Dipeptidyl Peptidase-IV Inhibitors, Risk Factor for Development of Bullous Pemphigoid?

NCT03636763 | Unknown

• 1 other identifier: 2017-29
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bullous Pemphigoid

Outcome Measures

Primary Outcomes (1)

• numbers of patients exposed to gliptin

  numbers of patients exposed to gliptin developing a Bullous pemphigoid

  3 years

Study Arms (2)

Bullous pemphigoid and diabetes 2

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

Drug: data report

diabete type 2

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

Drug: data report

Interventions

data report DRUG

the information "gliptin exposure" will be reported

Also known as: gliptin

Bullous pemphigoid and diabetes 2; diabete type 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients from three university departments of Dermatology with type 2 diabetes and a diagnosis of PB diagnosed for the first time between January 1, 2014 and July 31, 2016

You may qualify if:

• 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, 2016. 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

RECRUITING

MeSH Terms

Conditions

Pemphigoid, Bullous

Interventions

Research Design; Dipeptidyl-Peptidase IV Inhibitors

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• EMILIE GARRIDO PRADALIE

  APHM

  STUDY DIRECTOR

Central Study Contacts

Michael Joseph BENZAQUEN

CONTACT

+33 491964962; MICHAEL.BENZAQUEN@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 17, 2018
• Study Start: September 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

FR (1)