Diabetes Trial Files Throwback Thursday: Weight Loss & Exercise in T2DM, Darbepoetin in CKD & T2DM, and Metformin in T2DM
Cardiovascular Effects of Intensive Lifestyle Intervention in Type 2 Diabetes
Look AHEAD Research Group. NEJM (July 2013)
Bottom Line: This randomized controlled trial examined the effects of an intensive lifestyle intervention promoting weight loss through decreased caloric intake and increased physical activity on cardiovascular morbidity and mortality in overweight or obese patients with type 2 diabetes. A total of 5145 patients were randomly assigned to either the intervention group or the control group, which received diabetes support and education. The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina at a maximum follow-up of 13.5 years. Results showed that the intervention group had greater weight loss and improvements in fitness and cardiovascular risk factors, but there was no significant difference in the primary outcome between the two groups. The trial was stopped early due to futility. Overall, the intensive lifestyle intervention did not reduce the rate of cardiovascular events in this patient population.
A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease
Pfeffer MA et al. NEJM (November 2009)
Bottom Line: This randomized controlled trial studied the effect of darbepoetin alfa on clinical outcomes in 4038 patients with type 2 diabetes, chronic kidney disease, and anemia. The intervention group received darbepoetin alfa to achieve a target hemoglobin level of 13 g/dL, while the comparator group received placebo. The primary outcomes were death or a cardiovascular event and death or end-stage renal disease. There was no significant difference in these outcomes between the two groups. However, the intervention group did have a higher risk of stroke and need for red-cell transfusions. This study suggests that the potential risks of darbepoetin alfa may outweigh its benefits in this patient population.
Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34)
UK Prospective Diabetes Study Group. The Lancet (September 1998)
Bottom Line: This randomized controlled trial investigated the effects of intensive glucose control with metformin in overweight patients with newly diagnosed type 2 diabetes. The study included 4075 patients and compared metformin to conventional policy, primarily with diet alone. The primary outcomes showed risk reductions of 32% for any diabetes-related endpoint, 42% for diabetes-related death, and 36% for all-cause mortality in patients allocated metformin compared to conventional policy. Metformin also showed a greater effect than other medications for these outcomes. However, early addition of metformin in sulphonylurea-treated patients was associated with an increased risk of diabetes-related death. The study concluded that metformin may be the first-line pharmacological therapy of choice in overweight diabetic patients due to its decreased risk of diabetes-related endpoints, less weight gain, and fewer hypoglycaemic attacks compared to other medications.
Diabetes Trial Files Issue #DIA-2024-02
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