The association between statin use and polymyalgia rheumatica/arteritis temporalis: Demonstrated by spontaneous reports and self-described case-reports
De Jong, Hilda J.; Saldi, Siti R.; Klungel, Olaf H.; Vandebriel, Rob J.; Souverein, Patrick C.; Meyboom, Ron H.; Passier, Anneke; Van Loveren, Henk; Tervaert, Jan Willem Cohen
(2011) Pharmacoepidemiology and Drug Safety, volume 20, issue S1, pp.
(Abstract)
Abstract
Background: Two case reports of polymyalgia rheumatica (PMR) and one case-report of PMR and temporalis arteritis (AT) suggest that the use of statins may have triggered the development of these inflammatory rheumatic diseases. PMR is closely linked to the disease arteritis temporalis which makes it difficult for physicians to distinguish
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these two diseases. Data on the association between the use of statins and PMR and/or AT are scarce. Objectives: To assess the association between statin use and the occurrence of PMR/AT. Methods: A case/non-case study based on individual case safety reports (ICSR) listed in the World Health Organisation (WHO) global ICSR database (Vigibase) was conducted. According to WHO adverse reaction terminology, cases were defined as reports of PMR. Each case was matched with five non-cases by age, gender and time of reporting. Non-cases were all other ADR-reports. Use of statins was classified according to the Anatomical Therapeutic Chemical (ATC) classification code system (C10AA, C10BA, C10BX). Potential confounders in the analysis, i.e., use of corticosteroids, immunosuppressive drugs, non-steroidal anti-inflammatory drugs (NSAIDs), antidepressants, anti-epileptics, proton pump inhibitors and cardiovascular drugs were determined. Multivariate logistic regression was used to calculate the reporting odds ratios (RORs) with 95% confidence intervals (CI). In addition, three case-reports from the VigiBase were studied in detail. Results: We identified 327 reports of PMR/AT 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 statistically significantly associated with reports of PMR/AT (ROR 14.21; 95% CI 9.89-20.85). Conclusions: The result of this study underlines findings of the case reports that the use of statins may be associated with the occurrence of PMR/AT.
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Keywords: statin (protein), hydroxymethylglutaryl coenzyme A reductase inhibitor, corticosteroid, immunosuppressive agent, nonsteroid antiinflammatory agent, proton pump inhibitor, cardiovascular agent, antidepressant agent, case report, risk management, pharmacoepidemiology, human, data base, adverse drug reaction, gender, classification, epilepsy, logistic regression analysis, risk, confidence interval, rheumatic polymyalgia, arteritis, world health organization, temporal arteritis, physician, diseases, case study, safety, health, rheumatic disease
ISSN: 1053-8569
Publisher: John Wiley and Sons Ltd
Note: Abstracts 27th International Conference on Pharmacoepidemiology & Therapeutic Risk ManagementHyatt Regency Chicago, Chicago, Illinois, USA August 14–17, 2011