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Cataracts and statins. A disproportionality analysis using data from VigiBase.
Regulatory Toxicology and Pharmacology ( IF 3.0 ) Pub Date : 2019-10-26 , DOI: 10.1016/j.yrtph.2019.104509
Diego Macías Saint-Gerons 1 , Francisco Bosco Cortez 2 , Giset Jiménez López 3 , José Luis Castro 4 , Rafael Tabarés-Seisdedos 5
Affiliation  

The basis of the association between statin use and cataract has been explored using the World Health Organization (WHO) global database of individual case safety reports (ICSRs) for drug monitoring (VigiBase) through January 2019. The reporting odds ratios (RORs) as a measure of disproportionality for reported cataracts and individual statins have been calculated. Subgroup analyses according statin lipophilicity, sex, and age groups have been performed. Moreover, RORs have been calculated for non-statin lipid lowering drugs. An increased disproportionality have been found for most individual statins lovastatin: [ROR: 14.80, 95% confidence interval (CI): 13.30, 16.46)], atorvastatin (ROR: 3.48, 95% CI 3.19-3.80), pravastatin (ROR: 3.15, 95% CI: 2.54-3.90), rosuvastatin (ROR: 2.90, 95% CI: 2.53-3.31), simvastatin (ROR: 2.27, 95%CI: 1.99-2.60), fluvastatin (ROR: 2.03, 95% CI: 1.33-3.08) and statins (overall) ROR: 3.66, 95% CI:3.46-3.86). Increased disproportionality for cataract and statins (drug-class) have been found regardless of statin lipophilicity, sex and group age (more or less than 65 years old). No disproportionality was found for other lipid-lowering drugs (ezetimibe, fibrates or PCSK9 inhibitors). These findings suggest an increased risk of cataract associated with statins as a drug-class. Further studies to characterize the risk are advised. Benefits and potential harms should be considered before starting treatment with statins.

中文翻译:

白内障和他汀类药物。使用来自VigiBase的数据进行不成比例分析。

他汀类药物使用与白内障之间的关联基础已使用世界卫生组织(WHO)的全球个案监测数据库(ICSRs)进行了药物监测(VigiBase)至2019年1月进行了探索。报告的比值比(ROR)作为已计算出报告的白内障和个别他汀类药物的不相称性。已根据他汀类药物的亲脂性,性别和年龄组进行了亚组分析。此外,已计算出非他汀类降脂药物的ROR。发现大多数个体他汀类药物洛伐他汀的比例失调增加:[ROR:14.80,95%置信区间(CI):13.30,16.46)],阿托伐他汀(ROR:3.48,95%CI 3.19-3.80),普伐他汀(ROR:3.15 ,95%CI:2.54-3.90),瑞舒伐他汀(ROR:2.90、95%CI:2.53-3.31),辛伐他汀(ROR:2.27、95%CI:1.99-2.60),氟伐他汀(ROR:2.03,95%CI:1.33-3.08)和他汀类药物(总体)ROR:3.66,95%CI:3.46-3.86)。已经发现白内障和他汀类药物(药物类)的比例失调增加,而与他汀类药物的亲脂性,性别和年龄(大于或小于65岁)无关。没有发现其他降脂药物(依泽麦布,贝特类或PCSK9抑制剂)存在不成比例的情况。这些发现表明,与他汀类药物相关的白内障风险增加。建议进一步研究以表征风险。在开始他汀类药物治疗之前,应考虑其益处和潜在危害。性别和小组年龄(大于或小于65岁)。没有发现其他降脂药物(依泽麦布,贝特类或PCSK9抑制剂)存在不成比例的情况。这些发现表明,与他汀类药物相关的白内障风险增加。建议进一步研究以表征风险。在开始他汀类药物治疗之前,应考虑其益处和潜在危害。性别和小组年龄(大于或小于65岁)。没有发现其他降脂药物(依泽麦布,贝特类或PCSK9抑制剂)存在不成比例的情况。这些发现表明,与他汀类药物相关的白内障风险增加。建议进一步研究以表征风险。在开始他汀类药物治疗之前,应考虑其益处和潜在危害。
更新日期:2019-10-26
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