[
www.medpagetoday.com]
This is membership only. Copy and paste. However it’s free to join and this article contains valuable illustrations:
Colchicine's Rebirth as Cardiovascular Drug Approved by FDA
— Repurposed anti-inflammatory drug may be used alone or in combination with standard meds
by Nicole Lou, Senior Staff Writer, MedPage Today
June 20, 2023
FDA APPROVED colchicine (Lodoco) over a photo of a section of an artery narrowed from atherosclerosis.
The FDA approved colchicine (Lodoco) for cardiovascular prevention in adults with established atherosclerotic disease or multiple risk factors, making it the first anti-inflammatory medicine with such an indication.
The drug is now indicated for reducing the risks of myocardial infarction, stroke, coronary revascularization, and cardiovascular deaths, following regulatory approval of Agepha Pharma's drug application for a new manufacturing process of the decades-old gout medication.
"Approval by the FDA of the first drug to target cardiovascular inflammation is an important step forward for the care of our patients," said Paul Ridker, MD, MPH, of Harvard Medical School and Brigham and Women's Hospital in Boston, in a press releaseopens in a new tab or window from the drug maker. "To treat coronary disease effectively, cardiologists must aggressively reduce inflammation and cholesterol."
Agepha Pharma said its colchicine will be available for prescription in the second half of 2023. The product is to be used at a dose of 0.5 mg orally once daily -- alone or in combination with standard lipid-lowering medications -- for the cardiovascular indication.
At this dose, the alkaloid drug had been found to reduce cardiovascular events by 31% compared with placebo when used with high-intensity statins and other cardiovascular prevention therapies among people with chronic coronary disease in the LoDoCo2 randomized trialopens in a new tab or window (6.8% vs 9.6%, respectively; HR 0.69, 95% CI 0.57-0.83, P<0.001).
"For the first time, patients with residual inflammatory risk, as measured by hs-CRP [high-sensitivity C-reactive protein], 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 Blaha, MD, MPH, of Johns Hopkins Medicine in Baltimore, in a statement.
Available generically, colchicine is derived from the autumn crocus plant used medicinally for thousands of years in Egypt.
The label for Lodocoopens in a new tab or window warns that concurrent use of strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole) or P-glycoprotein inhibitors (e.g., cyclosporine, ranolazine) is contraindicated due to potential excesses in the concentration of colchicine. The drug is also contraindicated in patients with kidney failure or severe liver disease
People on colchicine have reported blood dyscrasias and neuromuscular toxicity. Moreover, the most common side effects are gastrointestinal symptoms and myalgia.
Due Colchicine's Rebirth as Cardiovascular Drug Approved by FDA
— Repurposed anti-inflammatory drug may be used alone or in combination with standard meds
by Nicole Lou, Senior Staff Writer, MedPage Today
June 20, 2023
