Clinical Trials
ARBITER 6-HALTS
Trial Details
Acronym: ARterial Biology for the Investigation of Treatment Effects of Reducing Cholesterol 6 - HDL And LDL Treatment Study
Purpose: Evaluated patients on statin therapy randomized to extended-release niacin versus ezetimibe.
Format: prospective, randomized, parallel-group, open-label
Treatment Group 1: extended-release niacin (target dose, 2000 mg per day)
Treatment Group 2: ezetimibe (10 mg per day)
Number of Patients: 363
Inclusion Criteria:
- ≥30 years of age
- Atherosclerotic coronary or vascular disease or a CHD risk equivalent:
- diabetes mellitus
- a 10-year Framingham risk score of 20% or more
- a coronary calcium score above 200 for women or 400 for men
- Treated with statin monotherapy at a consistent dose
- LDL cholesterol level under 100 mg per deciliter
- HDL cholesterol level under 50 mg per deciliter for men or 55 mg per deciliter for women
Primary Endpoint: Between-group difference in the change from baseline in the mean common carotid intima–media thickness
Secondary Endpoints:
Follow-up: 14 months
Summary:
The mean HDL cholesterol level in the niacin group increased by 18.4%, and the mean LDL cholesterol level in the ezetimibe group decreased by 19.2%. Niacin therapy significantly reduced LDL cholesterol and triglyceride levels; ezetimibe reduced the HDL cholesterol and triglyceride levels. The use of extended-release niacin caused a significant regression of carotid intima–media thickness when combined with a statin