Bezafibrate in men with lower extremity arterial disease: randomised controlled trial


Meade, T; Zuhrie, R; Cook, C; Cooper, J; (2002) Bezafibrate in men with lower extremity arterial disease: randomised controlled trial. BMJ (Clinical research ed), 325 (7373). p. 1139. ISSN 0959-8138 DOI: https://doi.org/10.1136/bmj.325.7373.1139

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Abstract

OBJECTIVE: To assess the effect of bezafibrate on the risk of coronary heart disease and stroke in men with lower extremity arterial disease. DESIGN: Double blind placebo controlled randomised trial. SETTING: 85 general practices and nine hospital vascular clinics. PARTICIPANTS: 1568 men, mean age 68.2 years (range 35 to 92) at recruitment. INTERVENTIONS: Bezafibrate 400 mg daily (783 men) or placebo (785 men). Main outcome measures: 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.

Item Type: Article
Keywords: Adult, Aged, Aged, 80 and over, Antifibrinolytic Agents/*therapeutic use, Arteries, Bezafibrate/*therapeutic use, Cerebrovascular Accident/*prevention & control, Coronary Disease/*prevention & control, Double-Blind Method, Human, Leg/*blood supply, Male, Middle Age, Peripheral Vascular Diseases/*complications, Support, Non-U.S. Gov't, Treatment Outcome, Adult, Aged, Aged, 80 and over, Antifibrinolytic Agents, therapeutic use, Arteries, Bezafibrate, therapeutic use, Cerebrovascular Accident, prevention & control, Coronary Disease, prevention & control, Double-Blind Method, Human, Leg, blood supply, Male, Middle Age, Peripheral Vascular Diseases, complications, Support, Non-U.S. Gov't, Treatment Outcome
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology
Faculty of Epidemiology and Population Health > Dept of Non-Communicable Disease Epidemiology
PubMed ID: 12433762
Web of Science ID: 179443100017
URI: http://researchonline.lshtm.ac.uk/id/eprint/17610

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