The Degge Group Ltd., Drug Safety and Epidemiology, Arlington, VA, USA.
Pharmacoepidemiol Drug Saf. 2009 Dec;18(12):1214-22. doi: 10.1002/pds.1843.
This study compared the effectiveness of rosuvastatin (RSV) to other statins prescribed in clinical practice in prevention of cardiovascular (CV) events.
This longitudinal inception cohort study, using Thomson Healthcare's MarketScan databases, included patients aged > or = 18 starting statin therapy during August 2003-December 2005. Patients were followed until 90 days after index statin monotherapy exposure, start of another lipid-lowering therapy, an event, end of eligibility, or end of study. The primary endpoint was a composite of CV death (in-hospital only), myocardial infarction, unstable angina, coronary revascularization, stroke, and carotid revascularization. Adjusted time-to-event analyses incorporating a propensity score covariate were used, and analyses were stratified by duration of statin exposure.
Among 395 039 patients who met inclusion/exclusion criteria, 12% initiated RSV, and 9622 (2.4%) of the total patient population experienced an outcome event. The median duration of statin treatment and follow-up was 100 days and 180 days, respectively. No statistically significant difference in CV event rates between RSV and other statins was observed after adjustment for demographics and medical/prescription history (HR = 0.99, 95%CI = 0.93-1.06). However, with longer exposure time, there was a suggestion of increased benefit with RSV compared to other statins.
The primary analysis showed similar incidence rates of CV-related events between the statin cohorts over a median of 180 days of follow-up.
本研究比较了瑞舒伐他汀(RSV)与其他在临床实践中开具的他汀类药物在预防心血管(CV)事件方面的疗效。
这项纵向起始队列研究使用 Thomson Healthcare 的 MarketScan 数据库,纳入了 2003 年 8 月至 2005 年 12 月期间开始他汀类药物治疗的年龄≥18 岁的患者。患者随访至索引他汀类药物单药治疗暴露后 90 天、开始另一种降脂治疗、发生事件、资格结束或研究结束。主要终点是 CV 死亡(仅限住院)、心肌梗死、不稳定型心绞痛、冠状动脉血运重建、卒中和颈动脉血运重建的复合事件。采用包含倾向评分协变量的调整后时间事件分析,并按他汀类药物暴露时间进行分层分析。
在符合纳入/排除标准的 395039 名患者中,有 12%的患者起始瑞舒伐他汀治疗,总患者人群中有 9622 例(2.4%)发生了结局事件。他汀类药物治疗和随访的中位时间分别为 100 天和 180 天。在调整了人口统计学和医疗/处方史后,RSV 和其他他汀类药物的 CV 事件发生率没有统计学差异(HR=0.99,95%CI=0.93-1.06)。然而,随着暴露时间的延长,瑞舒伐他汀与其他他汀类药物相比,获益可能增加。
主要分析显示,在中位随访 180 天内,他汀类药物队列之间的 CV 相关事件发生率相似。