Key result
Long-term colchicine 0.5 mg daily maintains safe serum concentrations in ~95% of patients with CCS.
Why the study?
Low-dose colchicine reduces cardiovascular events in patients with CCS, but data on colchicine serum levels in this population were not available to evaluate long-term safety and systemic exposure.
Cross-Sectional (n=885)
Long-term treatment with colchicine 0.5 mg once daily in patients with chronic coronary syndrome results in serum levels generally well within accepted safety ranges, supporting its long-term pharmacokinetic safety despite moderate increases in women, older patients, and those with impaired renal function.
Supports long-term colchicine safety in CCS; extends PK data but leaves outcome trials in renal impairment open.
Background Low-dose colchicine reduces cardiovascular events in patients with chronic coronary syndrome (CCS). However, data on colchicine serum levels in this population are not available. Insight into these levels may help evaluate long-term safety and identify patient characteristics associated with higher systemic exposure. Purpose To quantify colchicine serum levels in patients with CCS receiving long-term low-dose colchicine and to assess the relationship with clinical characteristics and concomitant medication use. Methods In this cross-sectional substudy of the Low-Dose Colchicine 2 (LoDoCo2) trial, end-of-study blood samples from 885 participants treated with colchicine 0.5 mg once daily were analysed. Participants had received treatment for a median of 32.6 months (interquartile range [IQR] 24.0-48.6). Colchicine levels were measured using a liquid chromatography-mass spectrometry assay and analysed using linear regression models adjusted for age, sex, estimated glomerular filtration rate (eGFR) and statin use. Results The median colchicine level was 0.80 ng/mL (IQR 0.43-1.51). Overall, 95.4% of participants had colchicine levels below 3.0 ng/mL, the commonly accepted upper safe limit. Colchicine levels were 32.3% (95% confidence interval [CI] 13.9%-55.3%) higher in women compared to men. Per 10 years increase in age, colchicine levels increased 11.6% (95%CI 4.1%-20.9%). Levels were 52.2% (95%CI 22.1%-91.6%) higher in participants with an eGFR <60 ml/min/1.73m2 compared to those with an eGFR >90 ml/min/1.73m2, and 13.9% (95%CI 1.0%-27.1%) higher in those who used betablocker therapy versus those who did not. Statin use was not associated with colchicine levels. Conclusion In patients with CCS receiving colchicine 0.5 mg once daily for a median of 32.6 months, colchicine levels were generally within accepted safety ranges. Although higher levels were observed in women, older individuals and those with impaired renal function, there were no clinically relevant increases. Levels exceeding the upper safe limit were uncommon. These findings support the safety of long-term, low-dose colchicine in this patient population.
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Jannink et al. (2026) conducted a cross-sectional in Chronic coronary syndrome (n=885). Colchicine was evaluated on Colchicine serum levels (median ng/mL and proportion below 3.0 ng/mL upper safe limit). Long-term colchicine 0.5 mg daily in chronic coronary syndrome yielded a median serum level of 0.80 ng/mL, with 95.4% of patients remaining below the 3.0 ng/mL upper safe limit.
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