| アブストラクト | AIM: We aimed to investigate French pharmacovigilance data. The objective was to characterize psoriatic conditions that occurred after beta-blocker (BB) exposure and bring to light a possible pharmacovigilance signal. METHODS: Spontaneous reports of psoriatic conditions recorded in the French National Pharmacovigilance Database (FPVD) between 1985 and 2019 were extracted. We performed a retrospective, descriptive analysis of reports linked to BB exposure. Association between psoriasis risk and BB exposure was assessed using a case/noncase study. RESULTS: Two hundred and twenty-five reports of psoriatic conditions after BB exposure were recorded in the FPVD during the study period. Both cardioselective and noncardioselective, topical and systemic BBs are involved. Therapeutic indication of BB was mainly hypertension. Mean time to onset was 5 months and outcome was favourable in 68% after BB discontinuation. These features were concordant with those of literature reports. The reporting odds ratio (ROR) was 8.95 (95% confidence interval 7.75-10.33). CONCLUSION: We highlighted a statistically significant disproportionality which constitutes a pharmacovigilance signal. Psoriasis risk with BBs is a class effect. Increasing surveillance during the first year of BB exposure is needed. |
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| ジャーナル名 | British journal of clinical pharmacology |
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| 投稿日 | 2022/3/31 |
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| 投稿者 | Azzouz, Brahim; De Guizelin, Apolline; Lambert, Aude; Fresse, Audrey; Morel, Aurore; Trenque, Thierry |
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| 組織名 | Regional Centre of Pharmacovigilance and Pharmacoepidemiology, Reims University;Hospital, Reims, France.;EA 3797 Vieillissement, Fragilite, Faculty of Medicine, University of Reims;Champagne-Ardenne, Reims, France.;Regional Pharmacovigilance Centre, Strasbourg University Hospital, Strasbourg,;France.;Regional Pharmacovigilance Centre, Nancy University Hospital, Nancy, France. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/35352377/ |
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