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一项大型观察性研究,评估了阿托伐他汀或辛伐他汀治疗无既往心血管疾病的高血压患者的心血管结局。

A large observational study of cardiovascular outcomes associated with atorvastatin or simvastatin therapy in hypertensive patients without prior cardiovascular disease.

机构信息

Division of Cardiovascular Medicine, Department of Internal Medicine, Harvard Medical School, Boston, MA, USA.

出版信息

Am J Ther. 2011 Mar-Apr;18(2):110-6. doi: 10.1097/MJT.0b013e3181cf12d2.

Abstract

The objective of this study was to examine whether differences in effectiveness exist between statins in hypertensive patients seen in clinical practice. We assessed cardiovascular (CV) outcomes in hypertensive patients without cardiovascular disease who began therapy with atorvastatin (10 or 20 mg/d) or simvastatin (20 or 40 mg/d) between January 1, 2003, and September 30, 2005, using claims data from 92 US managed care plans in the PharMetrics database. A total of 98,471 hypertensive patients were identified, comprising 74,685 atorvastatin users (mean dose 13.6 mg/d) and 23,786 simvastatin users (mean dose 28.6 mg/d), and followed a median 1.5 years for the occurrence of a first CV event. The crude CV event rates were 2.81 and 3.92 per 100 person-years for atorvastatin and simvastatin, respectively [unadjusted hazard ratio (HR): 0.73; 95% confidence interval (CI): 0.68-0.78, P < 0.001]. After adjusting for clinical and demographic confounders, use of atorvastatin was associated with fewer CV events compared with simvastatin (HR: 0.91; 95% CI: 0.84-0.98, P = 0.009). However, the lipid-lowering efficacy of the 2 statins could not be assessed as patient lipid data were unavailable. In conclusion, hypertensive patients without cardiovascular disease who initiated atorvastatin (10 or 20 mg/d) had a significantly lower risk of subsequent CV events compared with those who initiated simvastatin at doses of similar potency (20 or 40 mg/d). As with all observational studies, the study is subject to certain limitations, and the findings should be regarded as hypothesis generating.

摘要

本研究旨在探讨临床实践中高血压患者使用不同他汀类药物的疗效是否存在差异。我们利用 PharMetrics 数据库中 92 家美国管理式医疗计划的理赔数据,评估了 2003 年 1 月 1 日至 2005 年 9 月 30 日期间开始应用阿托伐他汀(10 或 20mg/d)或辛伐他汀(20 或 40mg/d)治疗的无心血管疾病的高血压患者的心血管(CV)结局。共确定了 98471 例高血压患者,其中阿托伐他汀使用者 74685 例(平均剂量 13.6mg/d),辛伐他汀使用者 23786 例(平均剂量 28.6mg/d),中位随访时间为 1.5 年,以发生首次 CV 事件。阿托伐他汀和辛伐他汀的粗 CV 事件发生率分别为 2.81 和 3.92/100 人年[未校正危险比(HR):0.73;95%置信区间(CI):0.68-0.78,P<0.001]。校正临床和人口统计学混杂因素后,与辛伐他汀相比,应用阿托伐他汀与较少的 CV 事件相关(HR:0.91;95%CI:0.84-0.98,P=0.009)。然而,由于患者的血脂数据不可用,无法评估这 2 种他汀类药物的降脂疗效。总之,与起始应用辛伐他汀(20 或 40mg/d)的高血压患者相比,起始应用阿托伐他汀(10 或 20mg/d)的高血压患者随后发生 CV 事件的风险显著降低。与所有观察性研究一样,本研究存在一定的局限性,研究结果应被视为假设产生。

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