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#407 Back on the stand: Colchicine for secondary cardiovascular prevention update


CLINICAL QUESTION
QUESTION CLINIQUE
 Is colchicine effective for secondary cardiovascular prevention?

BOTTOM LINE
RÉSULTAT FINAL
 For secondary cardiovascular prevention, colchicine 0.5mg provides a relative risk reduction of ~25% in major adverse cardiovascular events but does not affect mortality. While 1 randomized, controlled trial (RCT) reported a neutral effect, overall, pooled effects remain in favour of colchicine for cardiovascular benefit.   


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EVIDENCE
DONNÉES PROBANTES
  • 17 systematic reviews1-17 of RCTs published in 2025. Focusing on one including RCTs with ≥12 months follow-up and reporting absolute event rates for patient-important outcomes in secondary cardiovascular prevention (6 RCTs, 21800 patients, 12-34 months, colchicine 0.5mg daily):1
    • Major adverse cardiovascular events (MACE): Composite of cardiovascular death, myocardial infarction, ischaemic stroke, and urgent coronary revascularization.
      • Colchicine 8.2% versus placebo 10.3%; Relative risk reduction (RRR)=25%.
    • No difference in cardiovascular mortality, all-cause mortality or serious adverse events (including infections, hospitalizations for gastrointestinal effects, or cancer).
    • Limitations: 47% not randomized due to gastrointestinal symptoms during open-label colchicine run-in; data limited in stroke patients.
    • Results were consistent across RCTs except for the CLEAR-SYNERGY RCT,18 which showed no effect from colchicine on MACE.
    • Other systematic reviews found similar.2-17
 
  • CLEAR-SYNERGY RCT (7062 patients) randomized patients to colchicine 0.5mg versus placebo ~27 hours after percutaneous coronary intervention. At 3 years:18
    • MACE: No difference.
    • Cardiovascular or all-cause mortality: No difference.
    • Diarrhea: 10% versus 7% (placebo), Number needed to harm=28.
    • Limitations: Potentially underpowered due to underreporting of MACE outcomes during COVID-19 pandemic.1,18
CONTEXT
CONTEXTE
  • Low-dose colchicine is approved by Health Canada in patients with coronary artery disease for reducing atherothrombotic events.19
  • Canadian, European and American guidelines suggest low-dose colchicine in post-acute coronary syndrome patients.20-22
  • Cost (3 months): $90 (0.5mg), $25 (0.6mg).23
  • Despite neutral findings of CLEAR-SYNERGY, colchicine appears to lower the risk of cardiovascular events better than (example: ezetimibe, RRR ~6%) or comparably to (examples: acetylsalicylic acid or statins, RRR ~25%) other preventive therapies.24,25 Of the above, only statins and ASA lower the risk of mortality.

Walid Eshumani February 16, 2026

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Author(s)
Auteur(s)
  • Nicolas Dugré PharmD MSc
  • Amélie Gravel MD
  • Danielle Perry RN MSc

1. Samuel M, Berry C, Dubé MP, et al. Eur Heart J. 2025 Jul 7; 46(26):2552-2563.

2. Ebrahimi F, Ebrahimi R, Beer M, et al. Cochrane Database Syst Rev. 2025 Nov 13; 11(11):CD014808.

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11. Boracchi P, Marano G, Luconi E, et al. Eur J Intern Med. 2025 Oct; 140:106317.

12. Huntermann R, Peres de Oliveira J, Barbosa LM, et al Heart. 2025 May 16: heartjnl-2025-325826. doi: 10.1136/heartjnl-2025-325826.

13. D'Entremont MA, Poorthuis MHF, Fiolet ATL, et al. Eur Heart J. 2025 Jul 7; 46(26):2564-2575.

14. Tucker B, Tucker WJ, Chung JS, et al. Eur J Prev Cardiol. 2025 May 16: zwaf302.

15. Shaikh S, Hamza M, Neppala S, et al. Int J Cardiol. 2025 Apr 15; 425:133045.

16. Jaiswal V, Deb N, Hanif M, et al. Am J Cardiovasc Drugs. 2025 Jan; 25(1):83-93.

17. Younas A, Awan Z, Khan T, et al. Curr Probl Cardiol. 2025 Jan; 50(1):102878.

18. Jolly SS, d'Entremont MA, Lee SF, et al. N Engl J Med. 2025 Feb 13; 392(7):633-642.

19. Pendopharm. Product monograph: Myinfla. Montreal, Canada. August 2021. Available from: https://pendopharm.com/wp-content/uploads/2022/05/MYINFLA-PM-EN.pdf?x65764

20. Canadian Cardiovascular Society. Post-acute coronary syndrome: Secondary prevention pathway. October 2025. Available from: https://ccs.ca/wp-content/uploads/2025/10/CCS-ACS_Prevention_Pathway_Oct-2025.pdf. Accessed 2026 Jan 15.

21. Byrne RA, Rossello X, Coughlan JJ, et al. Eur Heart J. 2023 Oct 12; 44(38):3720-3826.

22. Rao SV, O'Donoghue ML, Ruel M, et al. Circulation. 2025 Apr; 151(13):e771-e862.

23. PharmaClik [website]. Montreal, QC: McKesson Canada; 2025. Available from: https://clients.mckesson.ca/. Accessed 2025 Nov 19.

24. Dugré N, Lindblad AJ, Perry D, et al. Can Fam Physician. 2023 Oct; 69(10):701-711.

25. Antithrombotic Trialists’ Collaboration. BMJ 2002; 324(7329):71.

Authors do not have any conflicts of interest to declare.