Statin-induced lupus: a case/non-case study in a nationwide pharmacovigilance database

Lupus
G MoulisFrench Association of PharmacoVigilance Centres

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.

References

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Citations

Apr 28, 2012·Arthritis Research & Therapy·Rob J VandebrielHenk Van Loveren
Jul 4, 2012·Arthritis Research & Therapy·Robert Weissert
Aug 9, 2012·Asia Pacific Allergy·Sujoy Khan
Apr 25, 2015·Expert Opinion on Drug Safety·Maciej BanachDimitri P Mikhailidis
Dec 30, 2015·Seminars in Arthritis and Rheumatism·Konstantinos TseliosMurray B Urowitz
Dec 3, 2014·La Revue de médecine interne·L ArnaudUNKNOWN groupe France Lupus Érythémateux systémique Réseau (FLEUR) et les centres de référence et de compétence des lupus et syndrom
Feb 11, 2015·Medicina clínica·Marcelo Alvarado CárdenasUNKNOWN en representación del Grupo para estudio de Autoinmunidad y Estatinas
Jun 29, 2017·Expert Opinion on Drug Safety·M Le MoigneC Victorri-Vigneau
Jul 8, 2017·Annals of the Rheumatic Diseases·Hilda J I De JongJan Willem Cohen Tervaert
Aug 28, 2020·Current Rheumatology Reports·Marisa C Mizus, Eleni Tiniakou
Feb 9, 2017·Immunologic Research·Melinda Zsuzsanna SzabóEmese Kiss
Feb 2, 2019·Thérapie·Julien Bezin, Nicholas Moore
Nov 6, 2018·Thérapie·Jean-Louis MontastrucAgnès Sommet

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Methods Mentioned

BETA
biopsy

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