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| Medical Economics | Drug Topics | Formulary | Contemporary OB/GYN |
 Daily highlights from the American Diabetes Association 70th Scientific Sessions. From June 25—29, the editors of Medical Economics and Advanstar Communications' other primary care and pharmacy publications will bring you the latest news from Orlando. |
Welcome Greetings from the American Diabetes Association’s 70th Scientific Sessions June 28 – Orlando — The editorial staff of Medical Economics brings you daily coverage of breaking news, the latest research findings, and reports of interest to the readers of Medical Economics, Drug Topics, Formulary, and Contemporary OB/GYN. Our five-day coverage of this year’s American Diabetes Association’s 70th Scientific Sessions begins today and includes the results of major clinical trials and ongoing news and information of interest to clinicians who treat type 1 and 2 diabetes. BREAKING NEWS HbA1clevels correlate strongly to future diabetes, cardiovascular risk
The ADA now recommends the use of HbA1c for the diagnosis of diabetes and identification of persons at increased risk for diabetes. The ADA defines an HbA1c of 5.7% to less than 6.5% as “high risk” for the future development of diabetes. In this analysis, 11,092 participants from ARIC, a large community-based epidemiologic study, without cardiovascular disease or diabetes at baseline had HbA1c measured from stored whole blood samples obtained between 1990 and 1992. Participants were followed for 15 years. “In individuals with an A1c of 5.7% to less than 6.5%, which is the group identified as high risk for the development of diabetes and other complications, we see a very high risk of the subsequent development of diabetes. We can also see that individuals in that range are at risk for kidney disease, CHD [coronary heart disease], and stroke,” said Selvin, assistant professor of epidemiology and medicine at Johns Hopkins in Baltimore. Compared with the reference population with an HbA1c level of 5% to less than 5.7%, those in the high-risk category of 5.7% to less than 6.5% had more than triple the risk of diagnosed diabetes, a 60% increase in the risk of CHD, a 56% increase in the risk of stroke, a 62% increased risk of end-stage renal disease, and a 42% increase in all-cause mortality, all adjusted for age, sex, race, and other potential confounders. These risks were even greater in the cohort with HbA1c levels of 6.5% or greater at baseline. “The vast majority of individuals with HbA1c greater than 6.5% will subsequently be diagnosed with diabetes during follow-up, and they’re at very high risk of kidney disease and have almost 4 times the risk of developing end-stage renal disease compared to those people in the normal range, and a 2-fold increased risk of developing CHD or stroke or dying during follow-up,” she said. More than 20% of the group with HbA1c values of 5.7% to less than 6.5% and almost 80% of those with values of 6.5% or greater developed diabetes within 10 years. CLINICAL TRIAL RESULTS One-year data on exenatide show that improvements in HbA1c and CV risk markers are maintained In patients with type 2 diabetes, treatment with exenatide once weekly for 1 year results in sustained improvements in glycemic control, body weight, cardiovascular risk markers, and markers of hepatic injury, according to a pooled analysis of 2 large clinical trials. The data were presented by Edward Horton, MD, associate program director, Joslin Clinical Research Center, Boston. The analysis included 223 patients who were treated with exenatide during the first 52 weeks of the DURATION-1 and DURATION-2 randomized clinical trials of patients with type 2 diabetes and baseline hemoglobin (Hb) A1c values of 7.1% to 11%. Patients in these trials were on background therapy with either diet and exercise, metformin, a sulfonylurea, or a thiazolidinedione (or 2 such agents in combination). Levels of HbA1c declined by a mean of more than 0.8% by 6 weeks of treatment with exenatide, a reduction that was maintained to 52 weeks with continuation of weekly exenatide (final mean reduction in HbA1c, 1.5%). Similarly, the mean fasting plasma glucose level improved by more than 35 mg/dL at 6 weeks, with a final reduction of 37 mg/dL at week 52. At 52 weeks, 65% of exenatide-treated patients achieved the ADA HbA1c target of less than 7%. A significant reduction in body weight was observed by week 6; and at week 52, the mean reduction in body weight from baseline was 3.0 kg. Significant reductions in systolic blood pressure, diastolic blood pressure, high-density lipoprotein cholesterol, and levels of the hepatic injury markers alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were also observed with exenatide for 52 weeks. The incidence of minor hypoglycemia was 5%, and there were no instances of major hypoglycemia with exenatide. “Diabesity” strongly associated with increased frequency of macrosomia
The finding comes from an analysis of the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study, which was designed to find the level of glucose tolerance, short of diabetes, that is associated with risk of adverse outcome. The study included 23,316 pregnant women who underwent 75-g oral glucose tolerance testing at 24 to 32 weeks’ gestation and whose glucose levels were blinded to caregivers. The main study, published in 2008, found continuous, independent associations of measures of maternal glycemia and body mass index (BMI) at the 75-g oral glucose tolerance test with predefined perinatal outcomes (increased birth weight and increased cord-blood serum C-peptide levels). For the present analysis, the relative contributions of gestational diabetes and maternal obesity to risk of macrosomia (birth weight of 4,000 g or greater) were examined. Maternal BMI was classified as nonobese or obese by modification of the 2009 Institute of Medicine recommendations. The observed number of cases of macrosomia in the nonobese group with gestational diabetes was 286, compared to an expected number of 186, for an excess number of 100 cases. “Obesity was associated with a 2-fold higher frequency of macrosomia” whether or not the women had gestational diabetes, said Metzger, professor of metabolism and nutrition, division of endocrinology, metabolism, and molecular medicine, Northwestern University, Chicago. Among the obese group, the excess number of cases of macrosomia was 154 in the group without gestational diabetes (151 expected, 305 observed) and 126 in the group with gestational diabetes (63 expected, 189 observed). In the 380 total instances of excess macrosomia, gestational diabetes only was present in 26%, gestational diabetes plus obesity was present in 33%, and obesity only was present in 41%. In 2009, a task force of the International Association of Diabetes and Pregnancy Study Groups recommended that the diagnosis of gestational diabetes be made when 1 or more of the following thresholds is met or exceeded: fasting plasma glucose of 92 mg/dL (5.1 mmol/L); 1-hour plasma glucose of 180 mg/dL (10 mmol/L); 2-hour plasma glucose of 153 mg/dL (8.5 mmol/L). These proposed diagnostic criteria are based on their predictive value for adverse pregnancy outcomes from the original HAPO study. Liraglutide clinical trial program suggests higher rates of achievement of HbA1c targets without weight gain or hypoglycemia versus active comparators A post hoc analysis of 5 clinical trials of liraglutide suggests that it was significantly better than active comparators on a composite endpoint of hemoglobin (Hb) A1c less than 7% without hypoglycemia or weight gain, reported French investigators. Five of 6 clinical trials in the phase 3 Liraglutide Effect and Action in Diabetes (LEAD) program compared liraglutide to active comparators (glimepiride, rosiglitazone, insulin glargine, or exenatide) in patients with type 2 diabetes. In these trials, which had as their primary endpoint a reduction in HbA1c levels, a reduction of HbA1c of 1.0% to 1.5% was observed with liraglutide 1.8 mg at 26 weeks, together with weight loss, no major hypoglycemic events, and a very low frequency of minor hypoglycemia, said Bernard Charbonnel, MD, professor of endocrinology and metabolic diseases at the University of Nantes, France, and head of the internal medicine, endocrinology and diabetes department at the Hôtel Dieu (University Hospital of Nantes). A composite endpoint of achievement of an HbA1c target of less than 7% with no hypoglycemia and no weight gain was assessed for all comparisons in the trials, all of which were 26 weeks in duration. All 3 components of the composite endpoint are key factors in developing treatment recommendations, notes Charbonnel. (This composite endpoint was not a predefined endpoint of the studies.)
NEW RESEARCH Diet can affect type 2 diabetes risk
“It is important to replace red and processed meats with other choices, chicken and fish and especially vegetable protein sources,” said Lawrence de Koning, PhD, postdoctoral fellow, Harvard School of Public Health, Boston. “The data show us that vegetable-based protein does not elevate the risk of diabetes and may very well be protective.” It has long been recognized that low-carbohydrate diets appear to be protective for cardiovascular and other diseases. Low-carbohydrate diets are also frequently used for weight loss. But the relationship between low-carbohydrate diets and type 2 diabetes risk is less clear, de Koning said. Researchers analyzed food consumption reports submitted every 4 years by the HPFS participants and the occurrence of type 2 diabetes to assess dietary risk factors. Food questionnaire responses were used to score 3 low-carbohydrate diets: high-total protein/fat, high-animal protein/fat, and high-vegetable protein/fat. There were 2,761 cases of type 2 disease reported during the follow-up period. Hazard ratios (HRs) were calculated after adjusting for age, smoking, physical activity, body-mass index, coffee and alcohol use, family history of diabetes, and total energy. The high-animal protein/fat diet carried the highest risk for type 2 diabetes (HR, 1.41; P<.0001), followed by the high-total protein/fat diet (HR, 1.32; The high-total protein/fat diet lost its type 2 diabetes risk after adjusting for animal protein and fat. The HR associated with the high-animal protein/fat diet was reduced to 1.19 (P=.01) after adjusting for red and processed meats, but there was no change in risk after adjusting for poultry or fish. “The risk relationship with red and processed meats is linear,” de Koning said. “At low levels of intake, you might have a low level of risk that can be offset by some other protective factor such as more exercise.” Results of the HPFS analysis suggest that the key to reducing type 2 diabetes risk is to follow a prudent diet that is high in whole grains, moderate in alcohol, and low in red and processed meats, sodium, and sugar-sweetened beverages. NEW RESEARCH Diet can affect type 2 diabetes risk
Dietary choices can have a discernable effect on the risk of developing type 2 diabetes. That conclusion is based on analysis of men in the Health Professionals Follow-Up Study (HPFS), which followed 41,212 men for up to 20 years. “It is important to replace red and processed meats with other choices, chicken and fish and especially vegetable protein sources,” said Lawrence de Koning, PhD, postdoctoral fellow, Harvard School of Public Health, Boston. “The data show us that vegetable-based protein does not elevate the risk of diabetes and may very well be protective.” It has long been recognized that low-carbohydrate diets appear to be protective for cardiovascular and other diseases. Low-carbohydrate diets are also frequently used for weight loss. But the relationship between low-carbohydrate diets and type 2 diabetes risk is less clear, de Koning said. Researchers analyzed food consumption reports submitted every 4 years by the HPFS participants and the occurrence of type 2 diabetes to assess dietary risk factors. Food questionnaire responses were used to score 3 low-carbohydrate diets: high-total protein/fat, high-animal protein/fat, and high-vegetable protein/fat. There were 2,761 cases of type 2 disease reported during the follow-up period. Hazard ratios (HRs) were calculated after adjusting for age, smoking, physical activity, body-mass index, coffee and alcohol use, family history of diabetes, and total energy. The high-animal protein/fat diet carried the highest risk for type 2 diabetes (HR, 1.41; P<.0001), followed by the high-total protein/fat diet (HR, 1.32; The high-total protein/fat diet lost its type 2 diabetes risk after adjusting for animal protein and fat. The HR associated with the high-animal protein/fat diet was reduced to 1.19 (P=.01) after adjusting for red and processed meats, but there was no change in risk after adjusting for poultry or fish. “The risk relationship with red and processed meats is linear,” de Koning said. “At low levels of intake, you might have a low level of risk that can be offset by some other protective factor such as more exercise.” Results of the HPFS analysis suggest that the key to reducing type 2 diabetes risk is to follow a prudent diet that is high in whole grains, moderate in alcohol, and low in red and processed meats, sodium, and sugar-sweetened beverages. NEW RESEARCH Diet can affect type 2 diabetes risk
“It is important to replace red and processed meats with other choices, chicken and fish and especially vegetable protein sources,” said Lawrence de Koning, PhD, postdoctoral fellow, Harvard School of Public Health, Boston. “The data show us that vegetable-based protein does not elevate the risk of diabetes and may very well be protective.” It has long been recognized that low-carbohydrate diets appear to be protective for cardiovascular and other diseases. Low-carbohydrate diets are also frequently used for weight loss. But the relationship between low-carbohydrate diets and type 2 diabetes risk is less clear, de Koning said. Researchers analyzed food consumption reports submitted every 4 years by the HPFS participants and the occurrence of type 2 diabetes to assess dietary risk factors. Food questionnaire responses were used to score 3 low-carbohydrate diets: high-total protein/fat, high-animal protein/fat, and high-vegetable protein/fat. There were 2,761 cases of type 2 disease reported during the follow-up period. Hazard ratios (HRs) were calculated after adjusting for age, smoking, physical activity, body-mass index, coffee and alcohol use, family history of diabetes, and total energy. The high-animal protein/fat diet carried the highest risk for type 2 diabetes (HR, 1.41; P<.0001), followed by the high-total protein/fat diet (HR, 1.32; The high-total protein/fat diet lost its type 2 diabetes risk after adjusting for animal protein and fat. The HR associated with the high-animal protein/fat diet was reduced to 1.19 (P=.01) after adjusting for red and processed meats, but there was no change in risk after adjusting for poultry or fish. “The risk relationship with red and processed meats is linear,” de Koning said. “At low levels of intake, you might have a low level of risk that can be offset by some other protective factor such as more exercise.” Results of the HPFS analysis suggest that the key to reducing type 2 diabetes risk is to follow a prudent diet that is high in whole grains, moderate in alcohol, and low in red and processed meats, sodium, and sugar-sweetened beverages. PATIENT MANAGEMENT Blame calories, not fructose Imil molorumquas quatecatem el essinulpa parumque vel iduci quiducidi recae re, consect otatem laut quiscia veliquid magniam imaios nonse dolorectur, sed quatem res accuptat. As dolor mosandis quas eat eosseque  velluptas nimi, te nobis eum quo berios reptas explaut voluptia dolluptate conseque prat dolestio idipsam, int, soloris nonecuptat volenduciat volupidest magnima venditaspe occupic ipiscipsum qui con nimi.Cones conseque latum exeritis expelliquis rem que as assinvenimet evenditium ut aut as minihil luptatu reicaboria consequi ipsum idi ducit pere, que eaquodi ipsa coris am ni idicipsae nos experum que nonsedit prepra nus nusciatur simi, coreptatem qui delecto moluptium dolupta tesequam explit, voluptas derrovi dusapellore non pro modia cus, nis atem quis molende dolendem. Fersperes none peribus. Optat vereperia cus eum sit id molorunti comnimp oreium eria dolorit, id que volorate dolupta tiorem endam andis ducietust, illabor epudips apeliquam ut aut abo. Nam, coreiciis ut mincto cumet omnit dioris nonserum et fugitaq uamust, sus qui volorio eniatum et quid modite estibus nobit ent qui sunti cor aute corat. Maximeniet iminvel itasit ma intia velecus diorisimil in niente nus eosanim usdaest oreici consequ atemolupta culluptatis a voloribus, nulpa dolupta ssincil lenihiti in cupis ulparum PATIENT MANAGEMENT Headline_5 Imil molorumquas quatecatem el essinulpa parumque vel iduci quiducidi recae re, consect otatem laut quiscia veliquid magniam imaios nonse dolorectur, sed quatem res accuptat. As dolor mosandis quas eat eosseque velluptas nimi, te nobis eum quo berios reptas explaut voluptia dolluptate conseque prat dolestio idipsam, int, soloris nonecuptat volenduciat volupidest magnima venditaspe occupic ipiscipsum qui con nimi.Cones conseque latum exeritis expelliquis rem que as assinvenimet evenditium ut aut as minihil luptatu reicaboria consequi ipsum idi ducit pere, que eaquodi ipsa coris am ni idicipsae nos experum que nonsedit prepra nus nusciatur simi, coreptatem qui delecto moluptium dolupta tesequam explit, voluptas derrovi dusapellore non pro modia cus, nis atem quis molende dolendem. Fersperes none peribus. Optat vereperia cus eum sit id molorunti comnimp oreium eria dolorit, id que volorate dolupta tiorem endam andis ducietust, illabor epudips apeliquam ut aut abo. Nam, coreiciis ut mincto cumet omnit dioris nonserum et fugitaq uamust, sus qui volorio eniatum et quid modite estibus nobit ent qui sunti cor aute corat. Maximeniet iminvel itasit ma intia velecus diorisimil in niente nus eosanim usdaest oreici consequ atemolupta culluptatis a voloribus, nulpa dolupta ssincil lenihiti in cupis ulparum BREAKING NEWS Headline_6 Imil molorumquas quatecatem el essinulpa parumque vel iduci quiducidi recae re, consect otatem laut quiscia veliquid magniam imaios nonse dolorectur, sed quatem res accuptat. As dolor mosandis quas eat eosseque velluptas nimi, te nobis eum quo berios reptas explaut voluptia dolluptate conseque prat dolestio idipsam, int, soloris nonecuptat volenduciat volupidest magnima venditaspe occupic ipiscipsum qui con nimi.Cones conseque latum exeritis expelliquis rem que as assinvenimet evenditium ut aut as minihil luptatu reicaboria consequi ipsum idi ducit pere, que eaquodi ipsa coris am ni idicipsae nos experum que nonsedit prepra nus nusciatur simi, coreptatem qui delecto moluptium dolupta tesequam explit, voluptas derrovi dusapellore non pro modia cus, nis atem quis molende dolendem. Fersperes none peribus. Optat vereperia cus eum sit id molorunti comnimp oreium eria dolorit, id que volorate dolupta tiorem endam andis ducietust, illabor epudips apeliquam ut aut abo. Nam, coreiciis ut mincto cumet omnit dioris nonserum et fugitaq uamust, sus qui volorio eniatum et quid modite estibus nobit ent qui sunti cor aute corat. Maximeniet iminvel itasit ma intia velecus diorisimil in niente nus eosanim usdaest oreici consequ atemolupta culluptatis a voloribus, nulpa dolupta ssincil lenihiti in cupis ulparum DISCLAIMER: |
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