It has been reported that some patients using incretin-based drugs, a relatively new therapy used in the management of type 2 diabetes, developed bile duct and gallbladder disease. The gallbladder is a pear-shaped organ that stores bile, and is connected to the small intestine through a tube called the common bile duct. It is hypothesized that the use of incretin-based drugs may lead to gallbladder stones and blockage of the bile duct, a condition that can be very painful which often requires surgery. To date, however, the link between incretin-based drugs and bile duct and gallbladder disease has not been thoroughly investigated. Therefore, the goal of this study is to assess whether there is a relationship between the use of incretin-based drugs and bile duct and gallbladder disease. As the use of incretin-based drugs has increased in recent years, this study will provide much needed information on the safety of these drugs in patients with type 2 diabetes.
The main objective of this study is to evaluate the association between the use of incretin-based drugs and the incidence of bile duct and gallbladder diseases in patients with type 2 diabetes. The United Kingdom Clinical Practice Research Datalink and the Hospital Episodes Statistics database will be used to conduct a cohort study among 75,000 patients initiating antidiabetic drugs between 2007 and 2014. A time-dependent exposure definition will be used, which will compare current use of incretin-based drugs with current use of at least two oral hypoglycaemic agents. Cox proportional hazards models will be used to estimate hazard ratios and 95% confidence intervals of hospitalized bile duct or gallbladder events. All models will be adjusted for relevant potential confounders. This large population-based study will provide much needed information on the safety of incretin-based drugs.
Samy Suissa - Chief Investigator - Sir Mortimer B Davis Jewish General Hospital
Laurent Azoulay - Corresponding Applicant - McGill University
Alan Barkun - Collaborator - McGill University
Dominique Hillaire-Buys - Collaborator - Montpellier University Hospital
Hui Yin - Collaborator - Sir Mortimer B Davis Jewish General Hospital
Jean-Luc Faillie - Collaborator - Montpellier University Hospital
Oriana Hoi Yun Yu - Collaborator - Sir Mortimer B Davis Jewish General Hospital
HES Admitted Patient Care