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Br J Dermatol. 2016 Aug;175(2):296-301. doi: 10.1111/bjd.14601. Epub 2016 Jul 19.

Bullous pemphigoid and dipeptidyl peptidase IV inhibitors: a case-noncase study in the French Pharmacovigilance Database.

Author information

1
Centre Régional de Pharmacovigilance du Nord Pas-de-Calais, Univ.Lille, CHU Lille, F-59000, Lille, France.
2
Service de Médecine Interne, CHU de Toulouse, Toulouse, France.
3
UMR 1027 INSERM-Université Paul Sabatier, Toulouse, France.
4
Centre d'Investigation Clinique 1436, CHU de Toulouse, France.
5
Service de Dermatologie, CHU de Toulouse, Toulouse, France.
6
Service Pharmacie, Centre Hospitalier de Valenciennes, Valenciennes, France.
7
Centre Régional de PharmacoVigilance, Hôpital Henri Mondor, Assistance Publique Hôpitaux de Paris, Créteil, France.
8
Centre Régional de PharmacoVigilance, Département de Pharmacologie Médicale et Toxicologie, Faculté de Médecine et CHRU, Montpellier, France.
9
Centre Régional de PharmacoVigilance, Service de Pharmacologie Clinique et Pharmacovigilance, Assistance Publique des Hôpitaux de Marseille, Aix Marseille Université, Marseille, France.

Abstract

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.

PMID:
27031194
DOI:
10.1111/bjd.14601
[Indexed for MEDLINE]

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