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Regul Toxicol Pharmacol. 2019 Dec;109:104509. doi: 10.1016/j.yrtph.2019.104509. Epub 2019 Oct 26.

Cataracts and statins. A disproportionality analysis using data from VigiBase.

Author information

1
Department of Medicine, University of Valencia, INCLIVA Health Research Institute and CIBERSAM, Valencia, Spain; Unit of Medicines and Health Technologies (MT), Dep. of Health Systems and Services (HSS), Pan American Health Organization (PAHO/WHO), United States. Electronic address: dmacias.sg@gmail.com.
2
Dirección Nacional de Medicamentos. Gobierno de El Salvador, Cd Merliot, El Salvador.
3
CECMED Departamento de Vigilancia Postcomercialización, La Habana, Cuba.
4
Unit of Medicines and Health Technologies (MT), Dep. of Health Systems and Services (HSS), Pan American Health Organization (PAHO/WHO), United States.
5
Department of Medicine, University of Valencia, INCLIVA Health Research Institute and CIBERSAM, Valencia, Spain.

Abstract

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.

KEYWORDS:

Anticholesteremic agents; Cataract; Hydroxymethylglutaryl-CoA reductase inhibitors; Pharmacovigilance; Statins

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