Empagliflozin reduces cardiovascular events and mortality in type 2 diabetes
Abstract
Review of: Zinnam, B, Wanner C, Lachin JM, et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. New England Journal of Medicine. 2015; 373: 2117-2128. Patients were required to have a history of established cardiovascular disease, along with Type 2 Diabetes but were either not on antidiabetic therapy for the preceding 12 weeks, with a glycated hemoglobin level between 7% and 9%, or were on stable antidiabetic therapy for the preceding 12 weeks, with a glycated hemoglobin between 7.0% and 10.0%. Patients were randomized in a 1:1:1 ratio to either empagliflozin 10 mg or 25 mg or matching placebo. Antidiabetic therapy was not to be changed for the first 12 weeks after randomization, with intensification of antidiabetic therapy allowed if the patient had a confirmed glucose of >240 mg/dl (>13.3 mmol/l). Physicians were encouraged to treat other cardiac risk factors like hyperlipidemia according to local guidelines. The primary outcome was a composite of death from cardiovascular causes, non-fatal myocardial infarction, or nonfatal stroke. Results showed a significant reduction in the rates of death from cardiovascular causes, overall mortality, and in hospital admissions for heart failure, while there was no reduction in the rates of non-fatal myocardial infarction or stroke.
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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