Diabetes Trial Files Throwback Thursday: Empa for CV outcomes in T2DM, ARBs in Diabetic Nephropathy, and GLP-1 in T2DM & High CVD Risk
Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes
Zinman B et al. NEJM (November 2015)
Bottom Line: This randomized controlled trial (phase not specified) evaluated the effects of empagliflozin, an inhibitor of sodium-glucose cotransporter 2, on cardiovascular morbidity and mortality in patients with type 2 diabetes at high cardiovascular risk. A total of 7020 patients were treated with empagliflozin (10 mg or 25 mg once daily) or placebo for a median of 3.1 years. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The empagliflozin group had a significantly lower rate of the primary composite outcome compared to the placebo group (hazard ratio 0.86, 95.02% CI 0.74 to 0.99, P=0.04). There were also significantly lower rates of death from cardiovascular causes, hospitalization for heart failure, and death from any cause in the empagliflozin group. The most common adverse event was genital infection in the empagliflozin group. In conclusion, adding empagliflozin to standard care for patients with type 2 diabetes at high cardiovascular risk resulted in improved cardiovascular outcomes and overall survival.
Effects of Losartan on Renal and Cardiovascular Outcomes in Patients with Type 2 Diabetes and Nephropathy
Brenner BM et al. NEJM (September 2001)
Bottom Line: This is a randomized, double-blind study of 1513 patients with type 2 diabetes and nephropathy, comparing the angiotensin-II-receptor antagonist losartan (50 to 100 mg once daily) to placebo, both taken in addition to conventional antihypertensive treatment, for a mean of 3.4 years. The primary outcome was a composite of a doubling of the base-line serum creatinine concentration, end-stage renal disease, or death. Losartan showed a 16% risk reduction compared to placebo, with significant reductions in the incidence of a doubling of the serum creatinine concentration and end-stage renal disease. It also showed a 35% reduction in proteinuria and a 32% reduction in first hospitalization for heart failure. Losartan was generally well tolerated. In conclusion, losartan showed significant renal benefits in patients with type 2 diabetes and nephropathy.
Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes
Marso SP et al. NEJM (November 2016)
Bottom Line: This randomized controlled trial, known as SUSTAIN-6, aimed to evaluate the cardiovascular safety of semaglutide, a glucagon-like peptide 1 analogue, in patients with type 2 diabetes. A total of 3297 patients were assigned to receive once-weekly semaglutide (0.5 mg or 1.0 mg) or placebo for 104 weeks. The primary outcome was the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. The results showed that semaglutide was noninferior to placebo for the primary outcome, with a hazard ratio of 0.74 (95% CI, 0.58 to 0.95; P<0.001 for noninferiority). The study also found lower rates of new or worsening nephropathy in the semaglutide group, but higher rates of retinopathy complications. In conclusion, once-weekly semaglutide was shown to be a safe option for patients with type 2 diabetes at high cardiovascular risk.
Diabetes Trial Files Issue #DIA-2024-06
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