1. Effect of empagliflozin on cardiovascular death in subgroups by age: Results from EMPA-REG outcome

Abstract

Abstract type Clinical Research. Presentation type Poster Presentation. Introduction Empagliflozin is a potent and selective SGLT2-I used in the treatment of T2DM. Methodology Study design: Patients with T2DM and established CV disease, and estimated glomerular filtration rate (eGFR;) ⩾30 ml/min/1.73 m2 were randomized to receive empagliflozin 10 mg, 25 mg, or placebo once daily in addition to standard of care for T2DM and CV risk management. The trial continued until 691 patients experienced an adjudicated event included in the primary outcome: 3P-MACE Analyses. Outcomes were assessed in patients treated with ⩾1 dose of study drug CV death was analysed in the pooled empagliflozin group vs placebo in subgroups by baseline age Cumulative incidence function estimates were corrected for mortality as a competing risk. Results The reduction in risk of CV death with empagliflozin vs placebo was consistent across age categories. Conclusion Empagliflozin in addition to standard of care reduced the risk of CV death in patients with T2DM and high CV risk irrespective of age at baseline. Across age subgroups, reported adverse events were consistent with the known safety profile of empagliflozin. Greater proportions of patients had events consistent with genital infections with the empagliflozin than placebo in all age subgroups. Diabetic ketoacidosis adverse events were rare and balanced overall between the empagliflozin and placebo groups. Events consistent with volume depletion were comparable between empagliflozin and placebo groups, except for a slightly higher frequency with empagliflozin than placebo in patients aged ⩾75 years.