Heart failure outcomes with empagliflozin in patients with type 2 diabetes at high cardiovascular risk: results of the EMPA-REG OUTCOME® trial
By D. Fitchett, B. Zinman, C. Wanner, J. Lachin, S. Hantel, A. Salsali, O. Johansen, H. Woerle, U. Broedl, Silvio E. Inzucchi. European Heart Journal, 2016
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Abstract Aims We previously reported that in the EMPA-REG OUTCOME® trial, empagliflozin added to standard of care reduced the risk of 3-point major adverse cardiovascular events, cardiovascular and all-cause death, and hospitalization for heart failure in patients with type 2 diabetes and high cardiovascular risk. We have now further investigated heart failure outcomes in all patients and in subgroups, including patients with or without baseline heart failure. Methods and results Patients were randomized to receive empagliflozin 10 mg, empagliflozin 25 mg, or placebo. Seven thousand and twenty patients were treated; 706 (10.1%) had heart failure at baseline. Heart failure hospitalization or cardiovascular death occurred in a significantly lower percentage of patients treated with empagliflozin [265/4687 patients (5.7%)] than with placebo [198/2333 patients (8.5%)] [hazard ratio, HR: 0.66 (95% confidence interval: 0.55–0.79); P < 0.001], corresponding to a number needed to treat to prevent one heart failure hospitalization or cardiovascular death of 35 over 3 years. Consistent effects of empagliflozin were observed across subgroups defined by baseline characteristics, including patients with vs. without heart failure, and across categories of medications to treat diabetes and/or heart failure. Empagliflozin improved other heart failure outcomes, including hospitalization for or death from heart failure [2.8 vs. 4.5%; HR: 0.61 (0.47–0.79); P < 0.001] and was associated with a reduction in all-cause hospitalization [36.8 vs. 39.6%; HR: 0.89 (0.82–0.96); P = 0.003]. Serious adverse events and adverse events leading to discontinuation were reported by a higher proportion of patients with vs. without heart failure at baseline in both treatment groups, but were no more common with empagliflozin than with placebo. Conclusion In patients with type 2 diabetes and high cardiovascular risk, empagliflozin reduced heart failure hospitalization and cardiovascular death, with a consistent benefit in patients with and without baseline heart failure.
Subfields: Endocrinology, Diabetes and Metabolism, Surgery
View Paper: https://www.semanticscholar.org/paper/d8ad89cb37549e0e15f92b1f3a648975e29e3671
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In Endocrinology, Diabetes and Metabolism
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Citations in the corpus
- Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2018, methodology): “In the EMPAREG OUTCOME study with empagliflozin [54], the ARR was 1.”
- Multi-dimensional roles of ketone bodies in fuel metabolism, signaling, and therapeutics (2017, background): “Strikingly, at least one of these agents decreased HF hospitalization (e.g., as revealed by the EMPA-REG OUTCOME trial), and improved cardiovascular mortality (Fitchett et al., 2016; Sonesson et al., 2016; Wu et al., 2016a; Zinman et al., 2015).”
- Empagliflozin for Type 2 Diabetes Mellitus: An Overview of Phase 3 Clinical Trials (2017, background): “001), with the risk reduction consistent in patients with versus without heart failure at baseline [45].”
- Vascular Inflammation and Oxidative Stress: Major Triggers for Cardiovascular Disease (2019, background): “In recent large-scale clinical trials (EMPA-REG), empagliflozin was the only modern antidiabetic drug that was able to reduce overall cardiovascular mortality in diabetic patients at high cardiovascular risk [270, 271].”