Real‐world safety of concomitant colchicine and statin therapy

OBJECTIVE: This study aimed to evaluate the risk of clinically meaningful muscle- and liver-related outcomes associated with concomitant colchicine-statin therapy in a real-world setting, and to determine whether concomitant therapy increases the incidence of toxicity compared with either agent alone. METHODS: A retrospective cohort study using the national Clalit Health Services database (≈5.4 million insured individuals). Adults with gout or familial Mediterranean fever between 2010 and 2024 were categorized into four exposure groups: no treatment, colchicine only, statin only, or concomitant therapy. Propensity-score matching was used to balance baseline characteristics. The primary outcome was creatine kinase (CK) elevation >3× the upper limit of normal (ULN), while secondary outcomes included alanine transaminase (ALT) elevation >5× the ULN, myopathy, liver disease, and hospitalizations related to these conditions. RESULTS: Eligible participants before and after propensity-score matching were 104,066 and 31,839, respectively (no treatment n=7,146; colchicine only n=7,146; statin only n=9,030; concomitant therapy n=8,517). Compared with no treatment, CK elevations >3× ULN were observed with statin therapy (HR 1.64, 95% CI 1.39-1.93) and concomitant colchicine-statin therapy (HR 1.74, 95% CI 1.44-2.09), but not with colchicine therapy alone (HR 1.08, 95% CI 0.89-1.31). Clinically diagnosed myopathy was infrequent and showed a graded increase across exposure groups, with the highest risk observed in the concomitant treatment group (HR 1.50, 95% CI 1.31-1.72). CONCLUSION: Although colchicine-statin concomitant therapy was associated with higher rates of laboratory and clinical adverse events, the additional risk beyond statin monotherapy was small, supporting their use when clinically indicated.