| アブストラクト | BACKGROUND: Angiotensin receptor blockers (ARBs) can induce or exacerbate psoriasis. Psoriasis is unlisted in the Summary of Product Characteristics (SmPC) of ARBs. We aimed to investigate the association between psoriasis and ARB exposure. METHODS: We reviewed spontaneous reports recorded in the French national Pharmacovigilance Database (FPVD). The association between psoriasis and ARB exposure was assessed using the case/non-case method. We also analyzed literature reports. RESULTS: We identified 89 reports of psoriasis during ARB exposure in the FPVD. Time to onset was most often less than 1 year. Outcome was favorable in 67% of reports after ARB discontinuation. Almost all ARBs were concerned. The reporting odds ratio (ROR) for psoriasis with this therapeutic class was 4.86 (95%CI 3.92-6.03). In the literature, we found 14 published reports of psoriasis with ARB exposure. Time to onset ranged from 6 weeks to 9 months. Outcome was also favorable after ARB discontinuation in the literature. CONCLUSIONS: This underestimated adverse drug reaction is a class effect, time to onset is most often less than 1 year and outcome seems favorable after ARB discontinuation. The case/non-case approach highlights a potential safety signal. The SmPC of ARBs should be updated, increased awareness among healthcare professionals is warranted. |
| ジャーナル名 | Expert opinion on drug safety |
| Pubmed追加日 | 2018/8/4 |
| 投稿者 | Azzouz, Brahim; Abou Taam, Malak; Morel, Aurore; Trenque, Thierry |
| 組織名 | a Regional Centre of Pharmacovigilance and Pharmacoepidemiology , Reims;University Hospital , REIMS Cedex , France.;b EA 3797, Faculty of Medicine , University of Reims Champagne-Ardenne , REIMS;Cedex , France. |
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/30073879/ |