Sitagliptin increases acute pancreatitis risk within 2 years of its initiation: A retrospective cohort analysis of the National Health Insurance database in Taiwan.

Purpose: To evaluate the risk of acute pancreatitis hospitalization with sitagliptin use in patients with type 2 diabetes mellitus (T2DM).

Methods: This retrospective cohort analysis included newly diagnosed T2DM with onset age ≥25 years between 1999 and 2010 from the National Health Insurance database. Ever users (n = 89,800) and never users (n = 449,000) of sitagliptin were followed until end of 2011. A time-dependent approach was used to calculate event incidence and estimate hazard ratios adjusted for propensity score.

Results: During follow-up, 261 ever users and 5,840 never users were hospitalized for acute pancreatitis (respective incidence, 224.0 and 168.4 per 100,000 person-years), with adjusted hazard ratio of 1.59 (95% CI 1.40-1.81). The respective hazard ratio for the first, second, and third tertile of time since starting sitagliptin <9.5, 9.5-21.0, and >21.0 months was 8.10 (6.80-9.65), 1.70 (1.38-2.11), and 0.41 (0.30-0.56); 3.26 (2.67-3.98), 1.86 (1.52-2.27), and 0.76 (0.59-0.98) for cumulative duration <3.7, 3.7-10.3, and >10.3 months; and 3.21 (2.65-3.90), 1.89 (1.54-2.32), and 0.73 (0.57-0.95) for cumulative dose <9,000, 9,000-28,000, and >28,000 mg.

Conclusions: Sitagliptin is associated with a higher risk of acute pancreatitis within the first 2 years of its initiation. The risk diminishes thereafter, probably due to the depletion of susceptible patients.