6/28/23, 9:55 PM EMPA-REG OUTCOME Pathway Feedback Search Clinical Topics Home Studies EMPA REG OUTCOME EMPA REG OUTCOME Disease Diabetes mellitus type 2 Trial question What is the role of empagliflozin in patients with T2DM at high cardiovascular risk? Study design Multi-center Double blinded RCT Population Characteristics of study participants 29.0% female N = 7020 71.0% male 7020 patients (2004 female, 5016 male) Inclusion criteria: patients with T2DM at high cardiovascular risk who are on standard care Key exclusion criteria: uncontrolled hyperglycemia with glucose > 240 mg/dL, indication of liver disease, planned cardiac surgery or angioplasty within 3 months, bariatric surgery within the past 2 years, blood dyscrasias, medical history of cancer and/or treatment of cancer within the last 5 years, uncontrolled endocrine disorder, or pregnant or lactating women Interventions N=4687 empagliflozin (10 mg or 25 mg once daily) N=2333 placebo (matching placebo once daily) Primary outcome Death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke 12.1 % 12.1 10.5 https://web.pathway.md/studies/reca4EqrygEOvQkeU 1/2 6/28/23, 9:55 PM EMPA-REG OUTCOME Pathway 9.1 % 6.0 % Significant decrease 3.0 % NNT = 63 0.0 % Empagliflozin Placebo Significant decrease in death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke (10.5% vs. 12.1%; HR 0.86, 95% CI 0.74 to 0.99) Secondary outcomes Significant decrease in cardiovascular death (3.7% vs. 5.9%; HR 0.62, 95% CI 0.49 to 0.77) Safety outcomes No significant differences in adverse events, serious adverse events and adverse events leading to discontinuation of study drug. Significant difference in genital infection (6.4% vs. 1.8%). Conclusion In patients with T2DM at high cardiovascular risk who are on standard care, empagliflozin was superior to placebo with respect to death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Reference Zinman B, Wanner C, Lachin JM et al. Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. N Engl J Med. 2015 Nov 26;373(22):2117-28. Open reference URL https://web.pathway.md/studies/reca4EqrygEOvQkeU 2/2