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TUESDAY, Nov. 13, 2018 (HealthDay News) — Treatment with dapagliflozin is noninferior to placebo for major adverse cardiovascular events (MACE) among patients with type 2 diabetes with or at risk for atherosclerotic cardiovascular disease, according to a study published online Nov. 10 in the New England Journal of Medicine<\/i> to coincide with the annual meeting of the American Heart Association, held from Nov. 10 to 12 in Chicago.<\/p>\n
Stephen D. Wiviott, M.D., from Brigham and Women’s Hospital in Boston, and colleagues randomly assigned 17,160 patients with type 2 diabetes who had or were at risk for atherosclerotic cardiovascular disease (10,186 without) to receive dapagliflozin or placebo; participants were followed for a median of 4.2 years.<\/p>\n
The researchers found that dapagliflozin was noninferior to placebo with respect to the primary safety outcome, a composite of MACE. In terms of efficacy, dapagliflozin did not result in a lower rate of MACE versus placebo (8.8 versus 9.4 percent; hazard ratio, 0.93; 95 percent confidence interval, 0.84 to 1.03; P = 0.17) but was associated with a reduced rate of cardiovascular death or hospitalization for heart failure (4.9 versus 5.8 percent; hazard ratio, 0.83; 95 percent confidence interval, 0.73 to 0.95; P = 0.005), reflecting a reduced rate of hospitalization for heart failure (hazard ratio, 0.73; 95 percent confidence interval, 0.61 to 0.88).<\/p>\n
“These new data suggest that in patients without established atherosclerotic cardiovascular disease, sodium-glucose cotransporter 2 inhibition can prevent serious clinical events, particularly hospitalization for heart failure,” the authors write.<\/p>\n
The trial was funded by AstraZeneca and Bristol-Myers Squibb; AstraZeneca is the manufacturer of dapagliflozin.<\/p>\n
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