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ARBITER 6-HALTS
Arterial Biology for the Investigation of the Treatment Effects of Reducing cholesterol 6 – HDL and LDL Treatment Strategies
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Author(s) |
(a) Devine PJ, Turco MA, Taylor AJ
(b) Taylor AJ, Villines TC, Stanek EJ, Devine PJ, Griffen L, Miller M, Weissman NJ, Turco M |
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Title(s) |
(a) 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)
(b) Extended-release niacin or ezetimibe and carotid intima-media thickness |
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Reference(s) |
(a) Cardiovasc Drugs Ther 2007;21:221–5
(b) N Engl J Med 2009;361:2113–22 |
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Disease |
Atherosclerosis |
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Purpose |
To compare HDL-cholesterol and LDL-cholesterol focused strategies of lipid treatments for their effects on atherosclerosis |
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Study design |
Randomised, open, parallel-group |
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Follow-up |
14 months |
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Patients |
363 patients (176 ezetimibe, 187 niacin), mean age 65 ± 11 years, presenting with known coronary heart disease treated with a statin |
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Treatment regimen |
Ezetimibe, 10 mg/day, or niacin, ≥ 500 mg/day titrated to 2 g/day
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Results |
208 patients (111 ezetimibe, 97 niacin) completed the trial. The primary endpoint of change from baseline in mean common carotid intima-media thickness was -0.0007 ± 0.0035 mm among patients receiving ezetimibe and -0.0142 ± 0.0041 mm among those receiving niacin (p = 0.01) |
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Comments |
The trial was terminated early according to a prespecified efficacy analysis conducted after 208 patients had completed the trial
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