title: Statin-associated polymyalgia rheumatica. An analysis using WHO global individual case safety database: a case/non-case approach.
abstract: OBJECTIVE
  To assess whether there is an association between statin use and the occurrence of polymyalgia rheumatic (PMR) in the spontaneous reporting database of the World Health Organisation (WHO).
  
  
  METHODS
  We conducted a case/non-case study based on individual case safety reports (ICSR) in the WHO global ICSR database (VigiBase). Case reports containing the adverse event term polymyalgia rheumatica (WHOART or MedDRA Preferred Term) were defined as cases. Non-cases were all case reports containing other adverse event terms. Each case was matched to five non-cases by age, gender, and time of reporting. Case reports regarding a statin as suspected or concomitant drug were identified using the Anatomical Therapeutic Chemical (ATC) classification. Multivariate logistic regression was used to calculate reporting odds ratios (RORs) with 95% confidence intervals (CI).
  
  
  RESULTS
  We identified 327 reports of PMR as cases and 1635 reports of other ADRs as non-cases. Among cases, statins were more frequently reported as suspected agent (29.4%) compared to non-cases (2.9%). After adjustment for several covariates, statins were significantly associated with reports of PMR (ROR 14.21; 95% CI 9.89-20.85).
  
  
  CONCLUSIONS
  The results of this study lends support to previous anecdotal case reports in the literature suggesting that the use of a statin may be associated with the occurrence of PMR. Further studies are needed to study the strength of the association in more detail and to elucidate the underlying mechanism.
authors: Laboratory for Health Protection Research, National Institute for Public Health and the Environment, Bilthoven, The Netherlands.
authors: Hilda J I
authors: HJ
authors: de Jong
authors: Siti R F
authors: SR
authors: Saldi
authors: Olaf H
authors: OH
authors: Klungel
authors: Rob J
authors: RJ
authors: Vandebriel
authors: Patrick C
authors: PC
authors: Souverein
authors: Ronald H B
authors: RH
authors: Meyboom
authors: J L M Anneke
authors: JL
authors: Passier
authors: Henk
authors: H
authors: van Loveren
authors: Jan Willem
authors: JW
authors: Cohen Tervaert
mesh_terms: D062313:Databases, Pharmaceutical; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D011111:Polymyalgia Rheumatica / Q000139:chemically induced*; D012449:Safety; D014944:World Health Organization
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors