Department of Internal Medicine, National Taiwan University Hospital Hsin-Chu Branch, Hsin-Chu, Taiwan.
Drug Saf. 2013 Oct;36(10):1017-24. doi: 10.1007/s40264-013-0076-0.
Since a report of lenticular opacities in dogs treated with high dosages of statins, the debate on the relationship between statin therapy and cataracts has not reached a conclusion.
The aim of this study was to evaluate the association between statin therapy and the risk of cataract surgery in an elderly ethnic Chinese population using time-dependent analysis to minimize immortal time bias.
A retrospective cohort study using the Longitudinal Health Insurance Database 2005 randomly sampled from the National Health Insurance Research Database, Taiwan, was conducted. A total of 50,165 adults aged between 65 and 90 years in 1998 without records of statin therapy or diagnosis of cataracts between July 1997 and December 1997 were included in the analysis. The first record of lens extraction within the follow-up period (1998-2009) was set as the study endpoint. A propensity score was derived using a logistic regression model to model the receipt of statin therapy as a function of the baseline characteristics for every subject. We used the time-dependent Cox regression model to test the relative hazard of undergoing cataract surgery between statin users and non-users, while use of statins was treated as a time-dependent variable, controlling for baseline age and individual propensity score.
Of the 50,165 enrolled subjects, 17,670 individuals with an incident lens extraction were identified during a median follow-up of 10.7 years. The incidence of cataract surgery was 49.7/1,000 person-years in the statin-using period compared with 38.5/1,000 person-years in the statin-non-using period. The adjusted hazard ratio of cataract surgery was 1.20 (95 % CI 1.14-1.27; P < 0.001) in statin users compared with statin non-users.
Statin therapy was associated with a modestly increased risk of cataract surgery. We suggest regular checks for lens opacity in statin users.
自他汀类药物高剂量治疗犬类出现晶状体混浊的报告以来,关于他汀类药物治疗与白内障之间关系的争论尚未得出结论。
本研究旨在使用时间依赖性分析评估他汀类药物治疗与中国老年人群白内障手术风险之间的关联,以最大程度减少不朽时间偏倚。
本研究使用 1998 年从台湾全民健康保险研究数据库中随机抽取的纵向健康保险数据库 2005 进行回顾性队列研究。共纳入 1997 年 7 月至 1997 年 12 月期间无他汀类药物治疗或白内障诊断记录且年龄在 65-90 岁之间的 50165 名成年人。随访期间(1998-2009 年)内首次晶状体提取记录被设定为研究终点。使用逻辑回归模型得出倾向评分,将他汀类药物治疗作为每个患者的基线特征的函数。我们使用时间依赖性 Cox 回归模型来测试他汀类药物使用者和非使用者之间进行白内障手术的相对风险,同时将他汀类药物的使用作为一个时间依赖性变量,控制基线年龄和个体倾向评分。
在纳入的 50165 名受试者中,在中位随访 10.7 年后确定了 17670 名有晶状体提取事件的患者。在他汀类药物使用期间,白内障手术的发生率为 49.7/1000 人年,而在他汀类药物非使用期间为 38.5/1000 人年。与他汀类药物非使用者相比,他汀类药物使用者白内障手术的调整后危险比为 1.20(95%CI 1.14-1.27;P<0.001)。
他汀类药物治疗与白内障手术风险略有增加相关。我们建议在使用他汀类药物的患者中定期检查晶状体混浊情况。