WASHINGTON – The Food and โคDrug Administration approved colchicine on November 3,โ 2023, marking the first time a pill has been authorized to reduce the risk of heart attack and stroke in โpatients with established cardiovascular disease by โtargetingโ inflammation. The medication, marketed as Mitiga, represents a โฃnovel approach to preventing cardiovascular events beyondโค conventional methods like โขstatins and aspirin.
Cardiovascularโ disease remains โขthe leading โขcause of death globally,and chronicโฃ inflammation plays a important role inโฃ its progression. Mitiga offers a new preventative option for approximately 1 in 3โค adults in the โUnited States living with heart disease, a condition that accounts forโค roughly 697,000 deaths annually, โขaccordingโค to the Centers for disease Control and prevention. The FDA โapproval follows positive results from the LoDoCo2 trial, which demonstratedโ a โ31% reduction in cardiovascular events in patients takingโค colchicineโค 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 โworks by inhibiting a protein complexโ called the NLRP3 inflammasome,a key driver ofโ inflammationโ in arterial plaque. Byโ reducing inflammation withinโข the arteries, Mitiga aims to stabilize existing plaque and prevent rupture,โ a primary cause of heart โattacks 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 whereโ followed for three years. Participants taking 0.5 โmg ofโข colchicineโ daily experienced fewer cardiovascular deaths, heart attacks,โ and strokes. However, โคthe drug is not โคwithout side effects; common adverse reactions include gastrointestinal issuesโข like diarrhea.
Mitiga is available by prescription only andโฃ carries a boxed warning regarding serious side โคeffects, โincluding 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 ofโ $5.99 per tablet. Further research โis planned to explore colchicine’s potential benefits in other โinflammatory conditions.