| Abstract: | 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. Key messages Sitagliptin is significantly associated with an increased risk of acute pancreatitis within the first 2 years of its initiation, but the risk diminishes thereafter, probably due to the depletion of susceptible patients. The overall hazard ratio after adjustment for propensity score for ever users versus never users was 1.59 (95% CI 1.40-1.81). For users with cumulative dose >28,000 mg, the hazard ratio was 0.73 (0.57-0.95). |
