Design and rationale of the ARBITER 6 trial (arterial biology for the investigation of the treatment effects of reducing cholesterol)-6-HDL and LDL treatment strategies in atherosclerosis (HALTS)

• Published in: Cardiovascular drugs and therapy Vol. 21; no. 3; pp. 221 - 225
• Main Authors: DEVINE, Patrick J, TURCO, Mark A, TAYLOR, Allen J
• Format: Journal Article
• Language: English
• Published: Dordrecht Springer 01.06.2007; Springer Nature B.V
• Subjects: Arteriosclerosis; Atherosclerosis; Atherosclerosis (general aspects, experimental research); Atherosclerosis - blood; Atherosclerosis - prevention & control; Biological and medical sciences; Biology; Blood and lymphatic vessels; Cardiology. Vascular system; Cardiovascular disease; Cardiovascular diseases; Cardiovascular system; Carotid artery; Cholesterol; Cholesterol, LDL - blood; Coronary artery disease; Guidelines; Guidelines as Topic; Heart diseases; High density lipoprotein; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Lipids; Lipoproteins, HDL - blood; Low density lipoprotein; Medical sciences; Nicotinic acid; Pharmacology. Drug treatments; Prevention; Quality of life; Research Design; Statins; Therapy; atherosclerosis, carotid intima-media thickness, extended-release niacin, ezetimibe; Controlled release form; Nicotinic acid; Ezetimibe; lipid lowering therapy; Media; Cardiovascular disease; B-Vitamins; Biology; Artery; Pyridine derivatives; Vascular disease; Design; Thickness; Treatment; Cholesterol HDL; Blood vessel; Carotid; Atherosclerosis; Dosage form; Intima; Strategy; Circulatory system; Antilipemic agent
• ISSN: 0920-3206; 1573-7241
• DOI: 10.1007/s10557-007-6020-8

Recent evidence on the use of statin therapy indicates the potential for ultra-low levels of LDL-C to provide greater protection from recurrent coronary heart disease events. Guidelines for the treatment of lipid disorders were revised to indicate that an LDL-C treatment goal of 70 mg/dl was optional (NCEP ATPIII). In these same guidelines, low levels of HDL-C are also suggested but not specifically proscribed as a target of therapy. Recently ARBITER 2 (Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 2) has provided the first evidence of the potential of raising HDL-C with extended release niacin when added to statin monotherapy in secondary prevention. However, whether this approach would be superior to a strategy in which lower concentrations of LDL-C are targeted is unknown. ARBITER 6-HALTS ( HDL and LDL Treatment Strategies) will be a randomized, parallel group, open-label study comparing HDL-C and LDL-C focused strategies of lipid treatments for their effects on atherosclerosis. Up to 400 subjects will be assigned to either intensified LDL-C lowering therapy with ezetimibe or HDL-C raising therapy with extended-release niacin. The primary endpoint is the mean change in the intima-media thickness of the common carotid artery after 14 months. Secondary endpoints include the change in lipid values and lipid subfractions, drug discontinuation due to adverse effects, change in quality of life, and a composite endpoint consisting of all major adverse cardiovascular events. ARBITER 6-HALTS will guide clinicians on whether a lipid treatment strategy of raising HDL-C or further LDL-C reduction is superior in the secondary prevention of coronary heart disease.