Clinical trials of colchicine in cardiovascular disease.
| Study | Intervention | Duration | Population | Primary outcome | Result(s) | Reference |
|---|---|---|---|---|---|---|
| LoDoCo2 | 0.5 mg/day | Median follow-up 28.6 months | Patients with stable CAD ≥ 6 months (n = 5,522) | Composite of cardiovascular death, myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization | Colchicine 6.8%, placebo 9.6%, HR 0.69 (0.57–0.83) p < 0.001 | [74] |
| COLCOT | 0.5 mg/day | Median follow-up 22.6 months | Patients within 30 days after myocardial infarction with preserved ejection fraction (n = 4,745) | Composite cardiovascular death, resuscitated cardiac arrest, myocardial infarction, stroke, or coronary revascularization | Colchicine 5.5%, placebo 7.1%, HR 0.77 (0.61–0.96) p = 0.02 | [91] |
| COPS | 1st month 0.5 mg twice a day, 0.5 mg/day for 11 months | 12 months | Patients with acute coronary syndrome and CAD on angiography (n = 795) | Composite of all-cause mortality, acute coronary syndrome, ischemia-driven unplanned revascularization, and non-cardioembolic ischemic stroke | Colchicine 24 events, placebo 38 events (p = 0.09*, log-rank). Higher total death rate in colchicine (8:1; p = 0.017), and non-cardiovascular death (5:0; p = 0.024) | [92] |
| CLEAR SYNERGY | 0.5 mg/day, 0.5 mg twice daily for the first 90 days in those ≥ 70 kg with and without 25 mg spironolactone | Median follow-up 36 months | Patients following percutaneous intervention with myocardial infarction (n = 7,062) | Composite of death from cardiovascular causes, recurrent myocardial infarction, stroke, or unplanned ischemia-driven coronary revascularization | Colchicine 9.1%, placebo 9.3%, HR 0.99* (0.85–1.16) p ≤ 0.93 | [94] |
*: denotes non-significant result; CAD: coronary artery disease; HR: hazard ratio.
BP: Conceptualization, Writing—original draft, Writing—review & editing, Visualization. MT: Writing—review & editing. RTK: Writing—review & editing. MHP: Conceptualization, Writing—review & editing, Supervision. All authors read and approved the submitted version.
Robert T. Keenan, who serves as Editorial Board Member of Exploration of Musculoskeletal Diseases, had no involvement in the decision-making or review process of this manuscript. The authors declare that they have no other conflicts of interest regarding this manuscript. For completeness, they note the following financial disclosures: BP has nothing to declare. MT has consulting fees from Amgen Inc. and Scilex Pharmaceuticals. RTK is an employee of Arthrosi Therapeutics, Inc. MHP is supported by grants from the National Institutes of Health (1UL1 TR001445) and the VA (I01 CX002358), and has served as a consultant for Amgen, Federation Bio., Fortress Bioscience, Convergence Bio., and Scilex.
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