Al-Holou Shaza N, Tucker William R, Agrón Elvira, Clemons Traci E, Cukras Catherine, Ferris Frederick L, Chew Emily Y
Clinical Trials Branch, Division of Epidemiology and Clinical Applications, National Eye Institute/National Institutes of Health, Bethesda, Maryland.
Laboratory of Immunology, National Eye Institute/National Institutes of Health, Bethesda, Maryland.
Ophthalmology. 2015 Dec;122(12):2490-6. doi: 10.1016/j.ophtha.2015.08.028. Epub 2015 Oct 4.
To evaluate the association of statin use with progression of age-related macular degeneration (AMD).
Preplanned, prospective cohort study within a controlled clinical trial of oral supplementation for age-related eye diseases.
Age-Related Eye Disease Study 2 (AREDS2) participants, aged 50 to 85 years.
Factors, including age, gender, smoking status, aspirin use, and history of diabetes, hypertension, heart disease, angina, and stroke-all known to be associated with statin use-were included in a logistic regression model to estimate propensity scores for each participant. Age-adjusted proportional hazards regression models, with and without propensity score matching, were performed to evaluate the association of statin use with progression to late AMD. Analyses adjusting for the competing risk of death were also performed.
Baseline and annual stereoscopic fundus photographs were assessed centrally by masked graders for the development of late AMD, either neovascular AMD or geographic atrophy (GA).
Of the 3791 participants (2462 with bilateral large drusen and 1329 with unilateral late AMD at baseline), 1659 (43.8%) were statin users. The overall analysis, with no matching of propensity scores and no adjustment for death as a competing risk, showed that statin use was not associated with progression to late AMD (hazard ratio [HR], 1.08; 95% confidence interval [CI], 0.83-1.41; P = 0.56). When matched for propensity scores and adjusted for death as a competing risk, the result was not statistically significant (HR, 0.81; 95% CI, 0.55-1.20; P = 0.29). Furthermore, subgroup analyses of persons with or without late AMD at baseline and the various components of late AMD (neovascular AMD, central GA, or any GA) also showed no statistically significant association of statin use with progression to AMD.
Statin use was not statistically significantly associated with progression to late AMD in the AREDS2 participants, and these findings are consistent with findings in the majority of previous studies. Statins have been demonstrated to reduce the risk of cardiovascular disease, but our data do not provide evidence of a beneficial effect on slowing AMD progression.
评估他汀类药物的使用与年龄相关性黄斑变性（AMD）进展之间的关联。
在一项针对年龄相关性眼病的口服补充剂对照临床试验中进行的预先计划的前瞻性队列研究。
年龄相关性眼病研究2（AREDS2）的参与者，年龄在50至85岁之间。
将年龄、性别、吸烟状况、阿司匹林使用情况以及糖尿病、高血压、心脏病、心绞痛和中风病史等所有已知与他汀类药物使用相关的因素纳入逻辑回归模型，以估计每位参与者的倾向得分。采用年龄调整的比例风险回归模型，分别在有和没有倾向得分匹配的情况下，评估他汀类药物的使用与进展至晚期AMD之间的关联。还进行了针对死亡竞争风险的分析调整。
由蒙面分级人员集中评估基线和年度立体眼底照片，以确定晚期AMD（新生血管性AMD或地图样萎缩（GA））的发生情况。
在3791名参与者中（2462名基线时有双侧大玻璃膜疣，1329名基线时有单侧晚期AMD），1659名（43.8%）为他汀类药物使用者。总体分析中，未进行倾向得分匹配且未将死亡作为竞争风险进行调整，结果显示他汀类药物的使用与进展至晚期AMD无关（风险比[HR]，1.08；95%置信区间[CI]，0.83 - 1.41；P = 0.56）。在进行倾向得分匹配并将死亡作为竞争风险进行调整后，结果无统计学意义（HR，0.81；95% CI，0.55 - 1.20；P = 0.29）。此外，对基线时有无晚期AMD的人群以及晚期AMD的各个组成部分（新生血管性AMD、中心性GA或任何GA）进行的亚组分析也显示，他汀类药物的使用与进展至AMD之间无统计学意义的关联。
在AREDS2参与者中，他汀类药物的使用与进展至晚期AMD无统计学意义上的关联，这些发现与大多数先前研究的结果一致。他汀类药物已被证明可降低心血管疾病风险，但我们的数据并未提供其对减缓AMD进展有有益作用的证据。
