Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol (ARBITER) 2: a double-blind, placebo-controlled study of extended-release niacin on atherosclerosis progression in secondary prevention patients treated with statins

Circulation. 2004 Dec 7;110(23):3512-7. doi: 10.1161/01.CIR.0000148955.19792.8D. Epub 2004 Nov 10.


Background: Niacin reduces coronary heart disease morbidity and mortality when taken either alone or in combination with statins; however, the incremental impact of adding niacin to background statin therapy is unknown.

Methods and results: This was a double-blind randomized placebo-controlled study of once-daily extended-release niacin (1000 mg) added to background statin therapy in 167 patients (mean age 67 years) with known coronary heart disease and low levels of high-density lipoprotein cholesterol (HDL-C; <45 mg/dL). The primary end point was the change in common carotid intima-media thickness (CIMT) after 1 year. Baseline CIMT (0.884+/-0.234 mm), low-density lipoprotein cholesterol (89+/-20 mg/dL), and HDL-C (40+/-7 mg/dL) were comparable in the placebo and niacin groups. Adherence to niacin exceeded 90%, and 149 patients (89.2%) completed the study. HDL-C increased 21% (39 to 47 mg/dL) in the niacin group. After 12 months, mean CIMT increased significantly in the placebo group (0.044+/-0.100 mm; P<0.001) and was unchanged in the niacin group (0.014+/-0.104 mm; P=0.23). Although the overall difference in IMT progression between the niacin and placebo groups was not statistically significant (P=0.08), niacin significantly reduced the rate of IMT progression in subjects without insulin resistance (P=0.026). Clinical cardiovascular events occurred in 3 patients treated with niacin (3.8%) and 7 patients treated with placebo (9.6%; P=0.20).

Conclusions: The addition of extended-release niacin to statin therapy slowed the progression of atherosclerosis among individuals with known coronary heart disease and moderately low HDL-C.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Biomarkers / analysis
  • Carotid Artery Diseases / diagnostic imaging
  • Carotid Artery Diseases / pathology
  • Carotid Artery Diseases / prevention & control
  • Carotid Artery, Common / diagnostic imaging
  • Carotid Artery, Common / drug effects
  • Carotid Artery, Common / pathology
  • Cholesterol, HDL / blood*
  • Coronary Disease / epidemiology
  • Coronary Disease / prevention & control*
  • Delayed-Action Preparations
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use*
  • Male
  • Niacin / administration & dosage
  • Niacin / therapeutic use*
  • Tunica Intima / diagnostic imaging
  • Tunica Intima / drug effects
  • Tunica Intima / pathology
  • Tunica Media / diagnostic imaging
  • Tunica Media / drug effects
  • Tunica Media / pathology
  • Ultrasonography


  • Biomarkers
  • Cholesterol, HDL
  • Delayed-Action Preparations
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Niacin