ILLUMINATE trial

ILLUMINATE study, 2007	TRC9362
[NCT00134264]	download pdf: torcetrapib \| CEPT inhibition for cardiovascular prevention

Treatments

Studied treatment	torcetrapib 60mg daily plus atorvastatin (at a dose established during the runin period)
Control treatment	atorvastatin alone

Patients

patients at high cardiovascular risk

Method and design

Randomized effectives	7533 / 7534 (studied vs. control)
Design	Parallel groups
Blinding	double blind
Follow-up duration	1.52y
Number of centre	260
Geographic area	7 countries
Primary endpoint	MACE

Results

Endpoints and data reported in the trial's publication(s)

Endpoint	Events (%)		Relative Risk	95% CI
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI
Primary composite outcome	464 / 7533 (6,2%)	373 / 7534 (5,0%)	1,24	[1,09;1,42]
Death from coronary heart disease	40 / 7533 (0,5%)	33 / 7534 (0,4%)	1,21	[0,77;1,92]
Nonfatal myocardial infarction	142 / 7533 (1,9%)	118 / 7534 (1,6%)	1,20	[0,94;1,53]
Stroke	43 / 7533 (0,6%)	40 / 7534 (0,5%)	1,08	[0,70;1,65]
Hospitalization for unstable angina	270 / 7533 (3,6%)	201 / 7534 (2,7%)	1,34	[1,12;1,61]
Death from any cause	93 / 7533 (1,2%)	59 / 7534 (0,8%)	1,58	[1,14;2,18]
Composite of death from coronary heart disease, nonfatal myocardial infarction, and stroke§	214 / 7533 (2,8%)	185 / 7534 (2,5%)	1,16	[0,95;1,40]
Hemorrhagic Stroke	5 / 7533 (0,1%)	2 / 7534 (0,0%)	2,50	[0,49;12,88]
Ischemic Stroke	31 / 7533 (0,4%)	30 / 7534 (0,4%)	1,03	[0,63;1,71]
Embolic Stroke	7 / 7533 (0,1%)	9 / 7534 (0,1%)	0,78	[0,29;2,09]
Not classified Stroke	0 / 7533 (0,0%)	0 / 7534 (0,0%)	1,00	[0,02;50,40]
Coronary revascularization procedure	505 / 7533 (6,7%)	403 / 7534 (5,3%)	1,25	[1,10;1,42]
Peripheral vascular disease¶	110 / 7533 (1,5%)	159 / 7534 (2,1%)	0,69	[0,54;0,88]
Transient ischemic attack	23 / 7533 (0,3%)	13 / 7534 (0,2%)	1,77	[0,90;3,49]
Hospitalization with primary diagnosis of congestive heart failure	84 / 7533 (1,1%)	50 / 7534 (0,7%)	1,68	[1,19;2,38]
Major coronary event	179 / 7533 (2,4%)	147 / 7534 (2,0%)	1,22	[0,98;1,51]
Major cardiovascular event and coronary revascularization procedure	738 / 7533 (9,8%)	589 / 7534 (7,8%)	1,25	[1,13;1,39]
Major cardiovascular event, coronary revascularization pro-cedure, and peripheral vascular disease	820 / 7533 (10,9%)	723 / 7534 (9,6%)	1,13	[1,03;1,25]
Stroke and transient ischemic attack	65 / 7533 (0,9%)	53 / 7534 (0,7%)	1,23	[0,85;1,76]
Major coronary event, stroke, and transient ischemic attack	234 / 7533 (3,1%)	197 / 7534 (2,6%)	1,19	[0,99;1,43]
Procedure-related myocardial infarction	11 / 7533 (0,1%)	8 / 7534 (0,1%)	1,38	[0,55;3,42]
Any cardiovascular cause	49 / 7533 (0,7%)	35 / 7534 (0,5%)	1,40	[0,91;2,16]
Sudden death	26 / 7533 (0,3%)	25 / 7534 (0,3%)	1,04	[0,60;1,80]
Fatal myocardial infarction (not procedure-related)	8 / 7533 (0,1%)	6 / 7534 (0,1%)	1,33	[0,46;3,84]
Hemorrhagic Fatal stroke	4 / 7533 (0,1%)	0 / 7534 (0,0%)	8,00	[0,42;151,32]
Ischemic Fatal stroke	2 / 7533 (0,0%)	0 / 7534 (0,0%)	4,00	[0,18;88,70]
Embolic Fatal stroke	0 / 7533 (0,0%)	0 / 7534 (0,0%)	1,00	[0,02;50,40]
Not classified Fatal stroke	0 / 7533 (0,0%)	0 / 7534 (0,0%)	1,00	[0,02;50,40]
Fatal heart failure	2 / 7533 (0,0%)	1 / 7534 (0,0%)	2,00	[0,18;22,06]
Other vascular-related cause	1 / 7533 (0,0%)	2 / 7534 (0,0%)	0,50	[0,05;5,51]
Fatal myocardial infarction (procedure-related)	2 / 7533 (0,0%)	0 / 7534 (0,0%)	4,00	[0,18;88,70]
Other cardiac-related cause	4 / 7533 (0,1%)	1 / 7534 (0,0%)	4,00	[0,45;35,79]
death from Any noncardiovascular cause	40 / 7533 (0,5%)	20 / 7534 (0,3%)	2,00	[1,17;3,42]
death from Cancer	24 / 7533 (0,3%)	14 / 7534 (0,2%)	1,71	[0,89;3,31]
death from Infection	9 / 7533 (0,1%)	0 / 7534 (0,0%)	18,00	[1,04;310,49]
death from Trauma	3 / 7533 (0,0%)	3 / 7534 (0,0%)	1,00	[0,20;4,95]
Suicide or homicide	0 / 7533 (0,0%)	1 / 7534 (0,0%)	0,50	[0,02;14,90]
Odeath from ther cause	4 / 7533 (0,1%)	2 / 7534 (0,0%)	2,00	[0,37;10,92]
Reason unknown death	4 / 7533 (0,1%)	4 / 7534 (0,1%)	1,00	[0,25;4,00]

Endpoints used by the meta-analysis and data retained for this trial

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

Coronary revascularization

505 / 7533
403 / 7534
1,25 [1,10;1,42]

stroke (fatal and non fatal)

43 / 7533
40 / 7534
1,08 [0,70;1,65]

Non fatal MI

142 / 7533
118 / 7534
1,20 [0,94;1,53]

Coronary event

179 / 7533
147 / 7534
1,22 [0,98;1,51]

Cardiovascular death

49 / 7533
35 / 7534
classic 1,40 [0,91;2,16]

All cause death

93 / 7533
59 / 7534
classic 1,58 [1,14;2,18]

cardiovascular events

214 / 7533
185 / 7534
1,16 [0,95;1,40]

Coronary death

40 / 7533
33 / 7534
1,21 [0,77;1,92] 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
All cause death	93 / 7533 (1,2%)	59 / 7534 (0,8%)	1,58	[1,14;2,18]	Death from any cause
Non fatal MI	142 / 7533 (1,9%)	118 / 7534 (1,6%)	1,20	[0,94;1,53]	Nonfatal myocardial infarction
cardiovascular events	214 / 7533 (2,8%)	185 / 7534 (2,5%)	1,16	[0,95;1,40]	Composite of death from coronary heart disease, nonfatal myocardial infarction, and stroke§
Coronary death	40 / 7533 (0,5%)	33 / 7534 (0,4%)	1,21	[0,77;1,92]	Death from coronary heart disease
Cardiovascular death	49 / 7533 (0,7%)	35 / 7534 (0,5%)	1,40	[0,91;2,16]	Any cardiovascular cause
stroke (fatal and non fatal)	43 / 7533 (0,6%)	40 / 7534 (0,5%)	1,08	[0,70;1,65]	Stroke
Coronary revascularization	505 / 7533 (6,7%)	403 / 7534 (5,3%)	1,25	[1,10;1,42]	Coronary revascularization procedure
Coronary event	179 / 7533 (2,4%)	147 / 7534 (2,0%)	1,22	[0,98;1,51]	Major coronary event
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction:

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction (for a follow-up of 1.52y)
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
All cause death	1,23%	7,83‰	0,45%
Non fatal MI	1,89%	1,57%	0,32%
cardiovascular events	2,84%	2,46%	0,39%
Coronary death	5,31‰	4,38‰	0,09%
Cardiovascular death	6,50‰	4,65‰	0,19%
stroke (fatal and non fatal)	5,71‰	5,31‰	0,04%
Coronary revascularization	6,70%	5,35%	1,4%
Coronary event	2,38%	1,95%	0,43%

Meta-analysis of all similar trials:

CEPT inhibition in cardiovascular prevention for all type of patients

HDL increasing drugs in cardiovascular prevention for all type of patients

Reference(s)

TrialResults-center ID	TRC9362
Trials register #	NCT00134264