Real‐world safety of concomitant colchicine and statin therapy
Roni Meidan, Ranel Loutati, Dan Caspi, Ori Elkayam, Ran Abuhasira, Tali EviatarObjective
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.