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6,7 As a result of this intersection of diabetes, atherosclerotic cardiovascular disease, and heart failure, the importance of determining diabetes therapies that are not only safe but also effective in reducing cardiovascular risk is paramount. 5 The high risk of heart failure in patients with diabetes is independent of coronary disease, and limited data are available to guide treatments for the prevention of heart failure. 1 Patients with diabetes are at high risk for adverse outcomes from atherosclerotic cardiovascular disease, 2,3 heart failure, 4 and renal disease. The prevalence is increasing, and it is expected that more than 640 million adults will have diabetes by 2040.

(Funded by AstraZeneca DECLAREвЂ“TIMI 58 number, NCT01730534.) IntroductionДiabetes mellitus is estimated to affect more than 415 million adults worldwide. In patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease, treatment with dapagliflozin did not result in a higher or lower rate of MACE than placebo but did result in a lower rate of cardiovascular death or hospitalization for heart failure, a finding that reflects a lower rate of hospitalization for heart failure. 0.1%, P=0.02), as was the rate of genital infections that led to discontinuation of the regimen or that were considered to be serious adverse events (0.9% vs. Diabetic ketoacidosis was more common with dapagliflozin than with placebo (0.3% vs. 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 (в‰Ґ40% 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 sodiumвЂ“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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