| アブストラクト | 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. |
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| 投稿者 | Bene, J; Moulis, G; Bennani, I; Auffret, M; Coupe, P; Babai, S; Hillaire-Buys, D; Micallef, J; Gautier, S |
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| 組織名 | Centre Regional de Pharmacovigilance du Nord Pas-de-Calais, Univ.Lille, CHU;Lille, F-59000, Lille, France.;Service de Medecine Interne, CHU de Toulouse, Toulouse, France.;UMR 1027 INSERM-Universite Paul Sabatier, Toulouse, France.;Centre d'Investigation Clinique 1436, CHU de Toulouse, France.;Service de Dermatologie, CHU de Toulouse, Toulouse, France.;Service Pharmacie, Centre Hospitalier de Valenciennes, Valenciennes, France.;Centre Regional de PharmacoVigilance, Hopital Henri Mondor, Assistance Publique;Hopitaux de Paris, Creteil, France.;Centre Regional de PharmacoVigilance, Departement de Pharmacologie Medicale et;Toxicologie, Faculte de Medecine et CHRU, Montpellier, France.;Centre Regional de PharmacoVigilance, Service de Pharmacologie Clinique et;Pharmacovigilance, Assistance Publique des Hopitaux de Marseille, Aix Marseille;Universite, Marseille, France. |
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