EKSTROM trial results demonstrate low-dose colchicine, 0.5 mg significantly reduced total plaque volume in stable coronary artery disease compared to placebo at one year
AGEPHA Pharma USA, LLC, is pleased to highlight clinical data that provides new information about how low-dose colchicine, 0.5 mg reduces the risk of major adverse cardiovascular events (MACE) and supports its use in the treatment of cardiovascular disease. The study titled, “Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With Stable Coronary Artery Disease Compared To Placebo: The Ekstrom Trial,” was presented as a late-breaking clinical trial at the American College of Cardiology 74th Annual Scientific Session and Expo (ACC.25). These new data reinforce the use of LODOCO® (colchicine, 0.5 mg tablet), the first anti-inflammatory atheroprotective cardiovascular treatment, 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.
“The results from the EKSTROM trial offer powerful evidence that low-dose colchicine (0.5 mg) has potential to directly reduce inflammation, which plays a substantial role in the formation and progression of atherosclerotic plaque leading to heart disease,” said Matthew J. Budoff, M.D., investigator at The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, professor of medicine at the David Geffen School of Medicine at the University of California Los Angeles (UCLA) Medical Center and program director and director of Cardiac Computed Tomography (CT), Division of Cardiology at Harbor-UCLA Medical Center. “Together with statins, antihypertensives, and other standard of care treatments, this anti-inflammatory therapy may become a vital pillar in cardiovascular disease management, and could help reduce hospitalizations and cut long-term healthcare costs.”
“The EKSTROM trial findings demonstrate that anti-inflammatory treatment with low-dose colchicine, 0.5 mg improved several measures of plaque volume changes over a period of 12 months in patients with stable coronary artery disease,” Dr. Budoff continued. “These findings are concordant with prior research that demonstrates the low-dose colchicine, 0.5 mg improved coronary plaque stability in patients with acute coronary syndrome. Taken together, these results may point to the underlying mechanism explaining how low-dose colchicine, 0.5 mg can prevent heart attack and stroke in high-risk patients with established cardiovascular disease.”
The randomized, double-blind, placebo controlled EKSTROM trial evaluated the effects of low-dose colchicine, 0.5 mg on atherosclerotic plaque. A total of 84 participants were enrolled, of which 72 completed the trial, with participants randomized to receive either colchicine 0.5 mg/day or placebo (n=36 per treatment group) as add-on to their standard of care. All participants underwent coronary computed tomography angiography (CCTA), a non-invasive imaging technique used to assess coronary artery anatomy and stenosis, at baseline and at 12 months. The primary endpoint was change in low-attenuation plaque volume (LAP), a quantification of non-calcified, lipid-rich plaque, compared to placebo as measured by CCTA. Secondary endpoints included change in total plaque volume, and change in total non-calcified plaque, fibro-fatty, fibrous and dense calcified plaques.
The results demonstrate low-dose colchicine, 0.5 mg significantly reduced the total plaque volume compared to placebo at 12 months (change in percent atheroma volume [PAV] was ‑1.1% between treatment groups; P=0.015). The trial did not meet its primary endpoint as LAP was not significantly reduced with low-dose colchicine, 0.5 mg treatment (P=0.344), although this was potentially because of the restricted trial enrollment due to limited funding. Low-dose colchicine treatment significantly reduced dense calcified plaque volume (-0.9% PAV between treatment groups; P=0.009), another indicator of cardiovascular risk. Similarly, low-dose colchicine treatment demonstrated trends toward regression of non-calcified plaque, fibrous and fibro-fatty plaque. Future analyses are needed in a larger population of patients to confirm these findings.
The effectiveness and safety of LODOCO in preventing heart attacks and strokes is supported by randomized trial data reported in the New England Journal of Medicine, Circulation, Journal of the American College of Cardiology, and European Heart Journal, while data emphasizing the critical need to address inflammation as much as high cholesterol in heart disease patients has recently been described in The Lancet. Specifically, LODOCO reduces cardiac event risk in adult patients with established atherosclerotic cardiovascular disease by an additional 31% as compared to placebo. More recently, the favorable effects of LODOCO on coronary plaque in patients with acute coronary syndrome are supported by randomized trial data reported in Circulation and JACC: Cardiovascular Imaging. Prior research has shown that a 1% difference in PAV between treatment and placebo groups was associated with a 25% risk reduction in MACE.
“We are pleased that these findings from the EKSTROM trial continue to support the use of LODOCO in the treatment of cardiovascular disease for those with residual inflammatory risk,” said Steve Andrzejewski, Head of US Operations at AGEPHA Pharma. “This is now the third study that suggests LODOCO reduces coronary plaque and the first in patients with stable coronary disease. These data showcase the benefits of LODOCO in preventing recurrent life-threatening heart-related events in people living with multiple risk factors for atherosclerotic cardiovascular disease.”
About AGEPHA Pharma
AGEPHA Pharma is a family-owned, leading multinational pharmaceutical company focused on bringing treatments to patients who need them most. Since 1947, they have invested in proven therapies, including a wide range of pharmaceuticals, medical devices, and nutritional supplements, supported by a highly qualified team of clinical scientists and regulatory experts.
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IMPORTANT SAFETY INFORMATION
Indication
LODOCO is 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.
IMPORTANT SAFETY INFORMATION LODOCO® (COLCHICINE) 0.5 MG TABLETS
Do not take LODOCO if you:
- take certain medicines called strong CYP3A4 inhibitors or P-glycoprotein inhibitors. Ask your healthcare provider if you are not sure. Taking certain medicines with LODOCO may cause your level of LODOCO to be too high in your body and cause life-threatening side effects or death.
- have severe kidney or liver problems.
- have blood problems.
- are allergic to colchicine or any of the ingredients in LODOCO.
What are the possible side effects of LODOCO?
LODOCO may cause serious side effects, including:
- Blood problems. LODOCO can cause low red blood cell counts, low white blood cell counts, and low platelet counts, which can be life-threatening or may lead to death.
- Muscle weakness (neuromuscular toxicity). LODOCO can cause muscle weakness and muscle problems.
The most common side effects of LODOCO include:
- diarrhea, vomiting, and stomach-area (abdominal) cramping.
- muscle pain
Fatal overdoses have been reported with colchicine in adults and children. Keep LODOCO out of the reach of children.
Disclosure: Dr. Matthew J. Budoff is an AGEPHA Pharma consultant. AGEPHA Pharma does not guide or comment on their data and peer-review submissions. The EKSTROM trial was not funded by AGEPHA Pharma nor did AGEPHA Pharma have any input into the study design.
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