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Odkazy a zdroje - Studie - BIP



BIP

Bezafibrate Infarction Prevention

Author(s)
(a) Goldbourt U, Behar S, Reicher-Reiss H, Agmon J, Kaplinsky E, Graff E et al
(b) Barasch E, Benderly M, Graff E, Behar S, Reicher-Reiss H, Caspi A, Pelled B, Reisin L, Roguin N, Goldbourt U
(c)BIP Study Group

Title(s)
(a) Rationale and design of a secondary prevention trial of increasing serum high-density lipoprotein cholesterol and reducing triglycerides in patients with clinically manifest atherosclerotic heart disease (the Bezafibrate Infarction Prevention trial)
(b) Plasma fibrinogen levels and their correlates in 6457 coronary heart disease patients. The Bezafibrate Infarction Prevention (BIP) study
(c) Secondary prevention by raising HDL cholesterol and reducing triglycerides in patients with coronary artery disease. The Bezafibrate Infarction Prevention (BIP) study

Reference(s)
(a) Am J Cardiol 1993;71:909-15
(b) J Clin Epidemiol 1995;48:757-65
(c) Circulation 2000;102:21-7

Disease
Atherosclerotic heart disease

Purpose
To determine whether elevation of HDL cholesterol and reduction of triglycerides by bezafibrate can reduce fatal and nonfatal MI, and sudden death attributable to atherosclerosis of the coronary arteries. Secondary, to investigate the effect of therapy on total mortality, unstable angina pectoris, PTCA and CABG

Study design
Randomised, double-blind, placebo-controlled

Follow-up
Mean 6.2 years (range 4.7-7.6 years)

Patients
3090 patients (1548 bezafibrate, 1542 placebo), aged 45-74 years (mean 60.1 years), with previous MI or stable angina and with total serum cholesterol 180-250 mg/dl, HDL cholesterol ≤ 45 mg/ dl, triglycerides ≤ 300 mg/dl and LDL cholesterol ≤ 180 mg/dl (≤ 160 mg/dl for patients aged < 50)

Treatment regimen
Bezafibrate, 400 mg/day, or placebo

Concomitant therapy
-

Results
In the bezafibrate group, HDL cholesterol increased by 18% and triglycerides decreased by 21%. Fatal or nonfatal MI, or sudden death occurred in 13.6% in the bezafibrate group vs 15.0% in the placebo group (p = 0.26). In the subgroup of patients with high baseline triglyceride levels (≥ 200 mg/dl), the reduction in cumulative probability of fatal or nonfatal MI, or sudden death in the bezafibrate group was 39.5% (p = 0.02)