Abstract
OBJECTIVE: To evaluate the benefit of niacin in addition to statin therapy on plaque regression among older individuals with established atherosclerosis. DESIGN: Randomised, controlled, double-blind clinical trial. SETTING: University outpatient center. PATIENTS: 145 patients older than 65 years, half of them older than 75 years of age, with established atherosclerosis were enrolled. INTERVENTIONS: Participants received either extended release niacin (1500 mg daily) or placebo in addition to statin therapy to reach their National Cholesterol Education Program-defined low density lipoprotein (LDL) cholesterol target. MAIN OUTCOME MEASURES: The primary endpoint was reduction in the wall volume of the internal carotid artery (ICA) measured by MRI. RESULTS: After 18 months, high density lipoprotein cholesterol was higher with statins plus niacin compared with statins alone (1.6 ± 0.4 vs 1.4 ± 0.4 mmol/L p<0.001). Both groups had significant decreases in the main outcome measure of ICA wall volume, which regressed at 0.5%/month (SEM 0.2, p=0.004) in the statins plus placebo group and at 0.7%/month in the statins plus niacin group (SEM 0.2, p<0.001). There was no difference in the rate of regression between groups (p=0.49). CONCLUSIONS: Treatment with statin therapy to presently recommended LDL levels, with or without niacin, resulted in significant atherosclerosis reduction.