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See also:
All cardiovascular prevention clinical trials
All post myocardial infarction clinical trials
All clinical trials of HDL increasing drugs
All clinical trials of bezafibrate
|
|
Treatments
Studied treatment |
bezafibrate 400 mg/d
|
Control treatment |
placebo
|
Concomittant treatment |
R�gime; colestipol � 165 patients (57 dans le groupe bezafibrate et 107 dans le groupe contr�le) |
Patients
Patients |
patients with a previous myocardial infarction or stable angina, total cholesterol of 180 to 250 mg/dL, HDL-C < or =45 mg/dL, triglycerides < or =300 mg/dL, and low-density lipoprotein cholesterol < or =180 mg/dL |
Inclusion criteria |
age of 45 to 74 years, history of MI >=6 months but <5 years before enrollment into the study and/or stable angina pectoris confirmed by coronary angiography, and/or radionuclear studies or standard exercise tests; serum total cholesterol between 180 to 250 mg/dL, LDL-C <=180 mg/dL (>=160 mg/dL for patients ,50 years), HDL-C <=45 mg/dL, and triglycerides <=300 mg/dL |
Exclusion criteria |
insulin-dependent diabetes mellitus, severe heart failure, unstable angina pectoris, hepatic or renal failure, known sensitivity to bezafibrate, or current use of lipid-modifying drugs |
Baseline characteristics |
Age (mean), yrs |
60 |
Women (%) |
9 |
prior MI or CHD (%) |
100 |
Total cholesterol (mmol/l) |
5.5 mmol/L |
LDL (mmol/l) |
3.84 mmol/L |
HDL (mmol/l) |
0.89 mmol/L |
Triglycerides (mg/dl) |
145 |
Diabetes(%) |
10% |
BMI (kg/m2) |
26.7 |
Stroke history |
1% |
History of hypertension (%) |
32% |
|
Method and design
Randomized effectives |
1548 / 1542 (studied vs. control) |
Design |
Parallel groups |
Blinding |
double blind |
Follow-up duration |
6.2 y |
Number of centre |
multicentre |
Geographic area |
Israel |
Hypothesis |
Superiority |
Primary endpoint |
IDM fatal ou non fatal ou d�c�s coronarien |
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
Coronary event
211 / 1548
232 / 1542
0,91 [0,76;1,08]
All cause death
161 / 1548
152 / 1542
1,06 [0,86;1,30]
Coronary death
61 / 1548
60 / 1542
1,01 [0,71;1,44]
stroke (fatal and non fatal)
72 / 1548
77 / 1542
0,93 [0,68;1,27]
MACE
522 / 1548
559 / 1542
0,93 [0,84;1,02]
Non fatal MI
150 / 1548
172 / 1542
0,87 [0,71;1,07]
Coronary death and non fatal MI
211 / 1548
232 / 1542
0,91 [0,76;1,08]
cardiac death
61 / 1548
60 / 1542
1,01 [0,71;1,44]
non cardiovascular death
66 / 1548
64 / 1542
1,03 [0,73;1,44]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
Coronary event
|
211 / 1548 (13,6%) |
232 / 1542 (15,0%) |
0,91 |
[0,76;1,08] |
|
0 |
All cause death
|
161 / 1548 (10,4%) |
152 / 1542 (9,9%) |
1,06 |
[0,86;1,30] |
|
|
Coronary death
|
61 / 1548 (3,9%) |
60 / 1542 (3,9%) |
1,01 |
[0,71;1,44] |
|
|
stroke (fatal and non fatal)
|
72 / 1548 (4,7%) |
77 / 1542 (5,0%) |
0,93 |
[0,68;1,27] |
|
|
MACE
|
522 / 1548 (33,7%) |
559 / 1542 (36,3%) |
0,93 |
[0,84;1,02] |
cardiac events + revasc |
1750 |
Non fatal MI
|
150 / 1548 (9,7%) |
172 / 1542 (11,2%) |
0,87 |
[0,71;1,07] |
|
|
Coronary death and non fatal MI
|
211 / 1548 (13,6%) |
232 / 1542 (15,0%) |
0,91 |
[0,76;1,08] |
|
1750 |
cardiac death
|
61 / 1548 (3,9%) |
60 / 1542 (3,9%) |
1,01 |
[0,71;1,44] |
|
|
non cardiovascular death
|
66 / 1548 (4,3%) |
64 / 1542 (4,2%) |
1,03 |
[0,73;1,44] |
noncardiac death |
1750 |
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
0:
1750: ,Secondary prevention by raising HDL cholesterol and reducing triglycerides in patients with coronary artery disease: the Bezafibrate Infarction Prevention (BIP) study.Circulation 2000; 102:21-7
|
Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction (for a follow-up of 6.2 y)
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
Coronary event |
13,63% |
15,05% |
-1,41%
|
All cause death |
10,40% |
9,86% |
0,54%
|
Coronary death |
3,94% |
3,89% |
0,05%
|
stroke (fatal and non fatal) |
4,65% |
4,99% |
-0,34%
|
MACE |
33,72% |
36,25% |
-2,53%
|
Non fatal MI |
9,69% |
11,15% |
-1,46%
|
Coronary death and non fatal MI |
13,63% |
15,05% |
-1,41%
|
cardiac death |
3,94% |
3,89% |
0,05%
|
non cardiovascular death |
4,26% |
4,15% |
0,11%
|
Meta-analysis of all similar trials:
cholesterol lowering intervention in cardiovascular prevention for all chronical situations
cholesterol lowering intervention in post myocardial infarction for all type of patients
HDL increasing drugs in cardiovascular prevention for all type of patients
Reference(s)
TrialResults-center ID |
TRC2584
|
Trials register # |
NA
|
-
,.
Secondary prevention by raising HDL cholesterol and reducing triglycerides in patients with coronary artery disease: the Bezafibrate Infarction Prevention (BIP) study..
Circulation 2000; 102:21-7
Pubmed
|
Hubmed
| Fulltext
-
Goldenberg I, Boyko V, Tennenbaum A, Tanne D, Behar S, Guetta V.
Long-term benefit of high-density lipoprotein cholesterol-raising therapy with bezafibrate: 16-year mortality follow-up of the bezafibrate infarction prevention trial..
Arch Intern Med 2009;169:508-14
Pubmed
|
Hubmed
| Fulltext
|