COLCHICINE (LODOCO®)



















LoDoCo2 Trial - Colchicine vs Placebo for CVD Event Prevention in Chronic Coronary Disease, NEJM (2023) [PubMed abstract]
  • The LoDoCo2 trial enrolled 5522 patients with stable coronary artery disease
Main inclusion criteria
  • Age 35 to 82 years
  • CAD on cath or CTA, or CAC score ≥ 400
  • Clinically stable for ≥ 6 months
Main exclusion criteria
  • CrCl < 50 ml/min
  • NYHA III or IV heart failure
  • Severe valvular heart disease
  • Known side effects from colchicine
Baseline characteristics
  • Average age 66 years
  • Diabetes - 18%
  • Prior PCI - 76%
  • Prior CABG - 13%
Randomized treatment groups
  • Group 1 (2762 patients): Colchicine 0.5 mg once daily
  • Group 2 (2760 patients): Placebo
Primary outcome: Composite of cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization
Results

Duration: Median 28.6 months
Outcome Colchicine Placebo Comparisons
Primary outcome 6.8% 9.6% p<0.001
Cardiovascular death 0.7% 0.9% HR 0.80 95%CI (0.44 - 1.44)
Myocardial infarction 3% 4.2% p=0.01
Stroke 0.6% 0.9% p=0.20
Revascularization 4.9% 6.4% p=0.01
Overall mortality 2.6% 2.2% HR 1.21 95%CI (0.86 - 1.71)
Myalgia 21.2% 18.5% HR 1.15 95%CI (1.01 - 1.31)
Noncardiovascular death 1.9% 1.3% HR 1.51 95%CI (0.99 - 2.31)
  • The effects of colchicine on the primary outcome were similar between patients with a history of PCI and those without
  • Incidences of cancer, neutropenia, and myotoxicity were similar between groups
  • No clinically important interaction between low-dose colchicine and high-dose statins, used by 62% of subjects, was observed

Findings: In a randomized trial involving patients with chronic coronary disease, the risk of cardiovascular events was significantly lower among those who received 0.5 mg of colchicine once daily than among those who received placebo.
COLCOT trial - Colchicine vs Placebo for CVD Event Prevention after MI, NEJM (2019) [PubMed abstract]
  • The COLCOT trial enrolled 4745 patients with an MI in the past 30 days
Main inclusion criteria
  • MI within the past 30 days
  • Completed PCI
  • Receiving guideline-based therapy
Main exclusion criteria
  • Creatinine > 2 X ULN
  • NYHA class III or IV
  • CABG within 3 years
  • Chronic diarrhea
  • Crohn's disease or ulcerative colitis
  • CPK > 3 X ULN
Baseline characteristics
  • Average age 61 years
  • Previous history of PCI - 17%
  • History of CABG - 3.1%
  • Diabetes - 20%
Randomized treatment groups
  • Group 1 (2366 patients): Colchicine 0.5 mg once daily
  • Group 2 (2379 patients): Placebo
Primary outcome: Composite of death from cardiovascular causes, resuscitated cardiac arrest, myocardial infarction, stroke, or urgent hospitalization for angina leading to coronary revascularization in a time-to-event analysis
Results

Duration: Median 22.6 months
Outcome Colchicine Placebo Comparisons
Primary outcome 5.5% 7.1% p=0.02
Cardiovascular death 0.8% 1.0% HR 0.84 95%CI (0.46 - 1.52)
Myocardial infarction 3.8% 4.1% HR 0.91 95%CI (0.68 - 1.21)
Stroke 0.2% 0.8% HR 0.26 95%CI (0.10 - 0.70)
Revascularization 1.1% 2.1% HR 0.50 95%CI (0.31 - 0.81)
Resuscitated cardiac arrest 0.2% 0.3% HR 0.83 95%CI (0.25 - 2.73)
Overall mortality 1.8% 1.8% HR 0.98 95%CI (0.64 - 1.49)
  • Nausea (1.8% vs 1%), flatulence (0.6% vs 0.2%), and pneumonia (0.9% vs 0.4% ) were the only adverse events that were significantly more frequent in the colchicine group
  • There was no serious adverse event of myopathy linked to colchicine despite the use of statins in 99% of the patients in the trial

Findings: Among patients with a recent myocardial infarction, colchicine at a dose of 0.5 mg daily led to a significantly lower risk of ischemic cardiovascular events than placebo.