title: Association between statin use and lupus-like syndrome using spontaneous reports.
abstract: OBJECTIVE
  Several case reports of lupus-like syndrome suggest that statins could have triggered the development of this rare autoimmune disease. However, data on the association between statin use and lupus-like syndrome are scarce. We assessed whether there was an association between statin use and the occurrence of lupus-like syndrome.
  
  
  METHODS
  A case/noncase study based on individual case safety reports listed in the World Health Organization global individual case safety reports database (VigiBase) was conducted. According to World Health Organization adverse reaction terminology, cases were defined as reports of lupus-like syndrome. Each case was matched with 5 noncases by age, gender, and time of reporting. Use of statins was classified according to the Anatomical Therapeutic Chemical classification code system. Covariates, ie, use of corticosteroids, immunosuppressive drugs, nonsteroidal anti-inflammatory drugs, antidepressants, antiepileptics, proton pump inhibitors, and cardiovascular drugs, were determined. Multivariate logistic regression was used to calculate the reporting odds ratios with 95% confidence intervals.
  
  
  RESULTS
  We identified 3362 reports of lupus-like syndrome as cases and 27,092 reports of other adverse drug reactions as noncases. Statins were more frequently reported as suspected drug in cases (3.2%) than in noncases (1.5%). After adjustment for several covariates, statins were associated with the reporting of lupus-like syndrome (reporting odds ratios 2.01; 95% confidence intervals 1.61-2.51).
  
  
  CONCLUSIONS
  We found an association between reporting of statins and lupus-like syndrome. Further studies are needed to confirm this finding in more detail and establish causality.
authors.affiliation: Laboratory for Health Protection Research, National Institute for Public Health and Environment, Bilthoven, Netherlands.
authors.forename: Hilda J I
authors.initials: HJ
authors.lastname: de Jong
authors.forename: Jan Willem Cohen
authors.initials: JW
authors.lastname: Tervaert
authors.forename: Siti R F
authors.initials: SR
authors.lastname: Saldi
authors.forename: Rob J
authors.initials: RJ
authors.lastname: Vandebriel
authors.forename: Patrick C
authors.initials: PC
authors.lastname: Souverein
authors.forename: Ronald H B
authors.initials: RH
authors.lastname: Meyboom
authors.forename: Henk
authors.initials: H
authors.lastname: van Loveren
authors.forename: Olaf H
authors.initials: OH
authors.lastname: Klungel
mesh_terms: D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D016022:Case-Control Studies; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects*; D008180:Lupus Erythematosus, Systemic / Q000139:chemically induced*; D008297:Male; D008875:Middle Aged
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors