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{{CMG}}
{{CMG}}
==ARBITER 6-HALTS Trial==
 
===Objective===
'''Click [[media:ARBITER_6-HALTS_Trial.ppt|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]].
To study the effects of extended-release [[niacin]] or [[ezetimibe]] added to [[statin]] monotherapy on [[carotid intima-media thickness]].


===Methods===
==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.
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===
==Results==
* A significant increase in [[HDL]] levels, and a decrease in [[LDL]] and [[triglyceride]] levels was noted in the [[niacin]] group.
* 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.
* [[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.
* 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===
==Conclusion==
Extended release [[niacin]] causes statistically significant reduction in the [[carotid intima-media thickness]] and is superior to [[ezetimibe]].<ref name="pmid19915217">{{cite journal |author=Taylor AJ, Villines TC, Stanek EJ, ''et al.'' |title=Extended-release niacin or ezetimibe and carotid intima-media thickness |journal=[[The New England Journal of Medicine]] |volume=361 |issue=22 |pages=2113–22 |year=2009 |month=November|pmid=19915217 |doi=10.1056/NEJMoa0907569 |url=}}</ref><ref name="pmid20399059">{{cite journal |author=Villines TC, Stanek EJ, Devine PJ, ''et al.'' |title=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=[[Journal of the American College of Cardiology]]|volume=55 |issue=24 |pages=2721–6 |year=2010 |month=June |pmid=20399059 |doi=10.1016/j.jacc.2010.03.017 |url=}}</ref>
Extended release [[niacin]] causes statistically significant reduction in the [[carotid intima-media thickness]] and is superior to [[ezetimibe]].<ref name="pmid19915217">{{cite journal |author=Taylor AJ, Villines TC, Stanek EJ, ''et al.'' |title=Extended-release niacin or ezetimibe and carotid intima-media thickness |journal=[[The New England Journal of Medicine]] |volume=361 |issue=22 |pages=2113–22 |year=2009 |month=November|pmid=19915217 |doi=10.1056/NEJMoa0907569 |url=}}</ref><ref name="pmid20399059">{{cite journal |author=Villines TC, Stanek EJ, Devine PJ, ''et al.'' |title=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=[[Journal of the American College of Cardiology]]|volume=55 |issue=24 |pages=2721–6 |year=2010 |month=June |pmid=20399059 |doi=10.1016/j.jacc.2010.03.017 |url=}}</ref>


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[[Category:Lipopedia]]
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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

  1. ↑ 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)
  2. ↑ 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)
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