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依那普利治疗方案联合或不联合他汀类药物对血管疾病患者结局的影响: ADVANCE、EUROPA 和 PROGRESS 试验的联合分析。

The Effects of a Perindopril-Based Regimen in Relation to Statin Use on the Outcomes of Patients with Vascular Disease: a Combined Analysis of the ADVANCE, EUROPA, and PROGRESS Trials.

机构信息

Department of Cardiology, Thorax Center, Erasmus University Medical Center, Dr. Molewaterplein 40, Rotterdam, 3015GD, the Netherlands.

Lille Heart Institute, Lille, France.

出版信息

Cardiovasc Drugs Ther. 2024 Feb;38(1):131-139. doi: 10.1007/s10557-022-07384-2. Epub 2022 Oct 4.

Abstract

PURPOSE

To study the effects of a perindopril-based regimen on cardiovascular (CV) outcomes in patients with vascular disease in relation to background statin therapy.

METHODS

A pooled analysis of the randomized ADVANCE, EUROPA, and PROGRESS trials was performed to evaluate CV outcomes in 29,463 patients with vascular disease treated with perindopril-based regimens versus placebo. The primary endpoint was a composite of CV mortality, nonfatal myocardial infarction, and stroke. Multivariable Cox regression analyses were performed to assess the effects of a perindopril-based regimen versus placebo in relation to statin use.

RESULTS

At randomization, 39.5% of the overall combined study population used statins. After a mean follow-up of 4.0 years (SD 1.0), the cumulative event-free survival was highest in the statin/perindopril group and lowest in the no statin/placebo group (91.2% vs. 85.6%, respectively, log-rank p < 0.001). In statin users (adjusted hazard ratio [aHR] 0.87, 95% confidence interval [CI] 0.77-0.98) and non-statin users (aHR 0.80, 95% CI 0.74-0.87), a perindopril-based regimen was associated with a significantly lower risk of the primary endpoint when compared to placebo. The additional treatment effect appeared numerically greater in non-statin users, but the observed difference was statistically nonsignificant.

CONCLUSION

Our data suggest that the treatment benefits of a perindopril-based regimen in patients with vascular disease are independent of statin use.

摘要

目的

研究依那普利为基础的治疗方案对伴有血管疾病患者心血管(CV)结局的影响,同时关注其背景他汀类药物治疗。

方法

对 ADVANCE、EUROPA 和 PROGRESS 这三项随机试验进行了合并分析,评估了 29463 例接受依那普利为基础的治疗方案与安慰剂治疗的血管疾病患者的 CV 结局。主要终点是 CV 死亡率、非致死性心肌梗死和卒中的复合结果。采用多变量 Cox 回归分析来评估依那普利为基础的治疗方案与安慰剂相比,在他汀类药物使用方面的效果。

结果

在整个联合研究人群中,随机分组时,39.5%的患者正在使用他汀类药物。经过平均 4.0 年(标准差 1.0)的随访后,他汀类药物/依那普利组的无事件生存累积率最高,而未使用他汀类药物/安慰剂组的则最低(分别为 91.2%和 85.6%,对数秩检验 p<0.001)。在他汀类药物使用者(调整后的危险比 [aHR]0.87,95%置信区间 [CI]0.77-0.98)和非他汀类药物使用者(aHR0.80,95%CI0.74-0.87)中,与安慰剂相比,依那普利为基础的治疗方案显著降低了主要终点事件的风险。在非他汀类药物使用者中,额外的治疗效果似乎在数值上更大,但观察到的差异无统计学意义。

结论

我们的数据表明,依那普利为基础的治疗方案在血管疾病患者中的治疗益处独立于他汀类药物的使用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5b0/10876738/69e6096b01d2/10557_2022_7384_Fig1_HTML.jpg

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