Effects of Gender on Clinical Outcomes in Empagliflozin-Treated Type 2 Diabetes

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Gender had no effect on clinical outcome events in empagliflozin-treated type 2 diabetes.

A study recently published in Diabetologia has shown that empagliflozin does not affect women and men with type 2 diabetes differently in terms of heart failure (HF) hospitalization, cardiovascular (CV) death, or worsening nephropathy rates.

The researchers performed a secondary analysis of the EMPA-REG OUTCOME trial (ClinicalTrials.gov Identifier: NCT01131676), which reported that adding empagliflozin to a type 2 diabetes treatment regimen significantly decreased rates of HF hospitalization, CV death risk, and for nephropathy endpoints.

The participants of this study were 28.5% women, were diagnosed with atherosclerotic CV disease, and had a type 2 diabetes diagnosis defined by glycated hemoglobin between 53 and 86 mmol/mol (7 to 10%) and estimated glomerular filtration rate greater than 30 mL/min (1.73 m-2). After random assignment into 3 groups, subjects were given standard care plus 10 mg empagliflozin doses, 25 mg empagliflozin doses, or placebo doses.

The EMPA-REG OUTCOME trial included 2004 women, aged 63.6 ± 8.8 years, and 5016 men, aged 63.0 ± 8.6 years. The baseline characteristics were similar in the 2 groups except for LDL-cholesterol (2.5 ± 1.0 mmol/L in women vs 2.1 ± 0.9 mmol/L in men) and likelihood of being a smoker (32% in women vs 70% in men).

Women given placebo had a lower incidence rate for CV death than men (1.58% vs 2.19%), a higher rate of HF hospitalization (1.75% vs 1.33%), and a comparable rate of renal events (7.22% vs 7.75%). However, there were no significant differential effects on women vs men for HF hospitalization (P =.2), CV death (P =.32), or decreases in incident or worsening neuropathy rates (P =.85).

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Empagliflozin led to higher rates of genital infection compared with placebo in both sexes (10% vs 2.5% in women; 2.6% vs 1.5% in men).

The study researchers conclude that “CV death, HF hospitalisation and incident or worsening nephropathy rate reductions induced by empagliflozin were not different between women and men.”


Zinman B, Inzucchi SE, Wanner C, et al; on behalf of the EMPA-REG OUTCOME® investigators. Empagliflozin in women with type 2 diabetes and cardiovascular disease – an analysis of EMPA-REG OUTCOME® [published online April 30, 2018]. Diabetologia. doi:10.1007/s00125-018-4630-2