Intravenous Nesiritide, a Natriuretic Peptide, in the Treatment of Decompensated Congestive Heart Failure
Wilson S. Colucci, M.D., Uri Elkayam, M.D., Darlene P. Horton, M.D., William T. Abraham, M.D., Robert C. Bourge, M.D., Allen D. Johnson, M.D., Lynne E. Wagoner, M.D., Michael M. Givertz, M.D., Chang-seng Liang, M.D., Ph.D., Matthew Neibaur, M.D., W. Herbert Haught, M.D., Thierry H. LeJemtel, M.D., for The Nesiritide Study Group
Background Intravenous infusion of nesiritide, a brain (B-type)natriuretic peptide, has beneficial hemodynamic effects in patientswith decompensated congestive heart failure. We investigatedthe clinical use of nesiritide in such patients.
Methods Patients hospitalized because of symptomatic congestiveheart failure were enrolled in either an efficacy trial or acomparative trial. In the efficacy trial, which required theplacement of a Swan–Ganz catheter, 127 patients with apulmonary-capillary wedge pressure of 18 mm Hg or higher anda cardiac index of 2.7 liters per minute per square meter ofbody-surface area or less were randomly assigned to double-blindtreatment with placebo or nesiritide (infused at a rate of 0.015or 0.030 µg per kilogram of body weight per minute) forsix hours. In the comparative trial, which did not require hemodynamicmonitoring, 305 patients were randomly assigned to open-labeltherapy with standard agents or nesiritide for up to seven days.
Results In the efficacy trial, at six hours, nesiritide infusionat rates of 0.015 and 0.030 µg per kilogram per minutedecreased pulmonary-capillary wedge pressure by 6.0 and 9.6mm Hg, respectively (as compared with an increase of 2.0 mmHg with placebo, P<0.001), resulted in improvements in globalclinical status in 60 percent and 67 percent of the patients(as compared with 14 percent of those receiving placebo, P<0.001),reduced dyspnea in 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 38 percent of the patients(as compared with 5 percent of those receiving placebo, P<0.001).In the comparative trial, the improvements in global clinicalstatus, dyspnea, and fatigue were sustained with nesiritidetherapy for up to seven days and were similar to those observedwith standard intravenous therapy for heart failure. The mostcommon side effect was dose-related hypotension, which was usuallyasymptomatic.
Conclusions In patients hospitalized with decompensated congestiveheart failure, nesiritide improves hemodynamic function andclinical status. Intravenous nesiritide is useful for the short-termtreatment of decompensated congestive heart failure.
Source Information
From Boston University Medical Center, Boston (W.S.C., M.M.G); the University of Southern California School of Medicine, Los Angeles (U.E.); the Clinical Research Department, Scios, Sunnyvale, Calif. (D.P.H.); University of Cincinnati Medical Center, Cincinnati (W.T.A., L.E.W.); the University of Alabama at Birmingham, Birmingham (R.C.B.); Scripps Clinic and Research Foundation, La Jolla, Calif. (A.D.J.); University of Rochester Medical Center, Rochester, N.Y. (C.L.); Jacksonville Heart Center, Jacksonville, Fla. (M.N.); Jacksonville Center for Research, Jacksonville, Fla. (W.H.H.); and Albert Einstein College of Medicine, Bronx, N.Y. (T.H.L.).
Address reprint requests to Dr. Colucci at the Section of Cardiovascular Medicine, Boston University Medical Center, 88 E. Newton St., Boston, MA 02118.
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A correction has been published: N Engl J Med 2000;343(12):896.
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