FDA Approves Colchicine for Decreasing CV Events
21 Jun 2023 • The US Food and Drug Administration has approved colchicine 0.5 mg as the first anti-inflammatory indicated for reducing cardiovascular events among adults who have established atherosclerotic cardiovascular disease (ASCVD) or are at risk of developing it. In a big moment for the “inflammatory hypothesis,” the drug, to be sold as Lodoco, is the first anti-inflammatory for CVD.
The drug, which targets residual inflammation as an underlying cause of atherosclerotic cardiovascular disease, has a dosage of 0.5 mg once daily, and can be used alone or in combination with cholesterol-lowering medications.
Data supporting the approval has come from two major randomized trials, LoDoCo-2 and COLCOT
- In the LoDoCo-2 trial, the anti-inflammatory drug cut the risk of cardiovascular events by one third when added to standard prevention therapies in patients with chronic coronary disease
- And in the COLCOT study, use of colchicine reduced cardiovascular events by 23% compared with placebo in patients with a recent MI.
Dr Paul M. Ridker, MD principal investigator for the LoDoCo2 trial of colchicine, claimed the news is “very, very exciting.” "This is a very big day for cardiology, the FDA approval of colchicine for patients with atherosclerotic disease is a huge signal that physicians need to be aware of inflammation as a key player in cardiovascular disease," he said.
A valid question now is who should be taking this drug, said Ridker. “You want to target your therapies to the people who have the highest risk related to that therapy. I measure high-sensitivity CRP to figure out who has inflammation that’s not well controlled,” he explained. “Assuming you’re on a statin, if your high-sensitivity CRP is greater than 2 milligrams per liter, I think you by definition have residual inflammatory risk” and can consider starting colchicine.
Source: tctMD | Read full story