奈西立肽治疗急性失代偿性心力衰竭：随机对照试验的汇总分析。

Nesiritide in acute decompensated heart failure: a pooled analysis of randomized controlled trials.

机构信息

Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio, USA.

出版信息

Clin Cardiol. 2010 Aug;33(8):484-9. doi: 10.1002/clc.20793.

DOI:10.1002/clc.20793

PMID:20734445

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6653138/

Abstract

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.

摘要

背景

先前评估奈西立肽治疗急性失代偿性心力衰竭（ADHF）的随机对照试验（RCT）报告奈西立肽与对照组相比，死亡率风险比差异很大，但这些单独的试验既不是设计也不是为了评估死亡率而进行的。本研究使用了截至 2006 年 6 月完成的奈西立肽治疗 ADHF 的所有 RCT 的相关数据，独立估计奈西立肽对 30 天和 180 天死亡率的影响。

假设

给予奈西立肽治疗 ADHF 患者不会显著增加 30 天或 180 天的死亡率。

方法

符合纳入标准的 6 项试验纳入本分析。这些试验的原始数据是从 Scis Inc.（加利福尼亚州弗里蒙特）获得的。统计模型用于估计 4 种效应：剂量反应、不同对照组、脆弱亚组相互作用和与奈西立肽给药相关的死亡时间。所有模型均包括 4 个与死亡率显著独立相关的基线协变量。

结果

在 1538 例患者中，有 1472 例（96%）获得了完整的协变量数据。调整风险后，30 天时死亡率的风险比为 1.05（95%置信区间[CI]：0.85-1.30），180 天时为 1.00（95%CI：0.88-1.14），与奈西立肽剂量无明显关系。除了在两个时间点的结果一致外，没有发现对照组或基线风险因素有明显的敏感性证据。