Key result
Probucol or the combination of probucol and cilostazol added to statin therapy did not significantly reduce mean carotid intima media thickness at 3 years compared to statin therapy alone.
Why the study?
The long-term effects of probucol or probucol and cilostazol added to statin on carotid mean intima media thickness had not been previously evaluated.
Does the addition of probucol or probucol plus cilostazol to statin therapy reduce carotid intima media thickness in hypercholesterolemic patients with coronary artery disease?
RCT (n=281)
Open blinded endpoint (PROBE)
Randomized to three groups (stratified by country and maximal carotid IMT)
Yes
Does the addition of probucol or probucol plus cilostazol to statin therapy reduce carotid intima media thickness in hypercholesterolemic patients with coronary artery disease?
The addition of probucol or a combination of probucol and cilostazol to standard statin therapy did not significantly reduce carotid intima media thickness compared to statin therapy alone over 3 years in patients with coronary artery disease.
Answers are grounded in this paper and cite their sources.
Adding probucol ± cilostazol to statin yielded no extra IMT regression versus statin alone; leaves open clinical outcome benefits.
AIM: In a prospective randomized multinational open blinded endpoint study, the long-term effects of probucol or probucol and cilostazol with statin on carotid mean intima media thickness (IMT) were evaluated for the first time. METHODS: Hypercholesterolemic patients with coronary artery disease were randomized to three groups and received study drugs for 3 years: the control with statin alone; the probucol group with statin and probucol; and the combo group with statin, probucol, and cilostazol. Primary efficacy endpoint was changes of mean carotid IMT at 3 years. Biomarkers, major adverse cerebro-cardiovascular events (MACCEs) and safety were secondary endpoints. RESULTS: Two hundred eighty-one patients were randomized into three groups. All three groups showed significant regression of carotid IMT at 3 years compared with baseline. Decrease in mean carotid IMT was significantly greater in the combo group than in the control group at 1 year. However, there were no significant differences in changes of mean carotid IMT between groups at 3 years (control; -0.12±0.36 mm vs. probucol; -0.11 ±0.32 mm vs. combo; -0.16±0.38 mm). MACCEs were frequent in the control group, but the difference was not significant (control; 10.8% vs. probucol; 4.4% vs. combo; 6.9%, p=0.35). Probucol and cilostazol were well tolerated in long-term treatment without serious drug-related adverse reactions. CONCLUSION: Probucol or probucol and cilostazol with statin did not reduce carotid IMT in comparison with statin alone in this study. However, the clinical outcome of probucol-based treatment with current standard statin treatment may need further studies.
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Kang et al. (2020) conducted an RCT in Coronary heart disease with hypercholesterolemia (n=281). Probucol and/or cilostazol vs. Statin alone was evaluated on Change in mean carotid intima media thickness (IMT) at 3 years (p=0.78 (probucol vs control); 0.56 (combo vs control)). Probucol or the combination of probucol and cilostazol added to statin therapy did not significantly reduce mean carotid intima media thickness at 3 years compared to statin therapy alone.
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