ARBITER 6-HALTS Trial
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Click here to download slides for ARBITER 6 HALTS Trial.
Objective
To study the effects of extended-release niacin or ezetimibe added to statin monotherapy on carotid intima-media thickness.
Methods
Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6-HDL and LDL Treatment Strategies in Atherosclerosis (ARBITER 6-HALTS) trial was an open labeled randomized trial. The study subjects consisted of patients who had coronary artery disease or equivalent on long standing statin therapy with LDL cholesterol levels below 100 mg/dl and HDL cholesterol levels below 50 mg/dl for men and 55 mg/dl in women. The patients were randomly assigned to extended-release niacin (target dose 2000 mg) or ezetimibe (10 mg daily). The primary end point was a change in the carotid intima-media thickness from baseline in both study groups. This trial was terminated early because of side-effects of the drugs which affected compliance.
Results
- A significant increase in HDL levels, and a decrease in LDL and triglyceride levels was noted in the niacin group.
- Niacin group showed a significant change in terms of CMIT, leading to a reduction in both mean and maximal carotid intima-media thickness.
- A paradoxical increase in the CMIT was noted along with a reduction in LDL levels in the ezetimibe group. There was also a fall in both HDL and triglyceride levels.
Conclusion
Extended release niacin causes statistically significant reduction in the carotid intima-media thickness and is superior to ezetimibe.[1][2]
References
- ↑ Taylor AJ, Villines TC, Stanek EJ; et al. (2009). "Extended-release niacin or ezetimibe and carotid intima-media thickness". The New England Journal of Medicine. 361 (22): 2113–22. doi:10.1056/NEJMoa0907569. PMID 19915217. Unknown parameter
|month=ignored (help) - ↑ Villines TC, Stanek EJ, Devine PJ; et al. (2010). "The ARBITER 6-HALTS Trial (Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6-HDL and LDL Treatment Strategies in Atherosclerosis): final results and the impact of medication adherence, dose, and treatment duration". Journal of the American College of Cardiology. 55 (24): 2721–6. doi:10.1016/j.jacc.2010.03.017. PMID 20399059. Unknown parameter
|month=ignored (help)