Laboratory of Social Pharmacy and Public Health, School of Pharmacy, University of Coimbra, Coimbra, Portugal.
CHAD-Centre for Health Technology Assessment and Drug Research, Coimbra Regional Pharmacovigilance Unit (UFC), AIBILI-Association for Innovation and Biomedical Research on Light and Image, Coimbra, Portugal.
Cardiovasc Ther. 2018 Dec;36(6):e12480. doi: 10.1111/1755-5922.12480. Epub 2019 Jan 25.
Two previous meta-analyses evaluated the risk of cataracts associated with statins, but did not include relevant studies suggesting a cataractogenic effect.
The aim of this systematic review and meta-analysis of observational studies is to evaluate such association considering the latest published evidence.
A literature search was conducted to identify observational, comparative studies evaluating the risk of developing cataracts in patients treated with statins. A meta-analysis was performed to estimate odds ratios (ORs). Results were stratified according to the following studies' subgroups: design, methodological quality, method of diagnosis of cataract, patients' age, and median follow-up. Meta-regressions evaluated the influence of the following risk factors: smoking, hypertension, corticosteroids, selective serotonin reuptake inhibitors (SSRI), diabetes mellitus, and cardiovascular disease.
Twenty-one studies were included. Treatment with statins was associated with an increased risk of cataracts [OR: 1.11 (95% CI: 1.02-1.21); P = 0.017; I = 97.5%]. This risk remained statistically significant among case-controls, good methodological quality studies, studies with length of follow-up ≥5 years and those which outcome was cataract surgery. Between-studies heterogeneity was high among all risk estimates. Meta-regressions identified an inverse relationship between the risk of cataracts and the proportion of diabetic patients in the studies.
The results point out an increased risk of cataract development with statins. However, since the magnitude of the effect is low and between-studies heterogeneity is high, the extent in which these results have impact on the benefit/risk ratio of statins is difficult to ascertain due to the uncertainty of the findings.
两项先前的荟萃分析评估了他汀类药物相关白内障的风险,但并未纳入表明白内障形成作用的相关研究。
本系统评价和观察性研究的荟萃分析旨在考虑最新发表的证据评估这种相关性。
进行文献检索,以确定评估他汀类药物治疗患者发生白内障风险的观察性、比较研究。进行荟萃分析以估计比值比(ORs)。结果根据以下研究亚组分层:设计、方法学质量、白内障诊断方法、患者年龄和中位随访时间。荟萃回归评估了以下风险因素的影响:吸烟、高血压、皮质类固醇、选择性 5-羟色胺再摄取抑制剂(SSRIs)、糖尿病和心血管疾病。
共纳入 21 项研究。他汀类药物治疗与白内障风险增加相关[OR:1.11(95% CI:1.02-1.21);P=0.017;I²=97.5%]。在病例对照研究、方法学质量良好的研究、随访时间≥5 年的研究以及以白内障手术为结局的研究中,这种风险仍然具有统计学意义。所有风险估计的组间异质性均很高。荟萃回归确定了研究中糖尿病患者比例与白内障风险之间的反比关系。
结果表明他汀类药物会增加白内障发生的风险。然而,由于效应幅度较小且组间异质性较高,由于对这些结果的不确定性,难以确定这些结果对他汀类药物的获益/风险比的影响程度。