Naslov
Empagliflozin and cerebrovascular events in patients with type 2 diabetes mellitus at high cardiovascular risk

Autori
Zinman, Bernard ; ... ; Tušek, Srećko ; Mirošević, Gorana, Goldoni, Vesna ; Jurišić-Eržen, Dubravka ; Balaško, Annemarie ; Balić, Stjepan ; Drvodelić- Šunić, Ema ; Canecki Varžić, Silvija ; ... ; Diener, Hans Christoph

Kolaboracija
EMPA-REG OUTCOME Investigators

Izvornik
Stroke (0039-2499) 48 (2017), 5; 1218-1225

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
blood pressure ; cardiovascular diseases ; hematocrit ; stroke ; type 2 diabetes mellitus

Sažetak
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 ; P= 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 ; P= 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.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti

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