title: Statin-induced lupus: a case/non-case study in a nationwide pharmacovigilance database.
abstract: Statin use has been advocated to prevent atheromatous complications in lupus patients and may be widely prescribed for these patients in future. Statin-induced lupus has also been described, though the risk is not confirmed. The goal of this study was to detect a safety signal regarding statin-induced lupus. We conducted a case/non-case study in the French PharmacoVigilance Database from January 2000 until December 2010. Cases were drug-induced lupus reports. Non-cases were all reports of other adverse drug reactions (ADRs). Exposure to statins at the time of ADR was screened in each report. Among 235,147 ADR reports, 232 were drug-induced lupus. Exposure to statins was present in 17 (7.3%) cases and in 10,601 (4.7%) non-cases. Reporting odds ratio (ROR) for statin exposure associated with lupus erythematosus was 1.67 (95% confidence interval 1.02-2.74). The ROR was > 1 for each statin but fluvastatin. This pharmacoepidemiological study suggests a link between statin exposure and lupus induction. The benefit-to-risk ratio of statin therapy in lupus patients should be evaluated through randomized controlled trials.
authors.affiliation: CHU Toulouse, Service de Médecine Interne, Toulouse, F-31059, France. guillaume.moulis@univ-tlse3.fr
authors.forename: G
authors.initials: G
authors.lastname: Moulis
authors.forename: J
authors.initials: J
authors.lastname: Béné
authors.forename: A
authors.initials: A
authors.lastname: Sommet
authors.forename: L
authors.initials: L
authors.lastname: Sailler
authors.forename: M
authors.initials: M
authors.lastname: Lapeyre-Mestre
authors.forename: J-L
authors.initials: JL
authors.lastname: Montastruc
mesh_terms: D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D000974:Antibodies, Antinuclear / Q000097:blood; D016022:Case-Control Studies; D016001:Confidence Intervals; D004247:DNA / Q000276:immunology; D016208:Databases, Factual; D003875:Drug Eruptions / Q000209:etiology; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects*; D008180:Lupus Erythematosus, Systemic / Q000097:blood / Q000139:chemically induced* / Q000453:epidemiology*; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D060735:Pharmacovigilance
chemical_list: D000974:Antibodies, Antinuclear; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D004247:DNA