TOPLINE

Concomitant colchicine-statin therapy was associated with a higher risk for elevated levels of creatine kinase (CK) and alanine transaminase (ALT) than no treatment among patients with gout and/or familial Mediterranean fever (FMF), but the additional risk beyond that observed with statin therapy alone was small. Clinically diagnosed myopathy and related hospitalizations were uncommon across all treatment groups.

METHODOLOGY

• Researchers conducted a retrospective cohort study using data from a healthcare database in Israel to assess real-world liver- and muscle-related adverse outcomes linked to the use of colchicine, statins, or both.
• They included 31,839 adult patients with gout and/or FMF after propensity score matching.
• Patients were categorized into four groups on the basis of their treatment exposure: those who received no treatment (n = 7146), those who received colchicine treatment only (n = 7146), those who received statin treatment only (n = 9030), or those who received concomitant therapy (n = 8517).
• The primary endpoint was elevated levels of CK, classified as exceeding the upper limit of normal (ULN) at thresholds ranging from one to three times the ULN to more than 10 times the ULN, with the highest value considered for each patient. Secondary outcomes included elevations in ALT levels at cutoffs of two, five, and 15 times the ULN.
• Colchicine exposure lasted a median of 7.7 months across all patients, 6.2 months among those with gout, and 76.3 months among those with FMF. Median durations of statin exposure for the respective groups were 46.7, 46.1, and 58.7 months.

TAKEAWAY

• Compared with no treatment, statin therapy (hazard ratio [HR], 1.64; 95% CI, 1.39-1.93) and colchicine-statin combination therapy (HR, 1.74; 95% CI, 1.44-1.99) were associated with an increased risk for elevations in CK levels more than three times the ULN. The risk was not increased with colchicine treatment alone (HR, 1.08; 95% CI, 0.89-1.31); however, the incidence rates across these groups were generally low.
• Treatment with colchicine (HR, 1.65; 95% CI, 1.35-2.01), statins (HR, 1.73; 95% CI, 1.44-2.09), and concomitant therapy (HR, 2.12; 95% CI, 1.72-2.61) was linked to an increased risk for elevated ALT levels more than five times the ULN compared with no treatment.
• Patients receiving concomitant therapy had the highest risk for myopathy (HR, 1.50; 95% CI, 1.31-1.72), although absolute rates remained low. The highest risk for liver involvement was also observed in the concomitant-therapy group (HR, 1.50; 95% CI, 1.37-1.64).
• Although myopathy-related hospitalizations occurred less frequently, they demonstrated a similar trend, with the highest risk among patients receiving combined treatment. In contrast, liver disease-related hospitalizations were highest in patients on statin-only treatment (HR, 1.68; 95% CI, 1.40-2.01), with a similar risk among those on combined therapy (HR, 1.66; 95% CI, 1.35-2.04).

IN PRACTICE

"[D]espite the observed relative increases in risk, absolute event rates for clinically significant muscle- and liver-related adverse events were low, supporting the overall safety of concomitant colchicine–statin therapy when clinically indicated," the authors wrote. "From a clinical perspective, this combination appears generally safe when indicated. A pragmatic approach involving awareness of potential interactions, patient-specific risk assessment (eg, renal function), and selective laboratory monitoring is appropriate," they added.

SOURCE

The study was led by Roni Meidan, MD, Department of Rheumatology, Tel Aviv Sourasky University Medical Center (Ichilov) in Tel Aviv, Israel. It was published online on September 28 in Arthritis Care & Research.

LIMITATIONS

Initial patient characteristics and clinical outcomes were derived from routinely gathered data and could be prone to misclassification. Exposure to medication varied over time, with prescribed daily doses not being available; these may have limited the evaluation of dose-response relationships. Laboratory testing lacked standardization and potentially differed across groups, thereby introducing possible surveillance bias.

DISCLOSURES

The study received no specific funding. One author received support from the Rothschild Foundation-Yad Hanadiv, the Zuckerman STEM Leadership Program, and the Fulbright Postdoctoral Fellowship. Another author declared receiving consulting fees, payments, or honoraria from pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.