Effect of the calcium antagonist felodipine as supplementary vasodilator therapy in patients with chronic heart failure treated with enalapril - V-HeFT III
Effect of the calcium antagonist felodipine as supplementary vasodilator therapy in patients with chronic heart failure treated with enalapril - V-HeFT III
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DOI：
10.1161/01.cir.96.3.856
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发表时间：
1997-08-05
期刊：
影响因子：
37.8
通讯作者：
Loss, L
中科院分区：
文献类型：
--
作者：
Cohn, JN;Ziesche, S;Loss, L
背景尽管使用利尿剂、ACE抑制剂和地高辛治疗，心力衰竭的发病率和死亡率仍然很高，可能对额外的血管扩张剂有良好的反应。（心功能不全和运动能力受损）（97%依那普利，89%利尿剂）被随机分配到非洛地平缓释（5 mg BID）或安慰剂的双盲治疗3至39个月（平均18个月）。非洛地平显著降低血压，3个月时，射血分数增加（安慰剂组为2.1% vs-0.1%单位，P= 0.001），血浆心钠素水平降低（安慰剂组为-2.9 vs 26.9 pg/mL，P= 0.01），但未改善运动耐量、生活质量或住院需求。在长期随访中，非洛地平对射血分数和心房肽的有利影响并不持久，但非洛地平防止了运动耐量和生活质量的恶化。在非洛地平组和安慰剂组，（分别为13.8%和12.8%）和住院治疗（43%对42%）率相似，外周水肿的发生率较高是非洛地平治疗的唯一明显副作用。结论非洛地平在依那普利治疗的心力衰竭患者中具有耐受性良好的额外持续血管扩张作用，但唯一可能的长期益处是在治疗的第二年中有更好的运动耐量和更少的生活质量抑郁的趋势。该药似乎是安全的，但对心力衰竭患者的疗效不明显。
Background Despite therapy with diuretics, ACE inhibitors and digoxin morbidity and mortality in heart failure remain high and might respond favorably to an additional vasodilator.Methods and Results Male patients (n=450) with chronic heart failure (cardiac dysfunction and impaired exercise performance) on optimal current therapy (97% enalapril, 89% diuretics) were randomly assigned to double-blind treatment with felodipine extended release (5 mg BID) or placebo for 3 to 39 months (average, 18 months). Felodipine significantly reduced blood pressure and, at 3 months, increased ejection fraction (2.1% versus -0.1% units in the placebo group, P=.001) and reduced plasma atrial natriuretic peptide levels (-2.9 versus 26.9 pg/mL in the placebo group, P=.01) but did not improve exercise tolerance, quality of life, or the need for hospitalization. During long-term follow-up, the favorable effects on ejection fraction and atrial peptide did not persist, but felodipine prevented worsening exercise tolerance and quality of life. In the felodipine and placebo groups, mortality (13.8% versus 12.8%, respectively) and hospitalization (43% versus 42%) rates were similar, and a higher incidence of peripheral edema was the only apparent side effect of felodipine therapy.Conclusions Felodipine exerts a well-tolerated additional sustained vasodilator effect in patients with heart failure treated with enalapril, but the only possible long-term benefit was a trend for better exercise tolerance and less depression of quality of life ih the second year of treatment. The drug appears to be safe but not clearly efficacious in patients with heart failure.