Diabetes Hub

SEATTLE – Metformin use before surgery for stage I and II non–small cell lung cancer (NSCLC) was associated with improved progression-free survival at 5 years in a retrospective database study of 138 patients who also had type 2 diabetes.

The patients were treated for stage I and II NSCLC at Rush University Medical Center, Chicago. They also had type 2 diabetes; 81 (59%) were on metformin in the 6 months before pulmonary resection, and 57 (41%) were not, reported Rush medical student Robert Medairos, who is one of the study researchers.

At 5 years follow-up, progression-free survival was 60% in the metformin group, but about 35% in the no-metformin group (P = .01). Overall survival was about 90% at 5 years in both study arms.

A larger study or longer follow-up may show overall survival benefits for metformin users, Mr. Medairos said at the annual meeting of the American Association for Thoracic Surgery.

Patients were about 70 years old on average in both groups, with 35 pack-year smoking histories, and an average body mass index of about 30 kg/m². Both study arms had slightly more men than women, and were otherwise balanced for ethnicity and comorbidities.

About 12% of patients in the metformin group and 40% in the no-metformin group, were on insulin prior to surgery. Mean preoperative creatinine was 1 mg/dL in the metformin group, and 1.7 mg/dL in the no-metformin group. There were trends towards higher-stage disease and more lymph node involvement in the no-metformin group. About half the patients in both arms had adenocarcinomas, but a greater proportion of patients in the no-metformin group had squamous cell carcinomas.

The Rush study might be the first to look into metformin for early NSCLC, but there have been several studies in advanced disease. A recent retrospective analysis of 750 diabetes patients with stage IV NSCLC found a median survival of 5 months for the 61% on metformin at diagnosis, but 3 months for those who were not (Am. J. Respir. Crit. Care. Med. 2015;191:448-54).

Currently, there are about a dozen ongoing trials of the drug for lung cancer, and scores more for prostate, breast, brain, uterine, colorectal, thyroid, and other cancers.

Metformin’s metabolic effects might reduce the ability of cancers to grow and metabolize, or the drug might somehow boost the antineoplastic effects of chemotherapeutics. “Our next step is to look at histological and tissues samples to see if metformin changes gene transcription in lung cancer cells,” Mr. Medairos said.

Mr. Medairos has no disclosures.

[email protected]

SEATTLE – Metformin use before surgery for stage I and II non–small cell lung cancer (NSCLC) was associated with improved progression-free survival at 5 years in a retrospective database study of 138 patients who also had type 2 diabetes.

The patients were treated for stage I and II NSCLC at Rush University Medical Center, Chicago. They also had type 2 diabetes; 81 (59%) were on metformin in the 6 months before pulmonary resection, and 57 (41%) were not, reported Rush medical student Robert Medairos, who is one of the study researchers.

At 5 years follow-up, progression-free survival was 60% in the metformin group, but about 35% in the no-metformin group (P = .01). Overall survival was about 90% at 5 years in both study arms.

A larger study or longer follow-up may show overall survival benefits for metformin users, Mr. Medairos said at the annual meeting of the American Association for Thoracic Surgery.

Patients were about 70 years old on average in both groups, with 35 pack-year smoking histories, and an average body mass index of about 30 kg/m². Both study arms had slightly more men than women, and were otherwise balanced for ethnicity and comorbidities.

About 12% of patients in the metformin group and 40% in the no-metformin group, were on insulin prior to surgery. Mean preoperative creatinine was 1 mg/dL in the metformin group, and 1.7 mg/dL in the no-metformin group. There were trends towards higher-stage disease and more lymph node involvement in the no-metformin group. About half the patients in both arms had adenocarcinomas, but a greater proportion of patients in the no-metformin group had squamous cell carcinomas.

The Rush study might be the first to look into metformin for early NSCLC, but there have been several studies in advanced disease. A recent retrospective analysis of 750 diabetes patients with stage IV NSCLC found a median survival of 5 months for the 61% on metformin at diagnosis, but 3 months for those who were not (Am. J. Respir. Crit. Care. Med. 2015;191:448-54).

Currently, there are about a dozen ongoing trials of the drug for lung cancer, and scores more for prostate, breast, brain, uterine, colorectal, thyroid, and other cancers.

Metformin’s metabolic effects might reduce the ability of cancers to grow and metabolize, or the drug might somehow boost the antineoplastic effects of chemotherapeutics. “Our next step is to look at histological and tissues samples to see if metformin changes gene transcription in lung cancer cells,” Mr. Medairos said.

Mr. Medairos has no disclosures.

[email protected]

SEATTLE – Metformin use before surgery for stage I and II non–small cell lung cancer (NSCLC) was associated with improved progression-free survival at 5 years in a retrospective database study of 138 patients who also had type 2 diabetes.

The patients were treated for stage I and II NSCLC at Rush University Medical Center, Chicago. They also had type 2 diabetes; 81 (59%) were on metformin in the 6 months before pulmonary resection, and 57 (41%) were not, reported Rush medical student Robert Medairos, who is one of the study researchers.

At 5 years follow-up, progression-free survival was 60% in the metformin group, but about 35% in the no-metformin group (P = .01). Overall survival was about 90% at 5 years in both study arms.

A larger study or longer follow-up may show overall survival benefits for metformin users, Mr. Medairos said at the annual meeting of the American Association for Thoracic Surgery.

Patients were about 70 years old on average in both groups, with 35 pack-year smoking histories, and an average body mass index of about 30 kg/m². Both study arms had slightly more men than women, and were otherwise balanced for ethnicity and comorbidities.

About 12% of patients in the metformin group and 40% in the no-metformin group, were on insulin prior to surgery. Mean preoperative creatinine was 1 mg/dL in the metformin group, and 1.7 mg/dL in the no-metformin group. There were trends towards higher-stage disease and more lymph node involvement in the no-metformin group. About half the patients in both arms had adenocarcinomas, but a greater proportion of patients in the no-metformin group had squamous cell carcinomas.

The Rush study might be the first to look into metformin for early NSCLC, but there have been several studies in advanced disease. A recent retrospective analysis of 750 diabetes patients with stage IV NSCLC found a median survival of 5 months for the 61% on metformin at diagnosis, but 3 months for those who were not (Am. J. Respir. Crit. Care. Med. 2015;191:448-54).

Currently, there are about a dozen ongoing trials of the drug for lung cancer, and scores more for prostate, breast, brain, uterine, colorectal, thyroid, and other cancers.

Metformin’s metabolic effects might reduce the ability of cancers to grow and metabolize, or the drug might somehow boost the antineoplastic effects of chemotherapeutics. “Our next step is to look at histological and tissues samples to see if metformin changes gene transcription in lung cancer cells,” Mr. Medairos said.

Mr. Medairos has no disclosures.

[email protected]

BOSTON – Adults with prediabetes who took part in an intensive lifestyle intervention program at YMCAs across the United States lost weight and spent less on health care over 3 years than did those who did not participate, according to results from a large nationwide study.

The findings, presented at the annual scientific sessions of the American Diabetes Association, represent the first evidence that a lifestyle intervention rolled out on a national scale can result in both clinical benefit – in this case, weight loss – and potential health care savings in people considered at risk for developing type 2 diabetes.

©wragg/iStockphoto.com

Previously, the Diabetes Prevention Program (DPP), a large randomized trial that compared an intensive lifestyle intervention with metformin treatment and placebo, established that focused training in diet, exercise, and behavior modification could result in a sharp reduction of progress to type 2 diabetes (T2D) in at-risk individuals. People randomized to the lifestyle intervention reduced their risk of progressing to T2D by 58% over placebo, compared with 31% for those randomized to metformin (N. Engl. J. Med. 2002;346:393-403).

But the risk reduction was achieved at a high intervention cost, and though smaller studies implementing DPP-like interventions in community health care settings saw meaningful results much more cheaply, questions lingered about cost-effectiveness when such interventions were scaled up, said Dr. Ronald T. Ackermann, director of the Center for Community Health-Institute for Public Health and Medicine and professor of medicine and geriatrics at the Northwestern University in Chicago.

Dr. Ackermann, principal investigator of the new study, presented findings from a nonrandomized “natural experiment” by which commercial health plan enrollees first identified and later clinically confirmed as having prediabetes (n = 11,737) by UnitedHealth Group, a large national insurer, were given the option to participate in the YMCA program at no cost.

Of this cohort with confirmed prediabetes, 4,064 people participated at least once in a diet and physical activity program, adapted from the DPP, involving weekly group counseling meetings lasting at least an hour for the first 4-6 months, then monthly maintenance sessions delivered by YMCA wellness instructors who were trained in the intervention protocol.

During the 3-year study period, participants lost a mean 3.6% of their body weight. Compared with a group of nonparticipating health plan enrollees who were matched for age, sex, comorbidities, metabolic markers including hemoglobin A_1c, and patterns of health care spending, the participants experienced a statistically significant lower rate of health care expenditures over a 3-year period after starting the program. The 3-year sum of total per-person health care expenditures was estimated to be $364 lower for participants than for the matched nonparticipants.

UnitedHealth Group’s coverage policy for this program directs higher payments to the YMCA for participants who attend the program more often and who reach weight goals. No payments were made for enrollees who never attended. On average, UnitedHealth paid the YMCA approximately $234 per person participating. Subtracting this cost from the estimated $364 in reduced health care expenses, “the best estimate is about $129 of savings per person” to the insurer after intervention costs were subtracted, Dr. Ackermann said.

One of the key questions the study hoped to resolve, he noted, was what proportion of high-risk adults would participate in such a program. Some 35% of those encouraged to try the program by their insurer did, and of these, more than 70% were considered highly compliant, with at least nine sessions attended in the first year, he said.

The YMCA offers its diabetes prevention intervention at sites nationwide and currently has about 30,000 participants under various public and private insurance programs, including UnitedHealth, Dr. Ackermann said.

The insurer found the study results “very encouraging” and continues to pay for the program. “If an individual is identified as at risk of diabetes by a primary care doctor or endocrinologist, UnitedHealth will pay for them to take part in the program,” he said.

Dr. Ackermann’s research was carried out under the auspices of the NEXT-D study network, a multi-institution effort investigating population-targeted measures to improve diabetes prevention and outcomes. The Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases fund NEXT-D. Dr. Ackermann disclosed no conflicts of interest.

BOSTON – Adults with prediabetes who took part in an intensive lifestyle intervention program at YMCAs across the United States lost weight and spent less on health care over 3 years than did those who did not participate, according to results from a large nationwide study.

The findings, presented at the annual scientific sessions of the American Diabetes Association, represent the first evidence that a lifestyle intervention rolled out on a national scale can result in both clinical benefit – in this case, weight loss – and potential health care savings in people considered at risk for developing type 2 diabetes.

©wragg/iStockphoto.com

Previously, the Diabetes Prevention Program (DPP), a large randomized trial that compared an intensive lifestyle intervention with metformin treatment and placebo, established that focused training in diet, exercise, and behavior modification could result in a sharp reduction of progress to type 2 diabetes (T2D) in at-risk individuals. People randomized to the lifestyle intervention reduced their risk of progressing to T2D by 58% over placebo, compared with 31% for those randomized to metformin (N. Engl. J. Med. 2002;346:393-403).

But the risk reduction was achieved at a high intervention cost, and though smaller studies implementing DPP-like interventions in community health care settings saw meaningful results much more cheaply, questions lingered about cost-effectiveness when such interventions were scaled up, said Dr. Ronald T. Ackermann, director of the Center for Community Health-Institute for Public Health and Medicine and professor of medicine and geriatrics at the Northwestern University in Chicago.

Dr. Ackermann, principal investigator of the new study, presented findings from a nonrandomized “natural experiment” by which commercial health plan enrollees first identified and later clinically confirmed as having prediabetes (n = 11,737) by UnitedHealth Group, a large national insurer, were given the option to participate in the YMCA program at no cost.

Of this cohort with confirmed prediabetes, 4,064 people participated at least once in a diet and physical activity program, adapted from the DPP, involving weekly group counseling meetings lasting at least an hour for the first 4-6 months, then monthly maintenance sessions delivered by YMCA wellness instructors who were trained in the intervention protocol.

During the 3-year study period, participants lost a mean 3.6% of their body weight. Compared with a group of nonparticipating health plan enrollees who were matched for age, sex, comorbidities, metabolic markers including hemoglobin A_1c, and patterns of health care spending, the participants experienced a statistically significant lower rate of health care expenditures over a 3-year period after starting the program. The 3-year sum of total per-person health care expenditures was estimated to be $364 lower for participants than for the matched nonparticipants.

UnitedHealth Group’s coverage policy for this program directs higher payments to the YMCA for participants who attend the program more often and who reach weight goals. No payments were made for enrollees who never attended. On average, UnitedHealth paid the YMCA approximately $234 per person participating. Subtracting this cost from the estimated $364 in reduced health care expenses, “the best estimate is about $129 of savings per person” to the insurer after intervention costs were subtracted, Dr. Ackermann said.

One of the key questions the study hoped to resolve, he noted, was what proportion of high-risk adults would participate in such a program. Some 35% of those encouraged to try the program by their insurer did, and of these, more than 70% were considered highly compliant, with at least nine sessions attended in the first year, he said.

The YMCA offers its diabetes prevention intervention at sites nationwide and currently has about 30,000 participants under various public and private insurance programs, including UnitedHealth, Dr. Ackermann said.

The insurer found the study results “very encouraging” and continues to pay for the program. “If an individual is identified as at risk of diabetes by a primary care doctor or endocrinologist, UnitedHealth will pay for them to take part in the program,” he said.

Dr. Ackermann’s research was carried out under the auspices of the NEXT-D study network, a multi-institution effort investigating population-targeted measures to improve diabetes prevention and outcomes. The Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases fund NEXT-D. Dr. Ackermann disclosed no conflicts of interest.

BOSTON – Adults with prediabetes who took part in an intensive lifestyle intervention program at YMCAs across the United States lost weight and spent less on health care over 3 years than did those who did not participate, according to results from a large nationwide study.

The findings, presented at the annual scientific sessions of the American Diabetes Association, represent the first evidence that a lifestyle intervention rolled out on a national scale can result in both clinical benefit – in this case, weight loss – and potential health care savings in people considered at risk for developing type 2 diabetes.

©wragg/iStockphoto.com

Previously, the Diabetes Prevention Program (DPP), a large randomized trial that compared an intensive lifestyle intervention with metformin treatment and placebo, established that focused training in diet, exercise, and behavior modification could result in a sharp reduction of progress to type 2 diabetes (T2D) in at-risk individuals. People randomized to the lifestyle intervention reduced their risk of progressing to T2D by 58% over placebo, compared with 31% for those randomized to metformin (N. Engl. J. Med. 2002;346:393-403).

But the risk reduction was achieved at a high intervention cost, and though smaller studies implementing DPP-like interventions in community health care settings saw meaningful results much more cheaply, questions lingered about cost-effectiveness when such interventions were scaled up, said Dr. Ronald T. Ackermann, director of the Center for Community Health-Institute for Public Health and Medicine and professor of medicine and geriatrics at the Northwestern University in Chicago.

Dr. Ackermann, principal investigator of the new study, presented findings from a nonrandomized “natural experiment” by which commercial health plan enrollees first identified and later clinically confirmed as having prediabetes (n = 11,737) by UnitedHealth Group, a large national insurer, were given the option to participate in the YMCA program at no cost.

Of this cohort with confirmed prediabetes, 4,064 people participated at least once in a diet and physical activity program, adapted from the DPP, involving weekly group counseling meetings lasting at least an hour for the first 4-6 months, then monthly maintenance sessions delivered by YMCA wellness instructors who were trained in the intervention protocol.

During the 3-year study period, participants lost a mean 3.6% of their body weight. Compared with a group of nonparticipating health plan enrollees who were matched for age, sex, comorbidities, metabolic markers including hemoglobin A_1c, and patterns of health care spending, the participants experienced a statistically significant lower rate of health care expenditures over a 3-year period after starting the program. The 3-year sum of total per-person health care expenditures was estimated to be $364 lower for participants than for the matched nonparticipants.

UnitedHealth Group’s coverage policy for this program directs higher payments to the YMCA for participants who attend the program more often and who reach weight goals. No payments were made for enrollees who never attended. On average, UnitedHealth paid the YMCA approximately $234 per person participating. Subtracting this cost from the estimated $364 in reduced health care expenses, “the best estimate is about $129 of savings per person” to the insurer after intervention costs were subtracted, Dr. Ackermann said.

One of the key questions the study hoped to resolve, he noted, was what proportion of high-risk adults would participate in such a program. Some 35% of those encouraged to try the program by their insurer did, and of these, more than 70% were considered highly compliant, with at least nine sessions attended in the first year, he said.

The YMCA offers its diabetes prevention intervention at sites nationwide and currently has about 30,000 participants under various public and private insurance programs, including UnitedHealth, Dr. Ackermann said.

The insurer found the study results “very encouraging” and continues to pay for the program. “If an individual is identified as at risk of diabetes by a primary care doctor or endocrinologist, UnitedHealth will pay for them to take part in the program,” he said.

Dr. Ackermann’s research was carried out under the auspices of the NEXT-D study network, a multi-institution effort investigating population-targeted measures to improve diabetes prevention and outcomes. The Centers for Disease Control and Prevention and the National Institute of Diabetes and Digestive and Kidney Diseases fund NEXT-D. Dr. Ackermann disclosed no conflicts of interest.

BOSTON – Eliminating copays on medications to control glucose, blood pressure, and cholesterol as a way to improve medication adherence can result in significant clinical improvements for uninsured low-income patients with chronic disease, including type 2 diabetes, reported John G. Ryan, Dr.P.H., director of research at the University of Miami Health System.

For this cross-sectional, single-site study, Dr. Ryan and his colleagues recruited 154 adults (mean age 55 years, 66% female, 55% black) from a university-affiliated, community outpatient clinic treating mostly uninsured adult patients. Average annual copays per patient were $458 before copays were waived, with a mean 58 prescriptions filled per year.

To qualify for the study, those who were enrolled had to have picked up at least two prescriptions to treat hypertension, diabetes, and/or high blood pressure.

The researchers took baseline hemoglobin A_1c, cholesterol, and blood pressure information from electronic health records within 6 months before study onset. They also used pharmacy data to determine the proportion of days in which patients had medication on hand over the 12-month study period. Patients with medication for 80% of covered days were considered to be adherent.

The investigators then paired clinical data from baseline and 12 months with adherence measures.

In the subset of patients taking diabetes medications for whom HbA_1c measures and paired adherence data were available (n = 47), just over half of diabetes patients were adherent over the course of a year – a proportion in keeping with published medication adherence rates in the general population of patients with type 2 diabetes, Dr. Ryan noted at the annual scientific sessions of the American Diabetes Association. Medication-adherent patients saw mean 6.67% HbA_1c at follow-up, compared with 8.4% for those considered nonadherent (P = .003).

Dr. Ryan noted that the zero-pay study protocol originated as a service to patients before institutional review was sought and the study initiated. This limited the researchers’ ability to collect information from patients on other potential barriers to adherence, such as cognitive impairment and health literacy. The study design “addressed only one external barrier for medication nonadherence: personal finances,” he said. “I would have loved to have barraged these patients with a lot of different patient-oriented measures to try and understand what’s really going on,” he added.

Still, the findings suggest “that, in a minority population such as ours, characterized by poverty, lack of health insurance, with multimorbitity and sometimes severe multimorbidity, medication adherence improved chronic disease outcomes from access to prescription drugs,” Dr. Ryan said.

Many states, including Florida, have substantial numbers of adults with chronic disease who neither qualify for Medicaid under current state rules nor can afford insurance or copayments under the Affordable Care Act.

Dr. Ryan said he had not done a rigorous cost analysis but suspected that, for community clinics receiving funds to treat type 2 diabetes patients, “depending on the cut point of HbA_1c, downriver you might see savings from deferring complications.”

Eliminating copays for uninsured patients “is something that a forward-looking public hospital might want to do if it can absorb short-term costs,” he said.

The study was funded by the University of Miami Health System. Dr. Ryan disclosed no conflicts of interest.

BOSTON – Eliminating copays on medications to control glucose, blood pressure, and cholesterol as a way to improve medication adherence can result in significant clinical improvements for uninsured low-income patients with chronic disease, including type 2 diabetes, reported John G. Ryan, Dr.P.H., director of research at the University of Miami Health System.

For this cross-sectional, single-site study, Dr. Ryan and his colleagues recruited 154 adults (mean age 55 years, 66% female, 55% black) from a university-affiliated, community outpatient clinic treating mostly uninsured adult patients. Average annual copays per patient were $458 before copays were waived, with a mean 58 prescriptions filled per year.

To qualify for the study, those who were enrolled had to have picked up at least two prescriptions to treat hypertension, diabetes, and/or high blood pressure.

The researchers took baseline hemoglobin A_1c, cholesterol, and blood pressure information from electronic health records within 6 months before study onset. They also used pharmacy data to determine the proportion of days in which patients had medication on hand over the 12-month study period. Patients with medication for 80% of covered days were considered to be adherent.

The investigators then paired clinical data from baseline and 12 months with adherence measures.

In the subset of patients taking diabetes medications for whom HbA_1c measures and paired adherence data were available (n = 47), just over half of diabetes patients were adherent over the course of a year – a proportion in keeping with published medication adherence rates in the general population of patients with type 2 diabetes, Dr. Ryan noted at the annual scientific sessions of the American Diabetes Association. Medication-adherent patients saw mean 6.67% HbA_1c at follow-up, compared with 8.4% for those considered nonadherent (P = .003).

Dr. Ryan noted that the zero-pay study protocol originated as a service to patients before institutional review was sought and the study initiated. This limited the researchers’ ability to collect information from patients on other potential barriers to adherence, such as cognitive impairment and health literacy. The study design “addressed only one external barrier for medication nonadherence: personal finances,” he said. “I would have loved to have barraged these patients with a lot of different patient-oriented measures to try and understand what’s really going on,” he added.

Still, the findings suggest “that, in a minority population such as ours, characterized by poverty, lack of health insurance, with multimorbitity and sometimes severe multimorbidity, medication adherence improved chronic disease outcomes from access to prescription drugs,” Dr. Ryan said.

Many states, including Florida, have substantial numbers of adults with chronic disease who neither qualify for Medicaid under current state rules nor can afford insurance or copayments under the Affordable Care Act.

Dr. Ryan said he had not done a rigorous cost analysis but suspected that, for community clinics receiving funds to treat type 2 diabetes patients, “depending on the cut point of HbA_1c, downriver you might see savings from deferring complications.”

Eliminating copays for uninsured patients “is something that a forward-looking public hospital might want to do if it can absorb short-term costs,” he said.

The study was funded by the University of Miami Health System. Dr. Ryan disclosed no conflicts of interest.

BOSTON – Eliminating copays on medications to control glucose, blood pressure, and cholesterol as a way to improve medication adherence can result in significant clinical improvements for uninsured low-income patients with chronic disease, including type 2 diabetes, reported John G. Ryan, Dr.P.H., director of research at the University of Miami Health System.

For this cross-sectional, single-site study, Dr. Ryan and his colleagues recruited 154 adults (mean age 55 years, 66% female, 55% black) from a university-affiliated, community outpatient clinic treating mostly uninsured adult patients. Average annual copays per patient were $458 before copays were waived, with a mean 58 prescriptions filled per year.

To qualify for the study, those who were enrolled had to have picked up at least two prescriptions to treat hypertension, diabetes, and/or high blood pressure.

The researchers took baseline hemoglobin A_1c, cholesterol, and blood pressure information from electronic health records within 6 months before study onset. They also used pharmacy data to determine the proportion of days in which patients had medication on hand over the 12-month study period. Patients with medication for 80% of covered days were considered to be adherent.

The investigators then paired clinical data from baseline and 12 months with adherence measures.

In the subset of patients taking diabetes medications for whom HbA_1c measures and paired adherence data were available (n = 47), just over half of diabetes patients were adherent over the course of a year – a proportion in keeping with published medication adherence rates in the general population of patients with type 2 diabetes, Dr. Ryan noted at the annual scientific sessions of the American Diabetes Association. Medication-adherent patients saw mean 6.67% HbA_1c at follow-up, compared with 8.4% for those considered nonadherent (P = .003).

Dr. Ryan noted that the zero-pay study protocol originated as a service to patients before institutional review was sought and the study initiated. This limited the researchers’ ability to collect information from patients on other potential barriers to adherence, such as cognitive impairment and health literacy. The study design “addressed only one external barrier for medication nonadherence: personal finances,” he said. “I would have loved to have barraged these patients with a lot of different patient-oriented measures to try and understand what’s really going on,” he added.

Still, the findings suggest “that, in a minority population such as ours, characterized by poverty, lack of health insurance, with multimorbitity and sometimes severe multimorbidity, medication adherence improved chronic disease outcomes from access to prescription drugs,” Dr. Ryan said.

Many states, including Florida, have substantial numbers of adults with chronic disease who neither qualify for Medicaid under current state rules nor can afford insurance or copayments under the Affordable Care Act.

Dr. Ryan said he had not done a rigorous cost analysis but suspected that, for community clinics receiving funds to treat type 2 diabetes patients, “depending on the cut point of HbA_1c, downriver you might see savings from deferring complications.”

Eliminating copays for uninsured patients “is something that a forward-looking public hospital might want to do if it can absorb short-term costs,” he said.

The study was funded by the University of Miami Health System. Dr. Ryan disclosed no conflicts of interest.

BOSTON – A mobile health diabetes self-management system improves diabetes knowledge, reminds users to take medications and attend appointments, and helps with health-related goal setting, according to findings in patients who used the system for at least 6 months.

The system – Care4life – is a mobile text, e-mail, app, and web-based system developed by digital health provider Voxiva in collaboration with the American Diabetes Association. It provides individualized education and reminders and can log and track blood glucose, weight, exercise, and blood pressure. Summary reports of progress in meeting treatment goals can be generated and shared with providers who can then help patients in their treatment and self-management decision making.

Milan_Zokic/Thinkstock.com

Of the 10,740 patients who enrolled in the Care4Life system through the ADA’s Living With Type 2 Diabetes Website between July 2013 and December 2014 and who used the system for at least 180 days, 97.7% were still receiving educational content after 6 months. Nearly 76% received that content via e-mail, and 68% received it by text message instead of, or in addition to, e-mail, Dr. Joshua L. Cohen reported at the annual scientific sessions of the American Diabetes Association.

About a quarter of the participants had used the system to set a weight loss goal, and 22% used it to set an exercise goal. About 10% used it for medication reminders, and 31% entered at least one health-related report (such as blood glucose measures, weight, blood pressure, medication compliance, or exercise activity.) About 80% of those who set a weight loss or exercise goal submitted at least one report.

About 10% entered one or more blood glucose reports, and of those, 68% entered a report during the first 30 days of system use, a third did so during days 90-120, and 22% did so at 180 or more days after enrollment.

Of 3,263 participants who completed a survey after 180 days of using the Care4Life system, 89% said the system improved their knowledge of diabetes, and 69% said the system helped them remember to take medications and attend appointments, said Dr. Cohen, professor of medicine at George Washington University, Washington, D.C., as well as director of both the diabetes and thyroid centers there.

Further, 82% of respondents reported that the system helped them set health goals, and about 96% said they would recommend the system to other patients with diabetes, he noted.

“Our patients need to make frequent decisions and choices in their personal management of diabetes. As physicians and health educators, one of our major tasks is to provide support to our patients in their own decision making,” Dr. Cohen said.

Although several randomized controlled trials have evaluated mobile health applications and systems and demonstrated benefit, most have been small studies.

The current study included a much larger patient population and further demonstrated the value of this type of technology, he said, noting that the areas of greatest interest were weight management and exercise.

Of note, although a considerable number of patients were still reporting blood glucose levels after 180 days (and the average levels declined over time), only 1% of participants requested reminders regarding blood pressure.

“The latter I find particularly interesting since, as we are all aware, hypertension is indeed a significant contributor to the morbidity and mortality associated with diabetes, and yet – at least in this patient group – the message may not be getting through about the significance of hypertension,” he said.

Dr. Cohen is on speakers panels for AstraZeneca and Pfizer, and he disclosed that one of his study coauthors has a financial interest in Voxiva.

[email protected]

BOSTON – A mobile health diabetes self-management system improves diabetes knowledge, reminds users to take medications and attend appointments, and helps with health-related goal setting, according to findings in patients who used the system for at least 6 months.

The system – Care4life – is a mobile text, e-mail, app, and web-based system developed by digital health provider Voxiva in collaboration with the American Diabetes Association. It provides individualized education and reminders and can log and track blood glucose, weight, exercise, and blood pressure. Summary reports of progress in meeting treatment goals can be generated and shared with providers who can then help patients in their treatment and self-management decision making.

Milan_Zokic/Thinkstock.com

Of the 10,740 patients who enrolled in the Care4Life system through the ADA’s Living With Type 2 Diabetes Website between July 2013 and December 2014 and who used the system for at least 180 days, 97.7% were still receiving educational content after 6 months. Nearly 76% received that content via e-mail, and 68% received it by text message instead of, or in addition to, e-mail, Dr. Joshua L. Cohen reported at the annual scientific sessions of the American Diabetes Association.

About a quarter of the participants had used the system to set a weight loss goal, and 22% used it to set an exercise goal. About 10% used it for medication reminders, and 31% entered at least one health-related report (such as blood glucose measures, weight, blood pressure, medication compliance, or exercise activity.) About 80% of those who set a weight loss or exercise goal submitted at least one report.

About 10% entered one or more blood glucose reports, and of those, 68% entered a report during the first 30 days of system use, a third did so during days 90-120, and 22% did so at 180 or more days after enrollment.

Of 3,263 participants who completed a survey after 180 days of using the Care4Life system, 89% said the system improved their knowledge of diabetes, and 69% said the system helped them remember to take medications and attend appointments, said Dr. Cohen, professor of medicine at George Washington University, Washington, D.C., as well as director of both the diabetes and thyroid centers there.

Further, 82% of respondents reported that the system helped them set health goals, and about 96% said they would recommend the system to other patients with diabetes, he noted.

“Our patients need to make frequent decisions and choices in their personal management of diabetes. As physicians and health educators, one of our major tasks is to provide support to our patients in their own decision making,” Dr. Cohen said.

Although several randomized controlled trials have evaluated mobile health applications and systems and demonstrated benefit, most have been small studies.

The current study included a much larger patient population and further demonstrated the value of this type of technology, he said, noting that the areas of greatest interest were weight management and exercise.

Of note, although a considerable number of patients were still reporting blood glucose levels after 180 days (and the average levels declined over time), only 1% of participants requested reminders regarding blood pressure.

“The latter I find particularly interesting since, as we are all aware, hypertension is indeed a significant contributor to the morbidity and mortality associated with diabetes, and yet – at least in this patient group – the message may not be getting through about the significance of hypertension,” he said.

Dr. Cohen is on speakers panels for AstraZeneca and Pfizer, and he disclosed that one of his study coauthors has a financial interest in Voxiva.

[email protected]

BOSTON – A mobile health diabetes self-management system improves diabetes knowledge, reminds users to take medications and attend appointments, and helps with health-related goal setting, according to findings in patients who used the system for at least 6 months.

The system – Care4life – is a mobile text, e-mail, app, and web-based system developed by digital health provider Voxiva in collaboration with the American Diabetes Association. It provides individualized education and reminders and can log and track blood glucose, weight, exercise, and blood pressure. Summary reports of progress in meeting treatment goals can be generated and shared with providers who can then help patients in their treatment and self-management decision making.

Milan_Zokic/Thinkstock.com

Of the 10,740 patients who enrolled in the Care4Life system through the ADA’s Living With Type 2 Diabetes Website between July 2013 and December 2014 and who used the system for at least 180 days, 97.7% were still receiving educational content after 6 months. Nearly 76% received that content via e-mail, and 68% received it by text message instead of, or in addition to, e-mail, Dr. Joshua L. Cohen reported at the annual scientific sessions of the American Diabetes Association.

About a quarter of the participants had used the system to set a weight loss goal, and 22% used it to set an exercise goal. About 10% used it for medication reminders, and 31% entered at least one health-related report (such as blood glucose measures, weight, blood pressure, medication compliance, or exercise activity.) About 80% of those who set a weight loss or exercise goal submitted at least one report.

About 10% entered one or more blood glucose reports, and of those, 68% entered a report during the first 30 days of system use, a third did so during days 90-120, and 22% did so at 180 or more days after enrollment.

Of 3,263 participants who completed a survey after 180 days of using the Care4Life system, 89% said the system improved their knowledge of diabetes, and 69% said the system helped them remember to take medications and attend appointments, said Dr. Cohen, professor of medicine at George Washington University, Washington, D.C., as well as director of both the diabetes and thyroid centers there.

Further, 82% of respondents reported that the system helped them set health goals, and about 96% said they would recommend the system to other patients with diabetes, he noted.

“Our patients need to make frequent decisions and choices in their personal management of diabetes. As physicians and health educators, one of our major tasks is to provide support to our patients in their own decision making,” Dr. Cohen said.

Although several randomized controlled trials have evaluated mobile health applications and systems and demonstrated benefit, most have been small studies.

The current study included a much larger patient population and further demonstrated the value of this type of technology, he said, noting that the areas of greatest interest were weight management and exercise.

Of note, although a considerable number of patients were still reporting blood glucose levels after 180 days (and the average levels declined over time), only 1% of participants requested reminders regarding blood pressure.

“The latter I find particularly interesting since, as we are all aware, hypertension is indeed a significant contributor to the morbidity and mortality associated with diabetes, and yet – at least in this patient group – the message may not be getting through about the significance of hypertension,” he said.

Dr. Cohen is on speakers panels for AstraZeneca and Pfizer, and he disclosed that one of his study coauthors has a financial interest in Voxiva.

[email protected]

BOSTON – The ELIXA trial confirms that the GLP-1 receptor agonist lixisenatide neither decreases nor increases the risk of major adverse cardiac events in postacute coronary syndrome patients, and that it improves glucose control, compared with placebo, and provides modest benefits with respect to body weight, blood pressure, progression of albuminuria, and hypoglycemia rates, Dr. Silvio E. Inzucchi said at the annual scientific sessions of the American Diabetes Association.

Particularly encouraging was the lack of any signal for pancreatic injury, thyroid cancer, or heart failure. The latter finding is especially timely given recent concerns raised by DPP-4 inhibitors, said Dr. Inzucchi, who was invited by the ADA to comment on the ELIXA (Evaluation of Lixisenatide in Acute Coronary Syndrome) trial findings.

As for whether the ELIXA trial represents a high-quality study with believable results and an important end point, “the answer to this is a resounding yes,” he said, congratulating the investigators, who “have done a fine job of conducting this study, which represents another example of the great collaboration between diabetologists and cardiologists.”

“We all see the same patients and we need to work more and more together to find out the best treatments for our patients,” he said, noting that finding a glucose-lowering agent that has a clearcut cardiovascular benefit represents the “holy grail.”

The neutral finding, as opposed to a positive one, in ELIXA with respect to effects on cardiovascular outcomes is not surprising, said Dr. Inzucchi, professor of medicine and director of the Yale Diabetes Center at Yale University in New Haven, Conn.

“Hypoglycemia is more tightly linked to micro- than to macrovascular outcomes, so not surprisingly it is much easier to show a benefit on these microvascular complications from controlling blood glucose. Any cardiovascular benefit accrues over many years, outside the time course of most of our randomized clinical trials, and any cardiovascular benefit is likely to be attenuated in those with pre-existing atherosclerosis,” he said.

Although Dr. Inzucchi said that he is skeptical that any of the numerous ongoing cardiovascular outcomes trials (CVOTs) will be able to show such a benefit unless a particular agent shows “some dramatic off-target effect on atherosclerosis,” which is an unlikely outcome since glucose lowering has only a modest effect that is disclosed only after a number of years, he noted. It is “just kind of fun to think that, if one of these CVOTs does turn positive … that drug may potentially be positioned as the favored treatment in addition to metformin. Obviously, it depends on the degree of risk reduction and other effects as well, but only then will we have achieved the holy grail.”

[email protected]

BOSTON – The ELIXA trial confirms that the GLP-1 receptor agonist lixisenatide neither decreases nor increases the risk of major adverse cardiac events in postacute coronary syndrome patients, and that it improves glucose control, compared with placebo, and provides modest benefits with respect to body weight, blood pressure, progression of albuminuria, and hypoglycemia rates, Dr. Silvio E. Inzucchi said at the annual scientific sessions of the American Diabetes Association.

Particularly encouraging was the lack of any signal for pancreatic injury, thyroid cancer, or heart failure. The latter finding is especially timely given recent concerns raised by DPP-4 inhibitors, said Dr. Inzucchi, who was invited by the ADA to comment on the ELIXA (Evaluation of Lixisenatide in Acute Coronary Syndrome) trial findings.

As for whether the ELIXA trial represents a high-quality study with believable results and an important end point, “the answer to this is a resounding yes,” he said, congratulating the investigators, who “have done a fine job of conducting this study, which represents another example of the great collaboration between diabetologists and cardiologists.”

“We all see the same patients and we need to work more and more together to find out the best treatments for our patients,” he said, noting that finding a glucose-lowering agent that has a clearcut cardiovascular benefit represents the “holy grail.”

The neutral finding, as opposed to a positive one, in ELIXA with respect to effects on cardiovascular outcomes is not surprising, said Dr. Inzucchi, professor of medicine and director of the Yale Diabetes Center at Yale University in New Haven, Conn.

“Hypoglycemia is more tightly linked to micro- than to macrovascular outcomes, so not surprisingly it is much easier to show a benefit on these microvascular complications from controlling blood glucose. Any cardiovascular benefit accrues over many years, outside the time course of most of our randomized clinical trials, and any cardiovascular benefit is likely to be attenuated in those with pre-existing atherosclerosis,” he said.

Although Dr. Inzucchi said that he is skeptical that any of the numerous ongoing cardiovascular outcomes trials (CVOTs) will be able to show such a benefit unless a particular agent shows “some dramatic off-target effect on atherosclerosis,” which is an unlikely outcome since glucose lowering has only a modest effect that is disclosed only after a number of years, he noted. It is “just kind of fun to think that, if one of these CVOTs does turn positive … that drug may potentially be positioned as the favored treatment in addition to metformin. Obviously, it depends on the degree of risk reduction and other effects as well, but only then will we have achieved the holy grail.”

[email protected]

BOSTON – The ELIXA trial confirms that the GLP-1 receptor agonist lixisenatide neither decreases nor increases the risk of major adverse cardiac events in postacute coronary syndrome patients, and that it improves glucose control, compared with placebo, and provides modest benefits with respect to body weight, blood pressure, progression of albuminuria, and hypoglycemia rates, Dr. Silvio E. Inzucchi said at the annual scientific sessions of the American Diabetes Association.

Particularly encouraging was the lack of any signal for pancreatic injury, thyroid cancer, or heart failure. The latter finding is especially timely given recent concerns raised by DPP-4 inhibitors, said Dr. Inzucchi, who was invited by the ADA to comment on the ELIXA (Evaluation of Lixisenatide in Acute Coronary Syndrome) trial findings.

As for whether the ELIXA trial represents a high-quality study with believable results and an important end point, “the answer to this is a resounding yes,” he said, congratulating the investigators, who “have done a fine job of conducting this study, which represents another example of the great collaboration between diabetologists and cardiologists.”

“We all see the same patients and we need to work more and more together to find out the best treatments for our patients,” he said, noting that finding a glucose-lowering agent that has a clearcut cardiovascular benefit represents the “holy grail.”

The neutral finding, as opposed to a positive one, in ELIXA with respect to effects on cardiovascular outcomes is not surprising, said Dr. Inzucchi, professor of medicine and director of the Yale Diabetes Center at Yale University in New Haven, Conn.

“Hypoglycemia is more tightly linked to micro- than to macrovascular outcomes, so not surprisingly it is much easier to show a benefit on these microvascular complications from controlling blood glucose. Any cardiovascular benefit accrues over many years, outside the time course of most of our randomized clinical trials, and any cardiovascular benefit is likely to be attenuated in those with pre-existing atherosclerosis,” he said.

Although Dr. Inzucchi said that he is skeptical that any of the numerous ongoing cardiovascular outcomes trials (CVOTs) will be able to show such a benefit unless a particular agent shows “some dramatic off-target effect on atherosclerosis,” which is an unlikely outcome since glucose lowering has only a modest effect that is disclosed only after a number of years, he noted. It is “just kind of fun to think that, if one of these CVOTs does turn positive … that drug may potentially be positioned as the favored treatment in addition to metformin. Obviously, it depends on the degree of risk reduction and other effects as well, but only then will we have achieved the holy grail.”

[email protected]

BOSTON – Findings presented at the annual scientific sessions of the American Diabetes Association showed that one widely used glucose-lowering agent, sitagliptin, was not associated with an increase in major atherosclerotic cardiovascular events or hospitalizations for heart failure, compared with placebo.

Results from TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin) were reassuring to clinicians who consider sitagliptin (Januvia), like other dipeptidyl peptidase-4 (DPP-4) inhibitors, to be a well-tolerated, effective drug not associated with weight gain or hypoglycemia in patients with type 2 diabetes.

The TECOS findings, however, did raise questions about whether sitagliptin was different than other DPP-4 inhibitors in people with known cardiovascular disease.

A randomized controlled trial of saxagliptin (Onglyza) found a 27% increased risk of hospitalization for heart failure, compared with placebo.

A trial of alogliptin (Nesina) saw a numerical imbalance in hospitalizations for heart failure that did not reach statistical significance.

Speaking at the conference after the presentation of the TECOS findings, Dr. Allison B. Goldfine, head of the section of clinical, behavioral, and outcomes research at the Joslin Diabetes Center and of Harvard Medical School, both in Boston, who was not an investigator on any of the three trials, suggested several potential reasons that the signal for heart failure hospitalizations was inconsistent across the trials.

Dr. Goldfine pointed to important differences in trial design and duration. Patients in the alogliptin trial had acute coronary syndrome at baseline and hemoglobin A_1c levels of between 6.5% and 11%, and they were followed up a median of 18 months.

Patients in the saxagliptin trial had either established cardiovascular disease or multiple risk factors for vascular disease, HbA_1c of 6.5%-12%, and were followed 2 years. TECOS patients had a history of coronary artery disease, ischemic cerebrovascular disease, or atherosclerotic peripheral arterial disease, and had an HbA_1c between 6.5% and 8%. They were followed for 3 years.

Dr. Goldfine also noted the potential for differences in activity among the individual agents. “There are some different specificities and the potential for on- and off-target effects across these drugs,” she said, though these remain poorly understood.

“Is it a class effect? Maybe not, as there was no hospitalization for heart failure increase in TECOS,” Dr. Goldfine said. “But I want you to be very cautious in using this interpretation. These were not head-to-head studies, and there were differences in the patient illnesses and severities, comorbidities and concomitant therapies, sample sizes, duration of follow up, and a potential for altered attentiveness and therapeutic practices due to these baseline differences.”

Clinicians considering use of the DPP4 inhibitors “need to realize that there’s some uncertainty when evaluating the risk and benefit of any of our drugs,” she noted.

The TECOS findings will not be the last word on DPP-4 inhibitors and the mixed signals on heart failure seen to date, Dr. Goldfine said. “I think a lot of effort will go on in the very near future to try to understand these better to see if there’s an explanation.”

Dr. Goldfine disclosed past research support from Amneal, LifeScan, Nestle, Novo, and Nordisk.

BOSTON – Findings presented at the annual scientific sessions of the American Diabetes Association showed that one widely used glucose-lowering agent, sitagliptin, was not associated with an increase in major atherosclerotic cardiovascular events or hospitalizations for heart failure, compared with placebo.

Results from TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin) were reassuring to clinicians who consider sitagliptin (Januvia), like other dipeptidyl peptidase-4 (DPP-4) inhibitors, to be a well-tolerated, effective drug not associated with weight gain or hypoglycemia in patients with type 2 diabetes.

The TECOS findings, however, did raise questions about whether sitagliptin was different than other DPP-4 inhibitors in people with known cardiovascular disease.

A randomized controlled trial of saxagliptin (Onglyza) found a 27% increased risk of hospitalization for heart failure, compared with placebo.

A trial of alogliptin (Nesina) saw a numerical imbalance in hospitalizations for heart failure that did not reach statistical significance.

Speaking at the conference after the presentation of the TECOS findings, Dr. Allison B. Goldfine, head of the section of clinical, behavioral, and outcomes research at the Joslin Diabetes Center and of Harvard Medical School, both in Boston, who was not an investigator on any of the three trials, suggested several potential reasons that the signal for heart failure hospitalizations was inconsistent across the trials.

Dr. Goldfine pointed to important differences in trial design and duration. Patients in the alogliptin trial had acute coronary syndrome at baseline and hemoglobin A_1c levels of between 6.5% and 11%, and they were followed up a median of 18 months.

Patients in the saxagliptin trial had either established cardiovascular disease or multiple risk factors for vascular disease, HbA_1c of 6.5%-12%, and were followed 2 years. TECOS patients had a history of coronary artery disease, ischemic cerebrovascular disease, or atherosclerotic peripheral arterial disease, and had an HbA_1c between 6.5% and 8%. They were followed for 3 years.

Dr. Goldfine also noted the potential for differences in activity among the individual agents. “There are some different specificities and the potential for on- and off-target effects across these drugs,” she said, though these remain poorly understood.

“Is it a class effect? Maybe not, as there was no hospitalization for heart failure increase in TECOS,” Dr. Goldfine said. “But I want you to be very cautious in using this interpretation. These were not head-to-head studies, and there were differences in the patient illnesses and severities, comorbidities and concomitant therapies, sample sizes, duration of follow up, and a potential for altered attentiveness and therapeutic practices due to these baseline differences.”

Clinicians considering use of the DPP4 inhibitors “need to realize that there’s some uncertainty when evaluating the risk and benefit of any of our drugs,” she noted.

The TECOS findings will not be the last word on DPP-4 inhibitors and the mixed signals on heart failure seen to date, Dr. Goldfine said. “I think a lot of effort will go on in the very near future to try to understand these better to see if there’s an explanation.”

Dr. Goldfine disclosed past research support from Amneal, LifeScan, Nestle, Novo, and Nordisk.

BOSTON – Findings presented at the annual scientific sessions of the American Diabetes Association showed that one widely used glucose-lowering agent, sitagliptin, was not associated with an increase in major atherosclerotic cardiovascular events or hospitalizations for heart failure, compared with placebo.

Results from TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin) were reassuring to clinicians who consider sitagliptin (Januvia), like other dipeptidyl peptidase-4 (DPP-4) inhibitors, to be a well-tolerated, effective drug not associated with weight gain or hypoglycemia in patients with type 2 diabetes.

The TECOS findings, however, did raise questions about whether sitagliptin was different than other DPP-4 inhibitors in people with known cardiovascular disease.

A randomized controlled trial of saxagliptin (Onglyza) found a 27% increased risk of hospitalization for heart failure, compared with placebo.

A trial of alogliptin (Nesina) saw a numerical imbalance in hospitalizations for heart failure that did not reach statistical significance.

Speaking at the conference after the presentation of the TECOS findings, Dr. Allison B. Goldfine, head of the section of clinical, behavioral, and outcomes research at the Joslin Diabetes Center and of Harvard Medical School, both in Boston, who was not an investigator on any of the three trials, suggested several potential reasons that the signal for heart failure hospitalizations was inconsistent across the trials.

Dr. Goldfine pointed to important differences in trial design and duration. Patients in the alogliptin trial had acute coronary syndrome at baseline and hemoglobin A_1c levels of between 6.5% and 11%, and they were followed up a median of 18 months.

Patients in the saxagliptin trial had either established cardiovascular disease or multiple risk factors for vascular disease, HbA_1c of 6.5%-12%, and were followed 2 years. TECOS patients had a history of coronary artery disease, ischemic cerebrovascular disease, or atherosclerotic peripheral arterial disease, and had an HbA_1c between 6.5% and 8%. They were followed for 3 years.

Dr. Goldfine also noted the potential for differences in activity among the individual agents. “There are some different specificities and the potential for on- and off-target effects across these drugs,” she said, though these remain poorly understood.

“Is it a class effect? Maybe not, as there was no hospitalization for heart failure increase in TECOS,” Dr. Goldfine said. “But I want you to be very cautious in using this interpretation. These were not head-to-head studies, and there were differences in the patient illnesses and severities, comorbidities and concomitant therapies, sample sizes, duration of follow up, and a potential for altered attentiveness and therapeutic practices due to these baseline differences.”

Clinicians considering use of the DPP4 inhibitors “need to realize that there’s some uncertainty when evaluating the risk and benefit of any of our drugs,” she noted.

The TECOS findings will not be the last word on DPP-4 inhibitors and the mixed signals on heart failure seen to date, Dr. Goldfine said. “I think a lot of effort will go on in the very near future to try to understand these better to see if there’s an explanation.”

Dr. Goldfine disclosed past research support from Amneal, LifeScan, Nestle, Novo, and Nordisk.

Food manufacturers will no longer be allowed to include partially hydrogenated oils (PHOs) in human food when a new requirement by the Food and Drug Administration becomes effective.

The FDA finalized its determination that PHOs, which are the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” for use in human food. This action was preceded by the FDA having requested comment on a tentative version of the determination in a Nov. 8, 2013 notice.

©Mark Poprocki/Thinkstockphotos.com

“This determination is based on extensive research into the effects of PHOs, as well as input from all stakeholders received during the public comment period,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition, in a written statement.

The order follows the FDA’s requirement that food manufacturers include trans fat content information on nutrition facts labels, which became effective in 2006. Currently, the FDA allows companies to state on the labels of foods containing less than 0.5 grams of trans fat per serving that such foods are made with 0 grams of trans fat.

The FDA’s new requirement “is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year,” said the FDA’s Acting Commissioner Stephen Ostroff in the written statement.

The agency is giving food producers 3 years to remove PHOs from their products and/or petition the FDA to permit specific uses of PHOs. A notice of the order is scheduled to be published in the Federal Register tomorrow (June 17, 2015).

[email protected]

Food manufacturers will no longer be allowed to include partially hydrogenated oils (PHOs) in human food when a new requirement by the Food and Drug Administration becomes effective.

The FDA finalized its determination that PHOs, which are the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” for use in human food. This action was preceded by the FDA having requested comment on a tentative version of the determination in a Nov. 8, 2013 notice.

©Mark Poprocki/Thinkstockphotos.com

“This determination is based on extensive research into the effects of PHOs, as well as input from all stakeholders received during the public comment period,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition, in a written statement.

The order follows the FDA’s requirement that food manufacturers include trans fat content information on nutrition facts labels, which became effective in 2006. Currently, the FDA allows companies to state on the labels of foods containing less than 0.5 grams of trans fat per serving that such foods are made with 0 grams of trans fat.

The FDA’s new requirement “is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year,” said the FDA’s Acting Commissioner Stephen Ostroff in the written statement.

The agency is giving food producers 3 years to remove PHOs from their products and/or petition the FDA to permit specific uses of PHOs. A notice of the order is scheduled to be published in the Federal Register tomorrow (June 17, 2015).

[email protected]

Food manufacturers will no longer be allowed to include partially hydrogenated oils (PHOs) in human food when a new requirement by the Food and Drug Administration becomes effective.

The FDA finalized its determination that PHOs, which are the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” for use in human food. This action was preceded by the FDA having requested comment on a tentative version of the determination in a Nov. 8, 2013 notice.

©Mark Poprocki/Thinkstockphotos.com

“This determination is based on extensive research into the effects of PHOs, as well as input from all stakeholders received during the public comment period,” said Susan Mayne, Ph.D., director of the FDA’s Center for Food Safety and Applied Nutrition, in a written statement.

The order follows the FDA’s requirement that food manufacturers include trans fat content information on nutrition facts labels, which became effective in 2006. Currently, the FDA allows companies to state on the labels of foods containing less than 0.5 grams of trans fat per serving that such foods are made with 0 grams of trans fat.

The FDA’s new requirement “is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year,” said the FDA’s Acting Commissioner Stephen Ostroff in the written statement.

The agency is giving food producers 3 years to remove PHOs from their products and/or petition the FDA to permit specific uses of PHOs. A notice of the order is scheduled to be published in the Federal Register tomorrow (June 17, 2015).

[email protected]

BOSTON – A family-focused diabetes self-management education program was feasible, well received, and more effective in African American patients with type 2 diabetes who brought along a household family member than among those who participated alone, according to findings from a randomized study.

In 21 participants who were randomized to attend the diabetes self-management education (DSME) program with a household family member or companion (HFMC), and who completed the study, significant reductions were seen at 3 months in body mass index, blood pressure, and cholesterol levels, but the same was not true among 27 participants who attended alone, Natasha Greene, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

BMI among those who brought an HFMC was reduced from 37.4 to 36.6, while those who attended alone experienced a reduction from 36 to 35.7. Mean systolic blood pressure was reduced from 154.2 mm Hg to 139.5 mm Hg, and from 146.3 mm Hg to 140.2 mm Hg in the groups, respectively. Mean diastolic blood pressure was reduced from 75 mm Hg to 69 mm Hg, and increased from 72.2 mm Hg to 73.5 mm Hg in the groups, respectively, said Dr. Greene of North Carolina Central University, Durham.

Mean total cholesterol was reduced from 175.7 mg/dL to 164.1 mg/dL, and increased from 167.2 mg/dL to 171.3 mg/dL and low density lipoprotein cholesterol was reduced from 106 mg/dL to 96.3 mg/dL, and increased from 95 mg/dL to 99 mg/dL in the groups, respectively, she said, noting that hemoglobin A1c levels improved, but not significantly, in either group.

“DSME interventions have drastically increased over the last 10 years. Most interventions have been successful, but statistically significant outcomes either weakened after 6-12 months or completely disappeared,” Dr. Greene said, adding that it is “therefore essential to develop some interventions that have sustainable outcomes, especially in African Americans.”

African Americans continue to experience higher rates of diabetes prevalence, complications, and premature age-adjusted deaths, compared with non-Hispanic European Americans, she explained.

“Moreover, African Americans report difficulty following recommendations because the regimens interfere with work, family life, beliefs, family food preferences, and the socialization of the African Americans within their environment,” she said.

The DSME program developed for this study thus focused on family interactions within the African American family in the context of health and nutrition. The curriculum was conceptually based on the family interaction theory, “loose adaptation” of a number of published curricula, and the clinical experiences of the investigators, including a family nurse practitioner, a family psychologist, and a licensed dietitian, Dr. Greene noted.

Four community lay persons and two dietitians were trained to implement the intervention, which included three classes related to diabetes, one on exercise, and four related to nutrition; all classes addressed family interactions, including communication, problem solving, and negotiation skills that would encourage a goal of health behaviors for the entire family.

Patients who participated were over age 40 years (mean of 58.9 years), and had been diagnosed at least 1 year prior to the program. Those in the experimental group were encouraged to select an HFMC who influenced the household diet and other health-related behaviors, and the experimental and control group participants did not differ significantly with respect to any baseline variables.

Classes lasted 1.5 hours each week for 8 weeks, and were held at local community churches; 70% of those in the experimental group and 81% in the control group attended at least six of the eight classes.

The trainers had high “intervention fidelity,” completing the class objectives 90% of the time, and they reported high satisfaction and ease with program implementation. Participants thought the intervention was fun, Dr. Greene said. “Their retention and attendance showed it,” she said, noting that 92% of those enrolled completed the study.

Further, participants consistently rated the program as highly acceptable, either agreeing or strongly agreeing that each class had content that was understandable, useful, and informative, and that the trainer was knowledgeable and the class was interactive.

The program was successful and unique in that it taught participants to think about healthy behaviors and improve communication and negotiation at home, Dr. Greene said.

“We incorporated the family and their interpersonal interactions into the intervention by asking them to think about it and work it out in favor of a healthy change for all,” she said, noting that future studies should investigate sustainability of the program in a larger sample and the possibility of increasing the intervention strength through goal-setting and numerous other measures at the end of each class.

The National Institutes of Health–National Institute on Minority and Health Disparities supported the study.

[email protected]

BOSTON – A family-focused diabetes self-management education program was feasible, well received, and more effective in African American patients with type 2 diabetes who brought along a household family member than among those who participated alone, according to findings from a randomized study.

In 21 participants who were randomized to attend the diabetes self-management education (DSME) program with a household family member or companion (HFMC), and who completed the study, significant reductions were seen at 3 months in body mass index, blood pressure, and cholesterol levels, but the same was not true among 27 participants who attended alone, Natasha Greene, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

BMI among those who brought an HFMC was reduced from 37.4 to 36.6, while those who attended alone experienced a reduction from 36 to 35.7. Mean systolic blood pressure was reduced from 154.2 mm Hg to 139.5 mm Hg, and from 146.3 mm Hg to 140.2 mm Hg in the groups, respectively. Mean diastolic blood pressure was reduced from 75 mm Hg to 69 mm Hg, and increased from 72.2 mm Hg to 73.5 mm Hg in the groups, respectively, said Dr. Greene of North Carolina Central University, Durham.

Mean total cholesterol was reduced from 175.7 mg/dL to 164.1 mg/dL, and increased from 167.2 mg/dL to 171.3 mg/dL and low density lipoprotein cholesterol was reduced from 106 mg/dL to 96.3 mg/dL, and increased from 95 mg/dL to 99 mg/dL in the groups, respectively, she said, noting that hemoglobin A1c levels improved, but not significantly, in either group.

“DSME interventions have drastically increased over the last 10 years. Most interventions have been successful, but statistically significant outcomes either weakened after 6-12 months or completely disappeared,” Dr. Greene said, adding that it is “therefore essential to develop some interventions that have sustainable outcomes, especially in African Americans.”

African Americans continue to experience higher rates of diabetes prevalence, complications, and premature age-adjusted deaths, compared with non-Hispanic European Americans, she explained.

“Moreover, African Americans report difficulty following recommendations because the regimens interfere with work, family life, beliefs, family food preferences, and the socialization of the African Americans within their environment,” she said.

The DSME program developed for this study thus focused on family interactions within the African American family in the context of health and nutrition. The curriculum was conceptually based on the family interaction theory, “loose adaptation” of a number of published curricula, and the clinical experiences of the investigators, including a family nurse practitioner, a family psychologist, and a licensed dietitian, Dr. Greene noted.

Four community lay persons and two dietitians were trained to implement the intervention, which included three classes related to diabetes, one on exercise, and four related to nutrition; all classes addressed family interactions, including communication, problem solving, and negotiation skills that would encourage a goal of health behaviors for the entire family.

Patients who participated were over age 40 years (mean of 58.9 years), and had been diagnosed at least 1 year prior to the program. Those in the experimental group were encouraged to select an HFMC who influenced the household diet and other health-related behaviors, and the experimental and control group participants did not differ significantly with respect to any baseline variables.

Classes lasted 1.5 hours each week for 8 weeks, and were held at local community churches; 70% of those in the experimental group and 81% in the control group attended at least six of the eight classes.

The trainers had high “intervention fidelity,” completing the class objectives 90% of the time, and they reported high satisfaction and ease with program implementation. Participants thought the intervention was fun, Dr. Greene said. “Their retention and attendance showed it,” she said, noting that 92% of those enrolled completed the study.

Further, participants consistently rated the program as highly acceptable, either agreeing or strongly agreeing that each class had content that was understandable, useful, and informative, and that the trainer was knowledgeable and the class was interactive.

The program was successful and unique in that it taught participants to think about healthy behaviors and improve communication and negotiation at home, Dr. Greene said.

“We incorporated the family and their interpersonal interactions into the intervention by asking them to think about it and work it out in favor of a healthy change for all,” she said, noting that future studies should investigate sustainability of the program in a larger sample and the possibility of increasing the intervention strength through goal-setting and numerous other measures at the end of each class.

The National Institutes of Health–National Institute on Minority and Health Disparities supported the study.

[email protected]

BOSTON – A family-focused diabetes self-management education program was feasible, well received, and more effective in African American patients with type 2 diabetes who brought along a household family member than among those who participated alone, according to findings from a randomized study.

In 21 participants who were randomized to attend the diabetes self-management education (DSME) program with a household family member or companion (HFMC), and who completed the study, significant reductions were seen at 3 months in body mass index, blood pressure, and cholesterol levels, but the same was not true among 27 participants who attended alone, Natasha Greene, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

BMI among those who brought an HFMC was reduced from 37.4 to 36.6, while those who attended alone experienced a reduction from 36 to 35.7. Mean systolic blood pressure was reduced from 154.2 mm Hg to 139.5 mm Hg, and from 146.3 mm Hg to 140.2 mm Hg in the groups, respectively. Mean diastolic blood pressure was reduced from 75 mm Hg to 69 mm Hg, and increased from 72.2 mm Hg to 73.5 mm Hg in the groups, respectively, said Dr. Greene of North Carolina Central University, Durham.

Mean total cholesterol was reduced from 175.7 mg/dL to 164.1 mg/dL, and increased from 167.2 mg/dL to 171.3 mg/dL and low density lipoprotein cholesterol was reduced from 106 mg/dL to 96.3 mg/dL, and increased from 95 mg/dL to 99 mg/dL in the groups, respectively, she said, noting that hemoglobin A1c levels improved, but not significantly, in either group.

“DSME interventions have drastically increased over the last 10 years. Most interventions have been successful, but statistically significant outcomes either weakened after 6-12 months or completely disappeared,” Dr. Greene said, adding that it is “therefore essential to develop some interventions that have sustainable outcomes, especially in African Americans.”

African Americans continue to experience higher rates of diabetes prevalence, complications, and premature age-adjusted deaths, compared with non-Hispanic European Americans, she explained.

“Moreover, African Americans report difficulty following recommendations because the regimens interfere with work, family life, beliefs, family food preferences, and the socialization of the African Americans within their environment,” she said.

The DSME program developed for this study thus focused on family interactions within the African American family in the context of health and nutrition. The curriculum was conceptually based on the family interaction theory, “loose adaptation” of a number of published curricula, and the clinical experiences of the investigators, including a family nurse practitioner, a family psychologist, and a licensed dietitian, Dr. Greene noted.

Four community lay persons and two dietitians were trained to implement the intervention, which included three classes related to diabetes, one on exercise, and four related to nutrition; all classes addressed family interactions, including communication, problem solving, and negotiation skills that would encourage a goal of health behaviors for the entire family.

Patients who participated were over age 40 years (mean of 58.9 years), and had been diagnosed at least 1 year prior to the program. Those in the experimental group were encouraged to select an HFMC who influenced the household diet and other health-related behaviors, and the experimental and control group participants did not differ significantly with respect to any baseline variables.

Classes lasted 1.5 hours each week for 8 weeks, and were held at local community churches; 70% of those in the experimental group and 81% in the control group attended at least six of the eight classes.

The trainers had high “intervention fidelity,” completing the class objectives 90% of the time, and they reported high satisfaction and ease with program implementation. Participants thought the intervention was fun, Dr. Greene said. “Their retention and attendance showed it,” she said, noting that 92% of those enrolled completed the study.

Further, participants consistently rated the program as highly acceptable, either agreeing or strongly agreeing that each class had content that was understandable, useful, and informative, and that the trainer was knowledgeable and the class was interactive.

The program was successful and unique in that it taught participants to think about healthy behaviors and improve communication and negotiation at home, Dr. Greene said.

“We incorporated the family and their interpersonal interactions into the intervention by asking them to think about it and work it out in favor of a healthy change for all,” she said, noting that future studies should investigate sustainability of the program in a larger sample and the possibility of increasing the intervention strength through goal-setting and numerous other measures at the end of each class.

The National Institutes of Health–National Institute on Minority and Health Disparities supported the study.

[email protected]

BOSTON – Adding a dipeptidyl peptidase-4 (DPP-4) inhibitor to metformin in patients with type 2 diabetes was associated with an increased, earlier need for treatment intensification, compared with adding a sulfonylurea in a large, retrospective, population-based study in the United Kingdom.

Conversely, adding a thiazolidinedione as a second-line glucose-lowering agent resulted in the most durable glycemic response, Jil Mamza reported at the annual scientific sessions of the American Diabetes Association.

Unadjusted survival analysis showed that 23% of 3,080 patients treated with second-line DDP-4 agents experienced treatment failure at 1 year, compared with 15% of 15,508 on a sulfonylurea, and 8% of 1,582 on a thiazolidinedione. The corresponding failure rates at 2 years were 38%, 26% and 12%, said Mr. Mamza, a clinical researcher and doctoral student at the University of Nottingham, Derby, England.

After multivariate adjustment, adding a DPP-4 inhibitor was associated with an increased hazard of intensification of therapy (adjusted hazard ratio, 1.58), while adding a thiazolidinedione was associated with a reduced hazard (adjusted HR, 0.45).

Several baseline factors were also shown to be associated an increased hazard of intensification, including hemoglobin A_1c level, diabetes duration, gender, smoking status, and the use of lipid-lowering medications, he said.

Patients included in this study were adults with a mean age of 60 years and a mean disease duration of 3 years from the The Health Initiative Network (THIN) database of United Kingdom general practice patients. All those included had added a second oral glucose lowering therapy (GLT) to metformin between 2007 and 2014.

Time to dual therapy failure was defined as time to treatment substitution or intensification with a third agent at an HbA_1c level greater than 58 mmol/mol.

The durability of glycemic response for different second-line treatments was previously unclear. These findings suggest that DPP-4 agents provide the least durable response, compared with sulfonylureas and thiazolidinediones as second-line GLTs, Dr. Mamza said.

Mr. Mamza reported having no disclosures.

[email protected]

BOSTON – Adding a dipeptidyl peptidase-4 (DPP-4) inhibitor to metformin in patients with type 2 diabetes was associated with an increased, earlier need for treatment intensification, compared with adding a sulfonylurea in a large, retrospective, population-based study in the United Kingdom.

Conversely, adding a thiazolidinedione as a second-line glucose-lowering agent resulted in the most durable glycemic response, Jil Mamza reported at the annual scientific sessions of the American Diabetes Association.

Unadjusted survival analysis showed that 23% of 3,080 patients treated with second-line DDP-4 agents experienced treatment failure at 1 year, compared with 15% of 15,508 on a sulfonylurea, and 8% of 1,582 on a thiazolidinedione. The corresponding failure rates at 2 years were 38%, 26% and 12%, said Mr. Mamza, a clinical researcher and doctoral student at the University of Nottingham, Derby, England.

After multivariate adjustment, adding a DPP-4 inhibitor was associated with an increased hazard of intensification of therapy (adjusted hazard ratio, 1.58), while adding a thiazolidinedione was associated with a reduced hazard (adjusted HR, 0.45).

Several baseline factors were also shown to be associated an increased hazard of intensification, including hemoglobin A_1c level, diabetes duration, gender, smoking status, and the use of lipid-lowering medications, he said.

Patients included in this study were adults with a mean age of 60 years and a mean disease duration of 3 years from the The Health Initiative Network (THIN) database of United Kingdom general practice patients. All those included had added a second oral glucose lowering therapy (GLT) to metformin between 2007 and 2014.

Time to dual therapy failure was defined as time to treatment substitution or intensification with a third agent at an HbA_1c level greater than 58 mmol/mol.

The durability of glycemic response for different second-line treatments was previously unclear. These findings suggest that DPP-4 agents provide the least durable response, compared with sulfonylureas and thiazolidinediones as second-line GLTs, Dr. Mamza said.

Mr. Mamza reported having no disclosures.

[email protected]

BOSTON – Adding a dipeptidyl peptidase-4 (DPP-4) inhibitor to metformin in patients with type 2 diabetes was associated with an increased, earlier need for treatment intensification, compared with adding a sulfonylurea in a large, retrospective, population-based study in the United Kingdom.

Conversely, adding a thiazolidinedione as a second-line glucose-lowering agent resulted in the most durable glycemic response, Jil Mamza reported at the annual scientific sessions of the American Diabetes Association.

Unadjusted survival analysis showed that 23% of 3,080 patients treated with second-line DDP-4 agents experienced treatment failure at 1 year, compared with 15% of 15,508 on a sulfonylurea, and 8% of 1,582 on a thiazolidinedione. The corresponding failure rates at 2 years were 38%, 26% and 12%, said Mr. Mamza, a clinical researcher and doctoral student at the University of Nottingham, Derby, England.

After multivariate adjustment, adding a DPP-4 inhibitor was associated with an increased hazard of intensification of therapy (adjusted hazard ratio, 1.58), while adding a thiazolidinedione was associated with a reduced hazard (adjusted HR, 0.45).

Several baseline factors were also shown to be associated an increased hazard of intensification, including hemoglobin A_1c level, diabetes duration, gender, smoking status, and the use of lipid-lowering medications, he said.

Patients included in this study were adults with a mean age of 60 years and a mean disease duration of 3 years from the The Health Initiative Network (THIN) database of United Kingdom general practice patients. All those included had added a second oral glucose lowering therapy (GLT) to metformin between 2007 and 2014.

Time to dual therapy failure was defined as time to treatment substitution or intensification with a third agent at an HbA_1c level greater than 58 mmol/mol.

The durability of glycemic response for different second-line treatments was previously unclear. These findings suggest that DPP-4 agents provide the least durable response, compared with sulfonylureas and thiazolidinediones as second-line GLTs, Dr. Mamza said.

Mr. Mamza reported having no disclosures.

[email protected]

BOSTON – Maintaining or improving cardiorespiratory fitness during the year following an intensive lifestyle intervention contributed to the prevention of advanced chronic kidney disease over 4 years among participants in Look AHEAD, according to findings from a substudy of that randomized clinical trial.

During the first 4 years of follow-up in 4,906 of the 5,145 original study subjects, the incidence of advanced chronic kidney disease – after adjustment for age, race, ethnicity, and disease-related baseline covariates – was reduced by nearly 60% in those who received the intervention in the original study, compared with those who received diabetes support and education (hazard ratio, 0.59), Dr. Margareta I. Hellgren reported at the annual scientific sessions of the American Diabetes Association.

At 1-year follow-up, fitness level was unchanged in 77% of the lifestyle intervention group patients, compared with 58% of those in the diabetes support and education group, and in a model that used the same covariates, plus 1-year fitness change, and which included annually updated weight, blood pressure, and hemoglobin A1c, both intervention group participation and unchanged or improved fitness predicted lower incidence of advanced CKD over 4 years (HR, 0.69, 0.49, respectively), said Dr. Hellgren of the University of Gothenburg, Sweden.

The multicenter Look AHEAD trial included overweight adults with type 2 diabetes who were followed for about 10 years. The findings, which were published in 2013, showed no difference between intensive lifestyle intervention – including physical activity and reduced calorie intake – and diabetes support and education for reducing the incidence of cardiovascular events (the primary outcome measure), but did demonstrate a benefit with intensive lifestyle intervention for a number of secondary outcomes, including nephropathy.

A secondary analysis published in The Lancet in 2014 showed that the incidence of advanced kidney disease was reduced by 31% over 8 years in those in the intervention group, compared with those in the diabetes care and intervention group – an effect that was partly attributable to reductions in body weight, HbA1c, and systolic blood pressure, she noted.

The outcome of the current substudy was very high risk kidney disease (classified according to the Kidney Disease Improving Global Outcomes Guidelines), which is an important cause of disability and high costs and is associated with high mortality, Dr. Hellgren said.

Study subjects had a mean age of 58.6 years at baseline, 59% were women, and 66% were non-Hispanic whites. Known diabetes duration was 6.7 years.

Fitness assessment was based on estimated metabolic equivalents (METs) during a graded treadmill exercise test at baseline and at 1 year. A significant association was seen between baseline fitness and class of chronic kidney disease, Dr. Hellgren said, noting that 31% of those with the lowest fitness level had abnormal kidney function, compared with 14% of those with the highest level.

“Physical fitness at baseline was positively associated with kidney function. Maintaining or improving fitness during the first year was associated with lower incidence of very high risk kidney disease in both intervention groups, with a 51% reduction overall,” she said, adding that the lifestyle intervention effect was only partially attenuated after accounting for fitness change and annually updated wight, blood pressure, and HbA1c, which suggests that an additional unknown mechanism is responsible for the benefits of intervention.

The National Institute of Diabetes and Digestive and Kidney Diseases sponsored Look AHEAD. Dr. Hellgren reported having no disclosures.

[email protected]

BOSTON – Maintaining or improving cardiorespiratory fitness during the year following an intensive lifestyle intervention contributed to the prevention of advanced chronic kidney disease over 4 years among participants in Look AHEAD, according to findings from a substudy of that randomized clinical trial.

During the first 4 years of follow-up in 4,906 of the 5,145 original study subjects, the incidence of advanced chronic kidney disease – after adjustment for age, race, ethnicity, and disease-related baseline covariates – was reduced by nearly 60% in those who received the intervention in the original study, compared with those who received diabetes support and education (hazard ratio, 0.59), Dr. Margareta I. Hellgren reported at the annual scientific sessions of the American Diabetes Association.

At 1-year follow-up, fitness level was unchanged in 77% of the lifestyle intervention group patients, compared with 58% of those in the diabetes support and education group, and in a model that used the same covariates, plus 1-year fitness change, and which included annually updated weight, blood pressure, and hemoglobin A1c, both intervention group participation and unchanged or improved fitness predicted lower incidence of advanced CKD over 4 years (HR, 0.69, 0.49, respectively), said Dr. Hellgren of the University of Gothenburg, Sweden.

The multicenter Look AHEAD trial included overweight adults with type 2 diabetes who were followed for about 10 years. The findings, which were published in 2013, showed no difference between intensive lifestyle intervention – including physical activity and reduced calorie intake – and diabetes support and education for reducing the incidence of cardiovascular events (the primary outcome measure), but did demonstrate a benefit with intensive lifestyle intervention for a number of secondary outcomes, including nephropathy.

A secondary analysis published in The Lancet in 2014 showed that the incidence of advanced kidney disease was reduced by 31% over 8 years in those in the intervention group, compared with those in the diabetes care and intervention group – an effect that was partly attributable to reductions in body weight, HbA1c, and systolic blood pressure, she noted.

The outcome of the current substudy was very high risk kidney disease (classified according to the Kidney Disease Improving Global Outcomes Guidelines), which is an important cause of disability and high costs and is associated with high mortality, Dr. Hellgren said.

Study subjects had a mean age of 58.6 years at baseline, 59% were women, and 66% were non-Hispanic whites. Known diabetes duration was 6.7 years.

Fitness assessment was based on estimated metabolic equivalents (METs) during a graded treadmill exercise test at baseline and at 1 year. A significant association was seen between baseline fitness and class of chronic kidney disease, Dr. Hellgren said, noting that 31% of those with the lowest fitness level had abnormal kidney function, compared with 14% of those with the highest level.

“Physical fitness at baseline was positively associated with kidney function. Maintaining or improving fitness during the first year was associated with lower incidence of very high risk kidney disease in both intervention groups, with a 51% reduction overall,” she said, adding that the lifestyle intervention effect was only partially attenuated after accounting for fitness change and annually updated wight, blood pressure, and HbA1c, which suggests that an additional unknown mechanism is responsible for the benefits of intervention.

The National Institute of Diabetes and Digestive and Kidney Diseases sponsored Look AHEAD. Dr. Hellgren reported having no disclosures.

[email protected]

BOSTON – Maintaining or improving cardiorespiratory fitness during the year following an intensive lifestyle intervention contributed to the prevention of advanced chronic kidney disease over 4 years among participants in Look AHEAD, according to findings from a substudy of that randomized clinical trial.

During the first 4 years of follow-up in 4,906 of the 5,145 original study subjects, the incidence of advanced chronic kidney disease – after adjustment for age, race, ethnicity, and disease-related baseline covariates – was reduced by nearly 60% in those who received the intervention in the original study, compared with those who received diabetes support and education (hazard ratio, 0.59), Dr. Margareta I. Hellgren reported at the annual scientific sessions of the American Diabetes Association.

At 1-year follow-up, fitness level was unchanged in 77% of the lifestyle intervention group patients, compared with 58% of those in the diabetes support and education group, and in a model that used the same covariates, plus 1-year fitness change, and which included annually updated weight, blood pressure, and hemoglobin A1c, both intervention group participation and unchanged or improved fitness predicted lower incidence of advanced CKD over 4 years (HR, 0.69, 0.49, respectively), said Dr. Hellgren of the University of Gothenburg, Sweden.

The multicenter Look AHEAD trial included overweight adults with type 2 diabetes who were followed for about 10 years. The findings, which were published in 2013, showed no difference between intensive lifestyle intervention – including physical activity and reduced calorie intake – and diabetes support and education for reducing the incidence of cardiovascular events (the primary outcome measure), but did demonstrate a benefit with intensive lifestyle intervention for a number of secondary outcomes, including nephropathy.

A secondary analysis published in The Lancet in 2014 showed that the incidence of advanced kidney disease was reduced by 31% over 8 years in those in the intervention group, compared with those in the diabetes care and intervention group – an effect that was partly attributable to reductions in body weight, HbA1c, and systolic blood pressure, she noted.

The outcome of the current substudy was very high risk kidney disease (classified according to the Kidney Disease Improving Global Outcomes Guidelines), which is an important cause of disability and high costs and is associated with high mortality, Dr. Hellgren said.

Study subjects had a mean age of 58.6 years at baseline, 59% were women, and 66% were non-Hispanic whites. Known diabetes duration was 6.7 years.

Fitness assessment was based on estimated metabolic equivalents (METs) during a graded treadmill exercise test at baseline and at 1 year. A significant association was seen between baseline fitness and class of chronic kidney disease, Dr. Hellgren said, noting that 31% of those with the lowest fitness level had abnormal kidney function, compared with 14% of those with the highest level.

“Physical fitness at baseline was positively associated with kidney function. Maintaining or improving fitness during the first year was associated with lower incidence of very high risk kidney disease in both intervention groups, with a 51% reduction overall,” she said, adding that the lifestyle intervention effect was only partially attenuated after accounting for fitness change and annually updated wight, blood pressure, and HbA1c, which suggests that an additional unknown mechanism is responsible for the benefits of intervention.

The National Institute of Diabetes and Digestive and Kidney Diseases sponsored Look AHEAD. Dr. Hellgren reported having no disclosures.

[email protected]