Data for: Cataracts and statins. A disproportionality analysis using data from VigiBase

Published: 31-10-2019| Version 1 | DOI: 10.17632/jpj2syvmc4.1
Diego Macias Saint-Gerons


The file include the number of Individual case safety reports for ICSRs contained in the World Health Organization (WHO) global database of individual case safety reports (VigiBase) in which the following MedDRA preferred terms (PTs): “Cataract”, “Cataract cortical”, “Cataract nuclear” and “Cataract subcapsular” were reported for HMG-CoA reductase inhibitors according to the anatomical therapeutic chemical classification (ATC: C10AA) between inception on Nov 14, 1967, and Jan 15, 2019. Fixed-dose combinations of statins with other drugs were not considered. We also searched for ICSRs for the PTs mentioned above and prednisolone as a positive control – a drug previously known to cause cataract- and paracetamol/acetaminophen which served as a negative control -a drug not likely to be related with the occurrence of cataracts. Furthermore, we searched ICSRs of cataracts related to other lipid-lowering drugs classes different from statins: fibrates (ATC: C10AB), ezetimibe (ATC: C10AX09) and proprotein convertase subtilisin/kexin type 9 (PCSK9) antibodies (ATC C10AX13, C10AX14). Disproportional reporting was investigated through the calculation of the Reporting Odds Ratio with their 95% Confidence Interval using Woolf’s method. Subgroup analysis of the ROR of statins as a drug class were performed by sex and by age groups (more or less than 65 years old).