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Doug Brunk is a San Diego-based award-winning reporter who began covering health care in 1991. Before joining the company, he wrote for the health sciences division of Columbia University and was an associate editor at Contemporary Long Term Care magazine when it won a Jesse H. Neal Award. His work has been syndicated by the Los Angeles Times and he is the author of two books related to the University of Kentucky Wildcats men's basketball program. Doug has a master’s degree in magazine journalism from the S.I. Newhouse School of Public Communications at Syracuse University. Follow him on Twitter @dougbrunk.
LDL Cholesterol Not a Good Marker of CVD in Type 1 Diabetes
SAN FRANCISCO – Among patients with type 1 diabetes, the ratio of total cholesterol to high-density lipoprotein cholesterol may be a better marker of cardiovascular disease, compared with elevated low-density lipoprotein cholesterol, observational data from a Swedish registry suggest.
"High LDL cholesterol is considered an important risk factor in the general population and in type 2 diabetes," Dr. Christel Hero said at the annual scientific sessions of the American Diabetes Association. "Subgroup and meta-analyses show a reduced risk for CVD with statin treatment in type 1 diabetes, but there is a lack of larger studies in type 1 diabetes concerning treatment of hyperlipidemia."
The aim of the current study was to assess LDL and total cholesterol to HDL cholesterol ratios as predictors of CVD in type 1 diabetes, and to evaluate the risk for CVD at different levels of LDL. To accomplish this, the researchers used different Swedish registries to link patients with type 1 diabetes, including the Swedish National Diabetes Registry, which contains data on more than 96% of individuals with the disease in that country. They also used the hospital discharge register, "from which we can get information about all hospital stays, including medical interventions and discharge diagnosis," said Dr. Hero of Sahlgrenska University Hospital in Gothenburg, Sweden. Reports of death were obtained from Sweden’s cause of death register.
The study population included 30,778 patients with type 1 diabetes who were between the ages of 18 and 79 years. Baseline data were collected during 2003-2006 and the patients were followed until 2011, or until the first event, which resulted in a mean follow-up of 7 years. Outcome events were fatal or nonfatal CVD, which encompassed acute myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft surgery, stroke, and peripheral vascular disease.
The patients were divided into two groups: those on lipid medication (8,172) and those not taking lipid medication (22,608). The researchers formed two subgroups: one from the patients on lipid medication with a history of CVD at baseline (1,973) and one from the overall study population that comprised patients 40 years of age or older who had one CVD risk factor at baseline (9,324).
The researchers used Cox regression analyses with LDL and total cholesterol to HDL ratio as predictors of outcomes, adjusted for CVD risk factors including diabetes duration, body mass index, systolic blood pressure, smoking, and use of antihypertensive and lipid medication.
At baseline, the mean age of patients was 46 years and their mean duration of diabetes was 20 years. Compared with the patients not taking lipid medication, those taking lipid medication were older (56 vs. 43 years, respectively), had longer diabetes duration (26 vs. 19 years), were more commonly treated with hypertensive medication (70% vs. 25%), and had a lower mean estimated glomerular filtration rate (75 vs. 87 mL/min per 1.73 m2), as well as a higher risk of CVD (24% vs. 4%).
Baseline lipid values were similar between the two main groups: a mean LDL of 106 mg/dL and a mean ratio of cholesterol to HDL of 3.2 units.
Dr. Hero reported that there were 13.8 CVD events per 1,000 person-years among patients taking lipid-lowering medications, compared with 51.7 events per 1,000 years among those who were not taking lipid medications. The researchers also found that 67.9% of patients with a history of CVD had a CVD event over 7 years of follow-up.
The adjusted hazard ratios per 1 mmol/L increase in LDL for CVD was 1.02 in those taking lipid medications and 1.08 in those who were not. Both hazard ratios were nonsignificant. A similar association was observed in patients aged 40 years and older who had one CVD risk factor at baseline. In this subgroup "there is a slight but weak significance for the LDL as a predictor of cardiovascular disease, but when looking at the octiles [of LDL] you can see no significance at all," Dr. Hero noted.
The adjusted hazard ratios per 1 mmol/L increase in the cholesterol to HDL ratio were 1.06 in those taking lipid medications and 1.08 in those who were not, both statistically significant differences. "There is a strong correlation between CVD and the cholesterol to HDL ratio as a continuous variable; also, when we look at the ratio divided into octiles, we can see an obvious correlation with a linear trend," Dr. Hero said. "The higher the ratio, the stronger the correlation. The same is true for the patients 40 years and older with one CVD risk factor. There is a strong correlation for the ratio as a continuous variable and also a linear trend for the octiles of the ratio."
The findings suggest "there is no support for an LDL treatment target of 100 mg/dL," Dr. Hero concluded. "The ratio of cholesterol to HDL is a significant predictor of CVD in patients without lipid-lowering medication. The ratio of cholesterol to HDL seems to be a more reliable marker for CVD risk when considering primary prevention."
Dr. Hero said that she had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
SAN FRANCISCO – Among patients with type 1 diabetes, the ratio of total cholesterol to high-density lipoprotein cholesterol may be a better marker of cardiovascular disease, compared with elevated low-density lipoprotein cholesterol, observational data from a Swedish registry suggest.
"High LDL cholesterol is considered an important risk factor in the general population and in type 2 diabetes," Dr. Christel Hero said at the annual scientific sessions of the American Diabetes Association. "Subgroup and meta-analyses show a reduced risk for CVD with statin treatment in type 1 diabetes, but there is a lack of larger studies in type 1 diabetes concerning treatment of hyperlipidemia."
The aim of the current study was to assess LDL and total cholesterol to HDL cholesterol ratios as predictors of CVD in type 1 diabetes, and to evaluate the risk for CVD at different levels of LDL. To accomplish this, the researchers used different Swedish registries to link patients with type 1 diabetes, including the Swedish National Diabetes Registry, which contains data on more than 96% of individuals with the disease in that country. They also used the hospital discharge register, "from which we can get information about all hospital stays, including medical interventions and discharge diagnosis," said Dr. Hero of Sahlgrenska University Hospital in Gothenburg, Sweden. Reports of death were obtained from Sweden’s cause of death register.
The study population included 30,778 patients with type 1 diabetes who were between the ages of 18 and 79 years. Baseline data were collected during 2003-2006 and the patients were followed until 2011, or until the first event, which resulted in a mean follow-up of 7 years. Outcome events were fatal or nonfatal CVD, which encompassed acute myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft surgery, stroke, and peripheral vascular disease.
The patients were divided into two groups: those on lipid medication (8,172) and those not taking lipid medication (22,608). The researchers formed two subgroups: one from the patients on lipid medication with a history of CVD at baseline (1,973) and one from the overall study population that comprised patients 40 years of age or older who had one CVD risk factor at baseline (9,324).
The researchers used Cox regression analyses with LDL and total cholesterol to HDL ratio as predictors of outcomes, adjusted for CVD risk factors including diabetes duration, body mass index, systolic blood pressure, smoking, and use of antihypertensive and lipid medication.
At baseline, the mean age of patients was 46 years and their mean duration of diabetes was 20 years. Compared with the patients not taking lipid medication, those taking lipid medication were older (56 vs. 43 years, respectively), had longer diabetes duration (26 vs. 19 years), were more commonly treated with hypertensive medication (70% vs. 25%), and had a lower mean estimated glomerular filtration rate (75 vs. 87 mL/min per 1.73 m2), as well as a higher risk of CVD (24% vs. 4%).
Baseline lipid values were similar between the two main groups: a mean LDL of 106 mg/dL and a mean ratio of cholesterol to HDL of 3.2 units.
Dr. Hero reported that there were 13.8 CVD events per 1,000 person-years among patients taking lipid-lowering medications, compared with 51.7 events per 1,000 years among those who were not taking lipid medications. The researchers also found that 67.9% of patients with a history of CVD had a CVD event over 7 years of follow-up.
The adjusted hazard ratios per 1 mmol/L increase in LDL for CVD was 1.02 in those taking lipid medications and 1.08 in those who were not. Both hazard ratios were nonsignificant. A similar association was observed in patients aged 40 years and older who had one CVD risk factor at baseline. In this subgroup "there is a slight but weak significance for the LDL as a predictor of cardiovascular disease, but when looking at the octiles [of LDL] you can see no significance at all," Dr. Hero noted.
The adjusted hazard ratios per 1 mmol/L increase in the cholesterol to HDL ratio were 1.06 in those taking lipid medications and 1.08 in those who were not, both statistically significant differences. "There is a strong correlation between CVD and the cholesterol to HDL ratio as a continuous variable; also, when we look at the ratio divided into octiles, we can see an obvious correlation with a linear trend," Dr. Hero said. "The higher the ratio, the stronger the correlation. The same is true for the patients 40 years and older with one CVD risk factor. There is a strong correlation for the ratio as a continuous variable and also a linear trend for the octiles of the ratio."
The findings suggest "there is no support for an LDL treatment target of 100 mg/dL," Dr. Hero concluded. "The ratio of cholesterol to HDL is a significant predictor of CVD in patients without lipid-lowering medication. The ratio of cholesterol to HDL seems to be a more reliable marker for CVD risk when considering primary prevention."
Dr. Hero said that she had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
SAN FRANCISCO – Among patients with type 1 diabetes, the ratio of total cholesterol to high-density lipoprotein cholesterol may be a better marker of cardiovascular disease, compared with elevated low-density lipoprotein cholesterol, observational data from a Swedish registry suggest.
"High LDL cholesterol is considered an important risk factor in the general population and in type 2 diabetes," Dr. Christel Hero said at the annual scientific sessions of the American Diabetes Association. "Subgroup and meta-analyses show a reduced risk for CVD with statin treatment in type 1 diabetes, but there is a lack of larger studies in type 1 diabetes concerning treatment of hyperlipidemia."
The aim of the current study was to assess LDL and total cholesterol to HDL cholesterol ratios as predictors of CVD in type 1 diabetes, and to evaluate the risk for CVD at different levels of LDL. To accomplish this, the researchers used different Swedish registries to link patients with type 1 diabetes, including the Swedish National Diabetes Registry, which contains data on more than 96% of individuals with the disease in that country. They also used the hospital discharge register, "from which we can get information about all hospital stays, including medical interventions and discharge diagnosis," said Dr. Hero of Sahlgrenska University Hospital in Gothenburg, Sweden. Reports of death were obtained from Sweden’s cause of death register.
The study population included 30,778 patients with type 1 diabetes who were between the ages of 18 and 79 years. Baseline data were collected during 2003-2006 and the patients were followed until 2011, or until the first event, which resulted in a mean follow-up of 7 years. Outcome events were fatal or nonfatal CVD, which encompassed acute myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft surgery, stroke, and peripheral vascular disease.
The patients were divided into two groups: those on lipid medication (8,172) and those not taking lipid medication (22,608). The researchers formed two subgroups: one from the patients on lipid medication with a history of CVD at baseline (1,973) and one from the overall study population that comprised patients 40 years of age or older who had one CVD risk factor at baseline (9,324).
The researchers used Cox regression analyses with LDL and total cholesterol to HDL ratio as predictors of outcomes, adjusted for CVD risk factors including diabetes duration, body mass index, systolic blood pressure, smoking, and use of antihypertensive and lipid medication.
At baseline, the mean age of patients was 46 years and their mean duration of diabetes was 20 years. Compared with the patients not taking lipid medication, those taking lipid medication were older (56 vs. 43 years, respectively), had longer diabetes duration (26 vs. 19 years), were more commonly treated with hypertensive medication (70% vs. 25%), and had a lower mean estimated glomerular filtration rate (75 vs. 87 mL/min per 1.73 m2), as well as a higher risk of CVD (24% vs. 4%).
Baseline lipid values were similar between the two main groups: a mean LDL of 106 mg/dL and a mean ratio of cholesterol to HDL of 3.2 units.
Dr. Hero reported that there were 13.8 CVD events per 1,000 person-years among patients taking lipid-lowering medications, compared with 51.7 events per 1,000 years among those who were not taking lipid medications. The researchers also found that 67.9% of patients with a history of CVD had a CVD event over 7 years of follow-up.
The adjusted hazard ratios per 1 mmol/L increase in LDL for CVD was 1.02 in those taking lipid medications and 1.08 in those who were not. Both hazard ratios were nonsignificant. A similar association was observed in patients aged 40 years and older who had one CVD risk factor at baseline. In this subgroup "there is a slight but weak significance for the LDL as a predictor of cardiovascular disease, but when looking at the octiles [of LDL] you can see no significance at all," Dr. Hero noted.
The adjusted hazard ratios per 1 mmol/L increase in the cholesterol to HDL ratio were 1.06 in those taking lipid medications and 1.08 in those who were not, both statistically significant differences. "There is a strong correlation between CVD and the cholesterol to HDL ratio as a continuous variable; also, when we look at the ratio divided into octiles, we can see an obvious correlation with a linear trend," Dr. Hero said. "The higher the ratio, the stronger the correlation. The same is true for the patients 40 years and older with one CVD risk factor. There is a strong correlation for the ratio as a continuous variable and also a linear trend for the octiles of the ratio."
The findings suggest "there is no support for an LDL treatment target of 100 mg/dL," Dr. Hero concluded. "The ratio of cholesterol to HDL is a significant predictor of CVD in patients without lipid-lowering medication. The ratio of cholesterol to HDL seems to be a more reliable marker for CVD risk when considering primary prevention."
Dr. Hero said that she had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
LDL cholesterol not a good marker of CVD in type 1 diabetes
SAN FRANCISCO – Among patients with type 1 diabetes, the ratio of total cholesterol to high-density lipoprotein cholesterol may be a better marker of cardiovascular disease, compared with elevated low-density lipoprotein cholesterol, observational data from a Swedish registry suggest.
"High LDL cholesterol is considered an important risk factor in the general population and in type 2 diabetes," Dr. Christel Hero said at the annual scientific sessions of the American Diabetes Association. "Subgroup and meta-analyses show a reduced risk for CVD with statin treatment in type 1 diabetes, but there is a lack of larger studies in type 1 diabetes concerning treatment of hyperlipidemia."
The aim of the current study was to assess LDL and total cholesterol to HDL cholesterol ratios as predictors of CVD in type 1 diabetes, and to evaluate the risk for CVD at different levels of LDL. To accomplish this, the researchers used different Swedish registries to link patients with type 1 diabetes, including the Swedish National Diabetes Registry, which contains data on more than 96% of individuals with the disease in that country. They also used the hospital discharge register, "from which we can get information about all hospital stays, including medical interventions and discharge diagnosis," said Dr. Hero of Sahlgrenska University Hospital in Gothenburg, Sweden. Reports of death were obtained from Sweden’s cause of death register.
The study population included 30,778 patients with type 1 diabetes who were between the ages of 18 and 79 years. Baseline data were collected during 2003-2006 and the patients were followed until 2011, or until the first event, which resulted in a mean follow-up of 7 years. Outcome events were fatal or nonfatal CVD, which encompassed acute myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft surgery, stroke, and peripheral vascular disease.
The patients were divided into two groups: those on lipid medication (8,172) and those not taking lipid medication (22,608). The researchers formed two subgroups: one from the patients on lipid medication with a history of CVD at baseline (1,973) and one from the overall study population that comprised patients 40 years of age or older who had one CVD risk factor at baseline (9,324).
The researchers used Cox regression analyses with LDL and total cholesterol to HDL ratio as predictors of outcomes, adjusted for CVD risk factors including diabetes duration, body mass index, systolic blood pressure, smoking, and use of antihypertensive and lipid medication.
At baseline, the mean age of patients was 46 years and their mean duration of diabetes was 20 years. Compared with the patients not taking lipid medication, those taking lipid medication were older (56 vs. 43 years, respectively), had longer diabetes duration (26 vs. 19 years), were more commonly treated with hypertensive medication (70% vs. 25%), and had a lower mean estimated glomerular filtration rate (75 vs. 87 mL/min per 1.73 m2), as well as a higher risk of CVD (24% vs. 4%).
Baseline lipid values were similar between the two main groups: a mean LDL of 106 mg/dL and a mean ratio of cholesterol to HDL of 3.2 units.
Dr. Hero reported that there were 13.8 CVD events per 1,000 person-years among patients taking lipid-lowering medications, compared with 51.7 events per 1,000 years among those who were not taking lipid medications. The researchers also found that 67.9% of patients with a history of CVD had a CVD event over 7 years of follow-up.
The adjusted hazard ratios per 1 mmol/L increase in LDL for CVD was 1.02 in those taking lipid medications and 1.08 in those who were not. Both hazard ratios were nonsignificant. A similar association was observed in patients aged 40 years and older who had one CVD risk factor at baseline. In this subgroup "there is a slight but weak significance for the LDL as a predictor of cardiovascular disease, but when looking at the octiles [of LDL] you can see no significance at all," Dr. Hero noted.
The adjusted hazard ratios per 1 mmol/L increase in the cholesterol to HDL ratio were 1.06 in those taking lipid medications and 1.08 in those who were not, both statistically significant differences. "There is a strong correlation between CVD and the cholesterol to HDL ratio as a continuous variable; also, when we look at the ratio divided into octiles, we can see an obvious correlation with a linear trend," Dr. Hero said. "The higher the ratio, the stronger the correlation. The same is true for the patients 40 years and older with one CVD risk factor. There is a strong correlation for the ratio as a continuous variable and also a linear trend for the octiles of the ratio."
The findings suggest "there is no support for an LDL treatment target of 100 mg/dL," Dr. Hero concluded. "The ratio of cholesterol to HDL is a significant predictor of CVD in patients without lipid-lowering medication. The ratio of cholesterol to HDL seems to be a more reliable marker for CVD risk when considering primary prevention."
Dr. Hero said that she had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
SAN FRANCISCO – Among patients with type 1 diabetes, the ratio of total cholesterol to high-density lipoprotein cholesterol may be a better marker of cardiovascular disease, compared with elevated low-density lipoprotein cholesterol, observational data from a Swedish registry suggest.
"High LDL cholesterol is considered an important risk factor in the general population and in type 2 diabetes," Dr. Christel Hero said at the annual scientific sessions of the American Diabetes Association. "Subgroup and meta-analyses show a reduced risk for CVD with statin treatment in type 1 diabetes, but there is a lack of larger studies in type 1 diabetes concerning treatment of hyperlipidemia."
The aim of the current study was to assess LDL and total cholesterol to HDL cholesterol ratios as predictors of CVD in type 1 diabetes, and to evaluate the risk for CVD at different levels of LDL. To accomplish this, the researchers used different Swedish registries to link patients with type 1 diabetes, including the Swedish National Diabetes Registry, which contains data on more than 96% of individuals with the disease in that country. They also used the hospital discharge register, "from which we can get information about all hospital stays, including medical interventions and discharge diagnosis," said Dr. Hero of Sahlgrenska University Hospital in Gothenburg, Sweden. Reports of death were obtained from Sweden’s cause of death register.
The study population included 30,778 patients with type 1 diabetes who were between the ages of 18 and 79 years. Baseline data were collected during 2003-2006 and the patients were followed until 2011, or until the first event, which resulted in a mean follow-up of 7 years. Outcome events were fatal or nonfatal CVD, which encompassed acute myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft surgery, stroke, and peripheral vascular disease.
The patients were divided into two groups: those on lipid medication (8,172) and those not taking lipid medication (22,608). The researchers formed two subgroups: one from the patients on lipid medication with a history of CVD at baseline (1,973) and one from the overall study population that comprised patients 40 years of age or older who had one CVD risk factor at baseline (9,324).
The researchers used Cox regression analyses with LDL and total cholesterol to HDL ratio as predictors of outcomes, adjusted for CVD risk factors including diabetes duration, body mass index, systolic blood pressure, smoking, and use of antihypertensive and lipid medication.
At baseline, the mean age of patients was 46 years and their mean duration of diabetes was 20 years. Compared with the patients not taking lipid medication, those taking lipid medication were older (56 vs. 43 years, respectively), had longer diabetes duration (26 vs. 19 years), were more commonly treated with hypertensive medication (70% vs. 25%), and had a lower mean estimated glomerular filtration rate (75 vs. 87 mL/min per 1.73 m2), as well as a higher risk of CVD (24% vs. 4%).
Baseline lipid values were similar between the two main groups: a mean LDL of 106 mg/dL and a mean ratio of cholesterol to HDL of 3.2 units.
Dr. Hero reported that there were 13.8 CVD events per 1,000 person-years among patients taking lipid-lowering medications, compared with 51.7 events per 1,000 years among those who were not taking lipid medications. The researchers also found that 67.9% of patients with a history of CVD had a CVD event over 7 years of follow-up.
The adjusted hazard ratios per 1 mmol/L increase in LDL for CVD was 1.02 in those taking lipid medications and 1.08 in those who were not. Both hazard ratios were nonsignificant. A similar association was observed in patients aged 40 years and older who had one CVD risk factor at baseline. In this subgroup "there is a slight but weak significance for the LDL as a predictor of cardiovascular disease, but when looking at the octiles [of LDL] you can see no significance at all," Dr. Hero noted.
The adjusted hazard ratios per 1 mmol/L increase in the cholesterol to HDL ratio were 1.06 in those taking lipid medications and 1.08 in those who were not, both statistically significant differences. "There is a strong correlation between CVD and the cholesterol to HDL ratio as a continuous variable; also, when we look at the ratio divided into octiles, we can see an obvious correlation with a linear trend," Dr. Hero said. "The higher the ratio, the stronger the correlation. The same is true for the patients 40 years and older with one CVD risk factor. There is a strong correlation for the ratio as a continuous variable and also a linear trend for the octiles of the ratio."
The findings suggest "there is no support for an LDL treatment target of 100 mg/dL," Dr. Hero concluded. "The ratio of cholesterol to HDL is a significant predictor of CVD in patients without lipid-lowering medication. The ratio of cholesterol to HDL seems to be a more reliable marker for CVD risk when considering primary prevention."
Dr. Hero said that she had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
SAN FRANCISCO – Among patients with type 1 diabetes, the ratio of total cholesterol to high-density lipoprotein cholesterol may be a better marker of cardiovascular disease, compared with elevated low-density lipoprotein cholesterol, observational data from a Swedish registry suggest.
"High LDL cholesterol is considered an important risk factor in the general population and in type 2 diabetes," Dr. Christel Hero said at the annual scientific sessions of the American Diabetes Association. "Subgroup and meta-analyses show a reduced risk for CVD with statin treatment in type 1 diabetes, but there is a lack of larger studies in type 1 diabetes concerning treatment of hyperlipidemia."
The aim of the current study was to assess LDL and total cholesterol to HDL cholesterol ratios as predictors of CVD in type 1 diabetes, and to evaluate the risk for CVD at different levels of LDL. To accomplish this, the researchers used different Swedish registries to link patients with type 1 diabetes, including the Swedish National Diabetes Registry, which contains data on more than 96% of individuals with the disease in that country. They also used the hospital discharge register, "from which we can get information about all hospital stays, including medical interventions and discharge diagnosis," said Dr. Hero of Sahlgrenska University Hospital in Gothenburg, Sweden. Reports of death were obtained from Sweden’s cause of death register.
The study population included 30,778 patients with type 1 diabetes who were between the ages of 18 and 79 years. Baseline data were collected during 2003-2006 and the patients were followed until 2011, or until the first event, which resulted in a mean follow-up of 7 years. Outcome events were fatal or nonfatal CVD, which encompassed acute myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft surgery, stroke, and peripheral vascular disease.
The patients were divided into two groups: those on lipid medication (8,172) and those not taking lipid medication (22,608). The researchers formed two subgroups: one from the patients on lipid medication with a history of CVD at baseline (1,973) and one from the overall study population that comprised patients 40 years of age or older who had one CVD risk factor at baseline (9,324).
The researchers used Cox regression analyses with LDL and total cholesterol to HDL ratio as predictors of outcomes, adjusted for CVD risk factors including diabetes duration, body mass index, systolic blood pressure, smoking, and use of antihypertensive and lipid medication.
At baseline, the mean age of patients was 46 years and their mean duration of diabetes was 20 years. Compared with the patients not taking lipid medication, those taking lipid medication were older (56 vs. 43 years, respectively), had longer diabetes duration (26 vs. 19 years), were more commonly treated with hypertensive medication (70% vs. 25%), and had a lower mean estimated glomerular filtration rate (75 vs. 87 mL/min per 1.73 m2), as well as a higher risk of CVD (24% vs. 4%).
Baseline lipid values were similar between the two main groups: a mean LDL of 106 mg/dL and a mean ratio of cholesterol to HDL of 3.2 units.
Dr. Hero reported that there were 13.8 CVD events per 1,000 person-years among patients taking lipid-lowering medications, compared with 51.7 events per 1,000 years among those who were not taking lipid medications. The researchers also found that 67.9% of patients with a history of CVD had a CVD event over 7 years of follow-up.
The adjusted hazard ratios per 1 mmol/L increase in LDL for CVD was 1.02 in those taking lipid medications and 1.08 in those who were not. Both hazard ratios were nonsignificant. A similar association was observed in patients aged 40 years and older who had one CVD risk factor at baseline. In this subgroup "there is a slight but weak significance for the LDL as a predictor of cardiovascular disease, but when looking at the octiles [of LDL] you can see no significance at all," Dr. Hero noted.
The adjusted hazard ratios per 1 mmol/L increase in the cholesterol to HDL ratio were 1.06 in those taking lipid medications and 1.08 in those who were not, both statistically significant differences. "There is a strong correlation between CVD and the cholesterol to HDL ratio as a continuous variable; also, when we look at the ratio divided into octiles, we can see an obvious correlation with a linear trend," Dr. Hero said. "The higher the ratio, the stronger the correlation. The same is true for the patients 40 years and older with one CVD risk factor. There is a strong correlation for the ratio as a continuous variable and also a linear trend for the octiles of the ratio."
The findings suggest "there is no support for an LDL treatment target of 100 mg/dL," Dr. Hero concluded. "The ratio of cholesterol to HDL is a significant predictor of CVD in patients without lipid-lowering medication. The ratio of cholesterol to HDL seems to be a more reliable marker for CVD risk when considering primary prevention."
Dr. Hero said that she had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: In type 1 diabetes, the ratio of total cholesterol to HDL better predicted CVD than did LDL cholesterol level.
Major finding: The adjusted HR for cardiovascular disease per 1 mmol/L increase in total cholesterol to HDL ratio were 1.06 in those taking lipid medications and 1.08 in those who were not. These hazard ratios reached statistical significance, with a P value of less than .01.
Data source: An observational analysis of 30,778 patients in Sweden with type 1 diabetes who were between the ages of 18 and 79 years and followed for a mean of 7 years.
Disclosures: Dr. Hero had no relevant financial conflicts to disclose.
Long-term findings from DPPOS unveiled
SAN FRANCISCO – Glycemic control has remained stable for an average of 15 years after initial randomization for patients in the Diabetes Prevention Program.
No significant differences in early microvascular complications were seen among interventions on intention to treat analysis, although intensive lifestyle intervention was effective in reducing microvascular complications in women.
Those are two key findings from an analysis of long-term outcomes from the Diabetes Prevention Program Outcomes Study (DPPOS), which were presented at the annual scientific sessions of the American Diabetes Association.
DPPOS is a follow-up to the Diabetes Prevention Program (DPP), a randomized clinical trial of intensive lifestyle and metformin, compared with placebo for the prevention of diabetes. Launched in 1996, the trial took place at 27 centers in the United States and was designed to determine whether the development of diabetes could be prevented or delayed in high-risk patients. A total of 3,234 patients were randomized to either an intensive lifestyle intervention to reduce their weight by 7% through a low-fat diet and increased physical activity, or standard advice on diet and exercise plus metformin, or standard advice on diet and exercise plus placebo.
The DPP ended 1 year ahead of schedule after an average of 3 years of study. The lifestyle intervention program, which had accomplished its goal of 7% weight loss at 1 year, and then maintained about a 5% weight loss over the remaining time of the study, resulted in a 58% reduction in diabetes. The metformin group reduced diabetes development by 31%.
"To put these reductions in perspective, approximately 11% per year of participants in the placebo group developed diabetes," Dr. David M. Nathan, chair of the DPP and DPPOS and professor of medicine at Harvard Medical School, Boston, said during a press briefing. "That was reduced to about 8%/year in the metformin group, and less than 5%/year in the lifestyle group."
The DPP results were "widely heralded and reported," Dr. Nathan continued, "but they only covered a very brief period: Three years in what is in fact a life-long disease or risk state." DPPOS was designed to examine "whether the diabetes development that we demonstrated was delayed over a brief period of time, would continue to be delayed or prevented over a longer period of time."
Of the original 3,234 DPP participants, 2,776 (86%) continued in DPPOS. Their average age at the first visit was 56 years and 68% were women. Their average age is now 67 years and 31% have developed diabetes since enrollment in DPP.
The annual diabetes incidence rates among the original DPP placebo and metformin groups have declined to approximately equal the rate in the lifestyle group, "which have remained remarkably stable, at approximately 5% per year over time," said Dr. William C. Knowler, chief of diabetes epidemiology and clinical research at the National Institute of Diabetes and Digestive and Kidney Diseases. While the reasons for this decline were not clear, one possibility is that an effective lifestyle intervention was offered to all study participants, he said.
Despite the convergence of the annual diabetes rates in long-term follow-up, the differences between groups obtained in the first 3 years of DPP "resulted in continued lower overall long-term incidence of diabetes over the 15 years of follow-up, during which the diabetes incidence rate overall was 18% lower in the metformin group and 27% lower in the original lifestyle group, than in the original placebo group."
Even though diabetes prevention or delay was substantial with lifestyle or metformin over 15 years, all three treatment groups maintained good glycemic control on average. HbA1c averages over follow-up were 6.1%, 6.0%, and 6.0% in the original placebo, metformin, and lifestyle groups, respectively.
"While these differences are statistically significant, they are very small and of questionable clinical importance," Dr. Knowler said. "The good news is that all three groups maintained good glycemic control on average, perhaps as a result not only of our interventions, but [also as] a result of rapid diagnosis and intensive treatment of diabetes once it developed."
As for microvascular outcomes such as retinopathy and neuropathy, Dr. Kieren J. Mather, professor of medicine at Indiana University, Indianapolis, reported that the average prevalence of microvascular disease at year 15 following DPP randomization was 12.4% in the placebo group, 13% in the metformin group, and 11.3% in the lifestyle group. While these differences between groups did not reach statistical significance, the mean prevalence of microvascular outcomes was about 50% higher in men than in women.
"This is not something we expected, and we have not had an opportunity to explain that," Dr. Mather said.
He went on to note that the intensive lifestyle intervention was associated with a lower prevalence of microvascular complications in women (21% vs. placebo; P = .03, and 22% vs. metformin; P = .02), but not in men. The DPPOS researchers also observed a significant difference in microvascular disease prevalence at year 15 in those who progressed to diabetes, compared with those who did not progress to diabetes (13% vs. about 10%, respectively). This equated to about a 28% lower prevalence in those who had not progressed to diabetes, an effect was present in all three treatment groups.
"This equates to a paradox. We have diabetes reduction and we have a reduced prevalence of complications in those who did not develop diabetes, compared to those who did, but we don’t have a treatment effect to prevent diabetes at this point," Dr. Mather said. "We interpret these findings in the context of the achieved levels of glycemia. Despite the rising prevalence of diabetes in our population, we started following them quite early, and even at year 15, all three treatment groups have very low mean hemoglobin A1cs, in the 6% range."
Dr. Nathan noted that even though the study is currently insufficiently powered to test the effects of interventions on CVD events, CVD risk factors improved in all subjects.
"This is a good news message, the fact that we had too few cardiac events to analyze and that CVD risk factors fell in the entire population speaks to the high level of care they were getting outside of the study."
At the same time, development of diabetes was accompanied by a worsening CVD risk factor profile and increased coronary artery calcification severity, compared with those who did not develop diabetes. The reduction in conventional CVD risk factors such as blood pressure and lipids, and in the novel CVD risk factors, such as C-reactive protein and other indices of inflammation, "was generally greater in the lifestyle group than the placebo group, and it was generally intermediate (somewhere between lifestyle and placebo) in the metformin group," Dr. Nathan explained. "Notably, it was not an increase in use of blood pressure– or lipid-lowering drugs that explained the differences among the treatment groups. In fact, during much of DPP and much of DPPOS, the lifestyle group was using fewer statins, using fewer blood pressure lowering medications. During DPPOS the development of diabetes and higher glucose levels was associated with higher levels of CVD risk factors."
Dr. Nathan added that there were no differences in the level of coronary calcification among the treatment groups. However, metformin reduced coronary artery calcification in men, which suggests that metformin has cardioprotective effects.
Dr. Jill P. Crandall, director of the diabetes clinical trials unit at the Albert Einstein College of Medicine, N.Y., discussed side effects and other consequences of long-term metformin therapy as well as the health impact implications of diabetes prevention. After an estimated 10,000 patient-years of follow-up with metformin use, there have been no reported cases of lactic acidosis or severe hypoglycemia requiring hospitalization. The prevalence of B12 deficiency was about 9% in original DPP participants randomized to the metformin group.
"Our data also show that metformin-associated vitamin B12 deficiency often occurs in the absence of anemia, leading us to recommend that B12 testing be considered for patients taking metformin," Dr. Crandall said.
The researchers also observed a "modest but surprisingly durable weight loss" among participants in the metformin group. "The most highly adherent patients in the metformin group lost or maintained about 5% of their initial body weight over 10 years of follow-up," she said. "To our knowledge, the DPP/DPPOS represents the longest pharmacologic weight-loss study ever conducted."
When considering the measured cost of the DPP/DPPOS interventions and the aggregate cost of medical care received by the participants outside of the study, metformin was actually cost saving, and both the intensive lifestyle intervention and metformin were cost effective. "The net cost of the lifestyle intervention was approximately $1,700 more than placebo over the 10 years of follow-up," Dr. Crandall said. "Since the nature of the costs associated with diabetes is related to its complications, additional cost benefits of the interventions may accrue over time if these complications are prevented or delayed."
The study was funded by the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases.
The researchers stated that they had no relevant financial conflicts to disclose.
* An earlier version of this story misspelled Dr. Mather's name.
SAN FRANCISCO – Glycemic control has remained stable for an average of 15 years after initial randomization for patients in the Diabetes Prevention Program.
No significant differences in early microvascular complications were seen among interventions on intention to treat analysis, although intensive lifestyle intervention was effective in reducing microvascular complications in women.
Those are two key findings from an analysis of long-term outcomes from the Diabetes Prevention Program Outcomes Study (DPPOS), which were presented at the annual scientific sessions of the American Diabetes Association.
DPPOS is a follow-up to the Diabetes Prevention Program (DPP), a randomized clinical trial of intensive lifestyle and metformin, compared with placebo for the prevention of diabetes. Launched in 1996, the trial took place at 27 centers in the United States and was designed to determine whether the development of diabetes could be prevented or delayed in high-risk patients. A total of 3,234 patients were randomized to either an intensive lifestyle intervention to reduce their weight by 7% through a low-fat diet and increased physical activity, or standard advice on diet and exercise plus metformin, or standard advice on diet and exercise plus placebo.
The DPP ended 1 year ahead of schedule after an average of 3 years of study. The lifestyle intervention program, which had accomplished its goal of 7% weight loss at 1 year, and then maintained about a 5% weight loss over the remaining time of the study, resulted in a 58% reduction in diabetes. The metformin group reduced diabetes development by 31%.
"To put these reductions in perspective, approximately 11% per year of participants in the placebo group developed diabetes," Dr. David M. Nathan, chair of the DPP and DPPOS and professor of medicine at Harvard Medical School, Boston, said during a press briefing. "That was reduced to about 8%/year in the metformin group, and less than 5%/year in the lifestyle group."
The DPP results were "widely heralded and reported," Dr. Nathan continued, "but they only covered a very brief period: Three years in what is in fact a life-long disease or risk state." DPPOS was designed to examine "whether the diabetes development that we demonstrated was delayed over a brief period of time, would continue to be delayed or prevented over a longer period of time."
Of the original 3,234 DPP participants, 2,776 (86%) continued in DPPOS. Their average age at the first visit was 56 years and 68% were women. Their average age is now 67 years and 31% have developed diabetes since enrollment in DPP.
The annual diabetes incidence rates among the original DPP placebo and metformin groups have declined to approximately equal the rate in the lifestyle group, "which have remained remarkably stable, at approximately 5% per year over time," said Dr. William C. Knowler, chief of diabetes epidemiology and clinical research at the National Institute of Diabetes and Digestive and Kidney Diseases. While the reasons for this decline were not clear, one possibility is that an effective lifestyle intervention was offered to all study participants, he said.
Despite the convergence of the annual diabetes rates in long-term follow-up, the differences between groups obtained in the first 3 years of DPP "resulted in continued lower overall long-term incidence of diabetes over the 15 years of follow-up, during which the diabetes incidence rate overall was 18% lower in the metformin group and 27% lower in the original lifestyle group, than in the original placebo group."
Even though diabetes prevention or delay was substantial with lifestyle or metformin over 15 years, all three treatment groups maintained good glycemic control on average. HbA1c averages over follow-up were 6.1%, 6.0%, and 6.0% in the original placebo, metformin, and lifestyle groups, respectively.
"While these differences are statistically significant, they are very small and of questionable clinical importance," Dr. Knowler said. "The good news is that all three groups maintained good glycemic control on average, perhaps as a result not only of our interventions, but [also as] a result of rapid diagnosis and intensive treatment of diabetes once it developed."
As for microvascular outcomes such as retinopathy and neuropathy, Dr. Kieren J. Mather, professor of medicine at Indiana University, Indianapolis, reported that the average prevalence of microvascular disease at year 15 following DPP randomization was 12.4% in the placebo group, 13% in the metformin group, and 11.3% in the lifestyle group. While these differences between groups did not reach statistical significance, the mean prevalence of microvascular outcomes was about 50% higher in men than in women.
"This is not something we expected, and we have not had an opportunity to explain that," Dr. Mather said.
He went on to note that the intensive lifestyle intervention was associated with a lower prevalence of microvascular complications in women (21% vs. placebo; P = .03, and 22% vs. metformin; P = .02), but not in men. The DPPOS researchers also observed a significant difference in microvascular disease prevalence at year 15 in those who progressed to diabetes, compared with those who did not progress to diabetes (13% vs. about 10%, respectively). This equated to about a 28% lower prevalence in those who had not progressed to diabetes, an effect was present in all three treatment groups.
"This equates to a paradox. We have diabetes reduction and we have a reduced prevalence of complications in those who did not develop diabetes, compared to those who did, but we don’t have a treatment effect to prevent diabetes at this point," Dr. Mather said. "We interpret these findings in the context of the achieved levels of glycemia. Despite the rising prevalence of diabetes in our population, we started following them quite early, and even at year 15, all three treatment groups have very low mean hemoglobin A1cs, in the 6% range."
Dr. Nathan noted that even though the study is currently insufficiently powered to test the effects of interventions on CVD events, CVD risk factors improved in all subjects.
"This is a good news message, the fact that we had too few cardiac events to analyze and that CVD risk factors fell in the entire population speaks to the high level of care they were getting outside of the study."
At the same time, development of diabetes was accompanied by a worsening CVD risk factor profile and increased coronary artery calcification severity, compared with those who did not develop diabetes. The reduction in conventional CVD risk factors such as blood pressure and lipids, and in the novel CVD risk factors, such as C-reactive protein and other indices of inflammation, "was generally greater in the lifestyle group than the placebo group, and it was generally intermediate (somewhere between lifestyle and placebo) in the metformin group," Dr. Nathan explained. "Notably, it was not an increase in use of blood pressure– or lipid-lowering drugs that explained the differences among the treatment groups. In fact, during much of DPP and much of DPPOS, the lifestyle group was using fewer statins, using fewer blood pressure lowering medications. During DPPOS the development of diabetes and higher glucose levels was associated with higher levels of CVD risk factors."
Dr. Nathan added that there were no differences in the level of coronary calcification among the treatment groups. However, metformin reduced coronary artery calcification in men, which suggests that metformin has cardioprotective effects.
Dr. Jill P. Crandall, director of the diabetes clinical trials unit at the Albert Einstein College of Medicine, N.Y., discussed side effects and other consequences of long-term metformin therapy as well as the health impact implications of diabetes prevention. After an estimated 10,000 patient-years of follow-up with metformin use, there have been no reported cases of lactic acidosis or severe hypoglycemia requiring hospitalization. The prevalence of B12 deficiency was about 9% in original DPP participants randomized to the metformin group.
"Our data also show that metformin-associated vitamin B12 deficiency often occurs in the absence of anemia, leading us to recommend that B12 testing be considered for patients taking metformin," Dr. Crandall said.
The researchers also observed a "modest but surprisingly durable weight loss" among participants in the metformin group. "The most highly adherent patients in the metformin group lost or maintained about 5% of their initial body weight over 10 years of follow-up," she said. "To our knowledge, the DPP/DPPOS represents the longest pharmacologic weight-loss study ever conducted."
When considering the measured cost of the DPP/DPPOS interventions and the aggregate cost of medical care received by the participants outside of the study, metformin was actually cost saving, and both the intensive lifestyle intervention and metformin were cost effective. "The net cost of the lifestyle intervention was approximately $1,700 more than placebo over the 10 years of follow-up," Dr. Crandall said. "Since the nature of the costs associated with diabetes is related to its complications, additional cost benefits of the interventions may accrue over time if these complications are prevented or delayed."
The study was funded by the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases.
The researchers stated that they had no relevant financial conflicts to disclose.
* An earlier version of this story misspelled Dr. Mather's name.
SAN FRANCISCO – Glycemic control has remained stable for an average of 15 years after initial randomization for patients in the Diabetes Prevention Program.
No significant differences in early microvascular complications were seen among interventions on intention to treat analysis, although intensive lifestyle intervention was effective in reducing microvascular complications in women.
Those are two key findings from an analysis of long-term outcomes from the Diabetes Prevention Program Outcomes Study (DPPOS), which were presented at the annual scientific sessions of the American Diabetes Association.
DPPOS is a follow-up to the Diabetes Prevention Program (DPP), a randomized clinical trial of intensive lifestyle and metformin, compared with placebo for the prevention of diabetes. Launched in 1996, the trial took place at 27 centers in the United States and was designed to determine whether the development of diabetes could be prevented or delayed in high-risk patients. A total of 3,234 patients were randomized to either an intensive lifestyle intervention to reduce their weight by 7% through a low-fat diet and increased physical activity, or standard advice on diet and exercise plus metformin, or standard advice on diet and exercise plus placebo.
The DPP ended 1 year ahead of schedule after an average of 3 years of study. The lifestyle intervention program, which had accomplished its goal of 7% weight loss at 1 year, and then maintained about a 5% weight loss over the remaining time of the study, resulted in a 58% reduction in diabetes. The metformin group reduced diabetes development by 31%.
"To put these reductions in perspective, approximately 11% per year of participants in the placebo group developed diabetes," Dr. David M. Nathan, chair of the DPP and DPPOS and professor of medicine at Harvard Medical School, Boston, said during a press briefing. "That was reduced to about 8%/year in the metformin group, and less than 5%/year in the lifestyle group."
The DPP results were "widely heralded and reported," Dr. Nathan continued, "but they only covered a very brief period: Three years in what is in fact a life-long disease or risk state." DPPOS was designed to examine "whether the diabetes development that we demonstrated was delayed over a brief period of time, would continue to be delayed or prevented over a longer period of time."
Of the original 3,234 DPP participants, 2,776 (86%) continued in DPPOS. Their average age at the first visit was 56 years and 68% were women. Their average age is now 67 years and 31% have developed diabetes since enrollment in DPP.
The annual diabetes incidence rates among the original DPP placebo and metformin groups have declined to approximately equal the rate in the lifestyle group, "which have remained remarkably stable, at approximately 5% per year over time," said Dr. William C. Knowler, chief of diabetes epidemiology and clinical research at the National Institute of Diabetes and Digestive and Kidney Diseases. While the reasons for this decline were not clear, one possibility is that an effective lifestyle intervention was offered to all study participants, he said.
Despite the convergence of the annual diabetes rates in long-term follow-up, the differences between groups obtained in the first 3 years of DPP "resulted in continued lower overall long-term incidence of diabetes over the 15 years of follow-up, during which the diabetes incidence rate overall was 18% lower in the metformin group and 27% lower in the original lifestyle group, than in the original placebo group."
Even though diabetes prevention or delay was substantial with lifestyle or metformin over 15 years, all three treatment groups maintained good glycemic control on average. HbA1c averages over follow-up were 6.1%, 6.0%, and 6.0% in the original placebo, metformin, and lifestyle groups, respectively.
"While these differences are statistically significant, they are very small and of questionable clinical importance," Dr. Knowler said. "The good news is that all three groups maintained good glycemic control on average, perhaps as a result not only of our interventions, but [also as] a result of rapid diagnosis and intensive treatment of diabetes once it developed."
As for microvascular outcomes such as retinopathy and neuropathy, Dr. Kieren J. Mather, professor of medicine at Indiana University, Indianapolis, reported that the average prevalence of microvascular disease at year 15 following DPP randomization was 12.4% in the placebo group, 13% in the metformin group, and 11.3% in the lifestyle group. While these differences between groups did not reach statistical significance, the mean prevalence of microvascular outcomes was about 50% higher in men than in women.
"This is not something we expected, and we have not had an opportunity to explain that," Dr. Mather said.
He went on to note that the intensive lifestyle intervention was associated with a lower prevalence of microvascular complications in women (21% vs. placebo; P = .03, and 22% vs. metformin; P = .02), but not in men. The DPPOS researchers also observed a significant difference in microvascular disease prevalence at year 15 in those who progressed to diabetes, compared with those who did not progress to diabetes (13% vs. about 10%, respectively). This equated to about a 28% lower prevalence in those who had not progressed to diabetes, an effect was present in all three treatment groups.
"This equates to a paradox. We have diabetes reduction and we have a reduced prevalence of complications in those who did not develop diabetes, compared to those who did, but we don’t have a treatment effect to prevent diabetes at this point," Dr. Mather said. "We interpret these findings in the context of the achieved levels of glycemia. Despite the rising prevalence of diabetes in our population, we started following them quite early, and even at year 15, all three treatment groups have very low mean hemoglobin A1cs, in the 6% range."
Dr. Nathan noted that even though the study is currently insufficiently powered to test the effects of interventions on CVD events, CVD risk factors improved in all subjects.
"This is a good news message, the fact that we had too few cardiac events to analyze and that CVD risk factors fell in the entire population speaks to the high level of care they were getting outside of the study."
At the same time, development of diabetes was accompanied by a worsening CVD risk factor profile and increased coronary artery calcification severity, compared with those who did not develop diabetes. The reduction in conventional CVD risk factors such as blood pressure and lipids, and in the novel CVD risk factors, such as C-reactive protein and other indices of inflammation, "was generally greater in the lifestyle group than the placebo group, and it was generally intermediate (somewhere between lifestyle and placebo) in the metformin group," Dr. Nathan explained. "Notably, it was not an increase in use of blood pressure– or lipid-lowering drugs that explained the differences among the treatment groups. In fact, during much of DPP and much of DPPOS, the lifestyle group was using fewer statins, using fewer blood pressure lowering medications. During DPPOS the development of diabetes and higher glucose levels was associated with higher levels of CVD risk factors."
Dr. Nathan added that there were no differences in the level of coronary calcification among the treatment groups. However, metformin reduced coronary artery calcification in men, which suggests that metformin has cardioprotective effects.
Dr. Jill P. Crandall, director of the diabetes clinical trials unit at the Albert Einstein College of Medicine, N.Y., discussed side effects and other consequences of long-term metformin therapy as well as the health impact implications of diabetes prevention. After an estimated 10,000 patient-years of follow-up with metformin use, there have been no reported cases of lactic acidosis or severe hypoglycemia requiring hospitalization. The prevalence of B12 deficiency was about 9% in original DPP participants randomized to the metformin group.
"Our data also show that metformin-associated vitamin B12 deficiency often occurs in the absence of anemia, leading us to recommend that B12 testing be considered for patients taking metformin," Dr. Crandall said.
The researchers also observed a "modest but surprisingly durable weight loss" among participants in the metformin group. "The most highly adherent patients in the metformin group lost or maintained about 5% of their initial body weight over 10 years of follow-up," she said. "To our knowledge, the DPP/DPPOS represents the longest pharmacologic weight-loss study ever conducted."
When considering the measured cost of the DPP/DPPOS interventions and the aggregate cost of medical care received by the participants outside of the study, metformin was actually cost saving, and both the intensive lifestyle intervention and metformin were cost effective. "The net cost of the lifestyle intervention was approximately $1,700 more than placebo over the 10 years of follow-up," Dr. Crandall said. "Since the nature of the costs associated with diabetes is related to its complications, additional cost benefits of the interventions may accrue over time if these complications are prevented or delayed."
The study was funded by the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases.
The researchers stated that they had no relevant financial conflicts to disclose.
* An earlier version of this story misspelled Dr. Mather's name.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: Diabetes is not inevitable in patients at high risk.
Major finding: Lifestyle intervention and metformin use reduce or delay the development of diabetes for as long as 15 years.
Data source: An analysis of long-term data from 2,776 participants in the Diabetes Prevention Program Outcomes Study.
Disclosures: The study was funded by the National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases. The researchers stated that they had no relevant financial conflicts to disclose.
Insulin independence achieved with novel stem cell therapy
SAN FRANCISCO – Autologous nonmyeloablative hematopoietic stem cell transplantation achieved insulin independence* in 59% of subjects with new-onset type 1 diabetes at 6 months of follow-up, and in 32% of subjects at up to 48 months of follow-up, results from a multicenter trial showed.
"Exogenous insulin therapy does not always achieve metabolic control in type 1 diabetes, nor prevent the occurrence of complications or halt beta-cell decline," Dr. Francesca D’Addio said at the annual scientific sessions of the American Diabetes Association. "Several clinical trials based on the preclinical successful targeting of innate/adaptive immune responses failed in type 1 diabetes. Recent trials conducted worldwide succeeded in exploiting hematopoietic stem cells [HSCs] to treat new-onset type 1 diabetes."
Dr. D’Addio of the Boston Children’s Hospital transplant research center noted that the rationale to use HSCs in type 1 diabetes is based on their immunoregulatory properties, "to rescue peripheral tolerance toward pancreatic beta cells." She presented updated results on the worldwide use of autologous HSC transplantation (AHSCT) in patients with type 1 diabetes, in an effort to evaluate potential adverse events "and to explore the successes and potential pitfalls of this novel therapy." Participating centers included the Medical University of Warsaw, the Affiliated Drum Tower Hospital of Nanjing (China), and Shanghai (China) Jiao Tong University.
The researchers screened 65 individuals aged 12-35 years who were diagnosed with type 1 diabetes within the past year and who were positive for at least one autoantibody against beta-cell antigens. Other inclusion criteria included the absence of cardiomyopathy, severe diabetic complications, malignancy, acute and chronic infection, liver disease, kidney diseases, allergic disease, and pregnancy.
At baseline, the mean age of study participants was 20 years, 63% were male, and their mean body mass index was 18 kg/m2. Autologous HSCs were administered after mobilization with hemopoietic growth factor granulocyte colony-stimulating factor (G-CSF) plus cyclophosphamide with an induction therapy based on cyclophosphamide and antithymocyte globulin (200 mg/kg and 4.5 mg/kg for 4 and 5 days, respectively).
Dr. D’Addio reported that insulin independence was achieved in 100% of individuals at least once during a follow-up period of up to 48 months, and mainly within the first 6 months after treatment. At the 6-month time point, 59% of patients had achieved insulin independence*, compared with 32% of subjects who were followed up to 48 months.
The researchers also observed a significant decrease in hemoglobin A1c level at 6 months, from a pretreatment level of 87.2 mmol/mol (10.1%) to 42.2 mmol/mol (6.0%) and then maintained over time, as well as a significant increase in C-peptide levels that was maintained up to 48 months (from a pretreatment level of 0.5 ng/mL to 1.2 ng/mL).
Slightly more than half of patients (52%) experienced adverse events, primarily neutropenic fever (seven cases), alopecia/gastric tract symptoms (five cases), and alopecia/fever (three cases). Treatment responders, defined as those who were insulin dependent at least 6 months after transplantation, showed improved glycometabolic status and beta-cell function, compared with nonresponders. They also had a greater number of CD34-positive cells injected.
"The response to AHSCT depends on the number of CD34-positive cells injected and relies on their immunoregulatory properties," Dr. D’Addio concluded. "HSC-based safer therapeutic options are required, including engineering of HSCs."
Dr. D’Addio said she had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
Correction, 6/16/2014: An earlier version of this article misstated the impact of the study intervention on insulin independence.
SAN FRANCISCO – Autologous nonmyeloablative hematopoietic stem cell transplantation achieved insulin independence* in 59% of subjects with new-onset type 1 diabetes at 6 months of follow-up, and in 32% of subjects at up to 48 months of follow-up, results from a multicenter trial showed.
"Exogenous insulin therapy does not always achieve metabolic control in type 1 diabetes, nor prevent the occurrence of complications or halt beta-cell decline," Dr. Francesca D’Addio said at the annual scientific sessions of the American Diabetes Association. "Several clinical trials based on the preclinical successful targeting of innate/adaptive immune responses failed in type 1 diabetes. Recent trials conducted worldwide succeeded in exploiting hematopoietic stem cells [HSCs] to treat new-onset type 1 diabetes."
Dr. D’Addio of the Boston Children’s Hospital transplant research center noted that the rationale to use HSCs in type 1 diabetes is based on their immunoregulatory properties, "to rescue peripheral tolerance toward pancreatic beta cells." She presented updated results on the worldwide use of autologous HSC transplantation (AHSCT) in patients with type 1 diabetes, in an effort to evaluate potential adverse events "and to explore the successes and potential pitfalls of this novel therapy." Participating centers included the Medical University of Warsaw, the Affiliated Drum Tower Hospital of Nanjing (China), and Shanghai (China) Jiao Tong University.
The researchers screened 65 individuals aged 12-35 years who were diagnosed with type 1 diabetes within the past year and who were positive for at least one autoantibody against beta-cell antigens. Other inclusion criteria included the absence of cardiomyopathy, severe diabetic complications, malignancy, acute and chronic infection, liver disease, kidney diseases, allergic disease, and pregnancy.
At baseline, the mean age of study participants was 20 years, 63% were male, and their mean body mass index was 18 kg/m2. Autologous HSCs were administered after mobilization with hemopoietic growth factor granulocyte colony-stimulating factor (G-CSF) plus cyclophosphamide with an induction therapy based on cyclophosphamide and antithymocyte globulin (200 mg/kg and 4.5 mg/kg for 4 and 5 days, respectively).
Dr. D’Addio reported that insulin independence was achieved in 100% of individuals at least once during a follow-up period of up to 48 months, and mainly within the first 6 months after treatment. At the 6-month time point, 59% of patients had achieved insulin independence*, compared with 32% of subjects who were followed up to 48 months.
The researchers also observed a significant decrease in hemoglobin A1c level at 6 months, from a pretreatment level of 87.2 mmol/mol (10.1%) to 42.2 mmol/mol (6.0%) and then maintained over time, as well as a significant increase in C-peptide levels that was maintained up to 48 months (from a pretreatment level of 0.5 ng/mL to 1.2 ng/mL).
Slightly more than half of patients (52%) experienced adverse events, primarily neutropenic fever (seven cases), alopecia/gastric tract symptoms (five cases), and alopecia/fever (three cases). Treatment responders, defined as those who were insulin dependent at least 6 months after transplantation, showed improved glycometabolic status and beta-cell function, compared with nonresponders. They also had a greater number of CD34-positive cells injected.
"The response to AHSCT depends on the number of CD34-positive cells injected and relies on their immunoregulatory properties," Dr. D’Addio concluded. "HSC-based safer therapeutic options are required, including engineering of HSCs."
Dr. D’Addio said she had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
Correction, 6/16/2014: An earlier version of this article misstated the impact of the study intervention on insulin independence.
SAN FRANCISCO – Autologous nonmyeloablative hematopoietic stem cell transplantation achieved insulin independence* in 59% of subjects with new-onset type 1 diabetes at 6 months of follow-up, and in 32% of subjects at up to 48 months of follow-up, results from a multicenter trial showed.
"Exogenous insulin therapy does not always achieve metabolic control in type 1 diabetes, nor prevent the occurrence of complications or halt beta-cell decline," Dr. Francesca D’Addio said at the annual scientific sessions of the American Diabetes Association. "Several clinical trials based on the preclinical successful targeting of innate/adaptive immune responses failed in type 1 diabetes. Recent trials conducted worldwide succeeded in exploiting hematopoietic stem cells [HSCs] to treat new-onset type 1 diabetes."
Dr. D’Addio of the Boston Children’s Hospital transplant research center noted that the rationale to use HSCs in type 1 diabetes is based on their immunoregulatory properties, "to rescue peripheral tolerance toward pancreatic beta cells." She presented updated results on the worldwide use of autologous HSC transplantation (AHSCT) in patients with type 1 diabetes, in an effort to evaluate potential adverse events "and to explore the successes and potential pitfalls of this novel therapy." Participating centers included the Medical University of Warsaw, the Affiliated Drum Tower Hospital of Nanjing (China), and Shanghai (China) Jiao Tong University.
The researchers screened 65 individuals aged 12-35 years who were diagnosed with type 1 diabetes within the past year and who were positive for at least one autoantibody against beta-cell antigens. Other inclusion criteria included the absence of cardiomyopathy, severe diabetic complications, malignancy, acute and chronic infection, liver disease, kidney diseases, allergic disease, and pregnancy.
At baseline, the mean age of study participants was 20 years, 63% were male, and their mean body mass index was 18 kg/m2. Autologous HSCs were administered after mobilization with hemopoietic growth factor granulocyte colony-stimulating factor (G-CSF) plus cyclophosphamide with an induction therapy based on cyclophosphamide and antithymocyte globulin (200 mg/kg and 4.5 mg/kg for 4 and 5 days, respectively).
Dr. D’Addio reported that insulin independence was achieved in 100% of individuals at least once during a follow-up period of up to 48 months, and mainly within the first 6 months after treatment. At the 6-month time point, 59% of patients had achieved insulin independence*, compared with 32% of subjects who were followed up to 48 months.
The researchers also observed a significant decrease in hemoglobin A1c level at 6 months, from a pretreatment level of 87.2 mmol/mol (10.1%) to 42.2 mmol/mol (6.0%) and then maintained over time, as well as a significant increase in C-peptide levels that was maintained up to 48 months (from a pretreatment level of 0.5 ng/mL to 1.2 ng/mL).
Slightly more than half of patients (52%) experienced adverse events, primarily neutropenic fever (seven cases), alopecia/gastric tract symptoms (five cases), and alopecia/fever (three cases). Treatment responders, defined as those who were insulin dependent at least 6 months after transplantation, showed improved glycometabolic status and beta-cell function, compared with nonresponders. They also had a greater number of CD34-positive cells injected.
"The response to AHSCT depends on the number of CD34-positive cells injected and relies on their immunoregulatory properties," Dr. D’Addio concluded. "HSC-based safer therapeutic options are required, including engineering of HSCs."
Dr. D’Addio said she had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
Correction, 6/16/2014: An earlier version of this article misstated the impact of the study intervention on insulin independence.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: Autologous hematopoietic stem cell transplantation was effective in patients with recently diagnosed type 1 diabetes, but that effect waned over time.
Major finding: At the 6-month time point after AHSCT, 59% of patients had achieved insulin dependence, compared with 32% of subjects who were followed up to 48 months.
Data source: A study of 65 individuals with a mean age of 20 years who were diagnosed with type 1 diabetes within the past year and who underwent autologous nonmyeloablative hematopoietic stem cell transplantation at one of three clinical sites.
Disclosures: Dr. D’Addio said she had no relevant financial conflicts to disclose.
Cancer risk elevated before and 90 days after diabetes diagnosis
SAN FRANCISCO – Among diabetes patients, the risk of cancer was significantly increased before diagnosis and 3 months after diabetes diagnosis, but not beyond that time point, results from a population-based study showed.
"Previous studies have focused on the risk of cancer following diabetes diagnosis or else compared risk of cancer between the pre- and postdiabetes period without taking into account the time period immediately following the diagnosis of diabetes," lead investigator Dr. Iliana C. Lega said in an interview prior to the annual scientific sessions of the American Diabetes Association, where the research was presented.
"We found that risk of cancer was highest in the prediabetes period and in the first 3 months following diabetes diagnosis, suggesting a role for hyperinsulinemia in the pathogenesis of cancer in the diabetes population. Furthermore, increased detection of preexisting cancers in the period following diabetes diagnosis may also contribute to the observed elevated risk of cancer," she said.
Dr. Lega, a clinician scientist with the division of endocrinology and metabolism at the University of Toronto, and her associates used population-based data from Ontario during 1997-2009 to identify incident diabetic cohorts that were matched 1:1 by age and gender to patients without diabetes. The researchers used time-varying Cox regression models to compare the relative risk of any invasive cancer between patients with and without diabetes in three separate time frames: 10 years prior to diagnosis, 3 months after diagnosis, and more than 3 months after diabetes diagnosis.
Dr. Lega and her associates evaluated cancer risk before diabetes diagnosis in 186,441 diabetes patients and matched controls and after diabetes in 51,463 diabetes patients and matched controls. Among diabetes patients, the risk of cancer was significantly increased before diabetes diagnosis (hazard ratio, 1.23) and 3 months after diabetes diagnosis (HR, 1.69), but the association abated beyond 3 months after diabetes diagnosis.
The findings "support a role for hyperinsulinemia in the relationship between diabetes and cancer, over surveillance bias," the researchers concluded in their abstract. "While further research is needed, these results support enhanced cancer screening in patients with diagnoses of prediabetes or diabetes."
Dr. Lega acknowledged certain limitations of the study, including the fact that other risk factors for cancer such as clinical features, smoking history, chronic alcoholism, and family history could not be taken into account.
Dr. Lega said that she had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
SAN FRANCISCO – Among diabetes patients, the risk of cancer was significantly increased before diagnosis and 3 months after diabetes diagnosis, but not beyond that time point, results from a population-based study showed.
"Previous studies have focused on the risk of cancer following diabetes diagnosis or else compared risk of cancer between the pre- and postdiabetes period without taking into account the time period immediately following the diagnosis of diabetes," lead investigator Dr. Iliana C. Lega said in an interview prior to the annual scientific sessions of the American Diabetes Association, where the research was presented.
"We found that risk of cancer was highest in the prediabetes period and in the first 3 months following diabetes diagnosis, suggesting a role for hyperinsulinemia in the pathogenesis of cancer in the diabetes population. Furthermore, increased detection of preexisting cancers in the period following diabetes diagnosis may also contribute to the observed elevated risk of cancer," she said.
Dr. Lega, a clinician scientist with the division of endocrinology and metabolism at the University of Toronto, and her associates used population-based data from Ontario during 1997-2009 to identify incident diabetic cohorts that were matched 1:1 by age and gender to patients without diabetes. The researchers used time-varying Cox regression models to compare the relative risk of any invasive cancer between patients with and without diabetes in three separate time frames: 10 years prior to diagnosis, 3 months after diagnosis, and more than 3 months after diabetes diagnosis.
Dr. Lega and her associates evaluated cancer risk before diabetes diagnosis in 186,441 diabetes patients and matched controls and after diabetes in 51,463 diabetes patients and matched controls. Among diabetes patients, the risk of cancer was significantly increased before diabetes diagnosis (hazard ratio, 1.23) and 3 months after diabetes diagnosis (HR, 1.69), but the association abated beyond 3 months after diabetes diagnosis.
The findings "support a role for hyperinsulinemia in the relationship between diabetes and cancer, over surveillance bias," the researchers concluded in their abstract. "While further research is needed, these results support enhanced cancer screening in patients with diagnoses of prediabetes or diabetes."
Dr. Lega acknowledged certain limitations of the study, including the fact that other risk factors for cancer such as clinical features, smoking history, chronic alcoholism, and family history could not be taken into account.
Dr. Lega said that she had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
SAN FRANCISCO – Among diabetes patients, the risk of cancer was significantly increased before diagnosis and 3 months after diabetes diagnosis, but not beyond that time point, results from a population-based study showed.
"Previous studies have focused on the risk of cancer following diabetes diagnosis or else compared risk of cancer between the pre- and postdiabetes period without taking into account the time period immediately following the diagnosis of diabetes," lead investigator Dr. Iliana C. Lega said in an interview prior to the annual scientific sessions of the American Diabetes Association, where the research was presented.
"We found that risk of cancer was highest in the prediabetes period and in the first 3 months following diabetes diagnosis, suggesting a role for hyperinsulinemia in the pathogenesis of cancer in the diabetes population. Furthermore, increased detection of preexisting cancers in the period following diabetes diagnosis may also contribute to the observed elevated risk of cancer," she said.
Dr. Lega, a clinician scientist with the division of endocrinology and metabolism at the University of Toronto, and her associates used population-based data from Ontario during 1997-2009 to identify incident diabetic cohorts that were matched 1:1 by age and gender to patients without diabetes. The researchers used time-varying Cox regression models to compare the relative risk of any invasive cancer between patients with and without diabetes in three separate time frames: 10 years prior to diagnosis, 3 months after diagnosis, and more than 3 months after diabetes diagnosis.
Dr. Lega and her associates evaluated cancer risk before diabetes diagnosis in 186,441 diabetes patients and matched controls and after diabetes in 51,463 diabetes patients and matched controls. Among diabetes patients, the risk of cancer was significantly increased before diabetes diagnosis (hazard ratio, 1.23) and 3 months after diabetes diagnosis (HR, 1.69), but the association abated beyond 3 months after diabetes diagnosis.
The findings "support a role for hyperinsulinemia in the relationship between diabetes and cancer, over surveillance bias," the researchers concluded in their abstract. "While further research is needed, these results support enhanced cancer screening in patients with diagnoses of prediabetes or diabetes."
Dr. Lega acknowledged certain limitations of the study, including the fact that other risk factors for cancer such as clinical features, smoking history, chronic alcoholism, and family history could not be taken into account.
Dr. Lega said that she had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: Among people with type 2 diabetes, cancer risk is elevated before and 3 months after diagnosis.
Major finding: The risk of cancer was significantly increased before diabetes diagnosis (HR, 1.23) and 3 months after diabetes diagnosis (HR, 1.69; P less than .001), but not beyond that time point (HR, 1.04).
Data source: A population-based study of patients from Ontario during 1997-2009.
Disclosures: Dr. Lega said that she had no relevant financial conflicts.
Fatty heart may bring on diabetes
SAN FRANCISCO – A high volume of pericardial adipose tissue was associated with the prevalence of diabetes, independent of overall obesity, results from a long-term, diverse cohort study showed.
"Obesity is associated with an increased risk for cardiovascular disease and type 2 diabetes, and specific fat deposits may increase the risk more than others," Amy C. Alman, Ph.D., said at the annual scientific sessions of the American Diabetes Association.
The findings come from an analysis of year-25 exam data among 3,079 participants in CARDIA (Coronary Artery Risk Development in Young Adults), a longitudinal cohort study of the development of cardiovascular risk and disease that began in 1985 and was conducted at centers in Alabama, Minnesota, Illinois, and California.
Visceral adiposity "is metabolically active and more strongly associated with cardiovascular risk than subcutaneous adiposity. Ectopic adipose depots are metabolically active fat found in and around tissues and organs throughout the body, including the liver, muscles, and around the heart," explained Dr. Alman of the department of epidemiology and biostatistics at the University of South Florida, Tampa.
Pericardial adipose tissue (PAT) is an ectopic fat depot composed of epicardial adipose tissue deep to the pericardium and surrounding the coronary arteries and paracardial tissue, which is located along the surface of the parietal pericardium. She and her associates tested whether PAT was positively associated with prevalent diabetes at the year-25 exam of the CARDIA study.
Examinations including volume of PAT measures from chest CT scans were performed during 2010-2011, and the researchers used multivariable logistic regression to examine the relation between quartiles of PAT and diabetes. There were four PAT quartiles: less than 33.5 cm3 (quartile 1/referent volume), between 33.5 and less than 48.7 cm3 (quartile 2), between 48.7 and less than 71.7 cm3 (quartile 3), and greater than 71.7 cm3 (quartile 4).
The mean age of the 3,079 study participants was 51 years, 44% were male, and their average body mass index was 31 kg/m2. Of these, 419 had prevalent diabetes. The prevalence of diabetes was highest in the fourth quartile of PAT volume (46% vs. 12% in the first quartile, 18% in the second, and 24% in the third), Dr. Alman reported.
In a logistic regression model of PAT volume on diabetes status by obesity, only PAT volume in the fourth quartile was significantly associated with diabetes status (odds ratio, 2.47), adjusted for field center, gender, age, race, systolic blood pressure, total cholesterol, triglycerides, and treatment with blood pressure– and cholesterol-lowering medications. A similar association was observed among nonobese patients (OR, 3.78).
"Deposition of a higher proportion of metabolically active ectopic fat is associated with diabetes in both obese and nonobese individuals," Dr. Alman concluded.
The analysis was "a very well characterized multicenter cohort study with a diverse racial cohort of middle-aged men and women," she added. Limitations of the study, she said, included its cross-sectional design, the fact that PAT was measured at a single point in time, and that it did not account for other ectopic fat depots such as liver fat. A longitudinal analysis of the participants is planned.
Dr. Alman had no relevant financial conflicts to disclose.
SAN FRANCISCO – A high volume of pericardial adipose tissue was associated with the prevalence of diabetes, independent of overall obesity, results from a long-term, diverse cohort study showed.
"Obesity is associated with an increased risk for cardiovascular disease and type 2 diabetes, and specific fat deposits may increase the risk more than others," Amy C. Alman, Ph.D., said at the annual scientific sessions of the American Diabetes Association.
The findings come from an analysis of year-25 exam data among 3,079 participants in CARDIA (Coronary Artery Risk Development in Young Adults), a longitudinal cohort study of the development of cardiovascular risk and disease that began in 1985 and was conducted at centers in Alabama, Minnesota, Illinois, and California.
Visceral adiposity "is metabolically active and more strongly associated with cardiovascular risk than subcutaneous adiposity. Ectopic adipose depots are metabolically active fat found in and around tissues and organs throughout the body, including the liver, muscles, and around the heart," explained Dr. Alman of the department of epidemiology and biostatistics at the University of South Florida, Tampa.
Pericardial adipose tissue (PAT) is an ectopic fat depot composed of epicardial adipose tissue deep to the pericardium and surrounding the coronary arteries and paracardial tissue, which is located along the surface of the parietal pericardium. She and her associates tested whether PAT was positively associated with prevalent diabetes at the year-25 exam of the CARDIA study.
Examinations including volume of PAT measures from chest CT scans were performed during 2010-2011, and the researchers used multivariable logistic regression to examine the relation between quartiles of PAT and diabetes. There were four PAT quartiles: less than 33.5 cm3 (quartile 1/referent volume), between 33.5 and less than 48.7 cm3 (quartile 2), between 48.7 and less than 71.7 cm3 (quartile 3), and greater than 71.7 cm3 (quartile 4).
The mean age of the 3,079 study participants was 51 years, 44% were male, and their average body mass index was 31 kg/m2. Of these, 419 had prevalent diabetes. The prevalence of diabetes was highest in the fourth quartile of PAT volume (46% vs. 12% in the first quartile, 18% in the second, and 24% in the third), Dr. Alman reported.
In a logistic regression model of PAT volume on diabetes status by obesity, only PAT volume in the fourth quartile was significantly associated with diabetes status (odds ratio, 2.47), adjusted for field center, gender, age, race, systolic blood pressure, total cholesterol, triglycerides, and treatment with blood pressure– and cholesterol-lowering medications. A similar association was observed among nonobese patients (OR, 3.78).
"Deposition of a higher proportion of metabolically active ectopic fat is associated with diabetes in both obese and nonobese individuals," Dr. Alman concluded.
The analysis was "a very well characterized multicenter cohort study with a diverse racial cohort of middle-aged men and women," she added. Limitations of the study, she said, included its cross-sectional design, the fact that PAT was measured at a single point in time, and that it did not account for other ectopic fat depots such as liver fat. A longitudinal analysis of the participants is planned.
Dr. Alman had no relevant financial conflicts to disclose.
SAN FRANCISCO – A high volume of pericardial adipose tissue was associated with the prevalence of diabetes, independent of overall obesity, results from a long-term, diverse cohort study showed.
"Obesity is associated with an increased risk for cardiovascular disease and type 2 diabetes, and specific fat deposits may increase the risk more than others," Amy C. Alman, Ph.D., said at the annual scientific sessions of the American Diabetes Association.
The findings come from an analysis of year-25 exam data among 3,079 participants in CARDIA (Coronary Artery Risk Development in Young Adults), a longitudinal cohort study of the development of cardiovascular risk and disease that began in 1985 and was conducted at centers in Alabama, Minnesota, Illinois, and California.
Visceral adiposity "is metabolically active and more strongly associated with cardiovascular risk than subcutaneous adiposity. Ectopic adipose depots are metabolically active fat found in and around tissues and organs throughout the body, including the liver, muscles, and around the heart," explained Dr. Alman of the department of epidemiology and biostatistics at the University of South Florida, Tampa.
Pericardial adipose tissue (PAT) is an ectopic fat depot composed of epicardial adipose tissue deep to the pericardium and surrounding the coronary arteries and paracardial tissue, which is located along the surface of the parietal pericardium. She and her associates tested whether PAT was positively associated with prevalent diabetes at the year-25 exam of the CARDIA study.
Examinations including volume of PAT measures from chest CT scans were performed during 2010-2011, and the researchers used multivariable logistic regression to examine the relation between quartiles of PAT and diabetes. There were four PAT quartiles: less than 33.5 cm3 (quartile 1/referent volume), between 33.5 and less than 48.7 cm3 (quartile 2), between 48.7 and less than 71.7 cm3 (quartile 3), and greater than 71.7 cm3 (quartile 4).
The mean age of the 3,079 study participants was 51 years, 44% were male, and their average body mass index was 31 kg/m2. Of these, 419 had prevalent diabetes. The prevalence of diabetes was highest in the fourth quartile of PAT volume (46% vs. 12% in the first quartile, 18% in the second, and 24% in the third), Dr. Alman reported.
In a logistic regression model of PAT volume on diabetes status by obesity, only PAT volume in the fourth quartile was significantly associated with diabetes status (odds ratio, 2.47), adjusted for field center, gender, age, race, systolic blood pressure, total cholesterol, triglycerides, and treatment with blood pressure– and cholesterol-lowering medications. A similar association was observed among nonobese patients (OR, 3.78).
"Deposition of a higher proportion of metabolically active ectopic fat is associated with diabetes in both obese and nonobese individuals," Dr. Alman concluded.
The analysis was "a very well characterized multicenter cohort study with a diverse racial cohort of middle-aged men and women," she added. Limitations of the study, she said, included its cross-sectional design, the fact that PAT was measured at a single point in time, and that it did not account for other ectopic fat depots such as liver fat. A longitudinal analysis of the participants is planned.
Dr. Alman had no relevant financial conflicts to disclose.
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: The greater the volume of pericardial adipose tissue, the greater the risk of diabetes.
Major finding: In a logistic regression model of PAT volume on diabetes status by obesity, only PAT volume in the fourth quartile was significantly associated with diabetes status (OR, 2.47).
Data source: An analysis of data from 3,079 participants at the year-25 exam of the CARDIA study.
Disclosures: Dr. Alman said that she had no relevant financial conflicts.
Diabetes found in 17% of MI patients in registry
SAN FRANCISCO – About 17% of patients presenting with a myocardial infarction have undiagnosed diabetes, and their long-term mortality is similar regardless of what type of MI they had, according to analysis of data from the SWEETHEART registry.
The findings suggest that clinicians should "look for pathologic glucose metabolism in cardiac patients to identify those at high risk for subsequent events," Dr. Anselm K. Gitt said in an interview at the annual scientific sessions of the American Diabetes Association.
Similar findings were first documented in the Euro Heart Survey Programme of the European Society of Cardiology (ESC), according to Dr. Gitt, a cardiologist at Klinikum Ludwigshafen, Germany. Those findings led to the first common guidelines of cardiologists and diabetologists in Europe (ESC and the European Association for the Study of Diabetes), which recommended the routine use of oral glucose tolerance testing (OGTT) in cardiac patients," he said. "SWEETHEART was the first registry documenting the application of these recommendations in clinical practice."
For the observational study, which was carried out at 30 sites in Germany from October 2007 to September 2009, researchers enrolled 2,767 consecutive patients with ST-segment MI (STEMI) or non-STEMI (NSTEMI) to identify newly diagnosed cases of diabetes mellitus and to document outcomes. In patients without DM, the researchers performed OGGT at day 4 after the MI and went on to examine the impact of known and newly diagnosed DM on 3-year outcomes.
Dr. Gitt reported that OGTT detected new DM in 16% of STEMI patients and in 17.8% of NSTEMI patients. Patients with newly diagnosed DM were younger, compared with those who had known DM (a mean age of 66 years vs. 70 years, respectively, among STEMI patients, and a mean of 70 vs. 72 years among NSTEMI patients). They also had fewer concomitant diseases and fewer prior cardiovascular interventions such as percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery.
Three-year mortality was similar in the newly diagnosed DM patients (11% and 13.9% for STEMI patients and NSTEMI, respectively). In the patients with known diabetes, the rates were also similar, at 22.6% and 21%, albeit significantly higher than in the newly diagnosed patients. The proportion of major adverse cardiac and cerebrovascular events at 3 years was also similar among the newly diagnosed DM patients with STEMI and NSTEMI, at 16.8% and 17.9%, and again similar in the known DM group (28.5% and 28.7%) but significantly higher than the newly diagnosed group.
The findings are akin to those of a study recently presented at the American Heart Association’s Quality of Care and Outcomes Research conference, which showed a lower percentage of undiagnosed diabetes (10%) in similar circumstances. In that study, however, hemoglobin A1c was used as a screening tool for previously unknown diabetes. HbA1c "is only the first step of screening," emphasized Dr. Gitt, who was not involved in the study. "OGTT has a much higher sensitivity than HbA1c."
Regarding the clinical implications of the SWEETHEART findings, Dr. Gitt said that "as a cardiologist, I would say we should treat [STEMI and NSTEMI high-risk] patients more stringently to the guideline-recommended targets for blood pressure and also for lipid control. Of course, we have to treat the diabetes, although we know that glucose control doesn’t alter mortality."
The study was supported by an unrestricted grant from Sanofi and Roche Diagnostics. Dr. Gitt disclosed that he is a member of Sanofi’s advisory board.
On Twitter @dougbrunk
SAN FRANCISCO – About 17% of patients presenting with a myocardial infarction have undiagnosed diabetes, and their long-term mortality is similar regardless of what type of MI they had, according to analysis of data from the SWEETHEART registry.
The findings suggest that clinicians should "look for pathologic glucose metabolism in cardiac patients to identify those at high risk for subsequent events," Dr. Anselm K. Gitt said in an interview at the annual scientific sessions of the American Diabetes Association.
Similar findings were first documented in the Euro Heart Survey Programme of the European Society of Cardiology (ESC), according to Dr. Gitt, a cardiologist at Klinikum Ludwigshafen, Germany. Those findings led to the first common guidelines of cardiologists and diabetologists in Europe (ESC and the European Association for the Study of Diabetes), which recommended the routine use of oral glucose tolerance testing (OGTT) in cardiac patients," he said. "SWEETHEART was the first registry documenting the application of these recommendations in clinical practice."
For the observational study, which was carried out at 30 sites in Germany from October 2007 to September 2009, researchers enrolled 2,767 consecutive patients with ST-segment MI (STEMI) or non-STEMI (NSTEMI) to identify newly diagnosed cases of diabetes mellitus and to document outcomes. In patients without DM, the researchers performed OGGT at day 4 after the MI and went on to examine the impact of known and newly diagnosed DM on 3-year outcomes.
Dr. Gitt reported that OGTT detected new DM in 16% of STEMI patients and in 17.8% of NSTEMI patients. Patients with newly diagnosed DM were younger, compared with those who had known DM (a mean age of 66 years vs. 70 years, respectively, among STEMI patients, and a mean of 70 vs. 72 years among NSTEMI patients). They also had fewer concomitant diseases and fewer prior cardiovascular interventions such as percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery.
Three-year mortality was similar in the newly diagnosed DM patients (11% and 13.9% for STEMI patients and NSTEMI, respectively). In the patients with known diabetes, the rates were also similar, at 22.6% and 21%, albeit significantly higher than in the newly diagnosed patients. The proportion of major adverse cardiac and cerebrovascular events at 3 years was also similar among the newly diagnosed DM patients with STEMI and NSTEMI, at 16.8% and 17.9%, and again similar in the known DM group (28.5% and 28.7%) but significantly higher than the newly diagnosed group.
The findings are akin to those of a study recently presented at the American Heart Association’s Quality of Care and Outcomes Research conference, which showed a lower percentage of undiagnosed diabetes (10%) in similar circumstances. In that study, however, hemoglobin A1c was used as a screening tool for previously unknown diabetes. HbA1c "is only the first step of screening," emphasized Dr. Gitt, who was not involved in the study. "OGTT has a much higher sensitivity than HbA1c."
Regarding the clinical implications of the SWEETHEART findings, Dr. Gitt said that "as a cardiologist, I would say we should treat [STEMI and NSTEMI high-risk] patients more stringently to the guideline-recommended targets for blood pressure and also for lipid control. Of course, we have to treat the diabetes, although we know that glucose control doesn’t alter mortality."
The study was supported by an unrestricted grant from Sanofi and Roche Diagnostics. Dr. Gitt disclosed that he is a member of Sanofi’s advisory board.
On Twitter @dougbrunk
SAN FRANCISCO – About 17% of patients presenting with a myocardial infarction have undiagnosed diabetes, and their long-term mortality is similar regardless of what type of MI they had, according to analysis of data from the SWEETHEART registry.
The findings suggest that clinicians should "look for pathologic glucose metabolism in cardiac patients to identify those at high risk for subsequent events," Dr. Anselm K. Gitt said in an interview at the annual scientific sessions of the American Diabetes Association.
Similar findings were first documented in the Euro Heart Survey Programme of the European Society of Cardiology (ESC), according to Dr. Gitt, a cardiologist at Klinikum Ludwigshafen, Germany. Those findings led to the first common guidelines of cardiologists and diabetologists in Europe (ESC and the European Association for the Study of Diabetes), which recommended the routine use of oral glucose tolerance testing (OGTT) in cardiac patients," he said. "SWEETHEART was the first registry documenting the application of these recommendations in clinical practice."
For the observational study, which was carried out at 30 sites in Germany from October 2007 to September 2009, researchers enrolled 2,767 consecutive patients with ST-segment MI (STEMI) or non-STEMI (NSTEMI) to identify newly diagnosed cases of diabetes mellitus and to document outcomes. In patients without DM, the researchers performed OGGT at day 4 after the MI and went on to examine the impact of known and newly diagnosed DM on 3-year outcomes.
Dr. Gitt reported that OGTT detected new DM in 16% of STEMI patients and in 17.8% of NSTEMI patients. Patients with newly diagnosed DM were younger, compared with those who had known DM (a mean age of 66 years vs. 70 years, respectively, among STEMI patients, and a mean of 70 vs. 72 years among NSTEMI patients). They also had fewer concomitant diseases and fewer prior cardiovascular interventions such as percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery.
Three-year mortality was similar in the newly diagnosed DM patients (11% and 13.9% for STEMI patients and NSTEMI, respectively). In the patients with known diabetes, the rates were also similar, at 22.6% and 21%, albeit significantly higher than in the newly diagnosed patients. The proportion of major adverse cardiac and cerebrovascular events at 3 years was also similar among the newly diagnosed DM patients with STEMI and NSTEMI, at 16.8% and 17.9%, and again similar in the known DM group (28.5% and 28.7%) but significantly higher than the newly diagnosed group.
The findings are akin to those of a study recently presented at the American Heart Association’s Quality of Care and Outcomes Research conference, which showed a lower percentage of undiagnosed diabetes (10%) in similar circumstances. In that study, however, hemoglobin A1c was used as a screening tool for previously unknown diabetes. HbA1c "is only the first step of screening," emphasized Dr. Gitt, who was not involved in the study. "OGTT has a much higher sensitivity than HbA1c."
Regarding the clinical implications of the SWEETHEART findings, Dr. Gitt said that "as a cardiologist, I would say we should treat [STEMI and NSTEMI high-risk] patients more stringently to the guideline-recommended targets for blood pressure and also for lipid control. Of course, we have to treat the diabetes, although we know that glucose control doesn’t alter mortality."
The study was supported by an unrestricted grant from Sanofi and Roche Diagnostics. Dr. Gitt disclosed that he is a member of Sanofi’s advisory board.
On Twitter @dougbrunk
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: Nearly one-fifth of MI patients have undiagnosed diabetes, and their 3-year mortality was similar whether they had a STEMI or NSTEMI.
Major finding: In all, 16% and 17.8% of STEMI and NSTEMI patients had previously undiagnosed diabetes. Three-year mortality was similar between the two groups, at 11.1% and 13.9%.
Data source: An analysis of observational data from the SWEETHEART Registry, which enrolled 2,767 consecutive patients with STEMI or NSTEMI to identify newly diagnosed cases of diabetes mellitus and to document outcomes.
Disclosures: The study was supported by an unrestricted grant from Sanofi and Roche. Dr. Gitt is a member of Sanofi’s advisory board.
CKD considered a type 2 diabetes risk equivalent in CAD patients
SAN FRANCISCO – Among patients with coronary artery disease, those who have both chronic kidney disease and type 2 diabetes face a significantly increased risk of cardiovascular events, compared with those who have either condition separately, results from a novel study showed.
"Type 2 diabetes is a paramount risk factor for cardiovascular disease, in particular among patients with established coronary artery disease," Dr. Christoph H. Saely said at the annual scientific sessions of the American Diabetes Association. "Similarly, chronic kidney disease [CKD] confers a high risk of cardiovascular events in CAD patients. Whether type 2 diabetes or CKD has a more severe impact on event risk in this population is unknown in CAD patients. Whether type 2 diabetes or CKD has a more severe impact on event risk in this population is unknown. We aimed at investigating the single and joint effects of type 2 diabetes and of CKD on cardiovascular risk in patients with angiographically proven CAD."
Dr. Saely, of the Academic Teaching Hospital of Feldkirch, Austria, and his associates prospectively recorded cardiovascular events in a cohort of 1,423 patients with coronary artery disease as evidenced by angiography and followed them for 8 years. They defined CKD as an estimated glomerular filtration rate of less than 60 mL/min per 1.73 m² and defined type 2 diabetes with ADA criteria.
At baseline, the mean age of patients was 65 years, 72% were male, and 66% had hypertension.
The researchers found that the risk of cardiovascular events was significantly higher in patients with type 2 diabetes than in nondiabetic subjects, at 39% and 29%, respectively. That risk was also significantly higher in patients with CKD than in those without it, at 47% and 29%, respectively.
Of the 1,423 patients, 841 had neither type 2 diabetes nor CKD, 336 had type 2 diabetes but not CKD, 145 had CKD but not diabetes, and 101 had both conditions. Dr. Saely reported that the rate of cardiovascular events among patients with neither type 2 diabetes nor CKD was 26%. In contrast, the rates of cardiovascular events were significantly higher in patients with type 2 diabetes who did not have CKD, at 35%; and in nondiabetic patients with CKD, at 43%; and were highest in patients with both conditions, at 54%.
The researchers also found that patients with type 2 diabetes and CKD faced a significantly higher risk of cardiovascular events, compared with those who had type 2 diabetes but no CKD, and in those without type 2 diabetes but with CKD. Event rates were similar in patients with type 2 diabetes but not CKD and in nondiabetic patients with CKD.
Dr. Saely said that he had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
SAN FRANCISCO – Among patients with coronary artery disease, those who have both chronic kidney disease and type 2 diabetes face a significantly increased risk of cardiovascular events, compared with those who have either condition separately, results from a novel study showed.
"Type 2 diabetes is a paramount risk factor for cardiovascular disease, in particular among patients with established coronary artery disease," Dr. Christoph H. Saely said at the annual scientific sessions of the American Diabetes Association. "Similarly, chronic kidney disease [CKD] confers a high risk of cardiovascular events in CAD patients. Whether type 2 diabetes or CKD has a more severe impact on event risk in this population is unknown in CAD patients. Whether type 2 diabetes or CKD has a more severe impact on event risk in this population is unknown. We aimed at investigating the single and joint effects of type 2 diabetes and of CKD on cardiovascular risk in patients with angiographically proven CAD."
Dr. Saely, of the Academic Teaching Hospital of Feldkirch, Austria, and his associates prospectively recorded cardiovascular events in a cohort of 1,423 patients with coronary artery disease as evidenced by angiography and followed them for 8 years. They defined CKD as an estimated glomerular filtration rate of less than 60 mL/min per 1.73 m² and defined type 2 diabetes with ADA criteria.
At baseline, the mean age of patients was 65 years, 72% were male, and 66% had hypertension.
The researchers found that the risk of cardiovascular events was significantly higher in patients with type 2 diabetes than in nondiabetic subjects, at 39% and 29%, respectively. That risk was also significantly higher in patients with CKD than in those without it, at 47% and 29%, respectively.
Of the 1,423 patients, 841 had neither type 2 diabetes nor CKD, 336 had type 2 diabetes but not CKD, 145 had CKD but not diabetes, and 101 had both conditions. Dr. Saely reported that the rate of cardiovascular events among patients with neither type 2 diabetes nor CKD was 26%. In contrast, the rates of cardiovascular events were significantly higher in patients with type 2 diabetes who did not have CKD, at 35%; and in nondiabetic patients with CKD, at 43%; and were highest in patients with both conditions, at 54%.
The researchers also found that patients with type 2 diabetes and CKD faced a significantly higher risk of cardiovascular events, compared with those who had type 2 diabetes but no CKD, and in those without type 2 diabetes but with CKD. Event rates were similar in patients with type 2 diabetes but not CKD and in nondiabetic patients with CKD.
Dr. Saely said that he had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
SAN FRANCISCO – Among patients with coronary artery disease, those who have both chronic kidney disease and type 2 diabetes face a significantly increased risk of cardiovascular events, compared with those who have either condition separately, results from a novel study showed.
"Type 2 diabetes is a paramount risk factor for cardiovascular disease, in particular among patients with established coronary artery disease," Dr. Christoph H. Saely said at the annual scientific sessions of the American Diabetes Association. "Similarly, chronic kidney disease [CKD] confers a high risk of cardiovascular events in CAD patients. Whether type 2 diabetes or CKD has a more severe impact on event risk in this population is unknown in CAD patients. Whether type 2 diabetes or CKD has a more severe impact on event risk in this population is unknown. We aimed at investigating the single and joint effects of type 2 diabetes and of CKD on cardiovascular risk in patients with angiographically proven CAD."
Dr. Saely, of the Academic Teaching Hospital of Feldkirch, Austria, and his associates prospectively recorded cardiovascular events in a cohort of 1,423 patients with coronary artery disease as evidenced by angiography and followed them for 8 years. They defined CKD as an estimated glomerular filtration rate of less than 60 mL/min per 1.73 m² and defined type 2 diabetes with ADA criteria.
At baseline, the mean age of patients was 65 years, 72% were male, and 66% had hypertension.
The researchers found that the risk of cardiovascular events was significantly higher in patients with type 2 diabetes than in nondiabetic subjects, at 39% and 29%, respectively. That risk was also significantly higher in patients with CKD than in those without it, at 47% and 29%, respectively.
Of the 1,423 patients, 841 had neither type 2 diabetes nor CKD, 336 had type 2 diabetes but not CKD, 145 had CKD but not diabetes, and 101 had both conditions. Dr. Saely reported that the rate of cardiovascular events among patients with neither type 2 diabetes nor CKD was 26%. In contrast, the rates of cardiovascular events were significantly higher in patients with type 2 diabetes who did not have CKD, at 35%; and in nondiabetic patients with CKD, at 43%; and were highest in patients with both conditions, at 54%.
The researchers also found that patients with type 2 diabetes and CKD faced a significantly higher risk of cardiovascular events, compared with those who had type 2 diabetes but no CKD, and in those without type 2 diabetes but with CKD. Event rates were similar in patients with type 2 diabetes but not CKD and in nondiabetic patients with CKD.
Dr. Saely said that he had no relevant financial conflicts to disclose.
On Twitter @dougbrunk
AT THE ADA ANNUAL SCIENTIFIC SESSIONS
Key clinical point: Type 2 diabetes and chronic kidney disease contribute synergistically to cardiac event risk in patients with established coronary artery disease.
Major finding: Among patients with CAD, the rate of cardiovascular events was 35% in those with type 2 diabetes but not CKD, 43% in nondiabetic patients with CKD, and 54% in those who had both diabetes and CKD.
Data source: A prospective study of 1,423 patients with CAD as evidenced by angiography.
Disclosures: Dr. Saely had no relevant financial conflicts to disclose.
Subsyndromal delirium common in critically ill patients
SAN DIEGO – Subsyndromal delirium was present in 86% of critically ill patients, results from a large observational study demonstrated. In addition, the duration of delirium was associated with increased odds of institutionalization, an association that was modified by the duration of delirium.
"In patients with less delirium, the effect of subsyndromal delirium on institutionalization was actually stronger," lead author Dr. Nathan E. Brummel said in an interview at an international conference of the American Thoracic Society, where the research was presented. "This identifies a cohort of people who previously were considered to have normal brain function, but it appears that this has long-term implications for their lives.
"Screening for delirium should occur not only in the ICU but on the wards as well. Patients who have delirium or delirium symptoms may benefit from measures used to prevent and treat this syndrome, such as the Hospital Elder Life Program, routine mobilization, and frequent reorientation through the use of nursing staff or even family members," he later added. This study data may help clinicians discuss long-term outcomes of critical illness with patients and their family members," he said.
For the study, Dr. Brummel, an instructor in medicine in the division of allergy, pulmonary and critical care medicine at Vanderbilt University Medical Center, Nashville, Tenn., and his associates evaluated 821 medical or surgical ICU patients with respiratory failure and/or shock who were enrolled in the BRAIN-ICU observational cohort study (N. Engl. J. Med. 2013;369:1306-16).
They used the Confusion Assessment Method for the ICU (CAM-ICU) to screen for delirium symptoms twice daily in the ICU and daily thereafter. The researchers considered delirium to be present if the CAM-ICU was positive. If the CAM-ICU was negative, they considered subsyndromal delirium (SSD) to be present if any delirium features were present or if inattention was present with or without other features of delirium.
SSD "is said to be present when a patient exhibits some delirium symptoms but does not meet the full delirium diagnostic criteria," the researchers wrote in their poster. "In patients without critical illness, SSD is associated with institutionalization, mortality, and cognitive decline, but these associations remain unclear in the critically ill."
The researchers tracked discharge location, mortality after hospital discharge and assessed for cognitive impairment at 3 and 12 months follow-up and used multivariate regression to determine the relationship between days of SSD and outcomes.
The mean age of the 821 patients was 61 years and their mean APACHE II score was 25. In all, 702 patients (86%) had SSD that lasted an average of 3 days. The most common SSU pattern based on the CAM-ICU was fluctuation of mental status (which occurred in 50% of assessments) and fluctuation in mental status plus altered level of consciousness (which occurred in 22% of assessments).
Dr. Brummel and his associates also found that the duration of SSD was independently associated with increased odds of institutionalization (odds ratio, 1.90), but SSD did not predict mortality or long-term cognitive impairment at 3 or 12 months. "We don’t yet understand the mechanism behind why subsyndromal delirium and institutionalization are associated," Dr. Brummel said. "It probably relates to an association between SSD and factors that drive institutionalization, such as physical disability and cognitive impairment. Once patients survived the hospital stay, subsyndromal delirium wasn’t associated with an increased risk of mortality. It may be the fact that this less severe form of brain dysfunction in the ICU does not have the same effect as the full syndrome of delirium."
He acknowledged certain limitations of the study, including the fact that the CAM-ICU measures only four features of delirium and that no assessments of cognitive or physical function were conducted at hospital discharge.
The study was supported by the National Institutes of Health, the Vanderbilt Clinical and Translational Scholars Program, and the Veterans Affairs Tennessee Valley Healthcare System Geriatric Research Education and Clinical Centers. Dr. Brummel said that he had no financial conflicts.
dbrunk@frontlinemedcom.com
SAN DIEGO – Subsyndromal delirium was present in 86% of critically ill patients, results from a large observational study demonstrated. In addition, the duration of delirium was associated with increased odds of institutionalization, an association that was modified by the duration of delirium.
"In patients with less delirium, the effect of subsyndromal delirium on institutionalization was actually stronger," lead author Dr. Nathan E. Brummel said in an interview at an international conference of the American Thoracic Society, where the research was presented. "This identifies a cohort of people who previously were considered to have normal brain function, but it appears that this has long-term implications for their lives.
"Screening for delirium should occur not only in the ICU but on the wards as well. Patients who have delirium or delirium symptoms may benefit from measures used to prevent and treat this syndrome, such as the Hospital Elder Life Program, routine mobilization, and frequent reorientation through the use of nursing staff or even family members," he later added. This study data may help clinicians discuss long-term outcomes of critical illness with patients and their family members," he said.
For the study, Dr. Brummel, an instructor in medicine in the division of allergy, pulmonary and critical care medicine at Vanderbilt University Medical Center, Nashville, Tenn., and his associates evaluated 821 medical or surgical ICU patients with respiratory failure and/or shock who were enrolled in the BRAIN-ICU observational cohort study (N. Engl. J. Med. 2013;369:1306-16).
They used the Confusion Assessment Method for the ICU (CAM-ICU) to screen for delirium symptoms twice daily in the ICU and daily thereafter. The researchers considered delirium to be present if the CAM-ICU was positive. If the CAM-ICU was negative, they considered subsyndromal delirium (SSD) to be present if any delirium features were present or if inattention was present with or without other features of delirium.
SSD "is said to be present when a patient exhibits some delirium symptoms but does not meet the full delirium diagnostic criteria," the researchers wrote in their poster. "In patients without critical illness, SSD is associated with institutionalization, mortality, and cognitive decline, but these associations remain unclear in the critically ill."
The researchers tracked discharge location, mortality after hospital discharge and assessed for cognitive impairment at 3 and 12 months follow-up and used multivariate regression to determine the relationship between days of SSD and outcomes.
The mean age of the 821 patients was 61 years and their mean APACHE II score was 25. In all, 702 patients (86%) had SSD that lasted an average of 3 days. The most common SSU pattern based on the CAM-ICU was fluctuation of mental status (which occurred in 50% of assessments) and fluctuation in mental status plus altered level of consciousness (which occurred in 22% of assessments).
Dr. Brummel and his associates also found that the duration of SSD was independently associated with increased odds of institutionalization (odds ratio, 1.90), but SSD did not predict mortality or long-term cognitive impairment at 3 or 12 months. "We don’t yet understand the mechanism behind why subsyndromal delirium and institutionalization are associated," Dr. Brummel said. "It probably relates to an association between SSD and factors that drive institutionalization, such as physical disability and cognitive impairment. Once patients survived the hospital stay, subsyndromal delirium wasn’t associated with an increased risk of mortality. It may be the fact that this less severe form of brain dysfunction in the ICU does not have the same effect as the full syndrome of delirium."
He acknowledged certain limitations of the study, including the fact that the CAM-ICU measures only four features of delirium and that no assessments of cognitive or physical function were conducted at hospital discharge.
The study was supported by the National Institutes of Health, the Vanderbilt Clinical and Translational Scholars Program, and the Veterans Affairs Tennessee Valley Healthcare System Geriatric Research Education and Clinical Centers. Dr. Brummel said that he had no financial conflicts.
dbrunk@frontlinemedcom.com
SAN DIEGO – Subsyndromal delirium was present in 86% of critically ill patients, results from a large observational study demonstrated. In addition, the duration of delirium was associated with increased odds of institutionalization, an association that was modified by the duration of delirium.
"In patients with less delirium, the effect of subsyndromal delirium on institutionalization was actually stronger," lead author Dr. Nathan E. Brummel said in an interview at an international conference of the American Thoracic Society, where the research was presented. "This identifies a cohort of people who previously were considered to have normal brain function, but it appears that this has long-term implications for their lives.
"Screening for delirium should occur not only in the ICU but on the wards as well. Patients who have delirium or delirium symptoms may benefit from measures used to prevent and treat this syndrome, such as the Hospital Elder Life Program, routine mobilization, and frequent reorientation through the use of nursing staff or even family members," he later added. This study data may help clinicians discuss long-term outcomes of critical illness with patients and their family members," he said.
For the study, Dr. Brummel, an instructor in medicine in the division of allergy, pulmonary and critical care medicine at Vanderbilt University Medical Center, Nashville, Tenn., and his associates evaluated 821 medical or surgical ICU patients with respiratory failure and/or shock who were enrolled in the BRAIN-ICU observational cohort study (N. Engl. J. Med. 2013;369:1306-16).
They used the Confusion Assessment Method for the ICU (CAM-ICU) to screen for delirium symptoms twice daily in the ICU and daily thereafter. The researchers considered delirium to be present if the CAM-ICU was positive. If the CAM-ICU was negative, they considered subsyndromal delirium (SSD) to be present if any delirium features were present or if inattention was present with or without other features of delirium.
SSD "is said to be present when a patient exhibits some delirium symptoms but does not meet the full delirium diagnostic criteria," the researchers wrote in their poster. "In patients without critical illness, SSD is associated with institutionalization, mortality, and cognitive decline, but these associations remain unclear in the critically ill."
The researchers tracked discharge location, mortality after hospital discharge and assessed for cognitive impairment at 3 and 12 months follow-up and used multivariate regression to determine the relationship between days of SSD and outcomes.
The mean age of the 821 patients was 61 years and their mean APACHE II score was 25. In all, 702 patients (86%) had SSD that lasted an average of 3 days. The most common SSU pattern based on the CAM-ICU was fluctuation of mental status (which occurred in 50% of assessments) and fluctuation in mental status plus altered level of consciousness (which occurred in 22% of assessments).
Dr. Brummel and his associates also found that the duration of SSD was independently associated with increased odds of institutionalization (odds ratio, 1.90), but SSD did not predict mortality or long-term cognitive impairment at 3 or 12 months. "We don’t yet understand the mechanism behind why subsyndromal delirium and institutionalization are associated," Dr. Brummel said. "It probably relates to an association between SSD and factors that drive institutionalization, such as physical disability and cognitive impairment. Once patients survived the hospital stay, subsyndromal delirium wasn’t associated with an increased risk of mortality. It may be the fact that this less severe form of brain dysfunction in the ICU does not have the same effect as the full syndrome of delirium."
He acknowledged certain limitations of the study, including the fact that the CAM-ICU measures only four features of delirium and that no assessments of cognitive or physical function were conducted at hospital discharge.
The study was supported by the National Institutes of Health, the Vanderbilt Clinical and Translational Scholars Program, and the Veterans Affairs Tennessee Valley Healthcare System Geriatric Research Education and Clinical Centers. Dr. Brummel said that he had no financial conflicts.
dbrunk@frontlinemedcom.com
Key clinical point: Patients who have even a few delirium symptoms may benefit from prevention and treatment measures.
Major finding: Among 821 critically ill patients, 702 (86%) had subsyndromal delirium that lasted an average of 3 days.
Data source: An evaluation of 821 medical or surgical ICU patients with respiratory failure and/or shock who were enrolled in the BRAIN-ICU observational cohort study.
Disclosures: The study was supported by the National Institutes of Health, the Vanderbilt Clinical and Translational Scholars Program, and the VA Tennessee Valley Healthcare System Geriatric Research Education and Clinical Centers. Dr. Brummel had no financial conflicts.
Home-based OSA testing costs less than lab-based testing
SAN DIEGO – Home-based testing for obstructive sleep apnea averaged $564 less than laboratory-based testing and did not increase other costs or produce clinically inferior outcomes, based on data from a study of Veterans Affairs patients.
"If you do the home testing approach, that saves you money right off the bat, compared with laboratory testing," Dr. Charles W. Atwood, FCCP, associate professor of medicine at the University of Pittsburgh, said in an interview in advance of an international conference of the American Thoracic Society.
"Everything else for the patients is pretty comparable," he said. "That’s a good thing for people in favor of home testing. People don’t have deleterious outcomes because they were evaluated in the home setting, or because treatment was initiated in the home setting instead of a laboratory setting. People don’t generate more health care bills because they were evaluated in the home instead of in a lab."
In what he characterized as the most comprehensive study of its kind, Dr. Atwood, also director of the sleep disorders program for the VA Pittsburgh Health Care System and his associates enrolled 296 patients from two VA sites who were randomized to standard in-laboratory polysomnography testing (lab group) or unattended home testing (home group). Patients in the home group underwent overnight recording with an Embla type 3 portable monitor followed by at least three nights of using a Philips Respironics auto-titrating positive airway pressure apparatus.
The researchers obtained data from case report forms, staff logs, and VA records, and categorized the costs as sleep-related, pharmaceutical, lab, hospital, or "other."
The majority of participants (95%) were male. Of the 296 patients, 223 (110 in the lab group and 113 in the home group) were initiated on continuous positive airway pressure (CPAP).
After an average follow-up of 2.75 years, the researchers determined that home-based testing costs were $564 lower, compared with lab-based testing (an average per-patient cost of $4,057 vs. $4,621, respectively; P = .007). Differences in the other four categories of cost did not reach statistical significance, with P values ranging between .19 and .82. Results of the Functional Outcomes of Sleep Questionnaire revealed no statistical difference in clinical outcomes between the two groups.
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Dr. Paul A. Selecky, FCCP, comments: Most doctors who practice sleep medicine would agree with these results, always considering that certain patients would not perform a home study well, such as the frail elderly patients. What is interesting in this study is that patients with comorbidities were not excluded, and yet the outcome was no different.
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Dr. Paul A. Selecky, FCCP, comments: Most doctors who practice sleep medicine would agree with these results, always considering that certain patients would not perform a home study well, such as the frail elderly patients. What is interesting in this study is that patients with comorbidities were not excluded, and yet the outcome was no different.
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Dr. Paul A. Selecky, FCCP, comments: Most doctors who practice sleep medicine would agree with these results, always considering that certain patients would not perform a home study well, such as the frail elderly patients. What is interesting in this study is that patients with comorbidities were not excluded, and yet the outcome was no different.
SAN DIEGO – Home-based testing for obstructive sleep apnea averaged $564 less than laboratory-based testing and did not increase other costs or produce clinically inferior outcomes, based on data from a study of Veterans Affairs patients.
"If you do the home testing approach, that saves you money right off the bat, compared with laboratory testing," Dr. Charles W. Atwood, FCCP, associate professor of medicine at the University of Pittsburgh, said in an interview in advance of an international conference of the American Thoracic Society.
"Everything else for the patients is pretty comparable," he said. "That’s a good thing for people in favor of home testing. People don’t have deleterious outcomes because they were evaluated in the home setting, or because treatment was initiated in the home setting instead of a laboratory setting. People don’t generate more health care bills because they were evaluated in the home instead of in a lab."
In what he characterized as the most comprehensive study of its kind, Dr. Atwood, also director of the sleep disorders program for the VA Pittsburgh Health Care System and his associates enrolled 296 patients from two VA sites who were randomized to standard in-laboratory polysomnography testing (lab group) or unattended home testing (home group). Patients in the home group underwent overnight recording with an Embla type 3 portable monitor followed by at least three nights of using a Philips Respironics auto-titrating positive airway pressure apparatus.
The researchers obtained data from case report forms, staff logs, and VA records, and categorized the costs as sleep-related, pharmaceutical, lab, hospital, or "other."
The majority of participants (95%) were male. Of the 296 patients, 223 (110 in the lab group and 113 in the home group) were initiated on continuous positive airway pressure (CPAP).
After an average follow-up of 2.75 years, the researchers determined that home-based testing costs were $564 lower, compared with lab-based testing (an average per-patient cost of $4,057 vs. $4,621, respectively; P = .007). Differences in the other four categories of cost did not reach statistical significance, with P values ranging between .19 and .82. Results of the Functional Outcomes of Sleep Questionnaire revealed no statistical difference in clinical outcomes between the two groups.
SAN DIEGO – Home-based testing for obstructive sleep apnea averaged $564 less than laboratory-based testing and did not increase other costs or produce clinically inferior outcomes, based on data from a study of Veterans Affairs patients.
"If you do the home testing approach, that saves you money right off the bat, compared with laboratory testing," Dr. Charles W. Atwood, FCCP, associate professor of medicine at the University of Pittsburgh, said in an interview in advance of an international conference of the American Thoracic Society.
"Everything else for the patients is pretty comparable," he said. "That’s a good thing for people in favor of home testing. People don’t have deleterious outcomes because they were evaluated in the home setting, or because treatment was initiated in the home setting instead of a laboratory setting. People don’t generate more health care bills because they were evaluated in the home instead of in a lab."
In what he characterized as the most comprehensive study of its kind, Dr. Atwood, also director of the sleep disorders program for the VA Pittsburgh Health Care System and his associates enrolled 296 patients from two VA sites who were randomized to standard in-laboratory polysomnography testing (lab group) or unattended home testing (home group). Patients in the home group underwent overnight recording with an Embla type 3 portable monitor followed by at least three nights of using a Philips Respironics auto-titrating positive airway pressure apparatus.
The researchers obtained data from case report forms, staff logs, and VA records, and categorized the costs as sleep-related, pharmaceutical, lab, hospital, or "other."
The majority of participants (95%) were male. Of the 296 patients, 223 (110 in the lab group and 113 in the home group) were initiated on continuous positive airway pressure (CPAP).
After an average follow-up of 2.75 years, the researchers determined that home-based testing costs were $564 lower, compared with lab-based testing (an average per-patient cost of $4,057 vs. $4,621, respectively; P = .007). Differences in the other four categories of cost did not reach statistical significance, with P values ranging between .19 and .82. Results of the Functional Outcomes of Sleep Questionnaire revealed no statistical difference in clinical outcomes between the two groups.
Key clinical point: Patients did not have poor outcomes because they were evaluated in the home setting, or because treatment was initiated in the home setting instead of a laboratory setting.
Major finding: Home-based testing costs for obstructive sleep apnea were $564 lower, compared with lab-based testing costs, after a follow-up of 2.75 years.
Data source: 296 patients from two VA sites who were randomized to standard in-laboratory polysomnography testing or unattended home testing.
Disclosures: Embla provided the portable monitors used in the study, and Philips Respironics provided the auto-titrating CPAP apparatus. The study was funded by the VA’s Health Research and Development Service. Dr. Atwood had no relevant financial conflicts to disclose.
