Related trials
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AIM-HIGH, 2011 - niacin vs placebo (on top statin)
dal-VESSEL, 2011 - dalcetrapib vs placebo
ACCORD lipid, 2010 - fenofibrate vs placebo (on top simvastatine)
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Emmerich, 2009 - etofibrate vs placebo
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ARBITER 2, 2009 - niacin vs placebo (on top statin)
ILLUMINATE, 2007 - torcetrapib vs placebo (on top of atorvastatin)
RADIANCE 1, 2007 - torcetrapib vs placebo (on top of atorvastatin)
ILLUSTRATE, 2007 - torcetrapib vs placebo (on top of atorvastatin)
RADIANCE 2, 2007 - torcetrapib vs placebo (on top of atorvastatin)
FIELD, 2005 - fenofibrate vs placebo
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BIP, 2000 - bezafibrate vs placebo
VA-HIT, 1999 - gemfibrozil vs placebo
SENDCAP, 1998 - bezafibrate vs placebo
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HHS (Frick)(secondary prev subgroup), 1993 - gemfibrozil vs placebo
Hanefeld, 1991 - clofibrate vs placebo
See also:
All cardiovascular prevention clinical trials
All clinical trials of HDL increasing drugs
All clinical trials of torcetrapib
|
|
Treatments
Studied treatment |
torcetrapib 60mg daily plus atorvastatin (at a dose established during the runin
period)
|
Control treatment |
atorvastatin alone
|
Patients
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 |
|
Studied treat. |
Control treat. |
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
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
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 |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction (for a follow-up of 1.52y)
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
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
|
-
Barter PJ, Caulfield M, Eriksson M, Grundy SM, Kastelein JJ, Komajda M, Lopez-Sendon J, Mosca L, Tardif JC, Waters DD, Shear CL, Revkin JH, Buhr KA, Fisher MR, Tall AR, Brewer B.
Effects of torcetrapib in patients at high risk for coronary events..
N Engl J Med 2007 Nov 22;357:2109-22
- 10.1056/NEJMoa0706628
Pubmed
|
Hubmed
| Fulltext
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