- In this third trial to address whether 48-hour serelaxin infusion is linked to cardiovascular mortality reductions in acute heart failure (HF), the therapy showed no such benefit.
- The treatment also showed no benefit for 5-day HF worsening or hospital-related measures.
Why this matters
- In an initial trial, this vasodilator was associated with a “dramatic reduction in mortality,” but a second trial planned to assess this endpoint found no such benefit.
- Editorial: this third trial confirms this lack of effect.
- For serelaxin vs placebo, 180-day cardiovascular mortality rates were, respectively, 8.7% vs 8.9%:
- HR, 0.98 (95% CI, 0.83-1.15; P=.77).
- Day-5 HF worsening rates for serelaxin vs placebo were, respectively, 6.9% vs 7.7%:
- HR, 0.89 (95% CI, 0.75-1.07; P=.19).
- All-cause death (drug vs placebo: 11.2% vs 11.9%) rehospitalization for HF, renal failure (24.3% vs 24.9%) at 180 days also did not differ between groups, nor did the length of the initial hospital stay (6.8 vs 6.9 days).
- Adverse event rates were similar between groups (drug vs placebo: 53.1% vs 52.1%).
- Multicentre, double-blind, placebo-controlled trial with 6600 patients with acute HF randomly allocated to serelaxin infusion (n=3298) or placebo (n=3302).
- Funding: Novartis Pharma.
- Protocol to prevent drug-induced hypotension led to smaller number of patients receiving serelaxin for the full 48 hours.