HDL raising with niacin superior to ezetimibe: ARBITER 6-HALTS

Extended-release niacin is superior to ezetimibe when combined with statins for the reduction of carotid intima-media thickness in patients with coronary heart disease, research presented at the American Heart Association 2009 scientific sessions shows. The Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6: HDL and LDL Treatment Strategies in Atherosclerosis (ARBITER 6-HALTS) trial included men and women with coronary heart disease or coronary-disease risk equivalents who were treated with statins for at least three months prior to randomisation. Participants had an LDL cholesterol level under 100mg/dL and an HDL level under 50mg/dL. Among the 363 patients enrolled in the study, half were randomised to ezetimibe (10 mg/daily), while the other half were randomised to extended-release niacin (2000 mg/daily). After 14 months of treatment, mean HDL-cholesterol levels among the niacin-treated patients increased 18.4% to 50 mg/dL. In the ezetimibe arm, LDL-cholesterol levels further declined 19.2% to 66 mg/dL. Compared with ezetimibe, treatment with niacin resulted in significantly larger changes in the mean and maximal carotid IMT over 14 months (p=0.003). Paradoxically, the study authors found greater reductions in the LDL cholesterol level with ezetimibe were significantly associated with an increase in the carotid intima media thickness. Although not powered for clinical outcomes, there were more major cardiovascular events in the ezetimibe arm compared with those in the niacin arm (nine events vs two events, respectively; p=0.04). The trial was halted early, on the basis of efficacy, after 208 patients had completed the trial. In an accompanying editorial Dr John Kastelein (Academic Medical Centre, Amsterdam, the Netherlands) and Dr Michel Bots (University Medical Centre, Utrecht, the Netherlands) said that despite the limitations of trial, the primary results are likely to be correct, although the magnitude of the difference between the arms may be overestimated. "Together, the results available to date provide support for the concept that the use of statins to reduce LDL to target levels with the subsequent addition of a drug to raise HDL-cholesterol levels (niacin), rather than a drug to lower LDL-cholesterol levels (ezetimibe), is a more effective treatment for patients at high cardiovascular risk," they concluded. New Engl J Med 2009; published online before print...