Statin use is associated with reduction in risk of de novo primary sclerosing cholangitis among patients with inflammatory bowel disease: A National Database Study

Background and Aims: Primary sclerosing cholangitis (PSC) is a liver disease without medical therapy that significantly increases the risk of malignancies, acute cholangitis and cirrhosis. Approximately 2-7% of patients with inflammatory bowel disease (IBD) develop PSC. No drug has been shown to prevent de novo PSC in patients with IBD. Statin use, however, has been associated with increased liver transplant-free survival. Yet, the impact of statins on development of new PSC among those with IBD is unknown. Methods: We conducted a retrospective cohort study of patients diagnosed with IBD with and without statin exposure using a large, representative national database. Patients were followed from the date of diagnosis of IBD. Patient demographics, co-morbidities, medications, and type of IBD were extracted. Unmatched and propensity score-matched Cox regression analyses were performed. Results: Our analysis included 33,813 patients with IBD of whom 8,813 were exposed to statins. PSC developed in 181 patients over a median follow-up of 3.7 years. Only nine patients (0.1%) who were exposed to statins developed PSC compared to 173 (0.69%) in the non-exposed population. In propensity score-matched analysis, statin therapy was associated with an 86% lower risk of developing PSC (HR 0.14; 95% CI 0.06-0.33, p<0.001). The findings were consistent when accounting for unmeasured confounders (E-value) in sensitivity analyses, including stratification by age group, duration of statin use, and type of statin. Conclusion: In a propensity score-matched analysis, statin use was associated with an 86% risk reduction in new PSC diagnosis among patients with known IBD, suggesting a potential benefit as a prophylactic agent. These findings warrant prospective validation.