Related trials
ACCELERATE, 2015 - evacetrapib vs placebo
IMPROVE-IT, 2014 - ezetimibe vs control
dal-OUTCOMES, 2012 - dalcetrapib vs placebo
dal-VESSEL, 2011 - dalcetrapib vs placebo
AIM-HIGH, 2011 - niacin vs placebo (on top statin)
SEARCH, 2010 - simvastatin high dose vs simvastatin
ACCORD lipid, 2010 - fenofibrate vs placebo (on top simvastatine)
DEFINE, 2010 - anacetrapib vs placebo
SHARP, 2010 - ezetimibe+simvastatin vs placebo
ARBITER-HALTS 6, 2010 - ezetimibe vs niacin
ARBITER 2, 2009 - niacin vs placebo (on top statin)
Oxford Niaspan Study, 2009 - niacin vs placebo (on top statin)
Emmerich, 2009 - etofibrate vs placebo
ARBITER 6-HALTS (niacin vs ezetimibe), 2009 - niacin vs ezetimibe
SANDS, 2008 - aggressive treatment vs standard teatment
Tuttle, 2008 - low fat diet vs mediterranean-style diet
Guyton, 2008 - niacin+ezetimibe vs simvastatin+ezetimibe
GISSI-HF rosuvastatine, 2008 - rosuvastatin vs placebo
JUPITER, 2008 - rosuvastatin vs placebo
SAGE, 2007 - atorvastatin high dose vs pravastatin
RADIANCE 2, 2007 - torcetrapib vs placebo (on top of atorvastatin)
Krum, 2007 - rosuvastatin vs placebo
ILLUMINATE, 2007 - torcetrapib vs placebo (on top of atorvastatin)
CORONA, 2007 - rosuvastatin vs placebo
METEOR, 2007 - rosuvastatin vs placebo
See also:
All cardiovascular prevention clinical trials
All clinical trials of niacin
All clinical trials of niacin
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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%
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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
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Hubmed
| Fulltext
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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
|