| cardiovascular prevention | versus placebo or control No demonstrated result for efficacy fenofibrate inferior to placebo in terms of Pancreatitis in FIELD, 2005 (diabetic patients) fenofibrate inferior to placebo in terms of venous thromboembolism in FIELD, 2005 (diabetic patients) | 4 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| FIELD, 2005 | fenofibrate vs placebo | MI non fatal 0.76 [0.62; 0.94] cardiovascular events 0.90 [0.81; 0.99] | Pancreatitis 1.74 [1.04; 2.90] venous thromboembolism 1.50 [1.13; 1.99] | all cause deaths 1.10 [0.95; 1.28] coronary deaths 1.18 [0.90; 1.56] coronary events 0.89 [0.76; 1.05] adverse events 1.58 [0.95; 2.64] cardiovascular death 1.10 [0.87; 1.40] décès par cancer 1.14 [0.91; 1.41] Rhabdomyolyses 3.00 [0.31; 28.86] stroke (fatal et non fatal) 0.90 [0.73; 1.12] cardiac death 1.18 [0.90; 1.56] Infarctus non mortel et décès coronariens 0.89 [0.76; 1.05] Myopathies 2.00 [0.18; 22.07] | | FIELD, 2005 | fenofibrate vs placebo | Cv events (CV death, MI, stroke) 0.90 [0.81; 0.99] | | Critère de jugement principal de l'étude 0.89 [0.76; 1.05] Infarctus non mortel et décès coronariens 0.89 [0.76; 1.05] Décès toutes causes 1.10 [0.95; 1.28] Evénement coronarien majeur 0.89 [0.76; 1.05] Décès cardiovasculaires 1.10 [0.87; 1.40] AVC 0.90 [0.73; 1.12] | | DAIS, 2001 | fenofibrate vs placebo | | | all cause deaths 0.68 [0.25; 1.88] coronary events 0.77 [0.53; 1.13] cardiac death 0.61 [0.15; 2.53] non cardiovascular death 0.51 [0.09; 2.75] | | ACCORD lipid, 2010 | fenofibrate vs placebo (on top simvastatine) | | | Critère de jugement principal de l'étude 0.93 [0.80; 1.09] Décès toutes causes 0.91 [0.76; 1.10] Evénement coronarien majeur 0.94 [0.81; 1.08] Décès cardiovasculaires 0.86 [0.66; 1.13] AVC 1.06 [0.72; 1.56] Cv events (CV death, MI, stroke) 0.93 [0.80; 1.09] |
| Trial | Treatments | Patients | Method |
|---|
| FIELD, 2005 | fenofibrate 200mg/d (n=4895) vs. Placebo (n=4900) | participants aged 50-75 years, with type 2 diabetes mellitus, and not taking statin therapy at study entry | double blind Parallel groups Sample size: 4895/4900 Primary endpoint: coronary events FU duration: 5 years | | FIELD, 2005 | fenofibrate 200 mg daily (n=4895) vs. placebo (n=4900) | aged 50-75 years, with type 2 diabetes mellitus, and not taking statin therapy at study entry | Sample size: 4895/4900 Primary endpoint: coronary events FU duration: 5y | | DAIS, 2001 | fenofibrate 200 mg/day (n=207) vs. placebo (n=211) | men and women with type 2 diabetes and coronary atherosclerosis | double-blind Parallel groups Sample size: 207/211 Primary endpoint: QCA (minimum lumen diameter) FU duration: 3.3 years | | ACCORD lipid, 2010 | fenofibrate on top simvastatin (n=2765) vs. placebo (on top simvastatine) (n=2753) participants were also randomized to either intensive or standard glycemic control and to either intensive or standard blood-pressure control. Glycemic-control ACCORD study was stopped early, in February 2008, because of higher mortality in the intensive-glycemic-control group. All patients were then transferred to a standard glycemia-control regimen | high-risk patients with type 2 diabetes | double-blind Factorial plan Sample size: 2765/2753 Primary endpoint: fatal cardiovascular events, nonfatal MI, or nonfatal stroke FU duration: 4.7y |
|
| diabetes type 2 | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| FIELD, 2005 | fenofibrate vs placebo | Cv events (CV death, MI, stroke) 0.90 [0.81; 0.99] | | Critère de jugement principal de l'étude 0.89 [0.76; 1.05] Infarctus non mortel et décès coronariens 0.89 [0.76; 1.05] Décès toutes causes 1.10 [0.95; 1.28] Evénement coronarien majeur 0.89 [0.76; 1.05] Décès cardiovasculaires 1.10 [0.87; 1.40] AVC 0.90 [0.73; 1.12] | | ACCORD lipid, 2010 | fenofibrate vs placebo (on top simvastatine) | | | Critère de jugement principal de l'étude 0.93 [0.80; 1.09] Décès toutes causes 0.91 [0.76; 1.10] Evénement coronarien majeur 0.94 [0.81; 1.08] Décès cardiovasculaires 0.86 [0.66; 1.13] AVC 1.06 [0.72; 1.56] Cv events (CV death, MI, stroke) 0.93 [0.80; 1.09] |
| Trial | Treatments | Patients | Method |
|---|
| FIELD, 2005 | fenofibrate 200 mg daily (n=4895) vs. placebo (n=4900) | aged 50-75 years, with type 2 diabetes mellitus, and not taking statin therapy at study entry | Sample size: 4895/4900 Primary endpoint: coronary events FU duration: 5y | | ACCORD lipid, 2010 | fenofibrate on top simvastatin (n=2765) vs. placebo (on top simvastatine) (n=2753) participants were also randomized to either intensive or standard glycemic control and to either intensive or standard blood-pressure control. Glycemic-control ACCORD study was stopped early, in February 2008, because of higher mortality in the intensive-glycemic-control group. All patients were then transferred to a standard glycemia-control regimen | high-risk patients with type 2 diabetes | double-blind Factorial plan Sample size: 2765/2753 Primary endpoint: fatal cardiovascular events, nonfatal MI, or nonfatal stroke FU duration: 4.7y |
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