title: 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.
abstract: 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.
  
  
  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.
authors.affiliation: Cardiovascular Research, Cardiology Service, Walter Reed Army Medical Center, 6900 Georgia Ave, NW, Bldg 2, Room 3L28, Washington, DC 20307-5001, USA. allen.taylor@na.amedd.army.mil
authors.forename: Allen J
authors.initials: AJ
authors.lastname: Taylor
authors.forename: Lance E
authors.initials: LE
authors.lastname: Sullenberger
authors.forename: Hyun J
authors.initials: HJ
authors.lastname: Lee
authors.forename: Jeannie K
authors.initials: JK
authors.lastname: Lee
authors.forename: Karen A
authors.initials: KA
authors.lastname: Grace
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000032:analysis; D002340:Carotid Artery Diseases / Q000000981:diagnostic imaging / Q000473:pathology / Q000517:prevention & control; D017536:Carotid Artery, Common / Q000000981:diagnostic imaging / Q000187:drug effects / Q000473:pathology; D008076:Cholesterol, HDL / Q000097:blood*; D003327:Coronary Disease / Q000453:epidemiology / Q000517:prevention & control*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D008297:Male; D009525:Niacin / Q000008:administration & dosage / Q000627:therapeutic use*; D017539:Tunica Intima / Q000000981:diagnostic imaging / Q000187:drug effects / Q000473:pathology; D017540:Tunica Media / Q000000981:diagnostic imaging / Q000187:drug effects / Q000473:pathology; D014463:Ultrasonography
chemical_list: D015415:Biomarkers; D008076:Cholesterol, HDL; D003692:Delayed-Action Preparations; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D009525:Niacin