See also:

ARBITER 6-HALTS (niacin vs ezetimibe) study, 2009	TRC10059
[NCT00397657]	download pdf: niacin | cholesterol lowering intervention for cardiovascular prevention

Treatments

Studied treatment	extended-release niacin 1 g/d, titrated to max tolerable dose up to 2 g/d (HDL-focused strategy)
Control treatment	ezetimibe 10 mg/d (LDL-focused strategy)

Patients

Patients

patients with known coronary or vascular disease or coronary risk equivalents

Method and design

Randomized effectives	97 / 111 (studied vs. control)
Design	Parallel groups
Blinding	open
Follow-up duration	14 months
Premature discontinuation	Premature discontinuation for futility
Number of centre	2
Geographic area	US
Primary endpoint	carotid intima-media thickness

Results

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

Coronary event

2 / 187
9 / 176
0,21 [0,05;0,95]

cardiovascular events

282 / 187
9 / 176
classic 29,49 [15,69;55,42] 0 2 1.0

Relative risks
Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
	Studied treat.	Control treat.
cardiovascular events	282 / 187 (150,8%)	9 / 176 (5,1%)	29,49	[15,69;55,42]		16313
Coronary event	2 / 187 (1,1%)	9 / 176 (5,1%)	0,21	[0,05;0,95]		16313
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 16313: Lavigne PM, Karas RHThe current state of niacin in cardiovascular disease prevention: a systematic review and meta-regression.J Am Coll Cardiol 2013 Jan 29;61:440-6

Endpoint	studied treat.	control treat.	mean diff

Absolute risk reduction (for a follow-up of 14 months)
Endpoint	Events rate		Absolute risk reduction (ARR)
	Studied treat.	Control treat.
cardiovascular events	150,80%	5,11%	145,7%
Coronary event	1,07%	5,11%	-4,04%

Meta-analysis of all similar trials:

cholesterol lowering intervention in cardiovascular prevention for all chronical situations

HDL increasing drugs in cardiovascular prevention for all type of patients

niacin in cardiovascular prevention for all type of patients

Reference(s)

TrialResults-center ID	TRC10059
Trials register #	NCT00397657

• Taylor AJ, Villines TC, Stanek EJ, Devine PJ, Griffen L, Miller M, Weissman NJ, Turco M. Extended-release niacin or ezetimibe and carotid intima-media thickness.. N Engl J Med 2009 Nov 26;361:2113-22
  Pubmed | Hubmed | Fulltext
• Villines TC, Stanek EJ, Devine PJ, Turco M, Miller M, Weissman NJ, Griffen L, Taylor AJ. 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.. J Am Coll Cardiol 2010 Apr 8;: - 10.1016/j.jacc.2010.03.017
  Pubmed | Hubmed | Fulltext

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