HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

Effect of nesiritide in patients with acute decompensated heart failure.

AbstractBACKGROUND:
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.).
AuthorsC M O'Connor, R C Starling, A F Hernandez, P W Armstrong, K Dickstein, V Hasselblad, G M Heizer, M Komajda, B M Massie, J J V McMurray, M S Nieminen, C J Reist, J L Rouleau, K Swedberg, K F Adams Jr, S D Anker, D Atar, A Battler, R Botero, N R Bohidar, J Butler, N Clausell, R Corbalán, M R Costanzo, U Dahlstrom, L I Deckelbaum, R Diaz, M E Dunlap, J A Ezekowitz, D Feldman, G M Felker, G C Fonarow, D Gennevois, S S Gottlieb, J A Hill, J E Hollander, J G Howlett, M P Hudson, R D Kociol, H Krum, A Laucevicius, W C Levy, G F Méndez, M Metra, S Mittal, B-H Oh, N L Pereira, P Ponikowski, W H W Tang, W H Wilson, S Tanomsup, J R Teerlink, F Triposkiadis, R W Troughton, A A Voors, D J Whellan, F Zannad, R M Califf
JournalThe New England journal of medicine (N Engl J Med) Vol. 365 Issue 1 Pg. 32-43 (Jul 07 2011) ISSN: 1533-4406 [Electronic] United States
PMID21732835 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Natriuretic Agents
  • Natriuretic Peptide, Brain
Topics
  • Acute Disease
  • Aged
  • Double-Blind Method
  • Dyspnea (drug therapy, etiology)
  • Female
  • Heart Failure (complications, drug therapy, mortality)
  • Humans
  • Hypotension (chemically induced)
  • Intention to Treat Analysis
  • Kidney Diseases (etiology)
  • Male
  • Middle Aged
  • Natriuretic Agents (adverse effects, therapeutic use)
  • Natriuretic Peptide, Brain (adverse effects, therapeutic use)
  • Patient Readmission (statistics & numerical data)
  • Recurrence

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: