MRI-measured regression of carotid atherosclerosis induced by statins with and without niacin in a randomised controlled trial: the NIA plaque study.

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.