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ARBITER 6-HALTS: Niacin superior to ezetimibe

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American Heart Association Scientific Sessions 2009

Extended-release niacin was superior to ezetimibe when combined with statins for the reduction of carotid intima-media thickness in patients with coronary heart disease, according to the anticipated ARBITER 6-HALTS results.

Researchers for the Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6-HDL and LDL Treatment Strategies (ARBITER 6-HALTS) enrolled 363 patients in the trial, with data on 208 patients included in the final analysis. The ARBITER 6-HALTS trial was prematurely terminated after an interim analysis showed that niacin was superior to ezetimibe for the reduction of carotid intima-media thickness. The primary study endpoint was the between-group difference in the change from baseline in the mean common carotid intima-media thickness.

According to the study results, the mean HDL level increased by 18.4% during the 14-month study period (P<.001) and mean LDL decreased in the ezetimibe group decreased by 19.2% (P<.001). Niacin was more efficacious than ezetimibe for the change in carotid intima-media thickness over the study period (P=.003). The researchers reported that niacin therapy caused a reduction in the mean and the maximal carotid intima-media thickness at both eight and 14 months, while no significant net changes in carotid intima-media thickness were reported in the ezetimibe group. They also reported that greater reductions in LDL in the ezetimibe group were associated with increased carotid intima-media thickness (P<.001).

“This study establishes combination therapy with statin-niacin is superior to statin-ezetimibe,” Alan J. Taylor, MD, co-director of noninvasive imaging at Washington Hospital Center, said in a press conference. “Prudent clinical practice presently favors avoidance of ezetimibe because its net effect on clinical outcomes is unknown and its relative effectiveness is known to be inferior.” – by Eric Raible

For more information:

• Taylor A. LBCTII #112. Presented at: American Heart Association Scientific Sessions; Nov. 14-18, 2009; Orlando, Fla.

A post hoc analysis revealed that large reductions in LDL conferred by ezetimibe were associated with an increase in carotid intima-media artery thickness. Post hoc analyses should only be performed with appropriate statistical modeling. Multivariable models are preferable above univariable correlation coefficients. An analysis for interaction should be provided to support that the reported relations were indeed different beyond chance. Published data on the relationship between the change in LDL and carotid intima-media thickness reported in the SANDS trial are at variance with the post hoc analysis presented for ARBITER 6-HALTS. The results of ARBITER 6-HALTS and a number of other clinical trials support the concept that the use of statins to reduce LDL to target and the subsequent addition of extended-release niacin (LD- lowering plus HDL-increasing), as compared with ezetimibe (only LD- lowering), will provide more effective treatment of the high-risk patient.

– John J.P. Kastelein, MD, PhD

Professor of Medicine

Academic Medical Centre, University of Amsterdam