Combination of isosorbide dinitrate and hydralazine in blacks with heart failure
Combination of isosorbide dinitrate and hydralazine in blacks with heart failure
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DOI：
10.1056/nejmoa042934
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发表时间：
2004-11-11
影响因子：
158.5
通讯作者：
Cohn, JN
中科院分区：
文献类型：
--
作者：
Taylor, AL;Ziesche, S;Cohn, JN
背景：我们研究了固定剂量的硝酸异山梨酯和呋喃西林是否能为患有晚期心力衰竭的黑人患者提供额外的益处，这是一个先前被认为对这种治疗有良好反应的亚组。方法：共有1050名患有纽约心脏协会III级或IV级心力衰竭并伴有脑室扩张的黑人患者被随机分配到除了标准的心力衰竭治疗之外，接受固定剂量的消心痛加肼丙嗪或安慰剂治疗。主要终点是由各种原因死亡、心力衰竭首次住院治疗和生活质量变化的加权值组成的综合评分。结果：由于安慰剂组的死亡率显著高于服用硝酸异山梨酯加肼丙嗪的组(10.2%比6.2%，P=0.02)，研究提前终止。给予硝酸异山梨酯+肼丙嗪的组的平均初级综合评分明显好于安慰剂组(-0.1+/-1.9对-0.5+/-2.0，P=0.01；可能的数值范围为-6至+2)，其各个组成部分(任何原因的死亡率降低43%[危险比，0.57；心力衰竭首次住院率相对降低33%[16.4%比22.4%，P=0.001]，生活质量得到改善[得分变化，-5.6vs.2.7+/-21.2，得分越低表明生活质量越好；P=0.02；可能的值范围从0到105]。结论：在包括神经激素阻滞剂在内的心衰的标准治疗中加入固定剂量的消心痛和肼丙嗪是有效的，并增加了患有晚期心力衰竭的黑人患者的生存率。
Background: We examined whether a fixed dose of both isosorbide dinitrate and hydralazine provides additional benefit in blacks with advanced heart failure, a subgroup previously noted to have a favorable response to this therapy.Methods: A total of 1050 black patients who had New York Heart Association class III or IV heart failure with dilated ventricles were randomly assigned to receive a fixed dose of isosorbide dinitrate plus hydralazine or placebo in addition to standard therapy for heart failure. The primary end point was a composite score made up of weighted values for death from any cause, a first hospitalization for heart failure, and change in the quality of life.Results: The study was terminated early owing to a significantly higher mortality rate in the placebo group than in the group given isosorbide dinitrate plus hydralazine (10.2 percent vs. 6.2 percent, P=0.02). The mean primary composite score was significantly better in the group given isosorbide dinitrate plus hydralazine than in the placebo group (-0.1+/-1.9 vs. -0.5+/-2.0, P=0.01; range of possible values, -6 to +2), as were its individual components (43 percent reduction in the rate of death from any cause [hazard ratio, 0.57; P=0.01] 33 percent relative reduction in the rate of first hospitalization for heart failure [16.4 percent vs. 22.4 percent, P=0.001], and an improvement in the quality of life [change in score, -5.6+/-20.6 vs. -2.7+/-21.2, with lower scores indicating better quality of life; P=0.02; range of possible values, 0 to 105]).Conclusions: The addition of a fixed dose of isosorbide dinitrate plus hydralazine to standard therapy for heart failure including neurohormonal blockers is efficacious and increases survival among black patients with advanced heart failure.