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

Diego Macías Saint-Gerons1, Francisco Bosco Cortez2, Giset Jiménez López3

  • 1Department 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.

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This study found a link between statin use and an increased risk of cataracts. The analysis of global drug safety reports suggests this association applies to statins as a drug class, regardless of specific drug properties.

Keywords:
Anticholesteremic agentsCataractHydroxymethylglutaryl-CoA reductase inhibitorsPharmacovigilanceStatins

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Area of Science:

  • Pharmacovigilance
  • Ophthalmology
  • Cardiovascular Medicine

Background:

  • Statins are widely prescribed lipid-lowering drugs.
  • The association between statin use and cataract risk requires further investigation.
  • Understanding potential adverse drug reactions is crucial for patient safety.

Purpose of the Study:

  • To explore the association between statin use and cataract development.
  • To quantify the risk of cataract associated with individual statins and the drug class.
  • To compare the risk with other lipid-lowering medications.

Main Methods:

  • Utilized the World Health Organization (WHO) VigiBase database of individual case safety reports (ICSRs).
  • Calculated reporting odds ratios (RORs) to assess disproportionality for cataract events.
  • Conducted subgroup analyses based on statin lipophilicity, sex, and age.

Main Results:

  • Significant increased disproportionality for cataract was observed for multiple individual statins, including lovastatin, atorvastatin, and rosuvastatin.
  • A higher risk of cataract was associated with statins as a drug class (ROR: 3.66).
  • No increased risk was found for other lipid-lowering drugs like ezetimibe, fibrates, or PCSK9 inhibitors.

Conclusions:

  • Findings suggest an increased risk of cataract associated with the use of statins.
  • The observed association appears consistent across different statin types and patient demographics.
  • Further research is recommended to fully characterize this risk; benefits and harms should be weighed before initiating statin therapy.