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DOI: 10.1055/s-0034-1374995
Baseline characteristics of participants enrolled in the empagliflozin cardiovascular outcome trial (EMPA-REG OUTCOME™) in patients with type 2 diabetes
Background, material and methods: The EMPA-REG OUTCOME™ trial (NCT01131676) will investigate the effect of the sodium glucose cotransporter 2 inhibitor empagliflozin 10 mg or 25 mg od compared with placebo, upon a background of optimal standard of care, on cardiovascular (CV) outcomes in patients with type 2 diabetes mellitus (T2DM) at increased CV risk. The study is a double-blind, double-dummy and event-driven (691 CV deaths, non-fatal myocardial infarctions or non-fatal strokes) trial, powered for CV non-inferiority and superiority.
Results: Between September 2010 and April 2013, 7063 patients were randomised at 594 sites. Most participants were recruited from Europe (41%), North America (20%) or Asia (19%), 29% were women, mean (SD) age was 63 (9) years (9% of patients were ≥75 years of age) and mean (SD) HbA1c was 8.1 (0.8)% (49% of patients had HbA1c < 8.0%). Diabetes duration was ≤5 years in 18% of patients and > 10 years in 57%. Most patients (99%) had previous CV complications. Most patients had mild (estimated glomerular filtration rate [eGFR] 60 – 90 ml/min/1.73 m2; 52%) or moderate (eGFR 30 – 60 ml/min/1.73 m2; 26%) renal impairment, and 40% had albuminuria.
Conclusion: Baseline characteristics of participants enrolled in this trial indicate that they are at high CV risk, as anticipated. We expect the results of the EMPA-REG OUTCOME™ trial to answer the hypothesis that empagliflozin is safe or even protective from a CV standpoint, given its glucose-, weight-, and blood pressure-lowering properties. This trial may further inform clinical decision-making for selecting glucose lowering therapy for patients with T2DM.