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临床试验/NCT03636763
NCT03636763Unknown不适用

Dipeptidyl Peptidase-IV Inhibitors, Risk Factor for Development of Bullous Pemphigoid? : Multicenter Retrospective Study in France and Switzerland

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 183 人开始时间: 2018年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
183
试验地点
1
主要终点
numbers of patients exposed to gliptin

研究概览

简要总结

Bullous pemphigoid (BP) is the most common autoimmune bullous dermatosis. It mainly affects the elderly, and its cutaneous manifestations are extremely varied. Since the publication of the first case of PB associated with sulfasalazine in 1970, several drugs have been reported for their potential link with the development of PB. Recently, cases of PB associated with dipeptidyl peptidase-IV (DPP4) inhibitors, also known as gliptins, have been reported. DPP4 inhibitors are oral antidiabetic agents prescribed to patients with type 2 diabetes, as monotherapy, in combination with other oral antidiabetic agents or with insulin.

In recent years, an increasing number of cases have been published, describing the potential role of gliptins in PB induction. All these clinical cases and pharmacovigilance analyzes tend to show an increased risk of developing BP in case of gliptin exposure.

The main objective is to evaluate the risk of developing a PB under DPP4 inhibitor treatment, comparing cases of diabetic patients with BP, to matched diabetic controls for sex and age, from French departments. Endocrinology in a retrospective study from 1 January 2014 to 31 July 2016.

The study will be conducted using databases of clinical and histological records. The investigators will perform a retrospective 1: 2 case-control study comparing cases with type 2 diabetes and BP to matched diabetic controls for sex and age, randomly drawn from French endocrinology departments (Marseille La Conception ) and Switzerland (Bern), between January 1, 2014 and July 31, 2016. the investigators will compare gliptin exposure in the case-control group versus the control group, adjusting for potential confounding bias using models. logistic regression.

详细描述

Bullous pemphigoid (BP) is the most common autoimmune bullous dermatosis. It mainly affects the elderly, and its cutaneous manifestations are extremely varied. Since the publication of the first case of PB associated with sulfasalazine in 1970, several drugs (spironolactone, furosemide, chloroquine, beta-blockers and various antibiotics) have been reported for their potential link with the development of PB. Recently, cases of PB associated with dipeptidyl peptidase-IV (DPP4) inhibitors, also known as gliptins, have been reported. DPP4 inhibitors are oral antidiabetic agents prescribed to patients with type 2 diabetes, as monotherapy, in combination with other oral antidiabetic agents or with insulin.

Problem raised:

In recent years, an increasing number of cases have been published, describing the potential role of gliptins in PB induction. All these clinical cases and pharmacovigilance analyzes tend to show an increased risk of developing BP in case of gliptin exposure, but this hypothesis has not yet been confirmed by a quality controlled study.

Goal:

The main objective is to evaluate the risk of developing a PB under DPP4 inhibitor treatment, comparing cases of diabetic patients with BP, to matched diabetic controls for sex and age, from French departments. Endocrinology (Marseille La Conception) and Dermatologie (Marseille North, Marseille La Timone) and Swiss (Bern), in a retrospective study from 1 January 2014 to 31 July 2016.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Case: Patients from three university departments of Dermatology (Marseille North, Marseille La Timone, Bern) with type 2 diabetes, and a diagnosis of PB diagnosed for the first time between January 1, 2014 and July 31,
  • The diagnosis of PB is based on compatible clinical presentation, compatible histology, positive direct immunofluorescence (IFD), and in some cases positive indirect immunofluorescence (IFI) and / or the presence of autoantibodies (BP180 and / or BP230) by ELISA.
  • Witnesses: Patients from two university departments of Endocrinology (Marseille La Conception and Bern) with type 2 diabetes, and matched 1: 2 to cases for sex and age.

排除标准

  • Case: Patients with another bullous dermatosis, not meeting the inclusion criteria. Patients biopsied before consultation in University Hospital, or patients seen in private dermatology practices.
  • Witnesses: Patients suffering at the time of inclusion of a chronic dermatosis, in particular of a bullous dermatosis.

研究组 & 干预措施

Bullous pemphigoid and diabetes 2

patients with Bullous pemphigoid and diabete type 2 data report about gliptin exposure will be performed

干预措施: data report (Drug)

diabete type 2

patients with diabetes type 2 data report about gliptin exposure will be performed

干预措施: data report (Drug)

结局指标

主要结局

numbers of patients exposed to gliptin

时间窗: 3 years

numbers of patients exposed to gliptin developing a Bullous pemphigoid

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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