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See also:
All cardiovascular prevention clinical trials
All clinical trials of HDL increasing drugs
All clinical trials of bezafibrate
|
|
Treatments
Studied treatment |
bezafibrate 400 mg daily
|
Control treatment |
placebo
|
Patients
Patients |
men with lower extremity arterial disease |
Inclusion criteria |
NA |
Exclusion criteria |
NA |
Baseline characteristics |
Age (mean), yrs |
68 |
Women (%) |
0% |
prior MI or CHD (%) |
45 |
Total cholesterol (mmol/l) |
7.1 mmol/L |
Diabetes(%) |
66% |
|
Method and design
Randomized effectives |
783 / 785 (studied vs. control) |
Design |
Parallel groups |
Blinding |
double-blind |
Follow-up duration |
4.6y |
Number of centre |
85 |
Geographic area |
UK |
Hypothesis |
Superiority |
Primary endpoint |
CHD, stroke |
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
Coronary event
90 / 783
111 / 785
0,81 [0,63;1,05]
All cause death
204 / 783
195 / 785
1,05 [0,89;1,24]
cardiovascular events
150 / 783
160 / 785
0,94 [0,77;1,15]
cardiac death
127 / 783
121 / 785
1,05 [0,84;1,32]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
Coronary event
|
90 / 783 (11,5%) |
111 / 785 (14,1%) |
0,81 |
[0,63;1,05] |
|
12545 |
All cause death
|
204 / 783 (26,1%) |
195 / 785 (24,8%) |
1,05 |
[0,89;1,24] |
|
|
cardiovascular events
|
150 / 783 (19,2%) |
160 / 785 (20,4%) |
0,94 |
[0,77;1,15] |
|
12545 |
cardiac death
|
127 / 783 (16,2%) |
121 / 785 (15,4%) |
1,05 |
[0,84;1,32] |
|
|
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
12545: Jun M, Foote C, Lv J, Neal B, Patel A, Nicholls SJ, Grobbee DE, Cass A, Chalmers J, Perkovic VEffects of fibrates on cardiovascular outcomes: a systematic review and meta-analysis.Lancet 2010 May 10;:
0:
|
Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction (for a follow-up of 4.6y)
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
Coronary event |
11,49% |
14,14% |
-2,65%
|
All cause death |
26,05% |
24,84% |
1,2%
|
cardiovascular events |
19,16% |
20,38% |
-1,23%
|
cardiac death |
16,22% |
15,41% |
0,81%
|
Meta-analysis of all similar trials:
cholesterol lowering intervention in cardiovascular prevention for patients with other atherosclerotic localisation
cholesterol lowering intervention in cardiovascular prevention for all chronical situations
HDL increasing drugs in cardiovascular prevention for all type of patients
Reference(s)
TrialResults-center ID |
TRC8164
|
Trials register # |
NA
|
-
Meade T, Zuhrie R, Cook C, Cooper J.
Bezafibrate in men with lower extremity arterial disease: randomised controlled trial..
BMJ 2002;325:1139
Pubmed
|
Hubmed
| Fulltext
|