WASHINGTON – The Food and Drug Administration approved colchicine on November 3, 2023, marking the first time a pill has been authorized to reduce the risk of heart attack and stroke in patients with established cardiovascular disease by targeting inflammation. The medication, marketed as Mitiga, represents a novel approach to preventing cardiovascular events beyond conventional methods like statins and aspirin.
Cardiovascular disease remains the leading cause of death globally,and chronic inflammation plays a important role in its progression. Mitiga offers a new preventative option for approximately 1 in 3 adults in the United States living with heart disease, a condition that accounts for roughly 697,000 deaths annually, according to the Centers for disease Control and prevention. The FDA approval follows positive results from the LoDoCo2 trial, which demonstrated a 31% reduction in cardiovascular events in patients taking colchicine compared to placebo.
Colchicine, derived from the autumn crocus plant, has been used for centuries to treat gout.Researchers discovered its anti-inflammatory properties could also benefit cardiovascular patients. The drug works by inhibiting a protein complex called the NLRP3 inflammasome,a key driver of inflammation in arterial plaque. By reducing inflammation within the arteries, Mitiga aims to stabilize existing plaque and prevent rupture, a primary cause of heart attacks and strokes.
The LoDoCo2 trial, published in The New England Journal of Medicine in November 2023, involved over 5,500 patients with established cardiovascular disease who where followed for three years. Participants taking 0.5 mg of colchicine daily experienced fewer cardiovascular deaths, heart attacks, and strokes. However, the drug is not without side effects; common adverse reactions include gastrointestinal issues like diarrhea.
Mitiga is available by prescription only and carries a boxed warning regarding serious side effects, including myopathy and renal dysfunction. the FDA approval mandates a Risk Evaluation and Mitigation Strategy (REMS) program to ensure patients are aware of these risks and receive appropriate monitoring. Pharmaceutical company Pharmacia & Upjohn, a Viatris company, will distribute Mitiga, with a list price of $5.99 per tablet. Further research is planned to explore colchicine’s potential benefits in other inflammatory conditions.