From the Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, Canada (B.Z.); Division of Endocrinology (B.Z.) and St Michael's Hospital, Division of Cardiology (D.F.), University of Toronto, Canada; Section of Endocrinology, Yale University School of Medicine, New Haven, CT (S.E.I.); The Biostatistics Center, The George Washington University, Rockville, MD (J.M.L.); Comprehensive Heart Failure Center and Renal Division, University of Wuerzburg and Hospital, Germany (C.W.); Boehringer Ingelheim Pharma GmbH and Co. KG, Ingelheim, Germany (S.K., M.M., H.J.W., U.C.B.); Boehringer Ingelheim Norway KS, Asker (O.E.J.); Department of Neurology and Neurological Sciences, Stanford Stroke Center, CA (G.W.A.); and Department of Neurology and Stroke Center, University Hospital Essen, Germany (H.C.D.).
Background And Purpose: In the EMPA-REG OUTCOME trial (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients), empagliflozin added to standard of care in patients with type 2 diabetes mellitus and high cardiovascular risk reduced the risk of 3-point major adverse cardiovascular events, driven by a reduction in cardiovascular mortality, with no significant difference between empagliflozin and placebo in risk of myocardial infarction or stroke. In a modified intent-to-treat analysis, the hazard ratio for stroke was 1.18 (95% confidence interval, 0.89-1.56; =0.26). We further investigated cerebrovascular events.
Methods: Patients were randomized to empagliflozin 10 mg, empagliflozin 25 mg, or placebo; 7020 patients were treated. Median observation time was 3.1 years.
Results: The numeric difference in stroke between empagliflozin and placebo in the modified intent-to-treat analysis was primarily because of 18 patients in the empagliflozin group with a first event >90 days after last intake of study drug (versus 3 on placebo). In a sensitivity analysis based on events during treatment or ≤90 days after last dose of drug, the hazard ratio for stroke with empagliflozin versus placebo was 1.08 (95% confidence interval, 0.81-1.45; =0.60). There were no differences in risk of recurrent, fatal, or disabling strokes, or transient ischemic attack, with empagliflozin versus placebo. Patients with the largest increases in hematocrit or largest decreases in systolic blood pressure did not have an increased risk of stroke.
Conclusions: In patients with type 2 diabetes mellitus and high cardiovascular risk, there was no significant difference in the risk of cerebrovascular events with empagliflozin versus placebo.
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