Intravenous nesiritide, a natriuretic peptide, in the treatment of decompensated congestive heart failure.

Background: Intravenous infusion of nesiritide, a brain (B-type) natriureti c peptide, has beneficial hemodynamic effects in patients with decompensate d congestive heart failure. We investigated the clinical use of nesiritide in such patients. Methods: Patients hospitalized because of symptomatic congestive heart fail ure were enrolled in either an efficacy trial or a comparative trial. In th e efficacy trial, which required the placement of a Swan-Ganz catheter, 127 patients with a pulmonary-capillary wedge pressure of 18 mm Hg or higher a nd a cardiac index of 2.7 liters per minute per square meter of body-surfac e area or less were randomly assigned to double-blind treatment with placeb o or nesiritide (infused at a rate of 0.015 or 0.030 mu g per kilogram of b ody weight per minute) for six hours. In the comparative trial, which did n ot require hemodynamic monitoring, 305 patients were randomly assigned to o pen-label therapy with standard agents or nesiritide for up to seven days. Results: In the efficacy trial, at six hours, nesiritide infusion at rates of 0.015 and 0.030 mu g per kilogram per minute decreased pulmonary-capilla ry wedge pressure by 6.0 and 9.6 mm Hg, respectively (as compared with an i ncrease of 2.0 mm Hg with placebo, P<0.001), resulted in improvements in gl obal clinical status in 60 percent and 67 percent of the patients (as compa red with 14 percent of those receiving placebo, P<0.001), reduced dyspnea i n 57 percent and 53 percent of the patients (as compared with 12 percent of those receiving placebo, P<0.001), and reduced fatigue in 32 percent and 3 8 percent of the patients (as compared with 5 percent of those receiving pl acebo, P<0.001). In the comparative trial, the improvements in global clini cal status, dyspnea, and fatigue were sustained with nesiritide therapy for up to seven days and were similar to those observed with standard intraven ous therapy for heart failure. The most common side effect was dose-related hypotension, which was usually asymptomatic. Conclusions: In patients hospitalized with decompensated congestive heart f ailure, nesiritide improves hemodynamic function and clinical status. Intra venous nesiritide is useful for the short-term treatment of decompensated c ongestive heart failure. (N Engl J Med 2000;343:246-53.) (C) 2000, Massachu setts Medical Society.