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


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

Original Publication:

Taylor AJ, et al. N Engl J Med. 2009;doi: 10.1056/NEJMoa0907569.