Regional centre of pharmacovigilance and pharmacoepidemiology, Reims university hospital, 51092 Reims, France; EA 3797 Vieillissement, Fragilité (VieFra), faculty of medicine, university of Reims Champagne-Ardenne, 51092 Reims, France.
Department of clinical pharmacology and pharmacovigilance, regional pharmacovigilance centre of Marseille Provence Corse, Assistance publique-Hôpitaux de Marseille, 13005 Marseille, France.
Therapie. 2021 Jan-Feb;76(1):5-11. doi: 10.1016/j.therap.2020.05.013. Epub 2020 Jun 26.
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.
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.
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.
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.
有关银屑病表现与钙通道阻滞剂(CCB)使用之间可能存在关联的证据很少。目前,CCB 的产品特性摘要(SmPC)中并未列出银屑病表现。在这种情况下,我们旨在研究银屑病与 CCB 暴露之间的关联。
我们回顾了 1985 年至 2019 年间在法国国家药物警戒数据库(FPVD)中记录的自发报告。使用病例/非病例方法评估 CCB 暴露与银屑病风险之间的关联。我们还分析了文献数据。
FPVD 记录了 94 例 CCB 暴露后出现银屑病表现的报告。观察到诱导和加重病例。64%的报告中发病时间小于 2 年,CCB 停药后 71%的报告结局良好。这些特征与文献报告一致。报告比值比(ROR)为 2.45(95%置信区间 1.99-3.02)。同时使用β受体阻滞剂或血管紧张素 II 受体阻滞剂不会影响 CCB 暴露与银屑病风险之间的关联。“使用血管紧张素转换酶抑制剂(ACEI)”亚组的 ROR 为 2.14(95%置信区间 1.29-3.55),而 ACEI 未使用者的 ROR 为 0.12(95%置信区间 0.10-0.15)。大规模的流行病学研究仅关注首次诊断,不包括加重病例;因此,银屑病风险可能被低估了。
我们发现 CCB 暴露与银屑病风险之间存在统计学显著关联,这构成了一个安全信号。这种风险是一种类效应,发病时间大多小于 2 年,CCB 停药后结局良好。所有 CCB 的 SmPC 中都应提及银屑病,医护人员应意识到这种风险。应注意同时使用 CCB 和 ACEI 的患者。