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EMPA-REG OUTCOME: Analysis in Women with T2DM and CVD

May 18, 2018
Veronica Hackenthal, MD

A recent trial found that empagliflozin can reduce the risk of cardiovascular deaths in type 2 diabetes patients; are results similar in men and women?

   

EMPA-REG OUTCOME: Analysis in Women with T2DM and CVD. Globally, women and men are equally impacted by type 2 diabetes (T2DM), but the relative risk of T2DM complications is greater for women although they continue to be under-represetned in cardiovascular (CV) trials. A secondary analysis of the EMPA-REG OUTCOME trial, which found that empagliflozin (EMPA) is linked to a decrease in both heart failure hospitilizations and CV deaths, sought to determine if those outcomes were applied to both men and women with T2DM. Scroll through the slideshow above to see what the outcome was.

T2DM Impact: Are Men, Women Equal? EMPA-REG OUTCOME trial found that EMPA, given in addition to standard care, reduced the risk of CV death and HF hospitalizations, but a secondary analysis was conducted to determine if those results apply to both men and women. 

EMPA-REG: In-depth Analysis by Sex. The secondary analysis of the EMPA-REG trial included 2004 women and 5016 men who were randomly assigned to either 10 or 25 mg of EMPA or a placebo once daily, in addition to standard care. The main outcomes were 3-point MACE, CV death, HF hospitalization, and incident/worsening nephropathy. 

CV Death, HF Hospitalization Similar for Women/Men with EMPA. Study found that taking EMPA is associated with a 14% decrease in 3-point MACE with no significant sex differences; genital infections for EMPA vs placebo did increase for both men and women as well. 

Clinical Implications. Results provided reassurance that EMPA has a similar impact on CV outcomes in both men and women. 

Take Home Points: 

  • The secondary analysis found no sex differences in all main outcomes.
  • Genital infections increased in women on EMPA vs placebo and in women vs men.
  • Results provide reassurance that EMPA has similar impact on CV outcomes in men and women. 

Source:  Zinman B, Inzucchi SE, Wanner C, et al. Empagliflozin in women with type 2 diabetes and cardiovascular disease – an analysis of EMPA-REG OUTCOME.® Diabetologia. 2018;61:1522-1527.

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