Document Detail


Nesiritide in acute decompensated heart failure: a pooled analysis of randomized controlled trials.
MedLine Citation:
PMID:  20734445     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Previous randomized controlled trials (RCTs) evaluating nesiritide for the treatment of acute decompensated heart failure (ADHF) have reported wide variances in mortality hazard ratios for nesiritide vs controls, but these individual trials were neither designed nor powered to evaluate mortality. This study used relevant data from all RCTs of nesiritide in ADHF completed as of June 2006 to independently estimate the effect of nesiritide on 30- and 180-day mortality.
HYPOTHESIS: Administration of nesiritide to treat patients with ADHF does not significantly increase mortality at 30 or 180 days.
METHODS: Six trials met prespecified criteria for inclusion in this analysis. Primary data from these trials were obtained from Scios Inc. (Fremont, CA). Statistical models were fitted to estimate 4 effects: dose response, differing control groups, vulnerable subgroup interactions, and time of death relative to nesiritide administration. All models included 4 baseline covariates that were significantly and independently associated with mortality.
RESULTS: Complete covariate data were available in 1472 of 1538 subjects (96%). The risk-adjusted hazard ratio for mortality was 1.05 (95% confidence interval [CI]: 0.85-1.30) at 30 and 1.00 (95% CI: 0.88-1.14) at 180 days with no clear relationship to nesiritide dose. In addition to consistent results across 2 time points, no significant evidence of sensitivity to control group or baseline risk factors was found.
CONCLUSIONS: Currently available data suggest nesiritide does not significantly increase mortality at 30 or 180 days.
Authors:
William T Abraham; Robin J Trupp; David Jarjoura
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Publication Detail:
Type:  Journal Article; Meta-Analysis    
Journal Detail:
Title:  Clinical cardiology     Volume:  33     ISSN:  1932-8737     ISO Abbreviation:  Clin Cardiol     Publication Date:  2010 Aug 
Date Detail:
Created Date:  2010-08-24     Completed Date:  2010-12-22     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7903272     Medline TA:  Clin Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  484-9     Citation Subset:  IM    
Affiliation:
Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio, USA. william.abraham@osumc.edu
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MeSH Terms
Descriptor/Qualifier:
Acute Disease
Evidence-Based Medicine
Heart Failure / drug therapy*,  mortality
Humans
Natriuretic Agents / administration & dosage,  adverse effects,  therapeutic use*
Natriuretic Peptide, Brain / administration & dosage,  adverse effects,  therapeutic use*
Proportional Hazards Models
Randomized Controlled Trials as Topic
Risk Assessment
Risk Factors
Time Factors
Treatment Outcome
Chemical
Reg. No./Substance:
0/Natriuretic Agents; 114471-18-0/Natriuretic Peptide, Brain

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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