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Research ArticleTools for Practice

Cardiovascular prevention trials: cross-examining colchicine

Nicolas Dugré, Stéphane Vanier and Ricky D. Turgeon
Canadian Family Physician January 2022; 68 (1) 35; DOI: https://doi.org/10.46747/cfp.680135
Nicolas Dugré
Clinical Assistant Professor in the Faculty of Pharmacy at the University of Montreal in Quebec.
PharmD MSc BCACP
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Stéphane Vanier
Family physician and Clinical Assistant Professor in the family medicine and emergency medicine departments at the University of Montreal.
MD FCFP
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Ricky D. Turgeon
Assistant Professor in the Faculty of Pharmaceutical Sciences at the University of British Columbia in Vancouver.
ACPR PharmD
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Clinical question

Is colchicine effective for secondary prevention in cardiovascular (CV) disease?

Bottom line

Daily low-dose colchicine lowers the risk of CV events in people with coronary artery disease (CAD) by about 1% per year (a relative risk reduction [RRR] of about 30%) but raises the risk of gastrointestinal events by approximately 2% and has no effect on mortality.

Evidence

Differences were statistically significant unless noted.

  • ● Three systematic reviews comparing the effects of colchicine versus placebo in addition to standard therapy in individuals with CAD (4 to 11 RCTs; 5820 to 12 869 participants; duration 5 days to 3 years) found1-3:

    • - colchicine was associated with a lower risk of CV events (RRR about 30%);

    • - no difference in mortality; and

    • - the absolute risk of gastrointestinal events (mostly diarrhea) increased by about 2% with colchicine.1-3

  • ● The 2 largest, placebo-controlled, non–industry funded RCTs were the LoDoCo24 and COLCOT trials.5

    • - LoDoCo24 compared colchicine 0.5 mg daily versus placebo for 2.5 years in 5522 people with stable CAD.

    • — The CV event rate (CV mortality, myocardial infarction [MI], ischemic strokes, urgent revascularization) was lower with colchicine (6.8% vs 9.6%), with a RRR of 29% and number needed to treat (NNT) of 36.

    • — Mortality did not differ (2.6% vs 2.2%).

    • — The only difference in adverse events was a higher risk of myalgia in the colchicine group (with a number needed to harm of 38).

    • - COLCOT5 compared colchicine 0.5 mg daily versus placebo for 23 months in 4745 participants within 1 month after MI.

      • — The rate of CV events was lower with colchicine (5.5% vs 7.1%, RRR = 24%, NNT = 63).

      • — Mortality did not differ (1.8% in both groups).

      • — Rates of adverse events did not differ.

Context

  • Recent guidelines for secondary prevention in CAD or after MI make no recommendations about colchicine.6

  • A 3-month supply of the new 0.5-mg dose costs approximately $45 (vs $25 for the 0.6-mg dose).7,8

  • Colchicine lowered the risk of CV events better than (eg, ezetimibe, RRR about 6%) or comparably to (eg, acetylsalicylic acid or statins, RRR about 25%) other preventive therapies, but without mortality benefits.9,10

Implementation

Although patients with CAD are generally at high risk of CV events, the 10-year risk varies from less than 10% to more than 40%.11 SMART12 and REACH13 scores can be used to estimate individual risk and the absolute benefits of colchicine. Colchicine could be offered to patients with CAD already taking standard secondary prevention medications with a discussion about the expected benefits, costs, and risks.

Notes

Tools for Practice articles in CFP are adapted from peer-reviewed articles at http://www.toolsforpractice.ca and summarize practice-changing medical evidence for primary care. Coordinated by Dr G. Michael Allan and Dr Adrienne J. Lindblad, articles are developed by the Patients, Experience, Evidence, Research (PEER) team and supported by the College of Family Physicians of Canada and its Alberta, Ontario, and Saskatchewan Chapters. Feedback is welcome at toolsforpractice{at}cfpc.ca.

Footnotes

  • Competing interests

    None declared

  • The opinions expressed in Tools for Practice articles are those of the authors and do not necessarily mirror the perspective and policy of the Alberta College of Family Physicians.

  • Copyright © 2022 the College of Family Physicians of Canada

References

  1. 1.↵
    1. Ullah W,
    2. Gowda SN,
    3. Fischman D.
    Safety and efficacy of colchicine in patients with coronary artery disease: a systematic review and meta-analysis. Cardiovasc Revasc Med 2021;23:1-6.
    OpenUrl
  2. 2.
    1. Xiang Z,
    2. Yang J,
    3. Yang J,
    4. Zhang J,
    5. Fan Z,
    6. Yang C, et al.
    Efficacy and safety of colchicine for secondary prevention of coronary heart disease: a systematic review and meta-analysis. Intern Emerg Med 2021;16(2):487-96.
    OpenUrl
  3. 3.↵
    1. Andreis A,
    2. Imazio M,
    3. Piroli F,
    4. Avondo S,
    5. Casula M,
    6. Paneva E, et al.
    Efficacy and safety of colchicine for the prevention of major cardiovascular and cerebrovascular events in patients with coronary artery disease: a systematic review and meta-analysis on 12 869 patients. Eur J Prev Cardiol 2021;zwab045.
  4. 4.↵
    1. Nidorf SM,
    2. Fiolet ATL,
    3. Mosterd A,
    4. Eikelboom JW,
    5. Schut A,
    6. Opstal TSJ, et al.
    Colchicine in patients with chronic coronary disease. N Engl J Med 2020;383:1838-47.
    OpenUrlCrossRefPubMed
  5. 5.↵
    1. Tardif JC,
    2. Kouz S,
    3. Waters DD,
    4. Bertrand OF,
    5. Diaz R,
    6. Maggioni AP, et al.
    Efficacy and safety of low-dose colchicine after myocardial infarction. N Engl J Med 2019;381:2497-505.
    OpenUrlCrossRefPubMed
  6. 6.↵
    1. Collet JP,
    2. Thiele H,
    3. Barbato E,
    4. Barthélémy O,
    5. Bauersachs J,
    6. Bhatt DL, et al.
    2020 ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J 2021;42(14):1289-367.
    OpenUrlCrossRefPubMed
  7. 7.↵
    Interactive Drug Benefit List [website]. Edmonton, AB: Government of Alberta; 2021. Available from: https://idbl.ab.bluecross.ca/idbl/load.do. Accessed 2021 Oct 28.
  8. 8.↵
    PharmaClik [website]. Montreal, QC: McKesson Canada; 2021. Available from: https://clients.mckesson.ca/. Accessed 2021 Sep 27.
  9. 9.↵
    1. Koskinas KC,
    2. Siontis GC,
    3. Piccolo R,
    4. Mavridis D,
    5. Raber L,
    6. Mach F, et al.
    Effect of statins and non-statin LDL-lowering medications on cardiovascular outcomes in secondary prevention: a meta-analysis of randomized trials. Eur Heart J 2018;39(14):1172-80.
    OpenUrlPubMed
  10. 10.↵
    1. Antithrombotic Trialists’ Collaboration
    . Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ 2002;324(7329):71.
    OpenUrlAbstract/FREE Full Text
  11. 11.↵
    1. McKay AJ,
    2. Gunn LH,
    3. Ference BA,
    4. Dorresteijn JAN,
    5. Berkelmans GFN,
    6. Visseren FLJ, et al.
    Is the SMART risk prediction model ready for real-world implementation? A validation study in a routine care setting of approximately 380 000 individuals. Eur J Prev Cardiol 2021;zwab093.
  12. 12.↵
    1. Dorresteijn JAN,
    2. Vissern F.
    The SMART Risk Score. Biot, Fr: European Society of Cardiology; 2021. Available from: https://www.escardio.org/Education/ESC-Prevention-of-CVD-Programme/Risk-assessment/SMART-Risk-Score. Accessed 2021 Oct 28.
  13. 13.↵
    1. Pandey A; Cambridge Cardiac Care Inc
    . REACH Risk Calculator. Cambridge, ON: Cambridge Cardiac Care Centre. Available from: https://www.cambridgecardiaccare.com/calculator/. Accessed 2021 Oct 28.
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Canadian Family Physician: 68 (1)
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Cardiovascular prevention trials: cross-examining colchicine
Nicolas Dugré, Stéphane Vanier, Ricky D. Turgeon
Canadian Family Physician Jan 2022, 68 (1) 35; DOI: 10.46747/cfp.680135

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Cardiovascular prevention trials: cross-examining colchicine
Nicolas Dugré, Stéphane Vanier, Ricky D. Turgeon
Canadian Family Physician Jan 2022, 68 (1) 35; DOI: 10.46747/cfp.680135
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