| アブストラクト | INTRODUCTION: Angiotensin-converting enzyme inhibitors (ACEIs) can induce or aggravate psoriasis. This risk is not specified in the Summary of Product Characteristics (SmPC) of some drugs of this class, such as captopril or enalapril. We aimed to investigate the association between psoriasis and ACEI exposure. METHODS: We analyzed spontaneous reports recorded in the French national Pharmacovigilance Database (FPVD) from 1985 to 31 December 2018. The association between psoriasis and ACEI exposure was assessed using the case/non-case method. We also reviewed literature reports. RESULTS: One hundred reports of psoriasis after ACEI exposure were registered in the FPVD. The reporting odds ratio (ROR) was 2.40 (95% CI 1.96-2.95). Time to onset was < 1 year in 67% of reports. Outcome was favorable in 73% of reports after ACEI discontinuation. Almost all ACEIs were concerned. In the literature, we found 21 published reports of psoriasis with ACEIs. Time to onset ranged from 1 week to 4 months. Outcome was also favorable after ACEI discontinuation in over half of the literature reports. CONCLUSIONS: We found a statistically significant association between psoriasis and ACEI, which constitutes a potential safety signal. The risk of psoriasis is a class effect, time to onset is less than 1 year, and outcome is favorable after ACEI discontinuation. Psoriasis should be mentioned in the SmPCs of all ACEIs, and healthcare professionals should be informed about this risk. |
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| 組織名 | Regional Centre of Pharmacovigilance and Pharmacoepidemiology, Reims University;Hospital, Avenue du General Koenig, Reims, France. bazzouz@chu-reims.fr.;EA 3797, Faculty of Medicine, University of Reims Champagne-Ardenne, 51 Rue;Cognacq-Jay, Reims, France. bazzouz@chu-reims.fr.;Hospital, Avenue du General Koenig, Reims, France.;Cognacq-Jay, Reims, France.;Department of Research and Public Health, Reims University Hospital, Avenue du;General Koenig, Reims, France. |
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