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依泽替米贝联合他汀类药物对急性冠脉综合征后心血管事件的影响:台湾的一项基于人群的 3 年回顾性队列研究。

Impact of ezetimibe coadministered with statins on cardiovascular events following acute coronary syndrome: a 3-year population-based retrospective cohort study in Taiwan.

机构信息

School of Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan.

出版信息

Clin Ther. 2011 Sep;33(9):1120-31. doi: 10.1016/j.clinthera.2011.08.002. Epub 2011 Aug 27.

Abstract

BACKGROUND

Conflicting results using the combination of ezetimibe and statins to reduce the risk of cardiovascular events in patients with acute coronary syndrome (ACS) have been reported.

OBJECTIVE

The aim of this work was to assess the effectiveness of ezetimibe coadministered with statins in reducing cardiovascular events in patients with ACS.

METHODS

A retrospective cohort study of patients discharged after hospitalization with ACS was conducted from January 1, 2006, to December 31, 2007, and included those who were prescribed statins alone (n = 37,753) and those who received ezetimibe plus statins (n = 1001) within 365 days after the hospitalization, based on patient data obtained from the National Health Insurance Research Database (NHIRD) in Taiwan. The propensity score method was used to identify a 1:1 matched cohort (n = 2002). Risk of rehospitalization for ACS was analyzed by a multivariable Cox proportional hazards regression model.

RESULTS

The crude event rate of rehospitalization due to ACS in the original cohort was 13.4 per 100 person-years (268 events) in the combination group and 22.6 per 100 person-years (12,724 events) in the statins-alone group (adjusted hazard ratio [HR] 0.69; 95% CI, 0.62-0.78). The crude event rates of rehospitalization due to ACS in the matched cohort were 13.4 and 20.0 per 100 person-years in the combination group and statins-alone group, respectively (HR 0.62; 95% CI, 0.53-0.73). Compared with statins alone, the adjusted HRs for rehospitalization for percutaneous transluminal coronary angioplasty without stent, with stent, and revascularization for the combination group in the matched cohort were 0.61 (0.50-0.75), 0.62 (0.48-0.81), and 0.62 (0.51-0.76), respectively.

CONCLUSIONS

Based on the data of Taiwan's NHIRD, our findings suggest that patients with ACS on ezetimibe combined with statins had a significantly lower risk of rehospitalization due to ACS, percutaneous transluminal coronary angioplasty, and revascularization than those on statins alone. The generalization of the results is limited because of using claims data of a specific population as the data source.

摘要

背景

在急性冠脉综合征(ACS)患者中,联合应用依折麦布和他汀类药物降低心血管事件风险的结果存在争议。

目的

本研究旨在评估 ACS 患者联合应用依折麦布和他汀类药物降低心血管事件的效果。

方法

本研究为回顾性队列研究,纳入 2006 年 1 月 1 日至 2007 年 12 月 31 日期间因 ACS 住院并出院的患者,基于从台湾全民健康保险研究数据库(NHIRD)获得的患者数据,将出院后 365 天内单独使用他汀类药物(n=37753)和联合使用依折麦布和他汀类药物(n=1001)的患者纳入研究。采用倾向性评分匹配法进行 1:1 匹配(n=2002)。采用多变量 Cox 比例风险回归模型分析 ACS 再住院的风险。

结果

在原始队列中,联合组 ACS 再住院的粗事件率为每 100 人年 13.4 次(268 例事件),他汀类药物组为每 100 人年 22.6 次(12724 例事件)(调整后的风险比[HR]0.69;95%CI,0.62-0.78)。匹配队列中,联合组和他汀类药物组 ACS 再住院的粗事件率分别为每 100 人年 13.4 和 20.0 次(HR 0.62;95%CI,0.53-0.73)。与单独使用他汀类药物相比,匹配队列中联合组行经皮冠状动脉介入治疗(PCI)未置入支架、置入支架和血运重建的调整后 HR 分别为 0.61(0.50-0.75)、0.62(0.48-0.81)和 0.62(0.51-0.76)。

结论

基于台湾 NHIRD 的数据,本研究结果表明,与单独使用他汀类药物相比,ACS 患者联合应用依折麦布和他汀类药物可显著降低 ACS、PCI 和血运重建导致的再住院风险。由于使用特定人群的索赔数据作为数据源,因此结果的推广受到限制。

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