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Aims <p>This meta-analysis aims to evaluate the efficacy and safety of colchicine for the secondary prevention of cardiovascular and cerebrovascular diseases, and examines how dose and treatment duration modify its risk–benefit profile.</p> Methods <p>A meta-analysis comparing colchicine to placebo or standard care was performed. The primary endpoint was major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal stroke. The secondary endpoint was expanded MACE (eMACE), defined as MACE plus ischemia-driven coronary revascularization.</p> Results <p>Colchicine significantly reduced the risk of MACE (relative risk [RR] 0.83, 95% confidence interval [CI] 0.72–0.96) and eMACE (RR 0.78, 95% CI 0.64–0.96), with benefits driven by reductions in non-fatal MI and ischemia-driven coronary revascularization. No significant effect was observed on cardiovascular or all-cause mortality. Colchicine increased gastrointestinal adverse reactions (RR 1.90, 95% CI 1.41–2.55) and drug-related adverse event (DAE)–related colchicine discontinuation (RR 1.54, 95% CI 1.06–2.25). Sensitivity analyses revealed that the guideline-recommended dosage (0.5 mg once daily) for &gt; 6 months maintained cardiovascular benefit (MACE RR 0.77, 95% CI 0.62–0.96), while gastrointestinal risk (RR 1.51, 95% CI 0.97–2.33) and DAE-related colchicine discontinuation risk (RR 1.42, 95% CI 0.80–2.51) became non-significant.</p> Conclusion <p>Colchicine provides lasting benefit for patients with cardiovascular and cerebrovascular diseases. Gastrointestinal risk is dose and time dependent, and higher early in treatment. Tolerating and maintaining long-term standard-dose therapy improves the benefit–risk balance. These findings highlight the early treatment phase as a period of higher gastrointestinal risk, suggesting that strategies to support adherence during this period warrant further investigation.</p> Registration <p>PROSPERO registration number CRD42024623329.</p> Graphical Abstract <p></p>

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Cardiovascular Benefit and Gastrointestinal Risk of Colchicine in Secondary Prevention: Risk Associated with Dose and Treatment Duration

  • 期刊论文

  • 发表日期：

    2026年4月25日

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  • Ce Bian,
  • Qi Shen,
  • Xin-Xin Liu,
  • Mengjun Zhou,
  • Zhexue Ren,
  • Zhe Dong,
  • Xiaodong Jin,
  • Beibei Song,
  • Bo Li

摘要

Aims

This meta-analysis aims to evaluate the efficacy and safety of colchicine for the secondary prevention of cardiovascular and cerebrovascular diseases, and examines how dose and treatment duration modify its risk–benefit profile.

Methods

A meta-analysis comparing colchicine to placebo or standard care was performed. The primary endpoint was major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction (MI), or non-fatal stroke. The secondary endpoint was expanded MACE (eMACE), defined as MACE plus ischemia-driven coronary revascularization.

Results

Colchicine significantly reduced the risk of MACE (relative risk [RR] 0.83, 95% confidence interval [CI] 0.72–0.96) and eMACE (RR 0.78, 95% CI 0.64–0.96), with benefits driven by reductions in non-fatal MI and ischemia-driven coronary revascularization. No significant effect was observed on cardiovascular or all-cause mortality. Colchicine increased gastrointestinal adverse reactions (RR 1.90, 95% CI 1.41–2.55) and drug-related adverse event (DAE)–related colchicine discontinuation (RR 1.54, 95% CI 1.06–2.25). Sensitivity analyses revealed that the guideline-recommended dosage (0.5 mg once daily) for > 6 months maintained cardiovascular benefit (MACE RR 0.77, 95% CI 0.62–0.96), while gastrointestinal risk (RR 1.51, 95% CI 0.97–2.33) and DAE-related colchicine discontinuation risk (RR 1.42, 95% CI 0.80–2.51) became non-significant.

Conclusion

Colchicine provides lasting benefit for patients with cardiovascular and cerebrovascular diseases. Gastrointestinal risk is dose and time dependent, and higher early in treatment. Tolerating and maintaining long-term standard-dose therapy improves the benefit–risk balance. These findings highlight the early treatment phase as a period of higher gastrointestinal risk, suggesting that strategies to support adherence during this period warrant further investigation.

Registration

PROSPERO registration number CRD42024623329.

Graphical Abstract