C. M. O'ConnorR. C. StarlingA. F. HernandezP. W. ArmstrongK. DicksteinV. HasselbladG. M. HeizerM. KomajdaB. M. MassieJ. J.V. McMurrayM. S. NieminenC. J. ReistJ. L. RouleauK. SwedbergK. F. AdamsS. D. AnkerD. AtarA. BattlerR. BoteroN. R. BohidarJ. ButlerN. ClausellR. CorbalánM. R. CostanzoU. DahlstromL. I. DeckelbaumR. DiazM. E. DunlapJ. A. EzekowitzD. FeldmanG. M. FelkerG. C. FonarowD. GennevoisS. S. GottliebJ. A. HillJ. E. HollanderJ. G. HowlettM. P. HudsonR. D. KociolH. KrumA. LauceviciusW. C. LevyG. F. MéndezM. MetraS. MittalB. H. OhN. L. PereiraP. PonikowskiW. H. WilsonS. TanomsupJ. R. TeerlinkF. TriposkiadisR. W. TroughtonA. A. VoorsD. J. WhellanF. ZannadR. M. CaliffDuke Clinical Research InstituteThe University of North Carolina at Chapel HillCleveland ClinicMetroHealth Medical CenterUniversity of AlbertaInstitut de Cardiologie de MontrealDalhousie UniversityStavanger University HospitalUniversite Pierre et Marie CurieUniversity of California, San FranciscoVA Medical CenterUniversity of GlasgowMeilahti HospitalGoteborgs UniversitetLinkopings universitetIRCCS San Raffaele PisanaCharite - Universitatsmedizin BerlinAker University HospitalRabin Medical Center IsraelClínica MedellínJohnson & Johnson Pharmaceutical Research & Development, RaritanEmory UniversityHospital de Clinicas de Porto AlegrePontificia Universidad Catolica de ChileMidwest Heart SpecialistsEstudios Clínicos Latino America and Instituto Cardiovascular de RosarioMinneapolis Heart InstituteRonald Reagan UCLA Medical CenterJanssen Alzheimer ImmunotherapyUniversity of Maryland Medical CenterUniversity of FloridaUniversity of PennsylvaniaJefferson Medical CollegeEdith and Benson Ford Heart and Vascular InstituteMonash UniversityVilniaus universitetasUniversity of Washington Medical CenterInstituto Mexicano del Seguro SocialUniversita degli Studi di BresciaEscorts Heart Institute and Research Centre IndiaSeoul National University HospitalMayo ClinicAkademia Medyczna WroclawiuMahidol UniversityUniversity Hospital of LarissaUniversity of OtagoUniversity of Groningen, University Medical Center GroningenCHU de Nancy2018-05-032018-05-032011-07-07New England Journal of Medicine. Vol.365, No.1 (2011), 32-4315334406002847932-s2.0-79960090547https://repository.li.mahidol.ac.th/handle/20.500.14594/12415BACKGROUND: Nesiritide is approved in the United States for early relief of dyspnea in patients with acute heart failure. Previous meta-analyses have raised questions regarding renal toxicity and the mortality associated with this agent. METHODS: We randomly assigned 7141 patients who were hospitalized with acute heart failure to receive either nesiritide or placebo for 24 to 168 hours in addition to standard care. Coprimary end points were the change in dyspnea at 6 and 24 hours, as measured on a 7-point Likert scale, and the composite end point of rehospitalization for heart failure or death within 30 days. RESULTS: Patients randomly assigned to nesiritide, as compared with those assigned to placebo, more frequently reported markedly or moderately improved dyspnea at 6 hours (44.5% vs. 42.1%, P = 0.03) and 24 hours (68.2% vs. 66.1%, P = 0.007), but the prespecified level for significance (P≤0.005 for both assessments or P≤0.0025 for either) was not met. The rate of rehospitalization for heart failure or death from any cause within 30 days was 9.4% in the nesiritide group versus 10.1% in the placebo group (absolute difference, -0.7 percentage points; 95% confidence interval [CI] , -2.1 to 0.7; P = 0.31). There were no significant differences in rates of death from any cause at 30 days (3.6% with nesiritide vs. 4.0% with placebo; absolute difference, -0.4 percentage points; 95% CI, -1.3 to 0.5) or rates of worsening renal function, defined by more than a 25% decrease in the estimated glomerular filtration rate (31.4% vs. 29.5%; odds ratio, 1.09; 95% CI, 0.98 to 1.21; P = 0.11). CONCLUSIONS: Nesiritide was not associated with an increase or a decrease in the rate of death and rehospitalization and had a small, nonsignificant effect on dyspnea when used in combination with other therapies. It was not associated with a worsening of renal function, but it was associated with an increase in rates of hypotension. On the basis of these results, nesiritide cannot be recommended for routine use in the broad population of patients with acute heart failure. (Funded by Scios; ClinicalTrials.gov number, NCT00475852.) Copyright © 2011 Massachusetts Medical Society.Mahidol UniversityMedicineArticleSCOPUS10.1056/NEJMoa1100171