Statin-Associated Polymyalgia Rheumatica. An Analysis Using WHO Global Individual Case Safety Database: A Case/Non-Case Approach

Jong, Hilda J. I. de; Saldi, Siti Rizny F; Klungel, Olaf H.; Vandebriel, Rob J.; Souverein, Patrick C.; Meyboom, R.H.B.; Passier, Anneke; Loveren, Henk Van; Tervaert, Jan Willem Cohen

doi:10.1371/journal.pone.0041289

Cited by 31 publications

(15 citation statements)

References 34 publications

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“…Several organizations maintain their own well-organized databases of spontaneously reported adverse events, and use them to analyze associations with drugs. The WHO Programme for International Drug Monitoring, starting in 1968, is a cornerstone of world-wide pharmacovigilance, and the Uppsala Monitoring Centre, Uppsala, Sweden, maintains the WHO Global Individual Case Safety Report Database, VigiBase 81-84. In France, pharmacovigilance activities are carried out by 31 regional centers based in clinical pharmacology departments of university hospitals 85, 86, and the French Pharmacovigilance Database has been used to analyze the safety profiles of various drugs 87-91.…”

Section: Closing Remarksmentioning

confidence: 99%

Data Mining of the Public Version of the FDA Adverse Event Reporting System

Sakaeda¹,

Tamon²,

Kadoyama³

et al. 2013

Int. J. Med. Sci.

538

412

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The US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS, formerly AERS) is a database that contains information on adverse event and medication error reports submitted to the FDA. Besides those from manufacturers, reports can be submitted from health care professionals and the public. The original system was started in 1969, but since the last major revision in 1997, reporting has markedly increased. Data mining algorithms have been developed for the quantitative detection of signals from such a large database, where a signal means a statistical association between a drug and an adverse event or a drug-associated adverse event, including the proportional reporting ratio (PRR), the reporting odds ratio (ROR), the information component (IC), and the empirical Bayes geometric mean (EBGM). A survey of our previous reports suggested that the ROR provided the highest number of signals, and the EBGM the lowest. Additionally, an analysis of warfarin-, aspirin- and clopidogrel-associated adverse events suggested that all EBGM-based signals were included in the PRR-based signals, and also in the IC- or ROR-based ones, and that the PRR- and IC-based signals were in the ROR-based ones. In this article, the latest information on this area is summarized for future pharmacoepidemiological studies and/or pharmacovigilance analyses.

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Section: Closing Remarksmentioning

confidence: 99%

Data Mining of the Public Version of the FDA Adverse Event Reporting System

Sakaeda¹,

Tamon²,

Kadoyama³

et al. 2013

Int. J. Med. Sci.

538

412

View full text Add to dashboard Cite

show abstract

“…Several case/non-case studies showed that statins might have been significantly associated with an increased risk of polymyalgia rheumatica (n = 327 cases; reporting odds ratio (ROR) 14.21) [69], rheumatoid arthritis (n = 508 patients; adjusted OR = 1.71, p = 0.007; a trend between the potency of statin treatment and the risk of RA was observed) [70] and lupus erythematosus (OR = 1.67) [71]. In the last study [71] cases were defined as drug-induced lupus reports.…”

Section: Rheumatic Diseases and Statin Intolerancementioning

confidence: 99%

Statin intolerance – an attempt at a unified definition. Position paper from an International Lipid Expert Panel

Banach

Rizzo²,

Tóth

et al. 2015

Expert Opinion on Drug Safety

182

204

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“…In Takayasu disease the use of antiplatelet treatment could be protective for ischemic events. Cumulative meta-analysis (6 retrospective studies, 914 pts), monocentric retrospective evaluation (48 pts), retrospective analysis (297 pts) [ 101 - 104 ] …”

Section: Introductionmentioning

confidence: 99%

“…A retrospective recent study has shown that patients using statins were less likely to develop GCA compared to patients not using them [ 103 ]. Interestingly, a recent association study performed using the World Health Organization database, has suggested that the occurrence of PMR could be correlated with statin use [ 104 ].…”

Section: Introductionmentioning

confidence: 99%

Thrombosis in vasculitis: from pathogenesis to treatment

et al. 2015

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In recent years, the relationship between inflammation and thrombosis has been deeply investigated and it is now clear that immune and coagulation systems are functionally interconnected.Inflammation-induced thrombosis is by now considered a feature not only of autoimmune rheumatic diseases, but also of systemic vasculitides such as Behçet’s syndrome, ANCA-associated vasculitis or giant cells arteritis, especially during active disease.These findings have important consequences in terms of management and treatment. Indeed, Behçet’syndrome requires immunosuppressive agents for vascular involvement rather than anticoagulation or antiplatelet therapy, and it is conceivable that also in ANCA-associated vasculitis or large vessel-vasculitis an aggressive anti-inflammatory treatment during active disease could reduce the risk of thrombotic events in early stages.In this review we discuss thrombosis in vasculitides, especially in Behçet’s syndrome, ANCA-associated vasculitis and large-vessel vasculitis, and provide pathogenetic and clinical clues for the different specialists involved in the care of these patients.

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Statin-Associated Polymyalgia Rheumatica. An Analysis Using WHO Global Individual Case Safety Database: A Case/Non-Case Approach

Cited by 31 publications

References 34 publications

Data Mining of the Public Version of the FDA Adverse Event Reporting System

Data Mining of the Public Version of the FDA Adverse Event Reporting System

Statin intolerance – an attempt at a unified definition. Position paper from an International Lipid Expert Panel

Thrombosis in vasculitis: from pathogenesis to treatment

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