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Effects of serelaxin in patients admitted for acute heart failure: a meta‐analysis
Author(s) -
Teerlink John R.,
Davison Beth A.,
Cotter Gad,
Maggioni Aldo P.,
Sato Naoki,
Chioncel Ovidiu,
Ertl Georg,
Felker G. Michael,
Filippatos Gerasimos,
Greenberg Barry H.,
Pang Peter S.,
Ponikowski Piotr,
Edwards Christopher,
Senger Stefanie,
Teichman Sam L.,
Nielsen Olav Wendelboe,
Voors Adriaan A.,
Metra Marco
Publication year - 2020
Publication title -
european journal of heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.149
H-Index - 133
eISSN - 1879-0844
pISSN - 1388-9842
DOI - 10.1002/ejhf.1692
Subject(s) - medicine , heart failure , nesiritide , hazard ratio , randomized controlled trial , acute decompensated heart failure , confidence interval , clinical endpoint , tolvaptan , adverse effect , cardiology , natriuretic peptide
Aims The effectiveness and safety of 48 h intravenous 30 μg/kg/day serelaxin infusion in acute heart failure (AHF) has been studied in six randomized, controlled clinical trials. Methods and results We conducted a fixed‐effect meta‐analysis including all studies of intravenous serelaxin initiated within the first 16 h of admission for AHF. Endpoints considered were the primary and secondary endpoints examined in the serelaxin phase III studies. In six randomized controlled trials, 6105 total patients were randomized to receive intravenous serelaxin 30 μg/kg/day and 5254 patients to control. Worsening heart failure to day 5 occurred in 6.0% and 8.1% of patients randomized to serelaxin and control, respectively (hazard ratio 0.77, 95% confidence interval 0.67–0.89; P = 0.0002). Serelaxin had no statistically significant effect on length of stay, or cardiovascular death, or heart or renal failure rehospitalization. Serelaxin administration resulted in statistically significant improvement in markers of renal function and reductions in both N‐terminal pro‐B‐type natriuretic peptide and troponin. No significant adverse outcomes were noted with serelaxin. Through the last follow‐up, which occurred at an average of 4.5 months (1–6 months), serelaxin administration was associated with a reduction in all‐cause mortality, with an estimated hazard ratio of 0.87 (95% confidence interval 0.77–0.98; P = 0.0261). Conclusions Administration of intravenous serelaxin to patients admitted for AHF was associated with a highly significant reduction in the risk of 5‐day worsening heart failure and in changes in renal function markers, but not length of stay, or cardiovascular death, or heart or renal failure rehospitalization. Serelaxin administration was safe and associated with a significant reduction in all‐cause mortality.