Bezafibrate in men with lower extremity arterial disease: randomised controlled trial.
OBJECTIVE
To assess the effect of bezafibrate on the risk of coronary heart disease and stroke in men with lower extremity arterial disease.


METHODS
Double blind placebo controlled randomised trial.


METHODS
85 general practices and nine hospital vascular clinics.


METHODS
1568 men, mean age 68.2 years (range 35 to 92) at recruitment.


METHODS
Bezafibrate 400 mg daily (783 men) or placebo (785 men).


METHODS
Combination of coronary heart disease and of stroke. All coronary events, fatal and non-fatal coronary events separately, and strokes alone (secondary end points).


RESULTS
Bezafibrate did not reduce the incidence of coronary heart disease and stroke. There were 150 and 160 events in the active and placebo groups respectively (relative risk 0.96, 95% confidence interval 0.76 to 1.21). There were 90 and 111 major coronary events in the active and placebo groups respectively (0.81, 0.60 to 1.08), of which 64 and 65 were fatal (0.95, 0.66 to 1.37) and 26 and 46 non-fatal (0.60, 0.36 to 0.99). Beneficial effects on non-fatal events were greatest in men aged <65 years at entry, in whom benefit was also seen for all coronary events (0.38, 0.20 to 0.72). There were no significant effects in older men. There were 60 strokes in those on active treatment and 49 in those on placebo (1.34, 0.80 to 2.01). There were 204 and 195 deaths from all causes in the two groups respectively (1.03, 0.83 to 1.26). Bezafibrate reduced the severity of intermittent claudication for up to three years.


CONCLUSIONS
Bezafibrate has no effect on the incidence of coronary heart disease and of stroke combined but may reduce the incidence of non-fatal coronary events, particularly in those aged <65 years at entry, in whom all coronary events may also be reduced.
Meade
Tom
T
Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK. Tom.meade@lshtm.ac.uk
Zuhrie
Riaz
R
Cook
Claire
C
Cooper
Jackie
J
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000933:Antifibrinolytic Agents / Q000627:therapeutic use*; D001158:Arteries; D001629:Bezafibrate / Q000627:therapeutic use*; D003327:Coronary Disease / Q000517:prevention & control*; D004311:Double-Blind Method; D006801:Humans; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000150:complications*; D020521:Stroke / Q000517:prevention & control*; D016896:Treatment Outcome
D000933:Antifibrinolytic Agents; D001629:Bezafibrate