AIM-HIGH trial

AIM-HIGH study, 2011	TRC9754
[NCT00120289]	download pdf: niacin \| cholesterol lowering intervention for cardiovascular prevention

Treatments

Studied treatment	high-dose, extended-release niacin in gradually increasing doses up to 2000 mg daily (+ simvastatin) high-dose extended-release niacin (Niaspan) given in addition to statin therapy
Control treatment	placebo
Concomittant treatment	simvastatin (and ezetimibe, in order to maintain LDL-cholesterol levels at the target range between 40 and 80 mg/dL)

Patients

patients with a history of cardiovascular disease, high triglycerides, and low levels of HDL cholesterol

Inclusion criteria

men and women; >=45 years old; with established vascular disease and atherogenic dyslipidemia; established vascular disease defined as one or more of the following: (1) documented coronary artery disease (CAD); (2) documented cerebrovascular or carotid disease; (3) documented symptomatic peripheral arterial disease (PAD) Atherogenic dyslipidemia defined as: (1) LDL-C of less than or equal to 160 mg/dL (4.1 mmol/L); (2) HDL-C of less than or equal to 40 mg/dL (1.0 mmol/L) for men or less than or equal to 50 mg/dL (1.3 mmol/L) for women; (3) TG greater than or equal to 150 mg/dL (1.7 mmol/L) and less than or equal to 400 mg/dL (4.5 mmol/L) For patients entering the trial on a statin: (1) the upper limit for LDL-C is adjusted according to the specific statin and statin dose; (2) HDL-C of less than or equal to 42 mg/dL (1.1 mmol/L) for men or less than or equal to 53 mg/dL (1.4 mmol/L) for women; (3) TG greater than or equal to 125 mg/dL (1.4 mmol/L) and less than or equal to 400 mg/DL (4.5 mmol/L)

Method and design

Randomized effectives	1718 / 1691 (studied vs. control)
Design	Parallel groups
Blinding	double blind
Follow-up duration	32 months
Premature discontinuation	Premature discontinuation for futility
Geographic area	US, Canada
Hypothesis	Superiority
Primary endpoint	CHD death, MI, ischaemic stroke, NSTEMI

Results

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

Coronary event

112 / 1718
106 / 1691
1,04 [0,80;1,34]

cardiovascular events

282 / 1718
274 / 1696
1,02 [0,87;1,18]

stroke (fatal and non fatal)

27 / 1718
15 / 1696
classic 1,78 [0,95;3,33] 0 2 1.0

Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
Relative risks
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI	Endpoint definition in the trial	Ref
cardiovascular events	282 / 1718 (16,4%)	274 / 1696 (16,2%)	1,02	[0,87;1,18]		16313
stroke (fatal and non fatal)	27 / 1718 (1,6%)	15 / 1696 (0,9%)	1,78	[0,95;3,33]		16313
Coronary event	112 / 1718 (6,5%)	106 / 1691 (6,3%)	1,04	[0,80;1,34]		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	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction (for a follow-up of 32 months)
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
cardiovascular events	16,41%	16,16%	0,26%
stroke (fatal and non fatal)	1,57%	8,84‰	0,69%
Coronary event	6,52%	6,27%	0,25%

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	TRC9754
Trials register #	NCT00120289