| アブストラクト | To date, no reports of hypersensitivity reactions (HSRs) among nonsteroidal anti-inflammatory drugs (NSAIDs) according to cyclo-oxygenase (COX) selectivity and chemical groups have been published in a single study. The present study assessed the reporting frequency of HSRs for NSAIDs based on their relative inhibitory potency toward COX enzymes and chemical groups, including the presence/absence of a functional sulfonamide group, in strata observed 5 years after market authorization. A case/noncase study was performed among individual case safety reports (ICSRs) with NSAIDs as suspected drugs in VigiBase, the WHO spontaneous reporting database. Cases were ICSRs mentioning angioedema and anaphylactic/anaphylactoid shock conditions, while noncases were ICSRs without HSRs. NSAIDs were categorized into (i) NSAIDs with high COX-2 selectivity (coxibs), (ii) noncoxib NSAIDs with COX-2 preference, (iii) NSAIDs with poor selectivity, or (iv) NSAIDs with unknown selectivity. Chemical groups were defined based on the Anatomical Therapeutic Chemical classification system and the presence/absence of a functional sulfonamide group. Reporting odds ratios (RORs) and 95% confidence intervals (95% CIs) were calculated using logistic regression analysis. We identified 13 229 cases and 106 444 noncases. In the first 5 years after marketing, poor-selectivity NSAIDs and acetic acid derivatives were associated with the highest ROR of HSRs (age- and sex-adjusted ROR 2.12, 95% CI 1.98-2.28; and ROR 2.21, 95% CI 1.83-2.66, respectively) compared with coxibs, and sulfonamide NSAIDs were associated with the highest ROR of HSRs compared with nonsulfonamide NSAIDs (age- and sex-adjusted ROR 1.38, 95% CI 1.29-1.47). After the first 5 years of marketing, most of the RORs returned to approximately 1. |
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| ジャーナル名 | Fundamental & clinical pharmacology |
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| 投稿日 | 2019/3/13 |
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| 投稿者 | Bakhriansyah, Mohammad; Meyboom, Ronald H B; Souverein, Patrick C; de Boer, Anthonius; Klungel, Olaf H |
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| 組織名 | Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for;Pharmaceutical Sciences (UIPS), Utrecht University, PO Box 80082, 3508 TB,;Utrecht, The Netherlands.;Department of Pharmacology, Medical Faculty, Lambung Mangkurat University, Jalan;Veteran No. 128, 70232 Banjarmasin, South Kalimantan, Indonesia. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/30860620/ |
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