The study by Agepha Pharma used by the FDA in its approval of this new indication for use ultimately involved 5478 patients between the ages of 35 and 82 with evidence of coronary artery disease upon imaging [1] and had been clinically stable for six months before enrollment. A larger cohort of 6528 patients was initially included and underwent a one-month open-label use of colchicine. Those who were not compliant, clinically unstable, or had “unacceptable” side effects from the colchicine were removed. [2] Patients were randomized to treatment with 0.5 mg of colchicine daily or placebo.
85% of patients had a history of an acute coronary event, severe chest pain, or myocardial infarction, two-thirds of which were more than two years previously. Mean age was 66, predominantly a...