Short-term Risk of Death After Treatment With Nesiritide for Decompensated Heart Failure A Pooled Analysis of Randomized Controlled Trials

摘要: ContextNesiritide improves symptoms in patients with acutely decompensated heart failure compared placebo and appears to be safer than dobutamine. Its short-term safety relative standard diuretic vasodilator therapies is less clear.ObjectiveTo investigate the of nesiritide noninotrope-based control therapies, primarily consisting diuretics or vasodilators.Data SourcesPrimary reports completed clinical trials as December 2004 were obtained from US Food Drug Administration (FDA), study sponsor (Scios Inc), a PubMed literature search using terms nesiritide, trials, humans, manual annual meetings 3 heart associations.Study SelectionOf 12 randomized controlled evaluating met all inclusion criteria: double-blind acutely decompensated failure, therapy administered single infusion (≥6 hours), inotrope not mandated control, reported 30-day mortality.Data ExtractionData were extracted FDA sponsor documents corroborated with published articles when available. Thirty-day survival was assessed by meta-analysis fixed-effects model time-dependent risk by Kaplan-Meier analysis Cox proportional hazards regression modeling. Where deaths were described within range days after treatment, an extreme assumption was made favoring over control therapy, approach relevant the time-dependent analyses.Data SynthesisIn 485 377 to therapy. Death 30 tended occur more often among patients (35 [7.2%] vs 15 [4.0%] of 377 patients; ratio meta-analysis, 1.74; 95% confidence interval [CI], 0.97-3.12; P = .059; hazard adjusting for study, 1.80; CI, 0.98-3.31; P = .057).ConclusionsCompared noninotrope-based may associated with increased death treatment for failure. The possibility should investigated in large-scale, adequately powered, trial before routine use of decompensated