Does Nesiritide work?
Partly: some human trials, with gaps: one very large trial of 7,141 patients.
Nesiritide was approved on short-term symptom trials, but the definitive outcome trial, ASCEND-HF with 7,141 patients, found no reduction in death or heart failure readmission and only a small, non-significant improvement in breathlessness. The approval exists, but the evidence for a meaningful clinical benefit is weak, which keeps it at B. 1
ASCEND-HF randomized 7,141 patients in hospital with acute decompensated heart failure. They got nesiritide or placebo infusion added to standard care. The trial had two primary measures. One was self-reported shortness of breath at 6 and 24 hours. The other was death or heart failure rehospitalization within 30 days. Nesiritide gave a small gain in breathing. It did not meet the trial's pre-set threshold for significance. It had no effect on the 30-day rate of death or readmission. 1
The trial also addressed two earlier worries. Pooled analyses from the mid-2000s had suggested nesiritide might worsen kidney function and raise deaths. ASCEND-HF found no rise in worsening kidney function and no rise in deaths. It did find more low blood pressure. This hit roughly one in four patients, compared with one in six on placebo. The authors concluded nesiritide could not be recommended for routine use. 1
Evidence checklist
- Randomised controlled trial ASCEND-HF, placebo-controlled
- Human study over 100 people ASCEND-HF 7,141 patients
- More than one research group One large trial cited
- Clinical outcomes, not surrogate markers Death and readmission: no effect
- Human safety data beyond case reports Low blood pressure; kidney worry not borne out
More on Nesiritide
Citations
- O'Connor 2011, N Engl J Med: effect of nesiritide in patients with acute decompensated heart failure (ASCEND-HF) doi.org
Reference information only, not medical advice. Drawn from the Nesiritide article, fact-checked against the cited sources. No dosing anywhere on this site.