Statins exposure and acute pancreatitis: a retrospective cohort study using a large national insurance database

OBJECTIVES: The association between the use of statins and the incidence of acute pancreatitis (AP) has yielded inconsistent findings. While statins have been implicated as an aetiology for drug-induced pancreatitis, more recent studies have found statin use is associated with a reduced risk of pancreatitis. We sought to examine the association between the use of any statin medications and the risk of AP using large real-world data. DESIGN: All data were collected retrospectively, but individuals were prospectively followed forward in time to determine the outcome of interest using International Classification of Diseases, 10th Revision, Clinical Modification codes indicating a diagnosis of AP. A stratified Cox proportional hazards regression model was conducted to examine the association of statins use with AP. SETTINGS: Merative MarketScan claims database 2017–2020. PARTICIPANTS: Individuals who filled any statin prescriptions with at least 80% proportion of days covered between 1 January 2017 and 31 December 2017 and were continuously enrolled in the database from 2016 to 2020. We also identified non-users of statins and constructed multiple strata of individuals based on the 14 confounders of interest. RESULTS: Among 1 695 914 individuals, 226 314 had filled their statins prescription during the study period. Unadjusted incidence rates of AP generally showed higher rates among statins users. The unadjusted incidence rate and 95% CI per 1000 person-years of follow-up was 0.63 (95% CI: 0.61 to 0.66) for non-statin users, versus 0.92 (95% CI: 0.86 to 0.98) for statins users. However, a stratified Cox proportional hazards regression analysis yielded a HR of 0.92 (95% CI: 0.84 to 1.01) for statins users, indicating no difference between the two groups. CONCLUSIONS: In this large real-world analysis, use of statins was not associated with a higher risk of AP in this US healthcare setting.