Key result
Intravenous serelaxin reduced the risk of 5-day worsening heart failure compared to control (6.0% vs 8.1%; HR 0.77; 95% CI 0.67-0.89; P=0.0002) and was associated with lower all-cause mortality.
Why the study?
The effectiveness and safety of 48-hour intravenous 30 μg/kg/day serelaxin infusion had been studied across six randomized controlled clinical trials in acute heart failure.
Does intravenous serelaxin reduce worsening heart failure and mortality in patients admitted for acute heart failure?
Meta-Analysis (n=11,359)
Does intravenous serelaxin reduce worsening heart failure and mortality in patients admitted for acute heart failure?
Hazard Ratio: 0.77 (95% CI 0.67–0.89)
Absolute Event Rate: 6% vs 8.1%
p-value: p=0.0002
Intravenous serelaxin in acute heart failure significantly reduces 5-day worsening heart failure and all-cause mortality at 4.5 months, though it does not impact cardiovascular death or rehospitalization.
Supports serelaxin in acute heart failure to cut early worsening; confirms mortality benefit across pooled trials.
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.
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Teerlink et al. (2019) conducted a meta-analysis in Acute heart failure (n=11,359). Serelaxin vs. Control was evaluated on Worsening heart failure to day 5 (HR 0.77, 95% CI 0.67-0.89, p=0.0002). Intravenous serelaxin reduced the risk of 5-day worsening heart failure compared to control (6.0% vs 8.1%; HR 0.77; 95% CI 0.67-0.89; P=0.0002) and was associated with lower all-cause mortality.
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