Effects of Serelaxin in Patients with Acute Heart Failure.
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Metra Marco, Teerlink John R, Cotter Gad, Davison Beth A, Felker G Michael, Filippatos Gerasimos, Greenberg Barry H, Pang Peter S, Ponikowski Piotr, Voors Adriaan A, Adams Kirkwood F, Anker Stefan D, Arias-Mendoza Alexandra, Avendaño Patricio, Bacal Fernando, Böhm Michael, Bortman Guillermo, Cleland John G F, Cohen-Solal Alain, Crespo-Leiro Maria G, Dorobantu Maria, Echeverría Luis E, Ferrari Roberto, Goland Sorel, Goncalvesová Eva, Goudev Assen, Køber Lars, Lema-Osores Juan, Levy Phillip D, McDonald Kenneth, Manga Pravin, Merkely Béla, Mueller Christian, Pieske Burkert, Silva-Cardoso Jose, Špinar Jindřich, Squire Iain, Stępińska Janina, Van Mieghem Walter, von Lewinski Dirk, Wikström Gerhard, Yilmaz Mehmet B, Hagner Nicole, Holbro Thomas, Hua Tsushung A, Sabarwal Shalini V, Severin Thomas, Szecsödy Peter, Gimpelewicz Claudio, RELAX-AHF-2 Committees Investigators
Аннотация
METHODS: In this multicenter, double-blind, placebo-controlled, event-driven trial, we enrolled patients who were hospitalized for acute heart failure and had dyspnea, vascular congestion on chest radiography, increased plasma concentrations of natriuretic peptides, mild-to-moderate renal insufficiency, and a systolic blood pressure of at least 125 mm Hg, and we randomly assigned them within 16 hours after presentation to receive either a 48-hour intravenous infusion of serelaxin (30 μg per kilogram of body weight per day) or placebo, in addition to standard care. The two primary end points were death from cardiovascular causes at 180 days and worsening heart failure at 5 days.
RESULTS: A total of 6545 patients were included in the intention-to-treat analysis. At day 180, death from cardiovascular causes had occurred in 285 of the 3274 patients (8.7%) in the serelaxin group and in 290 of the 3271 patients (8.9%) in the placebo group (hazard ratio, 0.98; 95% confidence interval [CI], 0.83 to 1.15; P = 0.77). At day 5, worsening heart failure had occurred in 227 patients (6.9%) in the serelaxin group and in 252 (7.7%) in the placebo group (hazard ratio, 0.89; 95% CI, 0.75 to 1.07; P = 0.19). There were no significant differences between the groups in the incidence of death from any cause at 180 days, the incidence of death from cardiovascular causes or rehospitalization for heart failure or renal failure at 180 days, or the length of the index hospital stay. The incidence of adverse events was similar in the two groups.
CONCLUSIONS: In this trial involving patients who were hospitalized for acute heart failure, an infusion of serelaxin did not result in a lower incidence of death from cardiovascular causes at 180 days or worsening heart failure at 5 days than placebo. (Funded by Novartis Pharma; RELAX-AHF-2 ClinicalTrials.gov number, NCT01870778.).