FDA Approves Colchicine Tablets for Reducing Cardiovascular Risk

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Announced by AGEPHA Pharma US on June 20, 2023, the US FDA approval of colchicine 0.5 mg tablets (Lodoco) for reducing cardiovascular event risk marks the first approval in agency history for an anti-inflammatory atheroprotective cardiovascular treatment.

The US Food and Drug Administration had awarded approval to colchicine 0.5 mg tablets (Lodoco) for reducing the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

Announced by parent company AGEPHA Pharma USA on June 20, 2023, the approval, which is supported by data from a 5522-person trial purporting a 31% relative reduction in risk of cardiovascular events, marks the first indication in FDA history for an anti-inflammatory atheroprotective cardiovascular treatment, according to a statement from AGEPHA.1

"For the first time, patients with residual inflammatory risk, as measured by hsCRP, will have an FDA-approved treatment option demonstrated to reduce the risk of cardiovascular disease by targeting the inflammatory pathways that influence major cardiac events,” said Michael J Blaha, MD, MPH, director of Clinical Research at the Ciccarone Center for the Prevention of Cardiovascular Disease and professor of Medicine with Johns Hopkins Medicine.1

A long-time staple in the management of rheumatic disease, colchicine has seen its role in the management of multiple diseases reexamined in recent years as the medical community learns more about associations between systemic inflammation and adverse event risk. In their statement announcing the approval, AGEPHA pointed to the LoDoCo2 trial as supporting evidence for the approval of colchicine 0.5 mg tablets.

A randomized, controlled, double-blind trial of patients with chronic coronary disease, LoDoCo2 enrolled and randomized 5522 patients to colchicine 0.5 mg tablets or placebo therapy. Designed with a composite primary endpoint consisting of cardiovascular death, spontaneous MI, ischemic stroke, or ischemia-driven coronary revascularization, results of the trial indicated such an event occurred among 6.8% of the colchicine group compared to 9.6% of the placebo group 2.5 vs. 3.6 events per 100 person-years; hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.57-0.83; P < .001).2

The growing recognition of the role of inflammation as a driver of risk among the cardiology community was on full display earlier this year at the American College of Cardiology 2023 annual scientific session where an analysis of 3 landmark trials brought further clarity to the discussion surrounding the role of inflammation in driving atherosclerotic cardiovascular risk.

In the study, which was presented by Paul Ridker, MD, director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital, investigators pooled data from the PROMINENT, REDUCE-IT, and STRENGTH trials to compare quartiles of increasing baseline hsCRP and LDL-C as predictors of major adverse cardiovascular events (MACE), cardiovascular mortality, and all-cause mortality.3

Results of the 31,245-patient study suggested there was a significantly greater residual inflammatory risk among those in the highest quartile for hsCRP, with these patients experiencing significantly greater risk for incident MACE (HR, 1.31; 95% CI, 1.20-1.43; P < .0001), cardiovascular mortality (HR, 2.68; 95% CI, 2.22-3.23; P < .0001), and all-cause mortality (HR, 2.42; 95% CI, 2.12-2.77; P < .0001) relative to those in the lowest quartile. When comparing the highest quartile of LDL-C against the lowest quartile of LDL-C, results indicated the relationship of residual cholesterol risk was neutral for MACE and of low magnitude for cardiovascular death (HR, 1.27; 95% CI, 1.07-1.50; P=.0086) and all-cause mortality (HR, 1.16; 95% CI, 1.03-1.32; P=.025).3

“Approval by the FDA of the first drug to target cardiovascular inflammation is an important step forward for the care of our patients,” said Ridker, in the aforementioned statement from AGEPHA Pharma.1 “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.”

In their statement, AGEPHA Pharma pointed out colchicine 0.5 mg tablets are contraindicated in patients with kidney failure or severe liver disease and patients taking colchicine 0.5 mg tablets should temporarily discontinue use if prescribed agent like azithromycin or ketoconazole.1


  1. AGEPHA Pharma US. U.S. FDA approves first anti-inflammatory drug for cardiovascular disease. Agepha Pharma US. June 20, 2023. Accessed June 20, 2023.
  2. Nidorf SM, Fiolet ATL, Mosterd A, et al. Colchicine in Patients with Chronic Coronary Disease. N Engl J Med. 2020;383(19):1838-1847. doi:10.1056/NEJMoa2021372
  3. Campbell P. New study indicates inflammation could be major driver of Atherosclerotic Risk. HCP Live. March 9, 2023. Accessed June 20, 2023.