Bezafibrate Infarction Bezafibrate Infarction Prevention Trial (BIP)Prevention Trial (BIP)

Results Presented at the European Results Presented at the European Society of Cardiology MeetingSociety of Cardiology Meeting

Vienna, Austria 1998Vienna, Austria 1998

BIP - Study DesignBIP - Study Design

• 3,122 men and women between 45 and 75 with documented 3,122 men and women between 45 and 75 with documented CAD.CAD.

• 400 mg bezafibrate vs. placebo.400 mg bezafibrate vs. placebo.• Lipid parameters:Lipid parameters:– LDL LDL << 180 mg/dL 180 mg/dL– TG TG << 300 mg/dL 300 mg/dL– HDL HDL << 45 mg/dL 45 mg/dL– TC 180-250 mg/dLTC 180-250 mg/dL

• Primary endpoint:Primary endpoint:– CHD death and non-fatal MICHD death and non-fatal MI

BIP - Baseline CharacteristicsBIP - Baseline Characteristics

CharacteristicCharacteristicAge, yrAge, yr 6060WomenWomen 9%9%Current SmokersCurrent Smokers 11%11%DiabeticsDiabetics 10%10%HypertensionHypertension 32%32%Prior MIPrior MI 78%78%ASA useASA use 70%70%Beta Blocker useBeta Blocker use 38%38%ACEI useACEI use 12%12%

BIP - Baseline LipidsBIP - Baseline Lipids

• TC TC 212 mg/dL212 mg/dL

• LDL LDL 148 mg/dL148 mg/dL

• HDL HDL 35 mg/dL35 mg/dL

• TGTG 149 mg/dL149 mg/dL

BIP - Change in Lipids/FibrinogenBIP - Change in Lipids/Fibrinogen

4.2

-6.2

15.4

-18

8.7

-30

-20

-10

0

10

20

30

TC LDL HDL TG Fibrinogen

% C

hang

e

BIP - Primary EndpointBIP - Primary Endpoint

211232

0

50

100

150

200

250

300

350

CHD Death/Nonfatal MI

Num

ber

of E

vent

s

BezafibratePlacebo

9% relative risk reduction

p=0.27

BIP - ConclusionBIP - Conclusion

• The primary endpoint was not significantly The primary endpoint was not significantly effected by bezafibrate therapy.effected by bezafibrate therapy.

• In a subset of patients with baseline TG > 200 In a subset of patients with baseline TG > 200 mg/dL (n=459), there was a 40% reduction in mg/dL (n=459), there was a 40% reduction in the primary endpoint (p=0.03)the primary endpoint (p=0.03)

Why Was VA-HIT Positive and BIP Negative?Why Was VA-HIT Positive and BIP Negative?

• BIPBIP– bezafibrate 400 mg/daybezafibrate 400 mg/day

• VA-HITVA-HIT– gemfibrozil 1200 mg/daygemfibrozil 1200 mg/day

• The VA-HIT population was:The VA-HIT population was:– OlderOlder– More obeseMore obese– More hypertensiveMore hypertensive– More diabeticsMore diabetics– More smokersMore smokers– Had lower baseline LDL/HDLHad lower baseline LDL/HDL

VA-HIT vs. BIPVA-HIT vs. BIPBaseline CharacteristicsBaseline Characteristics

CharacteristicCharacteristic BIP (n=3,122)BIP (n=3,122) VA-HIT (n-2,531)VA-HIT (n-2,531)

LDL, mg/dLLDL, mg/dL 148 148 111 111TG, mg/dLTG, mg/dL 149 149 161 161HDL, mg/dLHDL, mg/dL 35 35 32 32TC, mg/dLTC, mg/dL 212 212 175 175Mean age, yMean age, y 60 60 64 (70% > 60) 64 (70% > 60)Hypertension, %Hypertension, % 32 32 57 57Smokers, %Smokers, % 11 11 21 21Diabetes, %Diabetes, % 10 10 25 25BMIBMI 27 27 29 29