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See also:
All cardiovascular prevention clinical trials
All clinical trials of niacin
All clinical trials of niacin
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Treatments
Studied treatment |
niacin 2g daily (added to statin therapy)
|
Control treatment |
placebo (statins alone)
|
Concomittant treatment |
statin therapy |
Patients
Patients |
patients with low HDL-C (<40 mg/dl) and either a type 2 diabetes with coronary heart disease or a carotid/peripheral atherosclerosis |
Inclusion criteria |
1) HDL-C <40 mg/dl in the previous 12
months together with either: 2a) carotid atherosclerosis
(30% to 70% stenosis identified using carotid ultrasound);
2b) peripheral arterial disease (ankle-brachial pressure index
<0.9); or 2c) type 2 diabetes with coronary artery disease
(>50% stenosis of major epicardial vessel at angiography).
There was no specific LDL-C inclusion criterion, but all
patients were already taking statins |
Exclusion criteria |
contraindications to MRI or to NA (e.g., elevated liver enzymes or known intolerance); severe carotid stenosis (>70%); existing treatment with fibrates, nicorandil, or oral nitrates; recent acute coronary syndrome; uncontrolled diabetes; fasting triglyceride level >500 mg/dl; active peptic ulcer disease; and cardiac failure requiring diuretic treatment |
Baseline characteristics |
Male (%) |
94% |
Age (years) |
65y |
Diabetes (%) |
64% |
|
Method and design
Randomized effectives |
35 / 36 (studied vs. control) |
Design |
Parallel groups |
Blinding |
double blind |
Follow-up duration |
1 year |
Number of centre |
single-center |
Geographic area |
USA |
Hypothesis |
Superiority |
Primary endpoint |
carotid artery wall area |
Results
No results available for this trial
- no clinical endpoint reported
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 |
TRC10051
|
Trials register # |
NCT00232531
|
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Lee JM, Robson MD, Yu LM, Shirodaria CC, Cunnington C, Kylintireas I, Digby JE, Bannister T, Handa A, Wiesmann F, Durrington PN, Channon KM, Neubauer S, Choudhury RP.
Effects of high-dose modified-release nicotinic Acid on atherosclerosis and vascular function a randomized, placebo-controlled, magnetic resonance imaging study..
J Am Coll Cardiol 2009;54:1787-94
Pubmed
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Hubmed
| Fulltext
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