The Food and Drug Administration (FDA) has approved Lodoco® (colchicine) to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular (CV) death in adult patients with established atherosclerotic disease or with multiple risk factors for CV disease.
While the mechanism by which colchicine prevents major CV events is not fully understood, it is believed that its anti-inflammatory effects help reduce the risk in patients with established atherosclerotic disease. The approval was based on published data related to the effects of colchicine on cardiovascular events, as well as findings from the LoDoCo2 (Low Dose Colchicine for secondary prevention of cardiovascular disease) trial.
The placebo-controlled, double-blind, event-driven LoDoCo2 study included 5522 patients with stable coronary artery disease (mean age, 66±8.6 years, 15.3% were female) who were randomly assigned to receive colchicine 0.5mg once daily (n=2762) or placebo (n=2760). Study participants were treated with the following medications: 99.7% on an antiplatelet agent or an anticoagulant, 96.6% on a lipid-lowering agent, 97.3% on a statin, 62.1% on a beta-blocker, and 71.7% on an inhibitor of the renin–angiotensin system.
The primary endpoint of the trial was a composite of cardiovascular (CV) death, spontaneous MI, ischemic stroke, or ischemia-driven coronary revascularization. After a median follow-up of 28.6 months, results showed that treatment with colchicine 0.5mg once daily reduced the risk of the primary composite endpoint by 31% compared with placebo (hazard ratio, 0.69 [95% CI, 0.57-0.83] P <.001) and the number needed to treat was 36. There were 187 events reported in the colchicine arm and 264 events in the placebo arm.
“Approval by the FDA of the first drug to target cardiovascular inflammation is an important step forward for the care of our patients,” said Paul Ridker, MD, MPH, professor of medicine, Harvard Medical School and director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital and lead author of a recent Lancet study describing the role of inflammation in CV disease. “To treat coronary disease effectively, cardiologists must aggressively reduce inflammation and cholesterol. For appropriate patients already taking a statin, adding the anti-inflammatory drug colchicine at a dose of 0.5 mg daily has been proven to significantly lower risks of recurrent heart attack and stroke.”
Based on clinical trial data and published literature, the most common adverse reactions reported with colchicine include gastrointestinal symptoms (diarrhea, vomiting, abdominal cramping) and myalgia.
Treatment with colchicine is contraindicated in patients with renal failure or severe hepatic impairment, those with pre-existing blood dyscrasias, and with concurrent strong CYP3A4 inhibitors or P-gp inhibitors.
Lodoco is supplied as a 0.5mg tablet. It is expected to be available in the second half of 2023.
This article originally appeared on MPR
- US FDA approves first anti-inflammatory drug for cardiovascular disease. AGEPHA Pharma USA, LLC. News release. June 20, 2023. https://www.businesswire.com/news/home/20230620113838/en/U.S.-FDA-Approves-First-Anti-Inflammatory-Drug-for-Cardiovascular-Disease.
- Nidorf SM, Fiolet A, Mosterd A, et al. Colchicine in patients with chronic coronary disease. NEJM. Published online November 5, 2020. doi:10.1056/NEJMoa2021372
- Package insert. AGEPHA Pharma USA, LLC; 2023. Accessed June 20, 2023. https://us.agephapharma.com/product/.