The burden of coronary artery disease (CAD) remains high, with 600.000 patients in the Netherlands and 10,000 deaths/ year (RIVM). Costs of CAD are approximately 7 billion per year (2011, RIVM).
Inflammation plays a pivotal role in CAD, currently without a treatment strategy . First proof of possible effective treatment was given by the Low Dose Colchicine in Cardiovascular Disease (LoDoCo) trial in 2013. This trial in 532 patients with stable CAD showed a 67% event reduction in those treated with colchicine 0.5 mg/day versus no colchicine in the occurrence of acute coronary syndrome (ACS), out-of-hospital cardiac arrest, or noncardioembolic ischemic stroke (HR 0.33; 95% CI 0.18 to 0.59).
Colchicine is an old, low cost, anti-inflammatory drug used for gout, Familial Mediterranean Fever and pericarditis. There is broad clinical experience with the drug and side effects are well known and uncommon.
LoDoCo2 aims to confirm these promising results with a randomized, placebo controlled, multi-centre trial of colchicine 0,5mg once daily versus placebo in 4115 patients with stable CAD in the Netherlands and Australia. Primary outcome will be the occurrence of the composite endpoint of ACS, fatal or non-fatal out of hospital cardiac arrest and atherosclerotic stroke.
The study is an academic partnership between the Netherlands (55 hospitals from the Working Group on Cardiovascular Research Netherlands, WCN) and the group in Perth, Australia. The design is clinically oriented, pragmatic and low cost. Co-financing has been arranged with the Withering Stichting Netherlands and Teva /Disphar, both valuable organisations for future implementation
This trial investigates effect and cost-effectiveness of the well known drug colchicine (drug rediscovery). If proven successful, not only will this be breakthrough in cardiovascular research and revolutionise the treatment of coronary artery disease but it will also promote further research in expedient use of drugs.