General Information

Lodoco (colchicine) is an alkaloid.

Lodoco is specifically indicated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adult patients with established atherosclerotic disease or with multiple risk factors for cardiovascular disease.

Lodoco is supplied as tablets for oral administration. The recommended dosage is 0.5 mg orally once daily. If a dose of Lodoco is missed, the missed dose should be taken as soon as possible, and the patient should then return to the normal dosing schedule. If a dose is skipped, the patient should not double the next dose.

Mechanism of Action

The mechanism of action of colchicine in the prevention of major cardiovascular events is not understood. However, it is known that colchicine disrupts cytoskeletal functions through inhibition of β-tubulin polymerization into microtubules and consequently prevents the activation, degranulation, and migration of neutrophils. Colchicine may also interfere with the intracellular assembly of the inflammasome complex in neutrophils and monocytes that mediates activation of interleukin-1β. These anti-inflammatory effects are consistent with clinical data demonstrating that colchicine reduces high sensitivity C- reactive protein (hs-CRP).

Side Effects

Adverse effects associated with the use of Lodoco may include, but are not limited to, the following:

• gastrointestinal symptoms (diarrhea, vomiting, abdominal cramping)
• myalgia

Clinical Trial Results

The FDA approval of Lodoco was based on a multi-national, randomized, double-blind, placebo-controlled clinical trial among 5,522 patients with chronic coronary disease all of whom were taking guideline-directed medical care including high-intensity statins. In the trial, 0.5 mg colchicine was found to significantly reduce the overall risk of cardiovascular death, spontaneous myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization by 31% in comparison with the placebo group when added to high-intensity statins and other cardiology prevention therapies.