Bullous pemphigoid and dipeptidyl peptidase IV inhibitors: a case-noncase study in the French Pharmacovigilance Database
Bullous pemphigoid and dipeptidyl peptidase IV inhibitors: a case-noncase study in the French Pharmacovigilance Database
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DOI：
10.1111/bjd.14601
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发表时间：
2016-08-01
影响因子：
10.3
通讯作者：
Gautier, S.
中科院分区：
文献类型：
--
作者：
Bene, J.;Moulis, G.;Gautier, S.
二肽基肽酶(DPP)-IV抑制剂被怀疑与大疱性类天疱疮的发病有关。然而，评估DPP-IV抑制剂暴露与大疱性类天疱疮之间关系的比较研究尚未进行。目的通过比较研究，从法国药物警戒数据库（FPVD）中检测暴露于DPP-IV抑制剂期间大疱性类天疱疮风险的信号。方法对2008年4月至2014年8月期间FPVD患者自发性报告的DPP-IV抑制剂相关大疱性类天疱疮进行分析。我们进行了歧化分析（病例-非病例法）来评估DPP-IV抑制剂和大疱性类天疱疮之间的联系，计算报告优势比（RORs）。我们还比较了DPP-IV抑制剂诱导的大疱性类天疱疮报告，在研究期间每百万定义的每日剂量分配。结果在FPVD登记的217331例自发性药物不良反应报告中，1297例涉及DPP-IV抑制剂。在这些观察中，42例为大疱性类天疱疮（维格列汀，n = 31；西格列汀，n = 10；沙格列汀，n = 1）。合并DPP-IV抑制剂的ROR为67.5[95%可信区间（CI） 47.1-96.9]。每种DPP-IV抑制剂也观察到歧化：维格列汀（ROR 225.3, 95% CI 148.9-340.9）、西格列汀（ROR 17.0, 95% CI 8.9-32.5）和沙格列汀（ROR 16.5, 95% CI 2.3-119.1）。对配药数据进行调整后的分析得出了类似的结果。结论：这些数据证实了DPP-IV抑制剂暴露期间大疱性类天疱疮风险增加的强烈信号。观察到每种DPP-IV抑制剂的药物不良反应，提示有一类效应。维格列汀组的信号高于其他DPP-IV抑制剂组。
Background Inhibitors of dipeptidyl peptidase (DPP)-IV have been suspected in the onset of bullous pemphigoid for several years now. However, comparative studies assessing the link between DPP-IV inhibitor exposure and bullous pemphigoid have not yet been performed.Objectives To detect, from the French Pharmacovigilance Database (FPVD), a signal of risk of bullous pemphigoid during DPP-IV inhibitor exposure by comparative study.Methods All spontaneous reports of DPP-IV inhibitor-related bullous pemphigoid recorded in the FPVD between April 2008 and August 2014 were described. We conducted disproportionality analyses (case-noncase method) to assess the link between DPP-IV inhibitors and bullous pemphigoid, calculating reporting odds ratios (RORs). We also compared DPP-IV inhibitor-induced bullous pemphigoid reports rated per million defined daily doses dispensed during the study period.Results Among 217 331 spontaneous adverse drug reaction reports registered in the FPVD, 1297 involved DPP-IV inhibitors. Among these observations, 42 were bullous pemphigoid (vildagliptin, n = 31; sitagliptin, n = 10; saxagliptin, n = 1). The ROR for pooled DPP-IV inhibitors was 67.5 [95% confidence interval (CI) 47.1-96.9]. Disproportionality was also observed for each DPP-IV inhibitor: vildagliptin (ROR 225.3, 95% CI 148.9-340.9), sitagliptin (ROR 17.0, 95% CI 8.9-32.5) and saxagliptin (ROR 16.5, 95% CI 2.3-119.1). Analyses adjusted on dispensing data led to similar results.Conclusions These data confirm a strong signal for an increased risk of bullous pemphigoid during DPP-IV inhibitor exposure. This adverse drug reaction is observed for each DPP-IV inhibitor, suggesting a class effect. The signal was higher with vildagliptin than with the other DPP-IV inhibitors.