| アブストラクト | INTRODUCTION: Evidence regarding a possible association between psoriatic manifestations and use of calcium channel blockers (CCBs) is sparse. Currently, psoriatic manifestations are not listed in the summary of product characteristics (SmPC) of CCBs. In this context, we aimed to investigate the association between psoriasis and CCB exposure. METHODS: We reviewed spontaneous reports recorded in the French national pharmacovigilance database (FPVD) between 1985 and 2019. The association between CCB exposure and risk of psoriasis was assessed using the case/non-case method. We also analyzed literature data. RESULTS: Ninety-four reports of psoriatic manifestations after CCB exposure were recorded in the FPVD. Both induction and exacerbation cases were observed. Time to onset was less than 2 years in 64% of reports and outcome was favorable in 71% of reports after CCB discontinuation. These features were concordant with those of literature reports. The reporting odds ratio (ROR) was 2.45 (95% CI 1.99-3.02). Concomitant use of betablockers or angiotensin II receptor blockers did not interact with the association between CCB exposure and psoriasis risk. The ROR for the stratum "use of angiotensin converting enzyme inhibitors" (ACEI) was 2.14 (95% CI 1.29-3.55), while the ROR for the stratum ACEI non-use was 0.12 (95% CI 0.10-0.15). Large-scale epidemiologic studies were focused only on first diagnoses and did not include exacerbations; psoriasis risk was therefore probably underestimated. CONCLUSION: We found a statistically significant association between CCB exposure and psoriasis risk, which constitutes a safety signal. This risk is a class effect, time to onset is mostly less than 2 years and outcome is favorable after CCB discontinuation. Psoriasis should be mentioned in the SmPCs of all CCBs, and healthcare workers should be aware of this risk. Attention should be paid to patients taking CCB and ACEI concomitantly. |
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| 投稿者 | Azzouz, Brahim; Laugier-Castellan, Delphine; Sanchez-Pena, Paola; Rouault, Marie; Kanagaratnam, Lukshe; Morel, Aurore; Trenque, Thierry |
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| 組織名 | Regional centre of pharmacovigilance and pharmacoepidemiology, Reims university;hospital, 51092 Reims, France; EA 3797 Vieillissement, Fragilite (VieFra),;faculty of medicine, university of Reims Champagne-Ardenne, 51092 Reims, France.;Electronic address: bazzouz@chu-reims.fr.;Department of clinical pharmacology and pharmacovigilance, regional;pharmacovigilance centre of Marseille Provence Corse, Assistance;publique-Hopitaux de Marseille, 13005 Marseille, France.;Department of medical pharmacology, Bordeaux university hospital, 33000 Bordeaux,;France.;Department of pharmacology, Rouen university hospital, 76000 Rouen, France.;EA 3797 Vieillissement, Fragilite (VieFra), faculty of medicine, university of;Reims Champagne-Ardenne, 51092 Reims, France.;hospital, 51092 Reims, France. |
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