A renal event occurred in 4.3% in the dapagliflozin group and in 5.6% in the placebo group (hazard ratio, 0.76 95% CI, 0.67 to 0.87), and death from any cause occurred in 6.2% and 6.6%, respectively (hazard ratio, 0.93 95% CI, 0.82 to 1.04). 5.8% hazard ratio, 0.83 95% CI, 0.73 to 0.95 P=0.005), which reflected a lower rate of hospitalization for heart failure (hazard ratio, 0.73 95% CI, 0.61 to 0.88) there was no between-group difference in cardiovascular death (hazard ratio, 0.98 95% CI, 0.82 to 1.17).
In the two primary efficacy analyses, dapagliflozin did not result in a lower rate of MACE (8.8% in the dapagliflozin group and 9.4% in the placebo group hazard ratio, 0.93 95% CI, 0.84 to 1.03 P=0.17) but did result in a lower rate of cardiovascular death or hospitalization for heart failure (4.9% vs. In the primary safety outcome analysis, dapagliflozin met the prespecified criterion for noninferiority to placebo with respect to MACE (upper boundary of the 95% confidence interval, <1.3 P<0.001 for noninferiority). We evaluated 17,160 patients, including 10,186 without atherosclerotic cardiovascular disease, who were followed for a median of 4.2 years. Secondary efficacy outcomes were a renal composite (≥40% decrease in estimated glomerular filtration rate to <60 ml per minute per 1.73 m 2 of body-surface area, new end-stage renal disease, or death from renal or cardiovascular causes) and death from any cause. The primary efficacy outcomes were MACE and a composite of cardiovascular death or hospitalization for heart failure. The primary safety outcome was a composite of major adverse cardiovascular events (MACE), defined as cardiovascular death, myocardial infarction, or ischemic stroke. We randomly assigned patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease to receive either dapagliflozin or placebo. The cardiovascular safety profile of dapagliflozin, a selective inhibitor of sodium–glucose cotransporter 2 that promotes glucosuria in patients with type 2 diabetes, is undefined. The most trusted, influential source of new medical knowledge and clinical best practices in the world.
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