BACKGROUND: Nesiritide (recombinant human B-type natriuretic peptide) has been shown to provide symptomatic and hemodynamic improvement in acute decompensated heart failure. A previous meta-analysis of 3 randomized controlled trials has suggested an increased short-term risk of death with nesiritide use. We performed a meta-analysis of 7 available randomized controlled trials to evaluate the short- and long-term risk of death with nesiritide use for acute decompensated heart failure. METHODS: Seven large randomized controlled nonmortality trials on nesiritide with available data on 30-day mortality were included. Data on 180-day mortality were available only in 4 trials. Mortality data in nesiritide and control arms were extracted from the selected trials and the nesiritide database (Scios Inc, Fremont, CA). RESULTS: The pooled estimate of the relative risks (RRs) for unadjusted 30- and 180-day mortality revealed no significant differences between the nesiritide arm (RR 1.243, 95% CI 0.798-1.935) and control arm (RR, 0.002, 95% CI 0.798-1.259), respectively). CONCLUSIONS: Unlike a previous analysis, our meta-analysis indicates that nesiritide is not associated with a higher 30- or 180-day mortality. Further analysis of mortality adjusted for confounding variables such as nesiritide dose, duration of infusion, concurrent use of inotropes, heart failure stage, and arrhythmias may reveal subgroups in jeopardy. Large-scale randomized controlled trials powered to evaluate mortality are required to conclusively address these findings.
BACKGROUND: Nesiritide (recombinant human B-type natriuretic peptide) has been shown to provide symptomatic and hemodynamic improvement in acute decompensated heart failure. A previous meta-analysis of 3 randomized controlled trials has suggested an increased short-term risk of death with nesiritide use. We performed a meta-analysis of 7 available randomized controlled trials to evaluate the short- and long-term risk of death with nesiritide use for acute decompensated heart failure. METHODS: Seven large randomized controlled nonmortality trials on nesiritide with available data on 30-day mortality were included. Data on 180-day mortality were available only in 4 trials. Mortality data in nesiritide and control arms were extracted from the selected trials and the nesiritide database (Scios Inc, Fremont, CA). RESULTS: The pooled estimate of the relative risks (RRs) for unadjusted 30- and 180-day mortality revealed no significant differences between the nesiritide arm (RR 1.243, 95% CI 0.798-1.935) and control arm (RR, 0.002, 95% CI 0.798-1.259), respectively). CONCLUSIONS: Unlike a previous analysis, our meta-analysis indicates that nesiritide is not associated with a higher 30- or 180-day mortality. Further analysis of mortality adjusted for confounding variables such as nesiritide dose, duration of infusion, concurrent use of inotropes, heart failure stage, and arrhythmias may reveal subgroups in jeopardy. Large-scale randomized controlled trials powered to evaluate mortality are required to conclusively address these findings.
Authors: Selma F Mohammed; Josef Korinek; Horng H Chen; John C Burnett; Margaret M Redfield Journal: Rev Cardiovasc Med Date: 2008 Impact factor: 2.930