The Food and Drug Administration recently approved a low-dose version of colchicine, a drug previously used to alleviate joint pain, to treat cardiovascular inflammation. This could serve as a major step towards revolutionizing heart-attack prevention.
During the past 25 years, cardiologists have theorized that inflammation may be the key culprit to atherosclerosis, an artery-clogging disease – also known as arteriosclerosis – that can lead to heart attacks. The role of inflammation in heart disease is significant, and that’s where colchicine steps in.
Inflammation can lead to the growth of fatty plaque, a known cause of heart attacks and strokes. While cholesterol levels are still the primary indicator of potential cardiovascular events, elevated inflammation levels outside of, or in addition to, high cholesterol levels are also precursors to these medical emergencies.
Historically, approaches to heart attack prevention have included the use of statins to lower LDL cholesterol. Recent studies have indicated that adding low-dose colchicine reduces cardiovascular risk by hitting both biological targets that cause heart attacks, combining two effective ways to reduce risk with one drug.
Colchicine has been used to treat gout as well as familial Mediterranean fever and pericarditis for more than two millennia. One of the oldest remedies still in use today, evidence of its extraction from flowers to reduce joint pain dates back to 1500 BC in Egypt.
In 2006, new studies began testing the drug’s effectiveness in targeting inflammation to lower the risk of heart attacks.
After the American Heart Associate Conference in 2012, a double-blind study called Lodoco2 was conducted by researchers from Australia and the Netherlands, enrolling 5,522 patients with stable cardiovascular disease. They found that colchicine prevented two and a half to three heart attacks or other events for every 100 patients treated, demonstrating a 31 percent reduction in cardiovascular events.
Since this study, a small company named Agepha Pharma acquired the rights to market .5-milligram doses of colchicine and used the data to make a case for FDA approval. As of last fall, the drug was officially launched in the U.S. at a list price of $99 per month, a price significantly cheaper than competing drugs like Wegovy.
Despite the advantages of colchicine, there are still challenges that prevent doctors from immediately prescribing the drug. For one, diarrhea has been found to coincide with higher doses, but this was not a major issue for single-day low-dose usage. In addition to this, both the American College of Cardiology and American Heart Association gave colchicine a weak endorsement.
Furthermore, pharmaceutical companies lack the marketing resources to effectively get the word out to clinicians and patients. Because Agepha Pharma is the only company with FDA approval for the drug, the small family-owned business does not have the resources or marketingpresence in the U.S. to stay comparative in the market. Finally, the company has been unsuccessful in finding a partner to co-promote the drug.
There is an elevated risk for patients with kidney or liver disease in using the current .6-milligram generic colchicine already on the market. Because of this concern, patients with kidney or liver disease are given lower .5-milligram doses.
Incorporating colchicine into treatments for reducing cardiovascular risk allows doctors to take a more personalized approach that will maximize heart protection for high-risk patients.
While baseline treatments like taking statins, managing blood pressure and lifestyle modifications will stay the same, adding colchicine will help tailor the treatment to the individual risk factors of the patient.
Cailyn Burr is an editorial assistant at CityScene Media Group. Feedback welcome at feedback@cityscenemediagroup.com.