Use of a claims-based active drug safety surveillance system to assess the risk of acute pancreatitis with exenatide or sitagliptin compared to metformin or glyburide

TLDR

These results are limited by the data available in an administrative, healthcare database. The study estimates the risk and relative risk of acute pancreatitis in patients initiating exenatide or sitagliptin versus those initiating metformin or glyburide. Using a large US commercial insurance database and an active drug safety surveillance system, the authors matched exenatide and sitagliptin initiators to metformin or glyburide initiators via propensity scores and excluded patients with prior pancreatic disease, analyzing claims from June 2005 to June 2008. Acute pancreatitis occurred in 0.13% of exenatide users and 0.12% of sitagliptin users, with relative risks of 1.0 (95% CI 0.6–1.7) and 1.0 (95% CI 0.5–2.0) respectively, indicating no increased risk compared to metformin or glyburide initiators.

Abstract

Objective: To estimate risk and relative risk (RR) of acute pancreatitis among patients using incretin-based diabetes therapies (exenatide or sitagliptin) compared to patients treated with agents with established safety profiles (metformin or glyburide).Research design and methods: The study population was derived from a large US commercial health insurance transaction database using an active drug safety surveillance system (i3 Aperio*). This analysis is based on data from June 2005 through June 2008. Cohorts of exenatide and sitagliptin initiators were each matched to an equal number of metformin or glyburide (met/gly) initiators using propensity scores to reduce confounding in the comparison of outcomes during follow-up. Patients with claims suggesting pancreatic disease in the 6 months prior to cohort entry were excluded. Main outcome measure: Claims for hospitalizations associated with a primary diagnosis of acute pancreatitis (ICD-9 577.0).Results: There were 27 996 exenatide initiators and 16 276 sitagliptin initiators and approximately equal numbers of matched comparators. During follow-up of up to 1 year, acute pancreatitis occurred among 0.13% of patients treated with exenatide and 0.12% of patients treated with sitagliptin. The risk of acute pancreatitis was comparable for initiators of exenatide (RR 1.0; 95% confidence interval (CI) 0.6–1.7) and sitagliptin (RR 1.0; 95% CI 0.5–2.0) relative to the comparison cohorts.Conclusions: These data do not provide evidence for an association of acute pancreatitis among initiators of exenatide or sitagliptin compared to met/gly initiators. These results are limited by the data available in an administrative, healthcare database.