| pathology | Demonstrated benefit and harm | k | | | |
|---|
| cardiovascular prevention | versus placebo or control No demonstrated result for efficacy | 5 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| bezafibrate vs placebo | | | | | BECAIT, 1996 | bezafibrate vs placebo | coronary events 0.25 [0.08; 0.84] CV events (including revascularization) 0.26 [0.08; 0.88] | | all cause deaths ∞ [NaN; ∞] coronary deaths ∞ [NaN; ∞] cardiac death NaN [NaN; NaN] non cardiovascular death NaN [NaN; NaN] incident diabetes 0.57 [0.15; 2.26] | | BIP, 2000 | bezafibrate vs placebo | | | Pancreatitis 1.00 [0.32; 3.08] all cause deaths 1.06 [0.86; 1.30] coronary deaths 1.01 [0.71; 1.44] coronary events 0.91 [0.76; 1.08] CV events (including revascularization) 0.93 [0.84; 1.02] MI non fatal 0.87 [0.71; 1.07] stroke (fatal et non fatal) 0.93 [0.68; 1.27] cardiac death 1.01 [0.71; 1.44] Infarctus non mortel et décès coronariens 0.91 [0.76; 1.08] non cardiovascular death 1.03 [0.73; 1.44] | | SENDCAP, 1998 | bezafibrate vs placebo | coronary events 0.36 [0.15; 0.87] | | all cause deaths 0.00 [0.00; NaN] cardiac death NaN [NaN; NaN] | | LEADER, 2002 | bezafibrate vs placebo | | | all cause deaths 1.05 [0.89; 1.24] coronary events 0.81 [0.63; 1.05] cardiac death 1.05 [0.84; 1.32] cardiovascular events 0.94 [0.77; 1.15] |
| Trial | Treatments | Patients | Method |
|---|
| LEADER trial, 2000 | Bezafibrate: 400 mg/ jour pour les hommes avec créatininémie < 135 micromole/litre (n=783) vs. placebo de même aspect (n=785) | Stade de la maladie : II. | Double aveugle Parallel groups Sample size: 783/785 Primary endpoint: évts coronariens et AVC FU duration: 5 ans 85 praticiens généralistes et 9 hôpitaux ont participé à l'essai.
Si la crétininémie atteint 155 micro mole/l et jusqu'à 170micromole/l, les pts du gpe ttt passent à un ttt de 1j/2. Au delà, de cette valeur, un arrêt de ttt est décidé pour le patient qqe soit son ttt. | | BECAIT, 1996 | bezafibrate 200 mg three times daily (n=47) vs. placebo (n=45)
| dyslipidaemic male survivors of myocardial infarction who were younger than 45 years at the time of the event
| double blind Parallel groups Sample size: 47/45 Primary endpoint: change in mean minimum lumen diameter FU duration: 5.0 years
| | BIP, 2000 | bezafibrate 400 mg/d (n=1548) vs. placebo (n=1542) | 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 | double blind Parallel groups Sample size: 1548/1542 Primary endpoint: IDM fatal ou non fatal ou décès coronarien FU duration: 6.2 y | | SENDCAP, 1998 | bezafibrate 400 mg daily (n=81) vs. placebo (n=83) | type 2 diabetic subjects without a history of clinical cardiovascular | double blind Parallel groups Sample size: 81/83 Primary endpoint: B-mode ultrasound FU duration: 3.0 years | | LEADER, 2002 | bezafibrate 400 mg daily (n=783) vs. placebo (n=785) | men with lower extremity arterial disease | double-blind Parallel groups Sample size: 783/785 Primary endpoint: CHD, stroke FU duration: 4.6y |
|
| peripheral vascular diseases | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| bezafibrate vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| LEADER trial, 2000 | Bezafibrate: 400 mg/ jour pour les hommes avec créatininémie < 135 micromole/litre (n=783) vs. placebo de même aspect (n=785) | Stade de la maladie : II. | Double aveugle Parallel groups Sample size: 783/785 Primary endpoint: évts coronariens et AVC FU duration: 5 ans 85 praticiens généralistes et 9 hôpitaux ont participé à l'essai.
Si la crétininémie atteint 155 micro mole/l et jusqu'à 170micromole/l, les pts du gpe ttt passent à un ttt de 1j/2. Au delà, de cette valeur, un arrêt de ttt est décidé pour le patient qqe soit son ttt. |
|
| post myocardial infarction | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| BECAIT, 1996 | bezafibrate vs placebo | coronary events 0.25 [0.08; 0.84] CV events (including revascularization) 0.26 [0.08; 0.88] | | all cause deaths ∞ [NaN; ∞] coronary deaths ∞ [NaN; ∞] cardiac death NaN [NaN; NaN] non cardiovascular death NaN [NaN; NaN] incident diabetes 0.57 [0.15; 2.26] | | BIP, 2000 | bezafibrate vs placebo | | | Pancreatitis 1.00 [0.32; 3.08] all cause deaths 1.06 [0.86; 1.30] coronary deaths 1.01 [0.71; 1.44] coronary events 0.91 [0.76; 1.08] CV events (including revascularization) 0.93 [0.84; 1.02] MI non fatal 0.87 [0.71; 1.07] stroke (fatal et non fatal) 0.93 [0.68; 1.27] cardiac death 1.01 [0.71; 1.44] Infarctus non mortel et décès coronariens 0.91 [0.76; 1.08] non cardiovascular death 1.03 [0.73; 1.44] |
| Trial | Treatments | Patients | Method |
|---|
| BECAIT, 1996 | bezafibrate 200 mg three times daily (n=47) vs. placebo (n=45)
| dyslipidaemic male survivors of myocardial infarction who were younger than 45 years at the time of the event
| double blind Parallel groups Sample size: 47/45 Primary endpoint: change in mean minimum lumen diameter FU duration: 5.0 years
| | BIP, 2000 | bezafibrate 400 mg/d (n=1548) vs. placebo (n=1542) | 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 | double blind Parallel groups Sample size: 1548/1542 Primary endpoint: IDM fatal ou non fatal ou décès coronarien FU duration: 6.2 y |
|
