Bezafibrate Infarction Prevention Trial (BIP) Results Presented at the European Society of Cardiology Meeting Vienna, Austria 1998

BIP - Study Design 3,122 men and women between 45 and 75 with documented CAD.3,122 men and women between 45 and 75 with documented CAD. 400 mg bezafibrate vs. placebo.400 mg bezafibrate vs. placebo. Lipid parameters:Lipid parameters: –LDL < 180 mg/dL –TG < 300 mg/dL –HDL < 45 mg/dL –TC mg/dL Primary endpoint:Primary endpoint: –CHD death and non-fatal MI

BIP - Baseline Characteristics Characteristic Age, yr60 Women9% Current Smokers11% Diabetics10% Hypertension32% Prior MI78% ASA use70% Beta Blocker use38% ACEI use12%

BIP - Baseline Lipids TC 212 mg/dLTC 212 mg/dL LDL 148 mg/dLLDL 148 mg/dL HDL 35 mg/dLHDL 35 mg/dL TG149 mg/dLTG149 mg/dL

BIP - Change in Lipids/Fibrinogen

BIP - Primary Endpoint 9% relative risk reduction p=0.27

BIP - Conclusion The primary endpoint was not significantly effected by bezafibrate therapy.The primary endpoint was not significantly effected by bezafibrate therapy. In a subset of patients with baseline TG > 200 mg/dL (n=459), there was a 40% reduction in the primary endpoint (p=0.03)In a subset of patients with baseline TG > 200 mg/dL (n=459), there was a 40% reduction in the primary endpoint (p=0.03)

Why Was VA-HIT Positive and BIP Negative? BIPBIP –bezafibrate 400 mg/day VA-HITVA-HIT –gemfibrozil 1200 mg/day The VA-HIT population was:The VA-HIT population was: –Older –More obese –More hypertensive –More diabetics –More smokers –Had lower baseline LDL/HDL

VA-HIT vs. BIP Baseline Characteristics CharacteristicBIP (n=3,122)VA-HIT (n-2,531) LDL, mg/dL TG, mg/dL HDL, mg/dL TC, mg/dL Mean age, y (70% > 60) Hypertension, % Smokers, % Diabetes, % BMI 27 29