LoDoCo2: Low-Dose Colchicine vs. Placebo in Patients With Chronic Coronary Disease
A significantly lower occurrence of cardiovascular events was observed in chronic coronary disease patients receiving low-dose colchicine compared with those receiving placebo, according to results from the LoDoCo2 trial published in the New England Journal of Medicine and presented at ESC Congress 2020.
Trial investigators randomized a total of 5,522 patients to receive either 0.5 mg of colchicine once daily (2,762) or placebo (2,760). The primary endpoint was a composite of cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemic stroke or ischemia-driven coronary revascularization. The secondary endpoint was a composite of cardiovascular death, spontaneous myocardial infarction, or ischemic stroke. The median follow-up was 28.6 months.
Overall, a primary endpoint event occurred in 187 patients (6.8%) in the colchicine group compared with 264 patients (9.6%) in the placebo group. A secondary endpoint event occurred in 115 patients (4.2%) in the colchicine group and in 157 patients (5.7%) in the placebo group. Researchers led by Stefan M. Nidorf, MD, FACC, also noted significantly lower rates of spontaneous myocardial infarction or ischemia-driven coronary revascularization, cardiovascular death or spontaneous myocardial infarction, ischemia-driven coronary revascularization, and spontaneous myocardial infarction with colchicine than with placebo. However, the incidence of death from noncardiovascular causes was higher in the colchicine group than in the placebo group.
Limitations of the study included a lower-than-expected percentage of women, as well as the lack of baseline data collection on blood pressure, lipid levels or inflammatory state that would have allowed for reporting of outcomes according to risk-factor control. However, the researchers note the results "are consistent with those obtained in the first LoDoCo trial and the COLCOT trial and provide further support for the potential benefits of anti-inflammatory therapy in patients with coronary disease."
"The unexpected increase in non-cardiac death is of concern," said ACC.org Editor-in-Chief Kim A. Eagle, MD, MACC. "We need more trials to be confident that the risk-to-benefit ratio favors using this agent."
Clinical Topics: Stable Ischemic Heart Disease, Atherosclerotic Disease (CAD/PAD), Chronic Angina
Keywords: ESC Congress, ESC20, Colchicine, Coronary Artery Disease, Angina, Stable
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