Abstract Title:

Statin-Induced Lupus: a Case/non-Case Study in a Nationwide Pharmacovigilance Database.

Abstract Source:

Lupus. 2012 Feb 14. Epub 2012 Feb 14. PMID: 22333565

Abstract Author(s):

G Moulis, J Béné, A Sommet, L Sailler, M Lapeyre-Mestre, J-L Montastruc, French Asociation Of Regional Pharmacovigilance Centers

Article Affiliation:

CHU Toulouse, Service de Médecine Interne, Toulouse, F-31059, France.


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.

Study Type : Human Study

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