Comparative Study of the Effect of Ezetimibe Versus Extended-Release Niacin on Atherosclerosis
Status:
Terminated
Trial end date:
2009-10-01
Target enrollment:
Participant gender:
Summary
Recent evidence on the use of statin therapy indicates the potential for ultra-low levels of
low-density lipoprotein (LDL-C) to provide greater protection from recurrent coronary heart
disease (CHD) events. Thus, in August 2005, the guidelines for the treatment of lipid
disorders (NCEP ATPIII) were revised to indicate that an LDL-C treatment goal of 70 mg/dL
(revised from 100 mg/dL) was optional for patients with known CHD. In these same guidelines,
low levels of high-density lipoprotein (HDL-C) are also suggested but not specifically
proscribed as a target of therapy. Recently the ARBITER 2 trial has provided the first
evidence of the potential of raising HDL-C with extended release niacin when added to statin
monotherapy. However, whether this approach would be superior to a strategy in which lower
concentrations of LDL-C are targeted is unknown.
The purpose of ARBITER 6 - HALTS is to compare HDL and LDL-focused strategies of lipid
treatments for their effects of atherosclerosis. This study is a prospective, randomized,
open-label, blinded endpoint trial comparing treatment strategies of either HDL-raising
therapies or LDL reduction for dyslipidemia on carotid atherosclerosis. Subjects with known
atherosclerotic coronary or vascular disease or otherwise at high cardiovascular risk through
the presence of a coronary risk equivalent who are currently being treated with a statin will
be eligible. Subjects will be randomly assigned in an allocation-concealed fashion to open
label treatment with either Ezetimibe 10 mg/d for additional LDL-lowering OR Extended-release
niacin (1 gm/d, titrated to max tolerable dose up to 2 gm/d) for HDL improvement.
The effects of these 2 different strategies of intensified lipid management on
atherosclerosis will be assessed by the change in the carotid intima-media thickness, a
validated surrogate endpoint. The data will help guide clinicians on the potential benefits
of these lipid treatment strategies.