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A Randomized Controlled Trial

Publication Committee for the VMAC Investigators

JAMA. 2002;287:1531-1540.

Context  Decompensated congestive heart failure (CHF) is the leading hospital discharge diagnosis in patients older than 65 years.

Objective  To compare the efficacy and safety of intravenous nesiritide, intravenous nitroglycerin, and placebo.

Design, Setting, and Patients  Randomized, double-blind trial of 489 inpatients with dyspnea at rest from decompensated CHF, including 246 who received pulmonary artery catheterization, that was conducted at 55 community and academic hospitals between October 1999 and July 2000.

Interventions  Intravenous nesiritide (n = 204), intravenous nitroglycerin (n = 143), or placebo (n = 142) added to standard medications for 3 hours, followed by nesiritide (n = 278) or nitroglycerin (n = 216) added to standard medication for 24 hours.

Main Outcome Measures  Change in pulmonary capillary wedge pressure (PCWP) among catheterized patients and patient self-evaluation of dyspnea at 3 hours after initiation of study drug among all patients. Secondary outcomes included comparisons of hemodynamic and clinical effects between nesiritide and nitroglycerin at 24 hours.

Results  At 3 hours, the mean (SD) decrease in PCWP from baseline was –5.8 (6.5) mm Hg for nesiritide (vs placebo, P<.001; vs nitroglycerin, P = .03), –3.8 (5.3) mm Hg for nitroglycerin (vs placebo, P = .09), and –2 (4.2) mm Hg for placebo. At 3 hours, nesiritide resulted in improvement in dyspnea compared with placebo (P = .03), but there was no significant difference in dyspnea or global clinical status with nesiritide compared with nitroglycerin. At 24 hours, the reduction in PCWP was greater in the nesiritide group (-8.2 mm Hg) than the nitroglycerin group (-6.3 mm Hg), but patients reported no significant differences in dyspnea and only modest improvement in global clinical status.

Conclusion  When added to standard care in patients hospitalized with acutely decompensated CHF, nesiritide improves hemodynamic function and some self-reported symptoms more effectively than intravenous nitroglycerin or placebo.

VMAC Committees, Investigators, and Centers: Publication Committee: James B. Young, Cleveland Clinic Foundation; William T. Abraham, University of Kentucky, Lexington; Lynne Warner Stevenson, Brigham and Women's Hospital; Darlene P. Horton, Scios Inc; Uri Elkayam, Los Angeles County-USC Medical Center; Robert C. Bourge, University of Alabama, Birmingham. Steering Committee: James B. Young (chairperson), Cleveland Clinic Foundation; William T. Abraham, University of Kentucky, Lexington; Lynne Warner Stevenson, Brigham and Women's Hospital; Charles L. Emerman, MetroHealth Medical Center; Darlene P. Horton (sponsor representative). Statistical Analysis: Mei L. Cheng, Scios Inc. Nesiritide Pharmacokinetic/Pharmacodynamic Modeling: Nancy Sambol, University of California, San Francisco. Investigators and Centers (in alphabetical order by center): Albert Einstein Hospital (Thierry LeJemtel); Baylor College of Medicine (Guillermo Torre); Beth Israel Deaconess Medical Center (Andrew Burger); Buxmont Cardiology Associates, Lifemark Medical Center (Mitchell Greenspan); Cardiac Centers of LA at Willis Knighton Heart Institute (Jalal Ghali); Cardiology Associates of Gainesville (Steven F. Roark); Cardiovascular Medicine of Virginia at Pratt Medical Center Ltd (Robert Vranian); Cardiovascular Research Institute of Dallas (Martin Berk); Cardiovascular Research Institute of Southern California (Ronald Karlsberg); Care Group (Mary N. Walsh); Christ Hospital and Medical Center (Marc A. Silver); Community Hospital East (Edward Harlamert); Dartmouth Hitchcock Medical Center (Bruce D. Hettleman); Dorn Research Institute (Constantine Hassapoyannes); Durham VA Medical Center (Frederick R. Cobb); George Washington University Medical Center (Jacob Varghese); HeartCare Midwest (Alan Chu); Heart Center, Huntsville Hospital (W. Herbert Haught); Heart Institute of St Petersburg (Michael E. McIvor, Gregg Schuyler); Hennepin County Medical Center (Steven R. Goldsmith); Hillsboro Cardiology (Steven Promisloff); Jacksonville Center for Clinical Research (Michael Koren); Jacksonville Heart Center (Jay Dinerman); Johns Hopkins Hospital (Joshua Hare); Los Angeles County-USC Medical Center (Uri Elkayam); Med-Tech Research Inc (Salah El Hafi); Medical Research Consortium at Winona Memorial Hospital (Jack Hall); MediQuest Research Group Inc (Robert Feldman); Montefiore Medical Center (Robert Moskowitz); Mount Sinai Medical Center (Marrick Kukin, Gervasio Lamas); Northwestern Memorial Hospital (William Cotts); Oregon Health Sciences University (Ray Hershberger); Roudebush VA Medical Center (Lincoln E. Ford); Rush-Presbyterian-St Luke's Medical Center (Walter Kao); St Paul Heart Clinic (Alan J. Bank); San Diego Cardiac Center (Peter M. Hoagland); San Diego Cardiovascular Research Associates (George Dennish); Scripps Clinic, Heart, Lung, Vascular Center (Allen D. Johnson); Stern Cardiovascular Center (Frank A. McGrew); University of Alabama at Birmingham (Mark F. Aaron, Robert C. Bourge); University of Arizona Health Sciences Center (Charles Y. Lui); University of California, San Francisco Medical Center (Teresa DeMarco); James A. Haley Veterans Hospital, Tampa, Fla (Doug Schocken); University of Cincinnati Medical Center (Lynne Wagoner); University of Florida Medical Center, Jacksonville (Alan B. Miller); University of Florida Health Sciences Center, Gainesville (James A. Hill); University of Iowa Hospitals and Clinics (Ron M. Oren); University of Kansas Medical Center (David Wilson); University of Louisville Research Foundation (Geetha Bhat); University of Maryland Medical System (Stephen S. Gottlieb); University of Miami/Jackson Memorial Medical Center (Stephen M. Mallon); University of Missouri Health Sciences Center (Hanumanth Reddy); University of Rochester Medical Center (Chang-seng Liang); University of South Dakota School of Medicine (Kevin Vaska); University of Washington Medical Center (Daniel Fishbein); Vanderbilt University Medical Center (John R. Wilson); VA Medical Center IIIB (A. Maziar Zafari); Watson Clinic (Kevin Browne).

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