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高强度剂量阿托伐他汀治疗急性冠脉综合征患者的临床结局:一项使用真实世界数据的回顾性队列研究。

Clinical outcomes of high-intensity doses of atorvastatin in patients with acute coronary syndrome: A retrospective cohort study using real-world data.

机构信息

Heart Hospital, Hamad Medical Corporation, Doha, Qatar.

Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar.

出版信息

Br J Clin Pharmacol. 2021 Apr;87(4):2043-2052. doi: 10.1111/bcp.14613. Epub 2020 Nov 3.

DOI:10.1111/bcp.14613
PMID:33068036
Abstract

AIMS

To compare the effectiveness and safety of 2 high-intensity atorvastatin doses (40 mg vs 80 mg) among acute coronary syndrome (ACS) patients.

METHODS

This retrospective observational cohort study using real-world data included patients admitted with ACS to the Heart Hospital in Qatar between 1 January 2017 and 31 December 2018. The primary endpoint was a composite of cardiovascular disease-associated death, nonfatal ACS and nonfatal stroke. Cox proportional hazard regression analysis was used to determine the association between the 2 high-intensity atorvastatin dosing regimens and the primary outcome at 1 month and 12 months postdischarge.

RESULTS

Of the 626 patients included in the analyses, 475 (75.9%) received atorvastatin 40 mg, while 151 (24.1%) received atorvastatin 80 mg following ACS. Most of the patients were Asian (73%), male (97%) with a mean age of 50 years and presented with ST-elevation myocardial infarction (60%). The incidence of the primary effectiveness outcome did not differ between the atorvastatin 40-and 80-mg groups at 1 month (0.8 vs 1.3%; adjusted hazard ratio = 0.59, 95% confidence interval 0.04-8.13, P = .690) and at 12 months (3.2 vs 4%; adjusted hazard ratio = 0.57, 95% confidence interval 0.18-1.80, P = .340). Similarly, the use of the 2 doses of atorvastatin resulted in comparable safety outcomes, including liver toxicity, myopathy and rhabdomyolysis with an event rate of <1% in both groups.

CONCLUSION

The use of atorvastatin 40 mg in comparison to atorvastatin 80 mg in patients with ACS resulted in similar cardiovascular effectiveness and safety outcomes.

摘要

目的

比较两种高强度阿托伐他汀剂量(40 毫克与 80 毫克)在急性冠脉综合征(ACS)患者中的疗效和安全性。

方法

本回顾性观察性队列研究使用真实世界数据,纳入 2017 年 1 月 1 日至 2018 年 12 月 31 日期间在卡塔尔心脏医院因 ACS 入院的患者。主要终点是心血管疾病相关死亡、非致死性 ACS 和非致死性卒中的复合终点。采用 Cox 比例风险回归分析确定两种高强度阿托伐他汀给药方案与出院后 1 个月和 12 个月时主要结局的相关性。

结果

在纳入分析的 626 例患者中,475 例(75.9%)接受阿托伐他汀 40 毫克,151 例(24.1%)接受阿托伐他汀 80 毫克治疗 ACS。大多数患者为亚洲人(73%),男性(97%),平均年龄为 50 岁,表现为 ST 段抬高型心肌梗死(60%)。阿托伐他汀 40 毫克和 80 毫克组在 1 个月(0.8%与 1.3%;调整后的危险比=0.59,95%置信区间 0.04-8.13,P=0.690)和 12 个月(3.2%与 4%;调整后的危险比=0.57,95%置信区间 0.18-1.80,P=0.340)时主要有效性结局的发生率无差异。同样,两种剂量的阿托伐他汀的使用产生了相似的安全性结局,包括肝毒性、肌病和横纹肌溶解症,两组的发生率均<1%。

结论

与使用阿托伐他汀 80 毫克相比,ACS 患者使用阿托伐他汀 40 毫克在心血管疗效和安全性方面结果相似。

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