Spironolactone for Heart Failure with Preserved Ejection Fraction
Spironolactone for Heart Failure with Preserved Ejection Fraction
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DOI：
10.1056/nejmoa1313731
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发表时间：
2014-04-10
影响因子：
158.5
通讯作者：
McKinlay, Sonja M.
中科院分区：
文献类型：
--
作者：
Pitt, Bertram;Pfeffer, Marc A.;McKinlay, Sonja M.
背景：盐皮质激素受体拮抗剂可改善心力衰竭伴左室射血分数降低患者的预后。我们评估了安体舒通在心力衰竭和左心室射血分数正常的患者中的作用。MethodsIn this randomized，double-blind trial，我们将3445例有症状的心力衰竭和左心室射血分数为45%或更高的患者分为两组，一组接受安体舒通（每日15 - 45 mg），另一组接受安慰剂。主要结局是心血管原因死亡、心脏骤停流产或因心力衰竭而住院治疗的复合结局。结果平均随访3.3年，螺内酯组1722例患者中有320例发生主要结局（18.6%）和安慰剂组1723例患者中的351例（20.4%）（风险比，0.89; 95%置信区间[CI]，0.77至1.04; P = 0.14）。在主要结局的组成部分中，螺内酯组仅因心力衰竭住院的发生率显著低于安慰剂组（206例患者[12.0%] vs. 245例患者[14.2%];风险比，0.83; 95%CI，0.69 - 0.99，P = 0.04）。无论是总死亡还是任何原因的住院治疗，螺内酯都没有显着减少。螺内酯治疗与血清肌酐水平升高和高钾血症发生率加倍（18.7%，安慰剂组为9.1%）相关，但低钾血症减少。通过频繁监测，严重不良事件的发生率无显著差异，血清肌酐水平为3.0 mg/dl结论：在心力衰竭和射血分数正常的患者中，螺内酯治疗并不能显著降低心血管原因死亡、心脏骤停流产、或住院治疗心力衰竭。（由国家心肺血液研究所资助; TOPCAT www.example.com编号，NCT 00094302。在这项试验中，3445名射血分数正常的心力衰竭患者被分配接受螺内酯或安慰剂治疗。在平均3.3年的时间里，心血管原因导致的死亡、心脏骤停流产或因心力衰竭住院治疗没有显著差异。许多心力衰竭患者的左心室射血分数正常或接近正常。（1）-（4）此类患者与患有心力衰竭和射血分数降低的患者具有共同的体征和症状，以及受损的生活质量和不良预后。（5）-（8）然而，大多数心力衰竭药物治疗的受益仅限于射血分数降低的患者，通常为40%或更低。(1)，（2），（9）目前的指南反映了缺乏来自心力衰竭和左心室射血分数保留患者的临床结局试验的有利证据，该指南没有提供具体的证据。
BackgroundMineralocorticoid-receptor antagonists improve the prognosis for patients with heart failure and a reduced left ventricular ejection fraction. We evaluated the effects of spironolactone in patients with heart failure and a preserved left ventricular ejection fraction.MethodsIn this randomized, double-blind trial, we assigned 3445 patients with symptomatic heart failure and a left ventricular ejection fraction of 45% or more to receive either spironolactone (15 to 45 mg daily) or placebo. The primary outcome was a composite of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for the management of heart failure.ResultsWith a mean follow-up of 3.3 years, the primary outcome occurred in 320 of 1722 patients in the spironolactone group (18.6%) and 351 of 1723 patients in the placebo group (20.4%) (hazard ratio, 0.89; 95% confidence interval [CI], 0.77 to 1.04; P=0.14). Of the components of the primary outcome, only hospitalization for heart failure had a significantly lower incidence in the spironolactone group than in the placebo group (206 patients [12.0%] vs. 245 patients [14.2%]; hazard ratio, 0.83; 95% CI, 0.69 to 0.99, P=0.04). Neither total deaths nor hospitalizations for any reason were significantly reduced by spironolactone. Treatment with spironolactone was associated with increased serum creatinine levels and a doubling of the rate of hyperkalemia (18.7%, vs. 9.1% in the placebo group) but reduced hypokalemia. With frequent monitoring, there were no significant differences in the incidence of serious adverse events, a serum creatinine level of 3.0 mg per deciliter (265 mol per liter) or higher, or dialysis.ConclusionsIn patients with heart failure and a preserved ejection fraction, treatment with spironolactone did not significantly reduce the incidence of the primary composite outcome of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for the management of heart failure. (Funded by the National Heart, Lung, and Blood Institute; TOPCAT ClinicalTrials.gov number, NCT00094302.)In this trial, 3445 patients with heart failure and a preserved ejection fraction were assigned to spironolactone or placebo. At a mean of 3.3 years, there was no significant difference in death from cardiovascular causes, aborted cardiac arrest, or hospitalization for heart failure. Many patients with heart failure have a normal or near-normal left ventricular ejection fraction.(1)-(4) Such patients share common signs and symptoms, as well as an impaired quality of life and a poor prognosis, with patients who have heart failure and a reduced ejection fraction.(5)-(8) However, the benefit of most medical therapies for heart failure is limited to those with a reduced ejection fraction, generally 40% or less.(1),(2),(9) The lack of favorable evidence from clinical-outcome trials involving patients with heart failure and a preserved left ventricular ejection fraction is reflected in current guidelines, which offer no specific ...