Mary Ann Moon

For patients with type 1 diabetes who received 6.5 years of intensive therapy in the late 1980s and early 1990s, all-cause mortality decades later was modestly lower than that for patients who had received usual diabetes therapy, according to a report published online Jan. 6 in JAMA.

Intensive diabetes therapy was shown to prevent renal and cardiovascular complications in the Diabetes Control and Complications Trial (DCCT) in 1983-1993 and its successor, the Epidemiology of Diabetes Interventions and Complications (EDIC) follow-up trial in 1994-2012. The intensive approach became the recommended standard of care, but it was never determined whether a period of intensive therapy improved mortality outcomes, while other studies have reported that it does not. In particular, hypoglycemia is more frequent with intensive therapy and may contribute to car accidents and other trauma that raises mortality risk, said Dr. Trevor J. Orchard of the University of Pittsburgh, chair of the DCCT/EDIC writing group, and his associates.

They assessed mortality outcomes in an extended follow-up study involving 711 of the DCCT/EDIC participants who had received intensive diabetes therapy and 730 who had received conventional diabetes therapy an average of 27 years earlier. During the treatment phase of the DCCT, patients given intensive therapy achieved a mean hemoglobin A_1c level of 7% and those given usual therapy achieved a mean HbA_1c level of 9%; however, this benefit soon disappeared during follow-up, most likely because many patients found it difficult to maintain intensive therapy on their own, Dr. Orchard and his associates said (JAMA 2015 Jan. 6 [doi:10.1001/jama.2014.16107]). At the present extended follow-up, there were 43 deaths (6.0%) in the intensive-therapy group and 64 (8.8%) in the usual-therapy group. Mortality per 100,000 patient-years was modestly lower in the intensive-therapy group, with a hazard ratio of 0.67. The absolute risk reduction was “small,” at about 1 death per 1,000 patient-years, the researchers noted.

The slightly lower mortality with intensive therapy was consistent across all causes of death except for the category of accident/suicide. A history of severe hypoglycemia was associated with greater mortality (HR, 1.63), but none of the accidental or suicidal deaths in this study were clearly associated with hypoglycemia. And the small numbers of accidental and suicidal deaths (13 in the intensive group and 5 in the conventional group) “preclude any definitive conclusions” regarding intensive therapy’s potential to raise mortality risk through this mechanism, the investigators said.

The DCCT/EDIC study established that tight glycemic control reduces microvascular and macrovascular complications, “and we now show its association with subsequent mortality. Although the numbers are small, there were fewer diabetic renal deaths (1 vs. 6) and cardiovascular deaths (9 vs. 15) with intensive compared with conventional therapy, causes for which glycemia might be expected to play a major role,” they added.

For patients with type 1 diabetes who received 6.5 years of intensive therapy in the late 1980s and early 1990s, all-cause mortality decades later was modestly lower than that for patients who had received usual diabetes therapy, according to a report published online Jan. 6 in JAMA.

Intensive diabetes therapy was shown to prevent renal and cardiovascular complications in the Diabetes Control and Complications Trial (DCCT) in 1983-1993 and its successor, the Epidemiology of Diabetes Interventions and Complications (EDIC) follow-up trial in 1994-2012. The intensive approach became the recommended standard of care, but it was never determined whether a period of intensive therapy improved mortality outcomes, while other studies have reported that it does not. In particular, hypoglycemia is more frequent with intensive therapy and may contribute to car accidents and other trauma that raises mortality risk, said Dr. Trevor J. Orchard of the University of Pittsburgh, chair of the DCCT/EDIC writing group, and his associates.

They assessed mortality outcomes in an extended follow-up study involving 711 of the DCCT/EDIC participants who had received intensive diabetes therapy and 730 who had received conventional diabetes therapy an average of 27 years earlier. During the treatment phase of the DCCT, patients given intensive therapy achieved a mean hemoglobin A_1c level of 7% and those given usual therapy achieved a mean HbA_1c level of 9%; however, this benefit soon disappeared during follow-up, most likely because many patients found it difficult to maintain intensive therapy on their own, Dr. Orchard and his associates said (JAMA 2015 Jan. 6 [doi:10.1001/jama.2014.16107]). At the present extended follow-up, there were 43 deaths (6.0%) in the intensive-therapy group and 64 (8.8%) in the usual-therapy group. Mortality per 100,000 patient-years was modestly lower in the intensive-therapy group, with a hazard ratio of 0.67. The absolute risk reduction was “small,” at about 1 death per 1,000 patient-years, the researchers noted.

The slightly lower mortality with intensive therapy was consistent across all causes of death except for the category of accident/suicide. A history of severe hypoglycemia was associated with greater mortality (HR, 1.63), but none of the accidental or suicidal deaths in this study were clearly associated with hypoglycemia. And the small numbers of accidental and suicidal deaths (13 in the intensive group and 5 in the conventional group) “preclude any definitive conclusions” regarding intensive therapy’s potential to raise mortality risk through this mechanism, the investigators said.

The DCCT/EDIC study established that tight glycemic control reduces microvascular and macrovascular complications, “and we now show its association with subsequent mortality. Although the numbers are small, there were fewer diabetic renal deaths (1 vs. 6) and cardiovascular deaths (9 vs. 15) with intensive compared with conventional therapy, causes for which glycemia might be expected to play a major role,” they added.

For patients with type 1 diabetes who received 6.5 years of intensive therapy in the late 1980s and early 1990s, all-cause mortality decades later was modestly lower than that for patients who had received usual diabetes therapy, according to a report published online Jan. 6 in JAMA.

Intensive diabetes therapy was shown to prevent renal and cardiovascular complications in the Diabetes Control and Complications Trial (DCCT) in 1983-1993 and its successor, the Epidemiology of Diabetes Interventions and Complications (EDIC) follow-up trial in 1994-2012. The intensive approach became the recommended standard of care, but it was never determined whether a period of intensive therapy improved mortality outcomes, while other studies have reported that it does not. In particular, hypoglycemia is more frequent with intensive therapy and may contribute to car accidents and other trauma that raises mortality risk, said Dr. Trevor J. Orchard of the University of Pittsburgh, chair of the DCCT/EDIC writing group, and his associates.

They assessed mortality outcomes in an extended follow-up study involving 711 of the DCCT/EDIC participants who had received intensive diabetes therapy and 730 who had received conventional diabetes therapy an average of 27 years earlier. During the treatment phase of the DCCT, patients given intensive therapy achieved a mean hemoglobin A_1c level of 7% and those given usual therapy achieved a mean HbA_1c level of 9%; however, this benefit soon disappeared during follow-up, most likely because many patients found it difficult to maintain intensive therapy on their own, Dr. Orchard and his associates said (JAMA 2015 Jan. 6 [doi:10.1001/jama.2014.16107]). At the present extended follow-up, there were 43 deaths (6.0%) in the intensive-therapy group and 64 (8.8%) in the usual-therapy group. Mortality per 100,000 patient-years was modestly lower in the intensive-therapy group, with a hazard ratio of 0.67. The absolute risk reduction was “small,” at about 1 death per 1,000 patient-years, the researchers noted.

The slightly lower mortality with intensive therapy was consistent across all causes of death except for the category of accident/suicide. A history of severe hypoglycemia was associated with greater mortality (HR, 1.63), but none of the accidental or suicidal deaths in this study were clearly associated with hypoglycemia. And the small numbers of accidental and suicidal deaths (13 in the intensive group and 5 in the conventional group) “preclude any definitive conclusions” regarding intensive therapy’s potential to raise mortality risk through this mechanism, the investigators said.

The DCCT/EDIC study established that tight glycemic control reduces microvascular and macrovascular complications, “and we now show its association with subsequent mortality. Although the numbers are small, there were fewer diabetic renal deaths (1 vs. 6) and cardiovascular deaths (9 vs. 15) with intensive compared with conventional therapy, causes for which glycemia might be expected to play a major role,” they added.

Obese patients in the Veterans Administration health system who underwent bariatric surgery had lower all-cause mortality 5 and 10 years after the procedure than did matched patients who didn’t have bariatric surgery, according to a report published online Jan. 5 in JAMA.

In a retrospective cohort study of severely obese VA patients across the country, 2,500 who underwent bariatric surgery during 2000-2011 were matched for body mass index (BMI), age, sex, diabetes status, race, and area of residence with 7,462 who did not. The mean age of the study participants was 52-53 years, and the mean BMI was 46-47, said Dr. David E. Arterburn of the Group Health Research Institute and the University of Washington, both in Seattle, and his associates.

During a mean follow-up of approximately 7 years, there were 263 deaths in the surgical group and 1,277 in the control group. Estimated all-cause mortality was 6.4% at 5 years and 13.8% at 10 years for surgical patients, compared with 10.4% and 23.9%, respectively, for control subjects. Bariatric surgery was not associated with any difference in mortality for the first year of follow-up but was associated with lower mortality at 1-5 years (hazard ratio, 0.45) and at 5 or more years (HR, 0.47) of follow-up, the investigators said (JAMA 2015 January 5 [doi:10.1001;jama.2014.16968]). Over time, the association between bariatric surgery and lower mortality did not change even though criteria for patient selection and types of bariatric procedures did. And the association remained robust across several subgroups of patients, including patients who did and patients who did not have diabetes.

This VA study population was predominantly male and middle-aged, so the findings expand the evidence of bariatric surgery’s mortality benefit beyond that observed in previous studies of predominantly younger, female populations, Dr. Arterburn and his associates said.

This was a retrospective, nonrandomized, observational study, so the association identified between bariatric surgery and improved mortality cannot be considered causal on the basis of these results. “Only randomized clinical trials could provide definitive evidence that bariatric surgery improves survival,” but large enough RCTs would be very difficult to conduct and prohibitively expensive. So, at least for the present, both clinicians and patient must rely on observational research results such as those from this study to inform their treatment decisions regarding bariatric surgery, the investigators added.

Obese patients in the Veterans Administration health system who underwent bariatric surgery had lower all-cause mortality 5 and 10 years after the procedure than did matched patients who didn’t have bariatric surgery, according to a report published online Jan. 5 in JAMA.

In a retrospective cohort study of severely obese VA patients across the country, 2,500 who underwent bariatric surgery during 2000-2011 were matched for body mass index (BMI), age, sex, diabetes status, race, and area of residence with 7,462 who did not. The mean age of the study participants was 52-53 years, and the mean BMI was 46-47, said Dr. David E. Arterburn of the Group Health Research Institute and the University of Washington, both in Seattle, and his associates.

During a mean follow-up of approximately 7 years, there were 263 deaths in the surgical group and 1,277 in the control group. Estimated all-cause mortality was 6.4% at 5 years and 13.8% at 10 years for surgical patients, compared with 10.4% and 23.9%, respectively, for control subjects. Bariatric surgery was not associated with any difference in mortality for the first year of follow-up but was associated with lower mortality at 1-5 years (hazard ratio, 0.45) and at 5 or more years (HR, 0.47) of follow-up, the investigators said (JAMA 2015 January 5 [doi:10.1001;jama.2014.16968]). Over time, the association between bariatric surgery and lower mortality did not change even though criteria for patient selection and types of bariatric procedures did. And the association remained robust across several subgroups of patients, including patients who did and patients who did not have diabetes.

This VA study population was predominantly male and middle-aged, so the findings expand the evidence of bariatric surgery’s mortality benefit beyond that observed in previous studies of predominantly younger, female populations, Dr. Arterburn and his associates said.

This was a retrospective, nonrandomized, observational study, so the association identified between bariatric surgery and improved mortality cannot be considered causal on the basis of these results. “Only randomized clinical trials could provide definitive evidence that bariatric surgery improves survival,” but large enough RCTs would be very difficult to conduct and prohibitively expensive. So, at least for the present, both clinicians and patient must rely on observational research results such as those from this study to inform their treatment decisions regarding bariatric surgery, the investigators added.

Obese patients in the Veterans Administration health system who underwent bariatric surgery had lower all-cause mortality 5 and 10 years after the procedure than did matched patients who didn’t have bariatric surgery, according to a report published online Jan. 5 in JAMA.

In a retrospective cohort study of severely obese VA patients across the country, 2,500 who underwent bariatric surgery during 2000-2011 were matched for body mass index (BMI), age, sex, diabetes status, race, and area of residence with 7,462 who did not. The mean age of the study participants was 52-53 years, and the mean BMI was 46-47, said Dr. David E. Arterburn of the Group Health Research Institute and the University of Washington, both in Seattle, and his associates.

During a mean follow-up of approximately 7 years, there were 263 deaths in the surgical group and 1,277 in the control group. Estimated all-cause mortality was 6.4% at 5 years and 13.8% at 10 years for surgical patients, compared with 10.4% and 23.9%, respectively, for control subjects. Bariatric surgery was not associated with any difference in mortality for the first year of follow-up but was associated with lower mortality at 1-5 years (hazard ratio, 0.45) and at 5 or more years (HR, 0.47) of follow-up, the investigators said (JAMA 2015 January 5 [doi:10.1001;jama.2014.16968]). Over time, the association between bariatric surgery and lower mortality did not change even though criteria for patient selection and types of bariatric procedures did. And the association remained robust across several subgroups of patients, including patients who did and patients who did not have diabetes.

This VA study population was predominantly male and middle-aged, so the findings expand the evidence of bariatric surgery’s mortality benefit beyond that observed in previous studies of predominantly younger, female populations, Dr. Arterburn and his associates said.

This was a retrospective, nonrandomized, observational study, so the association identified between bariatric surgery and improved mortality cannot be considered causal on the basis of these results. “Only randomized clinical trials could provide definitive evidence that bariatric surgery improves survival,” but large enough RCTs would be very difficult to conduct and prohibitively expensive. So, at least for the present, both clinicians and patient must rely on observational research results such as those from this study to inform their treatment decisions regarding bariatric surgery, the investigators added.

Intra-articular treatments appear to be more effective than oral therapies for knee osteoarthritis, but that may be due to their greater placebo effect, according to a report published online Jan. 5, 2015, in the Annals of Internal Medicine.

Until now, the relative effectiveness of various OA treatments has been difficult to discern, in part because few studies have offered direct head-to-head comparisons, and traditional meta-analysis techniques “cannot integrate all of the evidence from several comparators.” So researchers used a network meta-analysis design that enabled multiple comparisons among five oral agents (acetaminophen, diclofenac, ibuprofen, naproxen, and celecoxib), two intra-articular agents (corticosteroids and hyaluronic acid), and two placebos. They included 137 randomized controlled trials involving 33,243 adults with primary knee OA who were treated for at least 3 months between 1980 and 2014, said Dr. Raveendhara R. Bannuru, director of the center for treatment comparison and integrative analysis, at Tufts Medical Center's Institute for Clinical Research and Health Policy Studies, Boston, and his associates.

©pixologicstudio/thinkstockphotos.com

All the treatments except acetaminophen produced clinically significant improvement in pain. Both of the intra-articular treatments, with effect sizes of up to 0.63, were superior to all of the oral treatments, with effect sizes as low as 0.18. Most striking was the finding that intra-articular hyaluronic acid was the most effective treatment of all, since it is “generally considered by expert panels to be minimally effective.” But this may be because intra-articular delivery itself was found to have a significant placebo effect (effect size of 0.29) – a result that traditional meta-analysis could not have revealed, the investigators said (Ann. Intern. Med. 2015 Jan. 5 [doi:10.7326/M14-1231]).

The study findings raise important questions about whether this is a true placebo response or a physiologic effect from injecting fluid into the knee joint. “Regardless of the mechanism of the apparent benefit attributable to needle placement in the knee, the practical reality is that this procedure contributes to the overall benefit conferred in clinical practice,” Dr. Bannuru and his associates noted.

“This information, along with the safety profiles and relative costs of [the] treatments, should be helpful to clinicians when making care decisions tailored to individual patient needs,” they wrote.

This study was supported by a grant from the U.S. Agency for Healthcare Research and Quality. Dr. Bannuru’s associates reported ties to the Patient-Centered Outcomes Research Institute, the National Center for Complementary and Alternative Medicine, the European League Against Rheumatism, Croma, Flexion Therapeutics, and Bioventus.

Intra-articular treatments appear to be more effective than oral therapies for knee osteoarthritis, but that may be due to their greater placebo effect, according to a report published online Jan. 5, 2015, in the Annals of Internal Medicine.

Until now, the relative effectiveness of various OA treatments has been difficult to discern, in part because few studies have offered direct head-to-head comparisons, and traditional meta-analysis techniques “cannot integrate all of the evidence from several comparators.” So researchers used a network meta-analysis design that enabled multiple comparisons among five oral agents (acetaminophen, diclofenac, ibuprofen, naproxen, and celecoxib), two intra-articular agents (corticosteroids and hyaluronic acid), and two placebos. They included 137 randomized controlled trials involving 33,243 adults with primary knee OA who were treated for at least 3 months between 1980 and 2014, said Dr. Raveendhara R. Bannuru, director of the center for treatment comparison and integrative analysis, at Tufts Medical Center's Institute for Clinical Research and Health Policy Studies, Boston, and his associates.

©pixologicstudio/thinkstockphotos.com

All the treatments except acetaminophen produced clinically significant improvement in pain. Both of the intra-articular treatments, with effect sizes of up to 0.63, were superior to all of the oral treatments, with effect sizes as low as 0.18. Most striking was the finding that intra-articular hyaluronic acid was the most effective treatment of all, since it is “generally considered by expert panels to be minimally effective.” But this may be because intra-articular delivery itself was found to have a significant placebo effect (effect size of 0.29) – a result that traditional meta-analysis could not have revealed, the investigators said (Ann. Intern. Med. 2015 Jan. 5 [doi:10.7326/M14-1231]).

The study findings raise important questions about whether this is a true placebo response or a physiologic effect from injecting fluid into the knee joint. “Regardless of the mechanism of the apparent benefit attributable to needle placement in the knee, the practical reality is that this procedure contributes to the overall benefit conferred in clinical practice,” Dr. Bannuru and his associates noted.

“This information, along with the safety profiles and relative costs of [the] treatments, should be helpful to clinicians when making care decisions tailored to individual patient needs,” they wrote.

This study was supported by a grant from the U.S. Agency for Healthcare Research and Quality. Dr. Bannuru’s associates reported ties to the Patient-Centered Outcomes Research Institute, the National Center for Complementary and Alternative Medicine, the European League Against Rheumatism, Croma, Flexion Therapeutics, and Bioventus.

Intra-articular treatments appear to be more effective than oral therapies for knee osteoarthritis, but that may be due to their greater placebo effect, according to a report published online Jan. 5, 2015, in the Annals of Internal Medicine.

Until now, the relative effectiveness of various OA treatments has been difficult to discern, in part because few studies have offered direct head-to-head comparisons, and traditional meta-analysis techniques “cannot integrate all of the evidence from several comparators.” So researchers used a network meta-analysis design that enabled multiple comparisons among five oral agents (acetaminophen, diclofenac, ibuprofen, naproxen, and celecoxib), two intra-articular agents (corticosteroids and hyaluronic acid), and two placebos. They included 137 randomized controlled trials involving 33,243 adults with primary knee OA who were treated for at least 3 months between 1980 and 2014, said Dr. Raveendhara R. Bannuru, director of the center for treatment comparison and integrative analysis, at Tufts Medical Center's Institute for Clinical Research and Health Policy Studies, Boston, and his associates.

©pixologicstudio/thinkstockphotos.com

All the treatments except acetaminophen produced clinically significant improvement in pain. Both of the intra-articular treatments, with effect sizes of up to 0.63, were superior to all of the oral treatments, with effect sizes as low as 0.18. Most striking was the finding that intra-articular hyaluronic acid was the most effective treatment of all, since it is “generally considered by expert panels to be minimally effective.” But this may be because intra-articular delivery itself was found to have a significant placebo effect (effect size of 0.29) – a result that traditional meta-analysis could not have revealed, the investigators said (Ann. Intern. Med. 2015 Jan. 5 [doi:10.7326/M14-1231]).

The study findings raise important questions about whether this is a true placebo response or a physiologic effect from injecting fluid into the knee joint. “Regardless of the mechanism of the apparent benefit attributable to needle placement in the knee, the practical reality is that this procedure contributes to the overall benefit conferred in clinical practice,” Dr. Bannuru and his associates noted.

“This information, along with the safety profiles and relative costs of [the] treatments, should be helpful to clinicians when making care decisions tailored to individual patient needs,” they wrote.

This study was supported by a grant from the U.S. Agency for Healthcare Research and Quality. Dr. Bannuru’s associates reported ties to the Patient-Centered Outcomes Research Institute, the National Center for Complementary and Alternative Medicine, the European League Against Rheumatism, Croma, Flexion Therapeutics, and Bioventus.

Greater consumption of whole-grain foods correlated with lower total mortality and lower cardiovascular disease mortality, according to a report published online Jan. 5 in JAMA Internal Medicine.

Although the health benefits of eating whole grains are well known, studies that specifically examined the relationship between whole-grain intake and mortality have yielded inconsistent results; several even found an inverse relation between whole-grain consumption and CVD mortality. That may be due, in part, to wide variations among the studies in dietary assessments and failure to properly adjust for participants’ demographic and lifestyle characteristics.

To avoid those pitfalls, researchers examined the relationship using data from two large, prospective cohort studies that meticulously assessed diet every 2 years for an extended period: the Nurses’ Health Study (NHS) and the Health Professionals Follow-Up Study (HPFS).

For the analyses, Hongyu Wu, Ph.D., of the department of nutrition at the Harvard School of Public Health, Boston, and her associates assessed data for 74,341 women in the NHS who were followed for 26 years and 43,744 men in the HPFS who were followed for up to 24 years. There were 15,106 deaths among the women and 11,814 among the men.

After the data were adjusted to account for many confounding factors, a greater intake of whole grains was associated with lower total mortality (hazard ratio, 0.91) and lower CVD mortality (HR, 0.85). Every additional daily serving of whole grains was associated with a 5% decrease in total mortality and a 9% decrease in CVD mortality.

Continue for food-substitution analysis >>

In a food-substitution analysis, replacing one serving of refined grains with one serving of whole grains every day was associated with a 4% decrease in total mortality and an 8% decrease in CVD mortality. Replacing one serving of red meat with one serving of whole grains was associated with a 10% decrease in total mortality and a 20% decrease in CVD mortality, the investigators said (JAMA Intern. Med. 2014 Jan. 5 [doi:10.1001/jamainternmed.2014.6283]).

Those associations were independent of numerous demographic and lifestyle predictors of mortality, and they persisted across subgroups of participants who had varying risk profiles.

The findings support current dietary guidelines and suggest that a diet enriched with whole grains may confer benefits that extend life expectancy, Dr. Wu and her associates said.

Most of the participants in the NHS and the HPFS were well-educated professionals of European ancestry, however, so these findings may not be generalizable to other demographic or ethnic groups, the authors cautioned.

The study was supported by research grants from the National Institutes of Health and the National Heart, Lung, and Blood Institute. Dr. Wu and her associates reported having no financial disclosures.

Greater consumption of whole-grain foods correlated with lower total mortality and lower cardiovascular disease mortality, according to a report published online Jan. 5 in JAMA Internal Medicine.

Although the health benefits of eating whole grains are well known, studies that specifically examined the relationship between whole-grain intake and mortality have yielded inconsistent results; several even found an inverse relation between whole-grain consumption and CVD mortality. That may be due, in part, to wide variations among the studies in dietary assessments and failure to properly adjust for participants’ demographic and lifestyle characteristics.

To avoid those pitfalls, researchers examined the relationship using data from two large, prospective cohort studies that meticulously assessed diet every 2 years for an extended period: the Nurses’ Health Study (NHS) and the Health Professionals Follow-Up Study (HPFS).

For the analyses, Hongyu Wu, Ph.D., of the department of nutrition at the Harvard School of Public Health, Boston, and her associates assessed data for 74,341 women in the NHS who were followed for 26 years and 43,744 men in the HPFS who were followed for up to 24 years. There were 15,106 deaths among the women and 11,814 among the men.

After the data were adjusted to account for many confounding factors, a greater intake of whole grains was associated with lower total mortality (hazard ratio, 0.91) and lower CVD mortality (HR, 0.85). Every additional daily serving of whole grains was associated with a 5% decrease in total mortality and a 9% decrease in CVD mortality.

Continue for food-substitution analysis >>

In a food-substitution analysis, replacing one serving of refined grains with one serving of whole grains every day was associated with a 4% decrease in total mortality and an 8% decrease in CVD mortality. Replacing one serving of red meat with one serving of whole grains was associated with a 10% decrease in total mortality and a 20% decrease in CVD mortality, the investigators said (JAMA Intern. Med. 2014 Jan. 5 [doi:10.1001/jamainternmed.2014.6283]).

Those associations were independent of numerous demographic and lifestyle predictors of mortality, and they persisted across subgroups of participants who had varying risk profiles.

The findings support current dietary guidelines and suggest that a diet enriched with whole grains may confer benefits that extend life expectancy, Dr. Wu and her associates said.

Most of the participants in the NHS and the HPFS were well-educated professionals of European ancestry, however, so these findings may not be generalizable to other demographic or ethnic groups, the authors cautioned.

The study was supported by research grants from the National Institutes of Health and the National Heart, Lung, and Blood Institute. Dr. Wu and her associates reported having no financial disclosures.

Greater consumption of whole-grain foods correlated with lower total mortality and lower cardiovascular disease mortality, according to a report published online Jan. 5 in JAMA Internal Medicine.

Although the health benefits of eating whole grains are well known, studies that specifically examined the relationship between whole-grain intake and mortality have yielded inconsistent results; several even found an inverse relation between whole-grain consumption and CVD mortality. That may be due, in part, to wide variations among the studies in dietary assessments and failure to properly adjust for participants’ demographic and lifestyle characteristics.

To avoid those pitfalls, researchers examined the relationship using data from two large, prospective cohort studies that meticulously assessed diet every 2 years for an extended period: the Nurses’ Health Study (NHS) and the Health Professionals Follow-Up Study (HPFS).

For the analyses, Hongyu Wu, Ph.D., of the department of nutrition at the Harvard School of Public Health, Boston, and her associates assessed data for 74,341 women in the NHS who were followed for 26 years and 43,744 men in the HPFS who were followed for up to 24 years. There were 15,106 deaths among the women and 11,814 among the men.

After the data were adjusted to account for many confounding factors, a greater intake of whole grains was associated with lower total mortality (hazard ratio, 0.91) and lower CVD mortality (HR, 0.85). Every additional daily serving of whole grains was associated with a 5% decrease in total mortality and a 9% decrease in CVD mortality.

Continue for food-substitution analysis >>

In a food-substitution analysis, replacing one serving of refined grains with one serving of whole grains every day was associated with a 4% decrease in total mortality and an 8% decrease in CVD mortality. Replacing one serving of red meat with one serving of whole grains was associated with a 10% decrease in total mortality and a 20% decrease in CVD mortality, the investigators said (JAMA Intern. Med. 2014 Jan. 5 [doi:10.1001/jamainternmed.2014.6283]).

Those associations were independent of numerous demographic and lifestyle predictors of mortality, and they persisted across subgroups of participants who had varying risk profiles.

The findings support current dietary guidelines and suggest that a diet enriched with whole grains may confer benefits that extend life expectancy, Dr. Wu and her associates said.

Most of the participants in the NHS and the HPFS were well-educated professionals of European ancestry, however, so these findings may not be generalizable to other demographic or ethnic groups, the authors cautioned.

The study was supported by research grants from the National Institutes of Health and the National Heart, Lung, and Blood Institute. Dr. Wu and her associates reported having no financial disclosures.

Greater consumption of whole-grain foods correlated with lower total mortality and lower cardiovascular disease mortality, according to a report published online Jan. 5 in JAMA Internal Medicine.

Although the health benefits of eating whole grains are well known, studies that specifically examined the relationship between whole-grain intake and mortality have yielded inconsistent results; several even found an inverse relation between whole-grain consumption and CVD mortality. That may be due, in part, to wide variations among the studies in dietary assessments and failure to properly adjust for participants’ demographic and lifestyle characteristics.

Courtesy of the National Cancer Institute (NCI)

To avoid those pitfalls, researchers examined the relationship using data from two large, prospective cohort studies that meticulously assessed diet every 2 years for an extended period: the Nurses’ Health Study (NHS) and the Health Professionals Follow-Up Study (HPFS).

For the analyses, Hongyu Wu, Ph.D., of the department of nutrition at the Harvard School of Public Health, Boston, and her associates assessed data for 74,341 women in the NHS who were followed for 26 years and 43,744 men in the HPFS who were followed for up to 24 years. There were 15,106 deaths among the women and 11,814 among the men.

After the data were adjusted to account for many confounding factors, a greater intake of whole grains was associated with lower total mortality (hazard ratio, 0.91) and lower CVD mortality (HR, 0.85). Every additional daily serving of whole grains was associated with a 5% decrease in total mortality and a 9% decrease in CVD mortality.

In a food-substitution analysis, replacing one serving of refined grains with one serving of whole grains every day was associated with a 4% decrease in total mortality and an 8% decrease in CVD mortality. Replacing one serving of red meat with one serving of whole grains was associated with a 10% decrease in total mortality and a 20% decrease in CVD mortality, the investigators said (JAMA Intern. Med. 2014 Jan. 5 [doi:10.1001/jamainternmed.2014.6283]).

Those associations were independent of numerous demographic and lifestyle predictors of mortality, and they persisted across subgroups of participants who had varying risk profiles.

The findings support current dietary guidelines and suggest that a diet enriched with whole grains may confer benefits that extend life expectancy, Dr. Wu and her associates said.

Most of the participants in the NHS and the HPFS were well-educated professionals of European ancestry, however, so these findings may not be generalizable to other demographic or ethnic groups, the authors cautioned.

The study was supported by research grants from the National Institutes of Health and the National Heart, Lung, and Blood Institute. Dr. Wu and her associates reported having no financial disclosures.

Greater consumption of whole-grain foods correlated with lower total mortality and lower cardiovascular disease mortality, according to a report published online Jan. 5 in JAMA Internal Medicine.

Although the health benefits of eating whole grains are well known, studies that specifically examined the relationship between whole-grain intake and mortality have yielded inconsistent results; several even found an inverse relation between whole-grain consumption and CVD mortality. That may be due, in part, to wide variations among the studies in dietary assessments and failure to properly adjust for participants’ demographic and lifestyle characteristics.

Courtesy of the National Cancer Institute (NCI)

To avoid those pitfalls, researchers examined the relationship using data from two large, prospective cohort studies that meticulously assessed diet every 2 years for an extended period: the Nurses’ Health Study (NHS) and the Health Professionals Follow-Up Study (HPFS).

For the analyses, Hongyu Wu, Ph.D., of the department of nutrition at the Harvard School of Public Health, Boston, and her associates assessed data for 74,341 women in the NHS who were followed for 26 years and 43,744 men in the HPFS who were followed for up to 24 years. There were 15,106 deaths among the women and 11,814 among the men.

After the data were adjusted to account for many confounding factors, a greater intake of whole grains was associated with lower total mortality (hazard ratio, 0.91) and lower CVD mortality (HR, 0.85). Every additional daily serving of whole grains was associated with a 5% decrease in total mortality and a 9% decrease in CVD mortality.

In a food-substitution analysis, replacing one serving of refined grains with one serving of whole grains every day was associated with a 4% decrease in total mortality and an 8% decrease in CVD mortality. Replacing one serving of red meat with one serving of whole grains was associated with a 10% decrease in total mortality and a 20% decrease in CVD mortality, the investigators said (JAMA Intern. Med. 2014 Jan. 5 [doi:10.1001/jamainternmed.2014.6283]).

Those associations were independent of numerous demographic and lifestyle predictors of mortality, and they persisted across subgroups of participants who had varying risk profiles.

The findings support current dietary guidelines and suggest that a diet enriched with whole grains may confer benefits that extend life expectancy, Dr. Wu and her associates said.

Most of the participants in the NHS and the HPFS were well-educated professionals of European ancestry, however, so these findings may not be generalizable to other demographic or ethnic groups, the authors cautioned.

The study was supported by research grants from the National Institutes of Health and the National Heart, Lung, and Blood Institute. Dr. Wu and her associates reported having no financial disclosures.

Greater consumption of whole-grain foods correlated with lower total mortality and lower cardiovascular disease mortality, according to a report published online Jan. 5 in JAMA Internal Medicine.

Although the health benefits of eating whole grains are well known, studies that specifically examined the relationship between whole-grain intake and mortality have yielded inconsistent results; several even found an inverse relation between whole-grain consumption and CVD mortality. That may be due, in part, to wide variations among the studies in dietary assessments and failure to properly adjust for participants’ demographic and lifestyle characteristics.

Courtesy of the National Cancer Institute (NCI)

To avoid those pitfalls, researchers examined the relationship using data from two large, prospective cohort studies that meticulously assessed diet every 2 years for an extended period: the Nurses’ Health Study (NHS) and the Health Professionals Follow-Up Study (HPFS).

For the analyses, Hongyu Wu, Ph.D., of the department of nutrition at the Harvard School of Public Health, Boston, and her associates assessed data for 74,341 women in the NHS who were followed for 26 years and 43,744 men in the HPFS who were followed for up to 24 years. There were 15,106 deaths among the women and 11,814 among the men.

After the data were adjusted to account for many confounding factors, a greater intake of whole grains was associated with lower total mortality (hazard ratio, 0.91) and lower CVD mortality (HR, 0.85). Every additional daily serving of whole grains was associated with a 5% decrease in total mortality and a 9% decrease in CVD mortality.

In a food-substitution analysis, replacing one serving of refined grains with one serving of whole grains every day was associated with a 4% decrease in total mortality and an 8% decrease in CVD mortality. Replacing one serving of red meat with one serving of whole grains was associated with a 10% decrease in total mortality and a 20% decrease in CVD mortality, the investigators said (JAMA Intern. Med. 2014 Jan. 5 [doi:10.1001/jamainternmed.2014.6283]).

Those associations were independent of numerous demographic and lifestyle predictors of mortality, and they persisted across subgroups of participants who had varying risk profiles.

The findings support current dietary guidelines and suggest that a diet enriched with whole grains may confer benefits that extend life expectancy, Dr. Wu and her associates said.

Most of the participants in the NHS and the HPFS were well-educated professionals of European ancestry, however, so these findings may not be generalizable to other demographic or ethnic groups, the authors cautioned.

The study was supported by research grants from the National Institutes of Health and the National Heart, Lung, and Blood Institute. Dr. Wu and her associates reported having no financial disclosures.

Patiromer, an oral potassium binder that is not absorbed by the body, reduces elevated potassium levels in patients with chronic kidney disease who develop hyperkalemia while taking renin-angiotensin-aldosterone system inhibitors, according to a report published online Nov. 21 in the New England Journal of Medicine.

In an international prospective clinical trial, patients given patiromer also maintained normokalemia more effectively than did those given placebo. The agent did not induce an excessive decrease in potassium (hypokalemia), and the rate of gastrointestinal adverse effects was low, said Dr. Matthew R. Weir of the division of nephrology, University of Maryland, Baltimore, and his associates.

Patiromer, formulated as a powder mixed with water for oral administration, is a polymer that binds potassium in exchange for calcium, primarily in the distal colon where the concentration of free potassium is highest. It lowers serum potassium levels by enhancing fecal potassium excretion.

©decade3d/thinkstockphotos.com

In the first phase of the industry-sponsored trial, 243 adults with chronic kidney disease were treated at 24 medical centers in Eastern Europe, 21 in the European Union, and 14 in the United States. A total of 92 patients had developed mild hyperkalemia and 151 had developed moderate to severe hyperkalemia while taking inhibitors of the renin-angiotensin-aldosterone system (RAAS) as protective therapy.

Most of the study participants were white men, and the mean age was 64 years; 97% had comorbid hypertension, 57% had type 2 diabetes, 42% had heart failure, and 25% had a history of MI. A total of 54% were taking diuretics in addition to RAAS inhibitors. The participants’ diet was not controlled during the trial, but patients were counseled frequently to restrict their intake of high-potassium foods and maintain a low-potassium diet.

In the first phase of the trial, participants with mild hyperkalemia were assigned in a single-blind fashion to receive a low dose of patiromer and those with moderate to severe hyperkalemia to receive a high dose of patiromer as an oral suspension given with breakfast and dinner each day for 4 weeks. The dose could be adjusted to reach and maintain a target potassium level for each patient.

Those who achieved normokalemia were then eligible to participate in the second phase of the trial, in which they were randomly assigned to either continue taking patiromer (55 participants) or to switch to a matching placebo (52 participants) for 8 more weeks. All patients were then followed for 1-2 weeks after discontinuing treatment.

In the first phase of the study, 76% of patients attained serum potassium levels in the target range. The proportion was similar regardless of whether patients had mild (74%) or moderate-to-severe (77%) hyperkalemia.

In the second phase, patients receiving continued patiromer maintained normokalemia, while those who switched to placebo showed a mean increase of 0.72 mmol/l in serum potassium level. The rate of recurrent hyperkalemia was 4 times lower with patiromrer (15%) than with placebo (60%). At the end of follow-up, 94% of patients who had taken patiromer were still able to continue their RAAS therapy, compared with only 44% of those who had taken placebo, Dr. Weir and his associates said (New Engl. J. Med. 2014 November 21 [doi:10.1056/NEJMoa1410853]).

Patiromer was generally well-tolerated. Mild to moderate constipation was the most frequent adverse event – affecting 11% of participants during the initial-treatment phase and 4% during the second phase – and it was not treatment limiting. There were few serious adverse events, and none were attributed to patiromer. The rates of all other adverse events were similarly low in the two study groups.

In particular, hypokalemia was “uncommon and reversible” among patients who took patiromer, “which suggests that it may be mitigated by monitoring serum potassium levels and adjusting the dose of patiromer as needed,” the investigators said.

More study is needed to assess longer-term treatment than the 12 weeks evaluated in this trial, they added.

This study was sponsored by Relypsa. Dr. Weir reported ties to Relypsa, ZS Pharma, Akebia, Janssen, AstraZeneca, Otsuka, Amgen, Merck Sharp & Dohme, AbbVie, Novartis, and Boston Sandoz; his associates reported ties to numerous industry sources.

Patiromer, an oral potassium binder that is not absorbed by the body, reduces elevated potassium levels in patients with chronic kidney disease who develop hyperkalemia while taking renin-angiotensin-aldosterone system inhibitors, according to a report published online Nov. 21 in the New England Journal of Medicine.

In an international prospective clinical trial, patients given patiromer also maintained normokalemia more effectively than did those given placebo. The agent did not induce an excessive decrease in potassium (hypokalemia), and the rate of gastrointestinal adverse effects was low, said Dr. Matthew R. Weir of the division of nephrology, University of Maryland, Baltimore, and his associates.

Patiromer, formulated as a powder mixed with water for oral administration, is a polymer that binds potassium in exchange for calcium, primarily in the distal colon where the concentration of free potassium is highest. It lowers serum potassium levels by enhancing fecal potassium excretion.

©decade3d/thinkstockphotos.com

In the first phase of the industry-sponsored trial, 243 adults with chronic kidney disease were treated at 24 medical centers in Eastern Europe, 21 in the European Union, and 14 in the United States. A total of 92 patients had developed mild hyperkalemia and 151 had developed moderate to severe hyperkalemia while taking inhibitors of the renin-angiotensin-aldosterone system (RAAS) as protective therapy.

Most of the study participants were white men, and the mean age was 64 years; 97% had comorbid hypertension, 57% had type 2 diabetes, 42% had heart failure, and 25% had a history of MI. A total of 54% were taking diuretics in addition to RAAS inhibitors. The participants’ diet was not controlled during the trial, but patients were counseled frequently to restrict their intake of high-potassium foods and maintain a low-potassium diet.

In the first phase of the trial, participants with mild hyperkalemia were assigned in a single-blind fashion to receive a low dose of patiromer and those with moderate to severe hyperkalemia to receive a high dose of patiromer as an oral suspension given with breakfast and dinner each day for 4 weeks. The dose could be adjusted to reach and maintain a target potassium level for each patient.

Those who achieved normokalemia were then eligible to participate in the second phase of the trial, in which they were randomly assigned to either continue taking patiromer (55 participants) or to switch to a matching placebo (52 participants) for 8 more weeks. All patients were then followed for 1-2 weeks after discontinuing treatment.

In the first phase of the study, 76% of patients attained serum potassium levels in the target range. The proportion was similar regardless of whether patients had mild (74%) or moderate-to-severe (77%) hyperkalemia.

In the second phase, patients receiving continued patiromer maintained normokalemia, while those who switched to placebo showed a mean increase of 0.72 mmol/l in serum potassium level. The rate of recurrent hyperkalemia was 4 times lower with patiromrer (15%) than with placebo (60%). At the end of follow-up, 94% of patients who had taken patiromer were still able to continue their RAAS therapy, compared with only 44% of those who had taken placebo, Dr. Weir and his associates said (New Engl. J. Med. 2014 November 21 [doi:10.1056/NEJMoa1410853]).

Patiromer was generally well-tolerated. Mild to moderate constipation was the most frequent adverse event – affecting 11% of participants during the initial-treatment phase and 4% during the second phase – and it was not treatment limiting. There were few serious adverse events, and none were attributed to patiromer. The rates of all other adverse events were similarly low in the two study groups.

In particular, hypokalemia was “uncommon and reversible” among patients who took patiromer, “which suggests that it may be mitigated by monitoring serum potassium levels and adjusting the dose of patiromer as needed,” the investigators said.

More study is needed to assess longer-term treatment than the 12 weeks evaluated in this trial, they added.

This study was sponsored by Relypsa. Dr. Weir reported ties to Relypsa, ZS Pharma, Akebia, Janssen, AstraZeneca, Otsuka, Amgen, Merck Sharp & Dohme, AbbVie, Novartis, and Boston Sandoz; his associates reported ties to numerous industry sources.

Patiromer, an oral potassium binder that is not absorbed by the body, reduces elevated potassium levels in patients with chronic kidney disease who develop hyperkalemia while taking renin-angiotensin-aldosterone system inhibitors, according to a report published online Nov. 21 in the New England Journal of Medicine.

In an international prospective clinical trial, patients given patiromer also maintained normokalemia more effectively than did those given placebo. The agent did not induce an excessive decrease in potassium (hypokalemia), and the rate of gastrointestinal adverse effects was low, said Dr. Matthew R. Weir of the division of nephrology, University of Maryland, Baltimore, and his associates.

Patiromer, formulated as a powder mixed with water for oral administration, is a polymer that binds potassium in exchange for calcium, primarily in the distal colon where the concentration of free potassium is highest. It lowers serum potassium levels by enhancing fecal potassium excretion.

©decade3d/thinkstockphotos.com

In the first phase of the industry-sponsored trial, 243 adults with chronic kidney disease were treated at 24 medical centers in Eastern Europe, 21 in the European Union, and 14 in the United States. A total of 92 patients had developed mild hyperkalemia and 151 had developed moderate to severe hyperkalemia while taking inhibitors of the renin-angiotensin-aldosterone system (RAAS) as protective therapy.

Most of the study participants were white men, and the mean age was 64 years; 97% had comorbid hypertension, 57% had type 2 diabetes, 42% had heart failure, and 25% had a history of MI. A total of 54% were taking diuretics in addition to RAAS inhibitors. The participants’ diet was not controlled during the trial, but patients were counseled frequently to restrict their intake of high-potassium foods and maintain a low-potassium diet.

In the first phase of the trial, participants with mild hyperkalemia were assigned in a single-blind fashion to receive a low dose of patiromer and those with moderate to severe hyperkalemia to receive a high dose of patiromer as an oral suspension given with breakfast and dinner each day for 4 weeks. The dose could be adjusted to reach and maintain a target potassium level for each patient.

Those who achieved normokalemia were then eligible to participate in the second phase of the trial, in which they were randomly assigned to either continue taking patiromer (55 participants) or to switch to a matching placebo (52 participants) for 8 more weeks. All patients were then followed for 1-2 weeks after discontinuing treatment.

In the first phase of the study, 76% of patients attained serum potassium levels in the target range. The proportion was similar regardless of whether patients had mild (74%) or moderate-to-severe (77%) hyperkalemia.

In the second phase, patients receiving continued patiromer maintained normokalemia, while those who switched to placebo showed a mean increase of 0.72 mmol/l in serum potassium level. The rate of recurrent hyperkalemia was 4 times lower with patiromrer (15%) than with placebo (60%). At the end of follow-up, 94% of patients who had taken patiromer were still able to continue their RAAS therapy, compared with only 44% of those who had taken placebo, Dr. Weir and his associates said (New Engl. J. Med. 2014 November 21 [doi:10.1056/NEJMoa1410853]).

Patiromer was generally well-tolerated. Mild to moderate constipation was the most frequent adverse event – affecting 11% of participants during the initial-treatment phase and 4% during the second phase – and it was not treatment limiting. There were few serious adverse events, and none were attributed to patiromer. The rates of all other adverse events were similarly low in the two study groups.

In particular, hypokalemia was “uncommon and reversible” among patients who took patiromer, “which suggests that it may be mitigated by monitoring serum potassium levels and adjusting the dose of patiromer as needed,” the investigators said.

More study is needed to assess longer-term treatment than the 12 weeks evaluated in this trial, they added.

This study was sponsored by Relypsa. Dr. Weir reported ties to Relypsa, ZS Pharma, Akebia, Janssen, AstraZeneca, Otsuka, Amgen, Merck Sharp & Dohme, AbbVie, Novartis, and Boston Sandoz; his associates reported ties to numerous industry sources.

Many patients with type 2 diabetes have “material need insecurities” – trouble paying for food, medications, housing, or utilities – which greatly impact control of the disease and their use of health care resources, according to a report published online Dec. 29 in JAMA Internal Medicine.

If these pressing but nonmedical needs aren’t identified and addressed, increasing access to health care and diabetes treatments will likely be futile, said Dr. Seth A. Berkowitz of Massachusetts General Hospital and Harvard Medical School, Boston, and his associates.

© Tashatuvango/Thinkstockphotos.com

Most previous research into such material needs have focused on a single need in isolation. In their study, Dr. Berkowitz and his colleagues assessed several material needs simultaneously, to obtain a more accurate picture of the real-world experience of diabetes patients at the lower end of the socioeconomic scale. They surveyed 411 patients attending two community health centers, an academic internal medicine practice, or a diabetes specialty clinic in the Boston area during a 1-year period. The mean patient age was 62 years; 48% were women, and 79% were of non-Hispanic white ethnicity. Health insurance coverage was very high, since Massachusetts has near-universal coverage; only 4% of the study participants were uninsured or self-pay clients, and less than 35 lacked coverage of prescription medication.

Eighty respondents reported having a limited or uncertain availability of food due to its cost. This likely included many who relied on cheap, calorie-dense, highly processed foods because of the inaccessibility of healthier alternatives recommended for glycemic control. A total of 104 respondents reported that they underused medications because of costs; 44 reported housing instability, including homelessness, evictions, frequent moves, or residing with friends or relatives to share living expenses; and 72 reported that they couldn’t consistently afford household heating or cooling.

Diabetes patients who had food, medication, housing, or utility insecurities were significantly more likely than others to have poor diabetes control, poor lipid profiles, poor control of hypertension, and to require more outpatient and emergency department/inpatient visits. Moreover, every additional material need insecurity raised the odds of poor diabetes control by 39%, the odds of outpatient visits by 9%, and the odds of emergency department/inpatient visits by 22%, Dr. Berkowitz and his associates said (JAMA Intern. Med. 2014 Dec. 29 [doi:10.1001/jamainternmed.2014.6888]). These findings indicate that to achieve diabetes control, many patients need not just standard medications but comprehensive interventions that also address access to food, medication, and stable housing. Programs that link patients to government and community resources would be beneficial, as would direct supplementation of healthy foods and “bundling” of low-cost (generic) medications such as metformin, statins, and ACE inhibitors, the investigators said.

This study was supported by the Institutional National Research Service, the Ryoichi Sasakawa Fellowship Fund, the division of general internal medicine at Massachusetts General Hospital, and the National Institutes of Health. Dr. Berkowitz and his associates reported having no relevant financial conflicts of interest.

Many patients with type 2 diabetes have “material need insecurities” – trouble paying for food, medications, housing, or utilities – which greatly impact control of the disease and their use of health care resources, according to a report published online Dec. 29 in JAMA Internal Medicine.

If these pressing but nonmedical needs aren’t identified and addressed, increasing access to health care and diabetes treatments will likely be futile, said Dr. Seth A. Berkowitz of Massachusetts General Hospital and Harvard Medical School, Boston, and his associates.

© Tashatuvango/Thinkstockphotos.com

Most previous research into such material needs have focused on a single need in isolation. In their study, Dr. Berkowitz and his colleagues assessed several material needs simultaneously, to obtain a more accurate picture of the real-world experience of diabetes patients at the lower end of the socioeconomic scale. They surveyed 411 patients attending two community health centers, an academic internal medicine practice, or a diabetes specialty clinic in the Boston area during a 1-year period. The mean patient age was 62 years; 48% were women, and 79% were of non-Hispanic white ethnicity. Health insurance coverage was very high, since Massachusetts has near-universal coverage; only 4% of the study participants were uninsured or self-pay clients, and less than 35 lacked coverage of prescription medication.

Eighty respondents reported having a limited or uncertain availability of food due to its cost. This likely included many who relied on cheap, calorie-dense, highly processed foods because of the inaccessibility of healthier alternatives recommended for glycemic control. A total of 104 respondents reported that they underused medications because of costs; 44 reported housing instability, including homelessness, evictions, frequent moves, or residing with friends or relatives to share living expenses; and 72 reported that they couldn’t consistently afford household heating or cooling.

Diabetes patients who had food, medication, housing, or utility insecurities were significantly more likely than others to have poor diabetes control, poor lipid profiles, poor control of hypertension, and to require more outpatient and emergency department/inpatient visits. Moreover, every additional material need insecurity raised the odds of poor diabetes control by 39%, the odds of outpatient visits by 9%, and the odds of emergency department/inpatient visits by 22%, Dr. Berkowitz and his associates said (JAMA Intern. Med. 2014 Dec. 29 [doi:10.1001/jamainternmed.2014.6888]). These findings indicate that to achieve diabetes control, many patients need not just standard medications but comprehensive interventions that also address access to food, medication, and stable housing. Programs that link patients to government and community resources would be beneficial, as would direct supplementation of healthy foods and “bundling” of low-cost (generic) medications such as metformin, statins, and ACE inhibitors, the investigators said.

This study was supported by the Institutional National Research Service, the Ryoichi Sasakawa Fellowship Fund, the division of general internal medicine at Massachusetts General Hospital, and the National Institutes of Health. Dr. Berkowitz and his associates reported having no relevant financial conflicts of interest.

Many patients with type 2 diabetes have “material need insecurities” – trouble paying for food, medications, housing, or utilities – which greatly impact control of the disease and their use of health care resources, according to a report published online Dec. 29 in JAMA Internal Medicine.

If these pressing but nonmedical needs aren’t identified and addressed, increasing access to health care and diabetes treatments will likely be futile, said Dr. Seth A. Berkowitz of Massachusetts General Hospital and Harvard Medical School, Boston, and his associates.

© Tashatuvango/Thinkstockphotos.com

Most previous research into such material needs have focused on a single need in isolation. In their study, Dr. Berkowitz and his colleagues assessed several material needs simultaneously, to obtain a more accurate picture of the real-world experience of diabetes patients at the lower end of the socioeconomic scale. They surveyed 411 patients attending two community health centers, an academic internal medicine practice, or a diabetes specialty clinic in the Boston area during a 1-year period. The mean patient age was 62 years; 48% were women, and 79% were of non-Hispanic white ethnicity. Health insurance coverage was very high, since Massachusetts has near-universal coverage; only 4% of the study participants were uninsured or self-pay clients, and less than 35 lacked coverage of prescription medication.

Eighty respondents reported having a limited or uncertain availability of food due to its cost. This likely included many who relied on cheap, calorie-dense, highly processed foods because of the inaccessibility of healthier alternatives recommended for glycemic control. A total of 104 respondents reported that they underused medications because of costs; 44 reported housing instability, including homelessness, evictions, frequent moves, or residing with friends or relatives to share living expenses; and 72 reported that they couldn’t consistently afford household heating or cooling.

Diabetes patients who had food, medication, housing, or utility insecurities were significantly more likely than others to have poor diabetes control, poor lipid profiles, poor control of hypertension, and to require more outpatient and emergency department/inpatient visits. Moreover, every additional material need insecurity raised the odds of poor diabetes control by 39%, the odds of outpatient visits by 9%, and the odds of emergency department/inpatient visits by 22%, Dr. Berkowitz and his associates said (JAMA Intern. Med. 2014 Dec. 29 [doi:10.1001/jamainternmed.2014.6888]). These findings indicate that to achieve diabetes control, many patients need not just standard medications but comprehensive interventions that also address access to food, medication, and stable housing. Programs that link patients to government and community resources would be beneficial, as would direct supplementation of healthy foods and “bundling” of low-cost (generic) medications such as metformin, statins, and ACE inhibitors, the investigators said.

This study was supported by the Institutional National Research Service, the Ryoichi Sasakawa Fellowship Fund, the division of general internal medicine at Massachusetts General Hospital, and the National Institutes of Health. Dr. Berkowitz and his associates reported having no relevant financial conflicts of interest.

Universal definitions and data standards have now been established for clinical research involving cardiovascular endpoints, according to a report published online Dec. 29 in both the Journal of the American College of Cardiology and Circulation.

The American College of Cardiology/American Heart Association Task Force on Clinical Data Standards, in collaboration with the Food and Drug Administration and the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI), described the standards as “a first step in developing a universal language for clinical trials and other types of health-related research.” The aim is to make patient data regarding CV endpoints as consistent as possible across electronic health records, clinical trial databases, registries, drug/device surveillance programs, and other health-related research, to facilitate information sharing, said Dr. Karen A. Hicks, chair of the task force’s writing committee to develop cardiovascular endpoints data standards, and her associates.

The report defines CV endpoints such as cardiovascular cause of death (as opposed to noncardiovascular or undetermined causes of death), MI, hospitalization for unstable angina, TIA, stroke, heart failure event, percutaneous coronary intervention, peripheral vascular intervention, and stent thrombosis. For example, the report notes that the outcome “hospitalization for unstable angina” is frequently assessed in research evaluating the safety of CV therapies, but by necessity involves subjective assessment of the most likely etiology of the symptoms that trigger hospitalization. To clarify that this outcome is truly due to cardiovascular ischemia, the definition must now include the presence of ECG abnormalities, such as deviations in the ST segment, the morphology of ST-segment changes (horizontal or downsloping vs. upsloping), and the magnitude of the deviation.

Similarly, the report’s definition of TIA now emphasizes the patient’s clinical presentation rather than the anatomic location of the lesion, because the availability of imaging modalities varies so much across medical centers. And, because heart failure can result from so many different etiologies, the key element in the definition of a heart failure event now is “the need for a resource-intensive response to failure of the primary therapeutic management strategy.”

Continue for more on the SCTI >>

“What makes this work unique is that it reviews and refines the terms as developed by the SCTI explicitly for use in reporting clinical trial results and in regulatory submissions, and it delineates where these concepts could or should not be used as the foundational vocabulary in routine clinical care,” Dr. Hicks, a cardiologist at the FDA, and her associates stated.

The SCTI is a working group comprised of experts from academia, professional societies, the FDA, and manufacturers of pharmaceuticals and CV devices. The ACC/AHA task force included 16 people with expertise in internal medicine, cardiovascular medicine, neurology, clinical research, epidemiology, invasive and interventional therapies, outcomes assessment, medical informatics, health information management, and healthcare services research and delivery.

The full report is available from the American College of Cardiology at www.acc.org and from the American Heart Association at www.myamericanheart.org.

This work received no commercial support. Dr. Hicks and her associates volunteered their time and were supported exclusively by the ACC and AHA.

Universal definitions and data standards have now been established for clinical research involving cardiovascular endpoints, according to a report published online Dec. 29 in both the Journal of the American College of Cardiology and Circulation.

The American College of Cardiology/American Heart Association Task Force on Clinical Data Standards, in collaboration with the Food and Drug Administration and the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI), described the standards as “a first step in developing a universal language for clinical trials and other types of health-related research.” The aim is to make patient data regarding CV endpoints as consistent as possible across electronic health records, clinical trial databases, registries, drug/device surveillance programs, and other health-related research, to facilitate information sharing, said Dr. Karen A. Hicks, chair of the task force’s writing committee to develop cardiovascular endpoints data standards, and her associates.

The report defines CV endpoints such as cardiovascular cause of death (as opposed to noncardiovascular or undetermined causes of death), MI, hospitalization for unstable angina, TIA, stroke, heart failure event, percutaneous coronary intervention, peripheral vascular intervention, and stent thrombosis. For example, the report notes that the outcome “hospitalization for unstable angina” is frequently assessed in research evaluating the safety of CV therapies, but by necessity involves subjective assessment of the most likely etiology of the symptoms that trigger hospitalization. To clarify that this outcome is truly due to cardiovascular ischemia, the definition must now include the presence of ECG abnormalities, such as deviations in the ST segment, the morphology of ST-segment changes (horizontal or downsloping vs. upsloping), and the magnitude of the deviation.

Similarly, the report’s definition of TIA now emphasizes the patient’s clinical presentation rather than the anatomic location of the lesion, because the availability of imaging modalities varies so much across medical centers. And, because heart failure can result from so many different etiologies, the key element in the definition of a heart failure event now is “the need for a resource-intensive response to failure of the primary therapeutic management strategy.”

Continue for more on the SCTI >>

“What makes this work unique is that it reviews and refines the terms as developed by the SCTI explicitly for use in reporting clinical trial results and in regulatory submissions, and it delineates where these concepts could or should not be used as the foundational vocabulary in routine clinical care,” Dr. Hicks, a cardiologist at the FDA, and her associates stated.

The SCTI is a working group comprised of experts from academia, professional societies, the FDA, and manufacturers of pharmaceuticals and CV devices. The ACC/AHA task force included 16 people with expertise in internal medicine, cardiovascular medicine, neurology, clinical research, epidemiology, invasive and interventional therapies, outcomes assessment, medical informatics, health information management, and healthcare services research and delivery.

The full report is available from the American College of Cardiology at www.acc.org and from the American Heart Association at www.myamericanheart.org.

This work received no commercial support. Dr. Hicks and her associates volunteered their time and were supported exclusively by the ACC and AHA.

Universal definitions and data standards have now been established for clinical research involving cardiovascular endpoints, according to a report published online Dec. 29 in both the Journal of the American College of Cardiology and Circulation.

The American College of Cardiology/American Heart Association Task Force on Clinical Data Standards, in collaboration with the Food and Drug Administration and the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI), described the standards as “a first step in developing a universal language for clinical trials and other types of health-related research.” The aim is to make patient data regarding CV endpoints as consistent as possible across electronic health records, clinical trial databases, registries, drug/device surveillance programs, and other health-related research, to facilitate information sharing, said Dr. Karen A. Hicks, chair of the task force’s writing committee to develop cardiovascular endpoints data standards, and her associates.

The report defines CV endpoints such as cardiovascular cause of death (as opposed to noncardiovascular or undetermined causes of death), MI, hospitalization for unstable angina, TIA, stroke, heart failure event, percutaneous coronary intervention, peripheral vascular intervention, and stent thrombosis. For example, the report notes that the outcome “hospitalization for unstable angina” is frequently assessed in research evaluating the safety of CV therapies, but by necessity involves subjective assessment of the most likely etiology of the symptoms that trigger hospitalization. To clarify that this outcome is truly due to cardiovascular ischemia, the definition must now include the presence of ECG abnormalities, such as deviations in the ST segment, the morphology of ST-segment changes (horizontal or downsloping vs. upsloping), and the magnitude of the deviation.

Similarly, the report’s definition of TIA now emphasizes the patient’s clinical presentation rather than the anatomic location of the lesion, because the availability of imaging modalities varies so much across medical centers. And, because heart failure can result from so many different etiologies, the key element in the definition of a heart failure event now is “the need for a resource-intensive response to failure of the primary therapeutic management strategy.”

Continue for more on the SCTI >>

“What makes this work unique is that it reviews and refines the terms as developed by the SCTI explicitly for use in reporting clinical trial results and in regulatory submissions, and it delineates where these concepts could or should not be used as the foundational vocabulary in routine clinical care,” Dr. Hicks, a cardiologist at the FDA, and her associates stated.

The SCTI is a working group comprised of experts from academia, professional societies, the FDA, and manufacturers of pharmaceuticals and CV devices. The ACC/AHA task force included 16 people with expertise in internal medicine, cardiovascular medicine, neurology, clinical research, epidemiology, invasive and interventional therapies, outcomes assessment, medical informatics, health information management, and healthcare services research and delivery.

The full report is available from the American College of Cardiology at www.acc.org and from the American Heart Association at www.myamericanheart.org.

This work received no commercial support. Dr. Hicks and her associates volunteered their time and were supported exclusively by the ACC and AHA.

Universal definitions and data standards have now been established for clinical research involving cardiovascular endpoints, according to a report published online Dec. 29 in both the Journal of the American College of Cardiology and Circulation.

The American College of Cardiology/American Heart Association Task Force on Clinical Data Standards, in collaboration with the Food and Drug Administration and the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI), described the standards as “a first step in developing a universal language for clinical trials and other types of health-related research.” The aim is to make patient data regarding CV endpoints as consistent as possible across electronic health records, clinical trial databases, registries, drug/device surveillance programs, and other health-related research, to facilitate information sharing, said Dr. Karen A. Hicks, chair of the task force’s writing committee to develop cardiovascular endpoints data standards, and her associates.

©Petr Vaclavek/Fotolia.com

The report defines CV endpoints such as cardiovascular cause of death (as opposed to noncardiovascular or undetermined causes of death), MI, hospitalization for unstable angina, TIA, stroke, heart failure event, percutaneous coronary intervention, peripheral vascular intervention, and stent thrombosis. For example, the report notes that the outcome “hospitalization for unstable angina” is frequently assessed in research evaluating the safety of CV therapies, but by necessity involves subjective assessment of the most likely etiology of the symptoms that trigger hospitalization. To clarify that this outcome is truly due to cardiovascular ischemia, the definition must now include the presence of ECG abnormalities, such as deviations in the ST segment, the morphology of ST-segment changes (horizontal or downsloping vs. upsloping), and the magnitude of the deviation.

Similarly, the report’s definition of TIA now emphasizes the patient’s clinical presentation rather than the anatomic location of the lesion, because the availability of imaging modalities varies so much across medical centers. And, because heart failure can result from so many different etiologies, the key element in the definition of a heart failure event now is “the need for a resource-intensive response to failure of the primary therapeutic management strategy.”

“What makes this work unique is that it reviews and refines the terms as developed by the SCTI explicitly for use in reporting clinical trial results and in regulatory submissions, and it delineates where these concepts could or should not be used as the foundational vocabulary in routine clinical care,” Dr. Hicks, a cardiologist at the FDA, and her associates stated.

The SCTI is a working group comprised of experts from academia, professional societies, the FDA, and manufacturers of pharmaceuticals and CV devices. The ACC/AHA task force included 16 people with expertise in internal medicine, cardiovascular medicine, neurology, clinical research, epidemiology, invasive and interventional therapies, outcomes assessment, medical informatics, health information management, and healthcare services research and delivery.

The full report is available from the American College of Cardiology at www.acc.org and from the American Heart Association at www.myamericanheart.org.

This work received no commercial support. Dr. Hicks and her associates volunteered their time and were supported exclusively by the ACC and AHA.

Universal definitions and data standards have now been established for clinical research involving cardiovascular endpoints, according to a report published online Dec. 29 in both the Journal of the American College of Cardiology and Circulation.

The American College of Cardiology/American Heart Association Task Force on Clinical Data Standards, in collaboration with the Food and Drug Administration and the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI), described the standards as “a first step in developing a universal language for clinical trials and other types of health-related research.” The aim is to make patient data regarding CV endpoints as consistent as possible across electronic health records, clinical trial databases, registries, drug/device surveillance programs, and other health-related research, to facilitate information sharing, said Dr. Karen A. Hicks, chair of the task force’s writing committee to develop cardiovascular endpoints data standards, and her associates.

©Petr Vaclavek/Fotolia.com

The report defines CV endpoints such as cardiovascular cause of death (as opposed to noncardiovascular or undetermined causes of death), MI, hospitalization for unstable angina, TIA, stroke, heart failure event, percutaneous coronary intervention, peripheral vascular intervention, and stent thrombosis. For example, the report notes that the outcome “hospitalization for unstable angina” is frequently assessed in research evaluating the safety of CV therapies, but by necessity involves subjective assessment of the most likely etiology of the symptoms that trigger hospitalization. To clarify that this outcome is truly due to cardiovascular ischemia, the definition must now include the presence of ECG abnormalities, such as deviations in the ST segment, the morphology of ST-segment changes (horizontal or downsloping vs. upsloping), and the magnitude of the deviation.

Similarly, the report’s definition of TIA now emphasizes the patient’s clinical presentation rather than the anatomic location of the lesion, because the availability of imaging modalities varies so much across medical centers. And, because heart failure can result from so many different etiologies, the key element in the definition of a heart failure event now is “the need for a resource-intensive response to failure of the primary therapeutic management strategy.”

“What makes this work unique is that it reviews and refines the terms as developed by the SCTI explicitly for use in reporting clinical trial results and in regulatory submissions, and it delineates where these concepts could or should not be used as the foundational vocabulary in routine clinical care,” Dr. Hicks, a cardiologist at the FDA, and her associates stated.

The SCTI is a working group comprised of experts from academia, professional societies, the FDA, and manufacturers of pharmaceuticals and CV devices. The ACC/AHA task force included 16 people with expertise in internal medicine, cardiovascular medicine, neurology, clinical research, epidemiology, invasive and interventional therapies, outcomes assessment, medical informatics, health information management, and healthcare services research and delivery.

The full report is available from the American College of Cardiology at www.acc.org and from the American Heart Association at www.myamericanheart.org.

This work received no commercial support. Dr. Hicks and her associates volunteered their time and were supported exclusively by the ACC and AHA.

Universal definitions and data standards have now been established for clinical research involving cardiovascular endpoints, according to a report published online Dec. 29 in both the Journal of the American College of Cardiology and Circulation.

The American College of Cardiology/American Heart Association Task Force on Clinical Data Standards, in collaboration with the Food and Drug Administration and the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI), described the standards as “a first step in developing a universal language for clinical trials and other types of health-related research.” The aim is to make patient data regarding CV endpoints as consistent as possible across electronic health records, clinical trial databases, registries, drug/device surveillance programs, and other health-related research, to facilitate information sharing, said Dr. Karen A. Hicks, chair of the task force’s writing committee to develop cardiovascular endpoints data standards, and her associates.

©Petr Vaclavek/Fotolia.com

The report defines CV endpoints such as cardiovascular cause of death (as opposed to noncardiovascular or undetermined causes of death), MI, hospitalization for unstable angina, TIA, stroke, heart failure event, percutaneous coronary intervention, peripheral vascular intervention, and stent thrombosis. For example, the report notes that the outcome “hospitalization for unstable angina” is frequently assessed in research evaluating the safety of CV therapies, but by necessity involves subjective assessment of the most likely etiology of the symptoms that trigger hospitalization. To clarify that this outcome is truly due to cardiovascular ischemia, the definition must now include the presence of ECG abnormalities, such as deviations in the ST segment, the morphology of ST-segment changes (horizontal or downsloping vs. upsloping), and the magnitude of the deviation.

Similarly, the report’s definition of TIA now emphasizes the patient’s clinical presentation rather than the anatomic location of the lesion, because the availability of imaging modalities varies so much across medical centers. And, because heart failure can result from so many different etiologies, the key element in the definition of a heart failure event now is “the need for a resource-intensive response to failure of the primary therapeutic management strategy.”

“What makes this work unique is that it reviews and refines the terms as developed by the SCTI explicitly for use in reporting clinical trial results and in regulatory submissions, and it delineates where these concepts could or should not be used as the foundational vocabulary in routine clinical care,” Dr. Hicks, a cardiologist at the FDA, and her associates stated.

The SCTI is a working group comprised of experts from academia, professional societies, the FDA, and manufacturers of pharmaceuticals and CV devices. The ACC/AHA task force included 16 people with expertise in internal medicine, cardiovascular medicine, neurology, clinical research, epidemiology, invasive and interventional therapies, outcomes assessment, medical informatics, health information management, and healthcare services research and delivery.

The full report is available from the American College of Cardiology at www.acc.org and from the American Heart Association at www.myamericanheart.org.

This work received no commercial support. Dr. Hicks and her associates volunteered their time and were supported exclusively by the ACC and AHA.

Poor results on ovarian reserve testing don’t signal an absolute inability to conceive “and should not be the sole criteria considered to limit or deny access to infertility treatment,” according to a policy statement from the American College of Obstetricians and Gynecologists.

Ovarian reserve tests can be predictive of the ovarian response to fertility treatment, but they do not reliably predict failure to conceive, according to the statement from ACOG’s Committee on Gynecologic Practice, which was published on Dec. 22 (Obstet. Gynecol. 2015;125:268-73).

The committee’s statement includes a discussion of the advantages and disadvantages of 10 available screens for ovarian reserve, as well as a list of seven general recommendations for clinicians.

In general, ovarian reserve testing should be performed for women older than 35 years who have not conceived after 6 months of trying and for women who are at increased risk for diminished ovarian reserve. This includes women who have a history of cancer treated with gonadotoxic therapy, pelvic irradiation, or both; those who have medical conditions treated with gonadotoxic therapy; and those who have undergone ovarian surgery for endometriomas.

For most ob.gyns., the most appropriate screening tests are basal follicle-stimulating hormone (FSH) plus estradiol levels or antimullerian hormone (AMH) levels. An antral follicle count (AFC) also may be useful if transvaginal ultrasound is already going to be performed for other indications, according to ACOG.

When test results suggest diminished ovarian reserve, it may be appropriate to initiate an infertility evaluation.

“It is reasonable to counsel the woman that her window of opportunity to conceive may be shorter than anticipated, and attempting to conceive sooner rather than later is encouraged,” ACOG wrote.

Poor results on ovarian reserve testing don’t signal an absolute inability to conceive “and should not be the sole criteria considered to limit or deny access to infertility treatment,” according to a policy statement from the American College of Obstetricians and Gynecologists.

Ovarian reserve tests can be predictive of the ovarian response to fertility treatment, but they do not reliably predict failure to conceive, according to the statement from ACOG’s Committee on Gynecologic Practice, which was published on Dec. 22 (Obstet. Gynecol. 2015;125:268-73).

The committee’s statement includes a discussion of the advantages and disadvantages of 10 available screens for ovarian reserve, as well as a list of seven general recommendations for clinicians.

In general, ovarian reserve testing should be performed for women older than 35 years who have not conceived after 6 months of trying and for women who are at increased risk for diminished ovarian reserve. This includes women who have a history of cancer treated with gonadotoxic therapy, pelvic irradiation, or both; those who have medical conditions treated with gonadotoxic therapy; and those who have undergone ovarian surgery for endometriomas.

For most ob.gyns., the most appropriate screening tests are basal follicle-stimulating hormone (FSH) plus estradiol levels or antimullerian hormone (AMH) levels. An antral follicle count (AFC) also may be useful if transvaginal ultrasound is already going to be performed for other indications, according to ACOG.

When test results suggest diminished ovarian reserve, it may be appropriate to initiate an infertility evaluation.

“It is reasonable to counsel the woman that her window of opportunity to conceive may be shorter than anticipated, and attempting to conceive sooner rather than later is encouraged,” ACOG wrote.

Poor results on ovarian reserve testing don’t signal an absolute inability to conceive “and should not be the sole criteria considered to limit or deny access to infertility treatment,” according to a policy statement from the American College of Obstetricians and Gynecologists.

Ovarian reserve tests can be predictive of the ovarian response to fertility treatment, but they do not reliably predict failure to conceive, according to the statement from ACOG’s Committee on Gynecologic Practice, which was published on Dec. 22 (Obstet. Gynecol. 2015;125:268-73).

The committee’s statement includes a discussion of the advantages and disadvantages of 10 available screens for ovarian reserve, as well as a list of seven general recommendations for clinicians.

In general, ovarian reserve testing should be performed for women older than 35 years who have not conceived after 6 months of trying and for women who are at increased risk for diminished ovarian reserve. This includes women who have a history of cancer treated with gonadotoxic therapy, pelvic irradiation, or both; those who have medical conditions treated with gonadotoxic therapy; and those who have undergone ovarian surgery for endometriomas.

For most ob.gyns., the most appropriate screening tests are basal follicle-stimulating hormone (FSH) plus estradiol levels or antimullerian hormone (AMH) levels. An antral follicle count (AFC) also may be useful if transvaginal ultrasound is already going to be performed for other indications, according to ACOG.

When test results suggest diminished ovarian reserve, it may be appropriate to initiate an infertility evaluation.

“It is reasonable to counsel the woman that her window of opportunity to conceive may be shorter than anticipated, and attempting to conceive sooner rather than later is encouraged,” ACOG wrote.