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心肌梗死后左心室功能不全患者中钙通道阻滞剂无有害作用:SAVE研究经验。SAVE研究组。生存与心室扩大。

Absence of a deleterious effect of calcium channel blockers in patients with left ventricular dysfunction after myocardial infarction: The SAVE Study Experience. SAVE Investigators. Survival and Ventricular Enlargement.

作者信息

Hager W D, Davis B R, Riba A, Moye L A, Wun C C, Rouleau J L, Lamas G A, Pfeffer M A

机构信息

Division of Cardiology, University of Connecticut Health Center, Farmington 06030, USA.

出版信息

Am Heart J. 1998 Mar;135(3):406-13. doi: 10.1016/s0002-8703(98)70315-1.

DOI:10.1016/s0002-8703(98)70315-1
PMID:9506325
Abstract

BACKGROUND

As a result of randomized controlled trials with calcium channel blockers after myocardial infarction, concern has developed that these agents are associated with an increased risk of cardiovascular events, particularly in the presence of left ventricular dysfunction.

METHODS

To test the hypothesis that calcium channel blockers increase cardiovascular events in such patients, the incidence of all-cause mortality, cardiovascular death, severe heart failure, and recurrent infarction was examined in 940 patients taking calcium channel blockers and 1180 not taking them 24 hours before randomization to placebo or captopril in the Survival and Ventricular Enlargement (SAVE) Trial. All patients had an ejection fraction < or =40%. Relative risks for calcium channel blocker users versus nonusers and the 95% confidence intervals were computed with univariate and multivariate Cox regressions. Adjustments were made for differences in baseline covariates.

RESULTS

For all causes of mortality, the relative risk for calcium channel blocker users versus nonusers was 0.96, with the 95% confidence interval of 0.78 to 1.17. In the SAVE placebo and captopril groups, the relative risks for the development of severe heart failure among the calcium channel block users versus nonusers were 0.95 and 1.23, with the 95% confidence interval of 0.72 to 1.25 and 0.88 to 1.71, respectively. A similar neutral result held for patients with and without a history of hypertension. Furthermore, calcium channel blockers did not alter the benefit of the angiotensin converting enzyme inhibitor, captopril.

CONCLUSIONS

This analysis of the nonrandomized clinical use of calcium channel blockers in the postmyocardial infarction population with left ventricular dysfunction did not identify either a clinical deterioration or improvement with respect to subsequent cardiovascular events.

摘要

背景

心肌梗死后使用钙通道阻滞剂的随机对照试验结果引发了人们的担忧,即这些药物与心血管事件风险增加有关,尤其是在存在左心室功能障碍的情况下。

方法

为检验钙通道阻滞剂会增加此类患者心血管事件这一假设,在生存与心室扩大(SAVE)试验中,对940名服用钙通道阻滞剂的患者和1180名未服用钙通道阻滞剂的患者在随机分组接受安慰剂或卡托普利治疗前24小时的全因死亡率、心血管死亡、严重心力衰竭和再发梗死的发生率进行了检查。所有患者的射血分数均≤40%。使用单变量和多变量Cox回归计算了服用钙通道阻滞剂者与未服用者的相对风险及95%置信区间。对基线协变量的差异进行了校正。

结果

在全因死亡率方面,服用钙通道阻滞剂者与未服用者的相对风险为0.96,95%置信区间为0.78至1.17。在SAVE试验的安慰剂组和卡托普利组中,服用钙通道阻滞剂者与未服用者发生严重心力衰竭的相对风险分别为0.95和1.23,95%置信区间分别为0.72至1.25和0.88至1.71。有高血压病史和无高血压病史的患者都得到了类似的中性结果。此外,钙通道阻滞剂并未改变血管紧张素转换酶抑制剂卡托普利的益处。

结论

对心肌梗死后左心室功能障碍人群中钙通道阻滞剂的非随机临床使用情况进行的这项分析未发现后续心血管事件出现临床恶化或改善的情况。

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