Incretin-based Drugs and Acute Pancreatitis

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether incretin-based drugs (used to treat type 2 diabetes) taken either alone or in combination with other anti-diabetic drugs are associated with an increased risk of acute pancreatitis (AP) compared to other combinations of oral hypoglycemic agents (OHA).

The investigators will carry out separate population based cohort studies using administrative health databases in six jurisdictions in Canada, the US, and the UK. Cohorts will be defined by the initiation of a new anti-diabetic drug when incretin-based drugs entered the market, with follow-up until hospitalization for AP. The results from the separate sites will be combined to provide an overall assessment of the risk of AP in users of incretin-based drugs and by class of incretin-based drugs.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Canadian Network for Observational Drug Effect Studies, CNODES
• Collaborators: Canadian Institutes of Health Research (CIHR); Drug Safety and Effectiveness Network, Canada
• Treatments: 2,4-thiazolidinedione; Acarbose; Acetohexamide; Biguanides; Buformin; Carbutamide; Chlorpropamide; Dipeptidyl-Peptidase IV Inhibitors; Exenatide; Glibornuride; Gliclazide; Glimepiride; Glipizide; Gliquidone; Glycoside Hydrolase Inhibitors; Hypoglycemic Agents; Incretins; Insulin; Insulin, Globin Zinc; Liraglutide; Meglitinide; Metformin; Miglitol; Nateglinide; Phenformin; Pioglitazone; Repaglinide; Rosiglitazone; Saxagliptin; Sitagliptin Phosphate; Tolazamide; Tolbutamide; Troglitazone; Vildagliptin; Voglibose

Criteria

Inclusion Criteria:

• Patients with a first-ever prescription for a non-insulin anti-diabetic drug, including biguanides, sulfonylureas, thiazolidinediones, DPP-4 inhibitors, GLP-1 analogs, alpha-glucosidase inhibitors, meglitinides or combinations of these drugs from the earliest availability of data at each site to the last date of availability of data.

• Patients with at least 1 year of history in the database.

• Patients at least 18 years of age.

Exclusion Criteria:

• Patients who died or left the cohort before the year the first incretin-based drug entered the market.

• Patients who never added-on or switched to a new anti-diabetic drug after incretin-based drugs entered the market up until June 30, 2014.

• Patients with a previous diagnosis of pancreatic cancer, those who underwent pancreatectomy, those with diagnoses of congenital defects of the pancreas, cystic fibrosis, lupus, or previous bariatric surgery, at any time prior to study cohort entry.

• Patients diagnosed with HIV or initiating HAART therapy before and at study cohort entry.

• Patients hospitalized for acute pancreatitis in the 30 days before study cohort entry.