ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
Outcomes data
| EMPA-REG OUTCOME6) | EMEPEROR-Reduced7) | EMEPEROR-Preserved8) | EMPULSE34) | |
|---|---|---|---|---|
| Primary outcomes | A composite of death from CV causes, nonfatal MI (excluding silent MI), or nonfatal stroke: empagliflozin 10.5% vs. placebo 12.1% (HR 0.86, 95% CI 0.74-0.99, p=0.04) | A composite of adjudicated CV death or hospitalization for HF: empagliflozin 19.4% vs. placebo 18.3% (HR 0.75, 95% CI 0.65-0.86, p<0.001) | A composite of adjudicated CV death or hospitalization for HF: empagliflozin 13.8% vs. placebo 17.1% (HR 0.79, 95% CI 0.69-0.9, p<0.001) | Clinical benefit, defined as a hierarchical composite of death from any cause, number of HF events and time to first HF event, or a 5-point or greater difference in change from baseline in the KCCQ Total Symptom Score at 90days: empagliflozin 53.9% vs. placebo 39.7% (WR 1.36, 95% CI 1.09-1.68, p=0.005) |
| Death from any cause | Empagliflozin 5.7% vs. placebo 8.3%(HR 0.68, 95% CI 0.57-0.82, p<0.001) | Empagliflozin 13.4% vs. placebo 14.2%(HR 0.92, 95% CI 0.77-1.1) | Empagliflozin 14.1% vs. placebo 14.3%(HR 1, 95% CI 0.87-1.15) | - |
| Death from CV causes | Empagliflozin 3.7% vs. placebo 5.9%(HR 0.62, 95% CI 0.49-0.77, p<0.001) | Empagliflozin 10% vs. placebo 10.8%(HR 0.92; 95% CI 0.75-1.12) | Empagliflozin 7.3% vs. placebo 8.2%(HR 0.91, 95% CI 0.76-1.09) | - |
| Hospitalization for HF | Empagliflozin 2.7% vs. placebo 4.1%(HR 0.65, 95% CI 0.5-0.85, p=0.002) | Empagliflozin 13.2% vs. placebo 18.3%(HR 0.69, 95% CI 0.59-0.81) | Empagliflozin 8.6% vs. placebo 11.8%(HR 0.71, 95% CI 0.60-0.83) | - |
| Conclusion | Patients with type 2 diabetes at high risk for cardiovascular events who received empagliflozin had a lower rate of the primary composite cardiovascular outcome and death from any cause as well as hospitalization for HF compared to placebo | Patients receiving empagliflozin had a lower risk of cardiovascular death or hospitalization for HF compared to placebo, regardless of presence of type 2 diabetes | Patients with HFpEF receiving empagliflozin had a lower risk of cardiovascular death or hospitalization for HF compared to placebo, regardless of presence of type 2 diabetes | Empagliflozin use in patients hospitalized for acute HF is associated with significant clinical benefit within 90 days of initiating the treatment |
BMI: body mass index; CI: confidence interval; CV: cardiovascular; CVD: cardiovascular disease; eGFR: estimated glomerular filtration rate; HbA1c: hemoglobin A1c; HF: heart failure; HFrEF: heart failure with reduced ejection fraction; HfpEF: heart failure with preserved ejection fraction; HR: hazard ratio; KCCQ: Kansas City Cardiomyopathy Questionnaire; LVEF: left ventricular ejection fraction; MI: myocardial infarction; UTI: urinary tract infection; WR: win ratio