Randomized double-blind trial of darbepoetin alfa in patients with symptomatic heart failure and anemia
Randomized double-blind trial of darbepoetin alfa in patients with symptomatic heart failure and anemia
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DOI：
10.1161/circulationaha.107.698514
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发表时间：
2008-01-29
期刊：
影响因子：
37.8
通讯作者：
Armstrong, Paul
中科院分区：
文献类型：
--
作者：
Ghali, Jalal K.;Anand, Inder S.;Armstrong, Paul
背景-大量证据表明，贫血是心力衰竭(HF)患者预后更差的独立危险因素。心力衰竭中的贫血研究试验(STATINA-HEFT)是迄今为止评估高频贫血治疗效果的最大的多中心、随机、双盲、安慰剂对照试验。方法和结果：有症状的心衰患者(N=319)，左心室射血分数分别为9.0g/dL和1.0g/dL。通过意向治疗分析，与安慰剂相比，达贝泊丁阿尔法治疗没有显著改善运动持续时间、纽约心脏协会分级或生活质量评分。与安慰剂相比，接受达贝泊丁阿尔法治疗的患者的全因死亡率或首次入院治疗的风险降低的趋势并不显著(风险比，0.68；95%CI，0.43，1.08；P=0.10)。两个治疗组的不良事件发生率相似。结论--在这项针对有症状的心力衰竭和贫血患者的研究中，达贝泊丁阿尔法的治疗与显著的临床益处无关。达贝泊丁阿尔法治疗耐受性良好，有效地提高了血红蛋白。观察到发病率和死亡率风险降低的趋势。
Background - Substantial evidence suggests that anemia is an independent risk factor for worse outcomes in patients with heart failure (HF). The Study of Anemia in Heart Failure Trial (STAMINA-HeFT) is the largest multicenter, randomized, double-blind, placebo-controlled trial to date evaluating the effect of treating anemia in HF.Methods and Results - Patients (N = 319) with symptomatic HF, left ventricular ejection fraction = 9.0 g/dL and = 1.0 g/dL from baseline. By intent-to-treat analysis, darbepoetin alfa treatment did not significantly improve exercise duration, New York Heart Association class, or quality of life score compared with placebo. A nonsignificant trend was observed toward a lower risk of all-cause mortality or first HF hospitalization in darbepoetin alfa - treated patients compared with placebo (hazard ratio, 0.68; 95% CI, 0.43, 1.08; P = 0.10). Occurrences of adverse events were similar in both treatment groups.Conclusions - In this study of patients with symptomatic HF and anemia, treatment with darbepoetin alfa was not associated with significant clinical benefits. Darbepoetin alfa treatment was well tolerated and effectively raised hemoglobin. A trend of lower risk of morbidity and mortality was observed.