dust. There was no association between the type of exposure and the prevalence of GERD.

The cohort was nearly all male (92%) and ranged in age from 34 to 50 years.

Data on these patients, seen between July 2005 and September 2006, were compared with data from the general population, serving as a control group in this retrospective study. The prevalence of GERD was 41% in the World Trade Center workers and 20% in the control group. PTSD was seen in 28% of the workers and 4% of the control group. Major depressive disorders affected 31% of the workers and 7% of the control group, and anxiety was diagnosed in 46% of the workers and 3% of the control group.

In addition, the 41% of workers who had GERD were significantly more likely than workers without GERD to have PTSD (21% vs. 7%), major depression (22% vs. 9%), and anxiety (30% vs. 16%), Dr. Lam and her associates reported.

Among 413 of the workers who came in for a follow-up visit 19-31 months after the first visit, those who had GERD at the second visit were significantly more likely than those without GERD to have PTSD (21% vs. 10%) and depression (33% vs. 12%).

Patients with more mental health disorders had a higher risk for GERD. The analysis showed that the prevalence of GERD increased to 72% among the patients with four mental health disorders.

More than 40,000 police, fire fighters, contract workers, and volunteers participated in the massive rescue and cleanup efforts at Ground Zero, recovering human remains and cleaning up debris over a 9-month period. A previous study of conditions in the World Trade Center workers found a 58% prevalence of GERD, among other disorders (Int. Arch. Occup. Environ. Health 2008;81:479-85).

In another previous study, people with anxiety disorders were three times more likely to have GERD, and people with depression were twice as likely to have GERD, compared with those without those mental health diagnoses (Aliment. Pharmacol. Ther. 2007;26:683-91).

Major Finding: A majority (57%) of adults taking insulin for diabetes said they intentionally skipped an insulin injection occasionally, and 20% did so regularly.

Data Source: Online survey with 502 participants in a sample weighted to be representative of insulin-using U.S. adults with diabetes.

Disclosures: Patton Medical Devices, which makes an insulin injection device, funded the study. Some of the investigators own stock in and have been advisers to the company.

Most adults with type 1 or type 2 diabetes intentionally skip insulin injections, and 20% skip them regularly, according to an online survey of 502 diabetic adults.

The study is one of the first to identify factors that were associated with a greater likelihood of purposefully omitting insulin shots at least occasionally, as 57% of respondents reported doing.

The 388 respondents with type 2 diabetes were more likely to report intentional omissions of insulin, compared with the 114 with type 1 diabetes, according to the report (Diabetes Care 2010;33:240-5).

Respondents who were more likely to skip insulin injections were younger, were students, had lower household incomes, had higher education levels, or did not eat a healthy diet. Skipping insulin also was more likely among respondents who either had to take more daily injections, said the injections interfered with daily activities, or reported pain or embarrassment from the injections.

Physicians should work with patients to discover their issues around injecting insulin and give them the information or tools they need to overcome some of these barriers, suggested Mark Peyrot, Ph.D., of the department of sociology, Loyola University Maryland, Baltimore, and his associates.

Insulin pens, finer-gauge needles, injection ports, needle-free injectors, and other device-related strategies can reduce pain or embarrassment. “However, we have found that patients do not feel that their health care providers are giving them adequate assistance in managing these problems, even when they raise the issue with their providers,” the investigators wrote.

Risk factors for intentionally skipping insulin injections differed for patients with type 1 and type 2 diabetes, separate analyses found. In respondents with type 1 diabetes, lack of a healthy diet, the number of daily insulin injections, and interference with daily activities were significantly associated with skipping insulin. In those with type 2 diabetes, age, education, income, pain, and embarrassment played greater roles in the risk for skipping insulin.

The investigators noted that insulin is used by more than 25% of people in the United States who have diabetes. Non-adherence with insulin regimens has been associated with higher hemoglobin A_1c levels and higher rates of hospitalization for diabetes-related complications.

Race and ethnicity were not associated with a likelihood of skipping insulin, contrary to findings in other studies, perhaps because the study controlled for the effects of income and education, or perhaps because the study did not have enough nonwhite participants. Whites comprised 73% of survey respondents, who were recruited by e-mail from the Harris Interactive Chronic Illness Panel.

Also contrary to some previous studies of adherence to insulin regimens, the current study found no significant association between omission of insulin and a history of depression, which surprised the investigators. This may be because the survey did not assess current depression.

Disabled respondents were less likely to skip an insulin injection, perhaps because they get more assistance with care or make a greater effort to attend to their health, the investigators speculated. They were not surprised that poor adherence with a healthy diet was associated with skipping insulin, as previously reported.

The survey's results suggest that intentional omission of insulin is a substantial problem, Katie Weinger, Ed.D., and Elizabeth A. Beverly, Ph.D., wrote in an editorial accompanying the report (Diabetes Care 2010;33:450-2).

The findings support previous studies that reported low levels of adherence to insulin regimens—intentional or not—in 59%–77% of patients with diabetes.

U.S. physicians are more likely than are doctors in other countries to delay prescribing insulin, and U.S. patients are less convinced of insulin's effectiveness and more likely to blame themselves for needing it, compared with patients in other countries, Dr. Weinger and Dr. Beverly noted. Physicians need to examine their own reluctance to initiate insulin and work with patients around these factors and the ones identified in Dr. Peyrot's study to minimize omission of insulin when needed, they suggested.

The few previous studies of reasons that patients decide to skip insulin injections have focused mainly on patients with type 1 diabetes, especially on an association between eating disorders and insulin omission. The current study shows that not all insulin omission is motivated by desire to lose weight in patients with type 1 diabetes. It's unclear whether patients with type 2 diabetes think that skipping insulin will reduce weight.

Weight concerns were not addressed in the study. Neither were some other important issues, said Dr. Weinger, a researcher in the department of psychiatry at Harvard University, Boston, and Dr. Beverly, a researcher at the Joslin Diabetes Center, Boston. These issues include self-care behaviors, and the impact of insulin delivery systems. Nonetheless, the study provides an important look at the avoidance of insulin therapy.

Major Finding: A majority (57%) of adults taking insulin for diabetes said they intentionally skipped an insulin injection occasionally, and 20% did so regularly.

Data Source: Online survey with 502 participants in a sample weighted to be representative of insulin-using U.S. adults with diabetes.

Disclosures: Patton Medical Devices, which makes an insulin injection device, funded the study. Some of the investigators own stock in and have been advisers to the company.

Most adults with type 1 or type 2 diabetes intentionally skip insulin injections, and 20% skip them regularly, according to an online survey of 502 diabetic adults.

The study is one of the first to identify factors that were associated with a greater likelihood of purposefully omitting insulin shots at least occasionally, as 57% of respondents reported doing.

The 388 respondents with type 2 diabetes were more likely to report intentional omissions of insulin, compared with the 114 with type 1 diabetes, according to the report (Diabetes Care 2010;33:240-5).

Respondents who were more likely to skip insulin injections were younger, were students, had lower household incomes, had higher education levels, or did not eat a healthy diet. Skipping insulin also was more likely among respondents who either had to take more daily injections, said the injections interfered with daily activities, or reported pain or embarrassment from the injections.

Physicians should work with patients to discover their issues around injecting insulin and give them the information or tools they need to overcome some of these barriers, suggested Mark Peyrot, Ph.D., of the department of sociology, Loyola University Maryland, Baltimore, and his associates.

Insulin pens, finer-gauge needles, injection ports, needle-free injectors, and other device-related strategies can reduce pain or embarrassment. “However, we have found that patients do not feel that their health care providers are giving them adequate assistance in managing these problems, even when they raise the issue with their providers,” the investigators wrote.

Risk factors for intentionally skipping insulin injections differed for patients with type 1 and type 2 diabetes, separate analyses found. In respondents with type 1 diabetes, lack of a healthy diet, the number of daily insulin injections, and interference with daily activities were significantly associated with skipping insulin. In those with type 2 diabetes, age, education, income, pain, and embarrassment played greater roles in the risk for skipping insulin.

The investigators noted that insulin is used by more than 25% of people in the United States who have diabetes. Non-adherence with insulin regimens has been associated with higher hemoglobin A_1c levels and higher rates of hospitalization for diabetes-related complications.

Race and ethnicity were not associated with a likelihood of skipping insulin, contrary to findings in other studies, perhaps because the study controlled for the effects of income and education, or perhaps because the study did not have enough nonwhite participants. Whites comprised 73% of survey respondents, who were recruited by e-mail from the Harris Interactive Chronic Illness Panel.

Also contrary to some previous studies of adherence to insulin regimens, the current study found no significant association between omission of insulin and a history of depression, which surprised the investigators. This may be because the survey did not assess current depression.

Disabled respondents were less likely to skip an insulin injection, perhaps because they get more assistance with care or make a greater effort to attend to their health, the investigators speculated. They were not surprised that poor adherence with a healthy diet was associated with skipping insulin, as previously reported.

The survey's results suggest that intentional omission of insulin is a substantial problem, Katie Weinger, Ed.D., and Elizabeth A. Beverly, Ph.D., wrote in an editorial accompanying the report (Diabetes Care 2010;33:450-2).

The findings support previous studies that reported low levels of adherence to insulin regimens—intentional or not—in 59%–77% of patients with diabetes.

U.S. physicians are more likely than are doctors in other countries to delay prescribing insulin, and U.S. patients are less convinced of insulin's effectiveness and more likely to blame themselves for needing it, compared with patients in other countries, Dr. Weinger and Dr. Beverly noted. Physicians need to examine their own reluctance to initiate insulin and work with patients around these factors and the ones identified in Dr. Peyrot's study to minimize omission of insulin when needed, they suggested.

The few previous studies of reasons that patients decide to skip insulin injections have focused mainly on patients with type 1 diabetes, especially on an association between eating disorders and insulin omission. The current study shows that not all insulin omission is motivated by desire to lose weight in patients with type 1 diabetes. It's unclear whether patients with type 2 diabetes think that skipping insulin will reduce weight.

Weight concerns were not addressed in the study. Neither were some other important issues, said Dr. Weinger, a researcher in the department of psychiatry at Harvard University, Boston, and Dr. Beverly, a researcher at the Joslin Diabetes Center, Boston. These issues include self-care behaviors, and the impact of insulin delivery systems. Nonetheless, the study provides an important look at the avoidance of insulin therapy.

Major Finding: A majority (57%) of adults taking insulin for diabetes said they intentionally skipped an insulin injection occasionally, and 20% did so regularly.

Data Source: Online survey with 502 participants in a sample weighted to be representative of insulin-using U.S. adults with diabetes.

Disclosures: Patton Medical Devices, which makes an insulin injection device, funded the study. Some of the investigators own stock in and have been advisers to the company.

Most adults with type 1 or type 2 diabetes intentionally skip insulin injections, and 20% skip them regularly, according to an online survey of 502 diabetic adults.

The study is one of the first to identify factors that were associated with a greater likelihood of purposefully omitting insulin shots at least occasionally, as 57% of respondents reported doing.

The 388 respondents with type 2 diabetes were more likely to report intentional omissions of insulin, compared with the 114 with type 1 diabetes, according to the report (Diabetes Care 2010;33:240-5).

Respondents who were more likely to skip insulin injections were younger, were students, had lower household incomes, had higher education levels, or did not eat a healthy diet. Skipping insulin also was more likely among respondents who either had to take more daily injections, said the injections interfered with daily activities, or reported pain or embarrassment from the injections.

Physicians should work with patients to discover their issues around injecting insulin and give them the information or tools they need to overcome some of these barriers, suggested Mark Peyrot, Ph.D., of the department of sociology, Loyola University Maryland, Baltimore, and his associates.

Insulin pens, finer-gauge needles, injection ports, needle-free injectors, and other device-related strategies can reduce pain or embarrassment. “However, we have found that patients do not feel that their health care providers are giving them adequate assistance in managing these problems, even when they raise the issue with their providers,” the investigators wrote.

Risk factors for intentionally skipping insulin injections differed for patients with type 1 and type 2 diabetes, separate analyses found. In respondents with type 1 diabetes, lack of a healthy diet, the number of daily insulin injections, and interference with daily activities were significantly associated with skipping insulin. In those with type 2 diabetes, age, education, income, pain, and embarrassment played greater roles in the risk for skipping insulin.

The investigators noted that insulin is used by more than 25% of people in the United States who have diabetes. Non-adherence with insulin regimens has been associated with higher hemoglobin A_1c levels and higher rates of hospitalization for diabetes-related complications.

Race and ethnicity were not associated with a likelihood of skipping insulin, contrary to findings in other studies, perhaps because the study controlled for the effects of income and education, or perhaps because the study did not have enough nonwhite participants. Whites comprised 73% of survey respondents, who were recruited by e-mail from the Harris Interactive Chronic Illness Panel.

Also contrary to some previous studies of adherence to insulin regimens, the current study found no significant association between omission of insulin and a history of depression, which surprised the investigators. This may be because the survey did not assess current depression.

Disabled respondents were less likely to skip an insulin injection, perhaps because they get more assistance with care or make a greater effort to attend to their health, the investigators speculated. They were not surprised that poor adherence with a healthy diet was associated with skipping insulin, as previously reported.

The survey's results suggest that intentional omission of insulin is a substantial problem, Katie Weinger, Ed.D., and Elizabeth A. Beverly, Ph.D., wrote in an editorial accompanying the report (Diabetes Care 2010;33:450-2).

The findings support previous studies that reported low levels of adherence to insulin regimens—intentional or not—in 59%–77% of patients with diabetes.

U.S. physicians are more likely than are doctors in other countries to delay prescribing insulin, and U.S. patients are less convinced of insulin's effectiveness and more likely to blame themselves for needing it, compared with patients in other countries, Dr. Weinger and Dr. Beverly noted. Physicians need to examine their own reluctance to initiate insulin and work with patients around these factors and the ones identified in Dr. Peyrot's study to minimize omission of insulin when needed, they suggested.

The few previous studies of reasons that patients decide to skip insulin injections have focused mainly on patients with type 1 diabetes, especially on an association between eating disorders and insulin omission. The current study shows that not all insulin omission is motivated by desire to lose weight in patients with type 1 diabetes. It's unclear whether patients with type 2 diabetes think that skipping insulin will reduce weight.

Weight concerns were not addressed in the study. Neither were some other important issues, said Dr. Weinger, a researcher in the department of psychiatry at Harvard University, Boston, and Dr. Beverly, a researcher at the Joslin Diabetes Center, Boston. These issues include self-care behaviors, and the impact of insulin delivery systems. Nonetheless, the study provides an important look at the avoidance of insulin therapy.