The approval of Lodoco by the FDA marks a significant milestone in the treatment of cardiovascular disease as it becomes the first anti-inflammatory drug to receive such recognition. This achievement holds great importance due to the potential impact it can have on managing and combating this prevalent health condition.
- LODOCO (colchicine), the newly approved medication by the FDA, has been proven to effectively decrease the risk of cardiac events in adults suffering from atherosclerotic cardiovascular disease (ASCVD) or those with multiple risk factors for cardiovascular disease.
- In comparison to standard-of-care treatment, LODOCO has demonstrated an additional 31% reduction in cardiac event risk.
- This medication can be utilized either as a standalone treatment or in conjunction with cholesterol-lowering medications.
The initial anti-inflammatory medication for cardiovascular disease has been authorized by the Food and Drug Administration (FDA). Known as LODOCO (colchicine, 0.5mg), this newly approved drug has demonstrated a 31% reduction in the risk of cardiac events in adults with atherosclerotic cardiovascular disease (ASCVD) or multiple risk factors for cardiovascular disease when compared to standard-of-care treatment. Consequently, colchicine can now be utilized for both the prevention and treatment of cardiovascular disease.
The FDA has granted approval based on evidence from a clinical trial involving 5,522 individuals with chronic coronary disease. This trial was conducted in multiple countries and followed a randomized, double-blind, placebo-controlled design. The participants were receiving guideline-directed medical care, which included the use of high-intensity statins.
The study’s results demonstrated that LODOCO effectively decreased the likelihood of: myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death.
LODOCO can be utilized either as a standalone treatment or in conjunction with cholesterol-lowering medications.
The mechanism of action of colchicine explained
Dr. Brett Nowlan, a cardiologist affiliated with the Hartford HealthCare Heart & Vascular Institute, emphasizes that our understanding of the connection between inflammation and the formation of arterial plaque has been established for several years.
Prior to the recent approval of colchicine, there were no medications available in the field of cardiology that specifically targeted this particular risk.
Nowlan further elucidates that the anti-inflammatory mechanisms operating in colchicine are distinct from those found in other medications, such as steroids or NSAIDs like aspirin.
According to the expert, this medication is designed to be taken once daily as a long-term preventive measure. It is meant to complement other risk-reducing medications like aspirin or statins, rather than replace them.
By acting on various pathways, the medication effectively reduces the activity of diverse inflammatory cells, thereby mitigating the potential risks associated with heart attack and stroke.