Consistent effect of empagliflozin on cardiovascular death in subgroups by type of cardiovascular disease: results from EMPA-REG OUTCOME

 

Aim:

In the EMPA-REG OUTCOME trial, empagliflozin given in addition to standard of care significantly reduced 3-point major adverse cardiovascular (CV) events (3-point MACE: composite of CV death, non-fatal myocardial infarction [MI], non-fatal stroke) in patients with type 2 diabetes (T2DM) and established CV disease. CV death and all-cause mortality were reduced by 38% and 32%, respectively, with empagliflozin vs. placebo. We analysed the association between the reduction in CV death with empagliflozin and type of CV disease at baseline.

Methods:

Patients were randomized (1:1:1) to receive empagliflozin 10 mg, empagliflozin 25 mg, or placebo in addition to standard of care. Risk of CV death was compared between the pooled empagliflozin group and placebo in subgroups by type of CV disease at baseline (history of MI, history of coronary artery bypass graft, peripheral artery disease, history of stroke, single vessel coronary artery disease [CAD], multi-vessel CAD, history of atrial fibrillation, or heart failure) using Cox regression analyses in patients treated with ≥1 dose of study drug.

Results:

A total of 7020 patients were treated. Median observation time was 3.1 years. The effect of empagliflozin vs. placebo on CV death was consistent across subgroups of patients by type of CV disease at baseline. P-values were > 0.05 for tests of treatment by subgroup interaction.

Conclusion:

The reduction in CV death observed with empagliflozin in patients with T2DM and established CV disease in the EMPA-REG OUTCOME trial was observed irrespective of type of CV disease at baseline.