TY - JOUR

T1 - Heart failure outcomes with empagliflozin in patients with type 2 diabetes at high cardiovascular risk

T2 - results of the EMPA-REG OUTCOME (R) trial

AU - EMPA-REG OUTCOME Trial

AU - Fitchett, David

AU - Zinman, Bernard

AU - Wanner, Christoph

AU - Lachin, John M.

AU - Hantel, Stefan

AU - Salsali, Afshin

AU - Johansen, Odd Erik

AU - Woerle, Hans J.

AU - Broedl, Uli C.

AU - Inzucchi, Silvio E.

AU - Aizenberg, D.

AU - Ulla, M.

AU - Waitman, J.

AU - De Loredo, L.

AU - Farias, J.

AU - Fideleff, H.

AU - Lagrutta, M.

AU - Maldonado, N.

AU - Colombo, H.

AU - Ferre Pacora, F.

AU - Wasserman, A.

AU - Maffei, L.

AU - Lehman, R.

AU - Selvanayagam, J.

AU - d'Emden, M.

AU - Fasching, P.

AU - Paulweber, B.

AU - Toplak, H.

AU - Luger, A.

AU - Drexel, H.

AU - Prager, R.

AU - Schnack, C.

AU - Tiburcio, A.

AU - Gupta, S.

AU - Park, S.

AU - Kim, Y.

AU - Yang, J.

AU - Kim, D.

AU - Lee, S.

AU - Petrov, A.

AU - Nikolaev, K.

AU - Potemkin, V.

AU - Bystrova, A.

AU - Tarasov, N.

AU - Obrezan, A.

AU - Khokhlov, A.

AU - Huang, C.

AU - Chen, J.

AU - Wang, J.

AU - Zotov, S.

PY - 2016/5/14

Y1 - 2016/5/14

N2 - Aims We previously reported that in the EMPA-REG OUTCOME(R) 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.

AB - Aims We previously reported that in the EMPA-REG OUTCOME(R) 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.

KW - Cardiovascular disease

KW - Hospitalization

KW - Mortality

KW - COTRANSPORTER 2 INHIBITION

KW - DOUBLE-BLIND

KW - BLOOD-PRESSURE

KW - MORTALITY

KW - INSULIN

KW - COLLABORATION

KW - GUIDELINES

KW - MELLITUS

KW - DISEASES

KW - SAFETY

U2 - 10.1093/eurheartj/ehv728

DO - 10.1093/eurheartj/ehv728

M3 - статья

VL - 37

SP - 1526

EP - 1534

JO - European Heart Journal

JF - European Heart Journal

SN - 0195-668X

IS - 19

ER -