Cited by 223Lipoproteins and Cardiovascular HealthCardiovascular Health and Disease PreventionAtherosclerosis and Cardiovascular Diseases

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The ARBITER 6-HALTS Trial (Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6–HDL and LDL Treatment Strategies in Atherosclerosis)

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Villines, Todd C., Stanek, Eric J., Devine, Patrick J., Turco, Mark, Miller, Michael, Weissman, Neil J., Griffen, Len, Taylor, Allen J.·2010·Journal of the American College of Cardiology

DOI 10.1016/j.jacc.2010.03.017

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Abstract

Objectives This report describes the final results of the ARBITER 6-HALTS (Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6-HDL and LDL Treatment Strategies in Atherosclerosis) trial.Background The ARBITER 6-HALTS trial was terminated early on the basis of a pre-specified interim analysis showing superiority of niacin over ezetimibe on change in carotid intima-media thickness (CIMT). After termination, an additional 107 subjects completed a close-out assessment.Methods Patients with coronary heart disease (CHD) or CHD equivalent with low-density lipoprotein cholesterol <100 mg/dl and high-density lipoprotein cholesterol <50 mg/dl for men or 55 mg/dl for women while receiving stable statin treatment were randomly assigned to ezetimibe (10 mg/day) or extended-release niacin (target dose, 2,000 mg/day). The primary end point was change in mean CIMT, analyzed according to a last observation carried forward method. The relationships of study medication adherence, dosage, and cumulative exposure (product of adherence, dose, and time) with change in CIMT were explored.Results Results in 315 patients included 208 with 14-month follow-up and 107 after mean treatment of 7 +/- 3 months. Niacin (n = 154) resulted in significant reduction (regression) in mean CIMT (-0.0102 +/- 0.0026 mm; p < 0.001) and maximal CIMT (-0.0124 +/- 0.0036 mm; p = 0.001), whereas ezetimibe (n = 161) did not reduce mean CIMT (-0.0016 +/- 0.0024 mm; p = 0.88) or maximal CIMT (-0.0005 +/- 0.0029 mm; p = 0.88) compared with baseline. There was a significant difference between ezetimibe and niacin treatment groups on mean changes in CIMT, favoring niacin, for both mean CIMT (p = 0.016) and maximal CIMT (p = 0.01). Increased cumulative drug exposure was related to regression of CIMT with niacin, and progression of CIMT with ezetimibe.Conclusions Niacin induces regression of CIMT and is superior to ezetimibe for patients taking statins. (Comparative Study of the Effect of Ezetimibe Versus Extended-Release Niacin on Atherosclerosis; NCT00397657).

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Authors: Villines, T. C., Stanek, E. J., Devine, P. J., Turco, M., Miller, M., Weissman, N. J., Griffen, L., & Taylor, A. J.
Affiliations: Walter Reed National Military Medical Center (US)
Washington Adventist Hospital (US)
University of Maryland Medical Center (US)
MedStar Washington Hospital Center (US)
Corresponding author: Villines, Todd C.
ORCID: Villines, Todd C.
Miller, Michael
Venue: Journal of the American College of Cardiology
Publisher: Elsevier BV
Published: 2010-06
Volume: 55
Issue: 24
Pages: 2721-2726
ISSN: 0735-1097 (ISSN-L)
DOI: 10.1016/j.jacc.2010.03.017
OpenAlex: W2187593761
Cited by: 223
References: 14
Citations by year: 2026: 1 · 2025: 2 · 2024: 5 · 2022: 2 · 2021: 5 · 2020: 10 · 2019: 7 · 2018: 3 · 2017: 6 · 2016: 12 · 2015: 11 · 2014: 20 · 2013: 33 · 2012: 40
FWCI: 46.84
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (vor, 1141 d)
Locations: Journal of the American College of Cardiology (publishedVersion)
PubMed (publishedVersion)
Funders: Henry M. Jackson Foundation
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Health and Disease Prevention
Life Sciences › Immunology and Microbiology › Immunology › Atherosclerosis and Cardiovascular Diseases
Keywords: nicotinic acid, ezetimibe, carotid intima-media thickness, atherosclerosis, coronary artery disease, statin-treated patients, LDL cholesterol, HDL cholesterol, medication adherence, cumulative drug exposure, atherosclerosis regression, lipid-lowering therapy, trial termination, cardiovascular risk reduction, statin-sparing therapy
MeSH terms: Ezetimibe, Aged, Anticholesteremic Agents, Azetidines, Coronary Disease, Dose-Response Relationship, Drug, Female, Follow-Up Studies, Humans, Cholesterol, HDL, Cholesterol, LDL, Male, Niacin, Time Factors, Ultrasonography, Single-Blind Method, Treatment Outcome, Carotid Artery, Common, Tunica Intima, Atherosclerosis, Medication Adherence

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