Bezafibrate in men with lower extremity arterial disease: randomised controlled trial
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Tom Meade1, Riaz Zuhrie, Claire Cook
1Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK. Tom.meade@lshtm.ac.uk
Insights
Bezafibrate did not reduce coronary heart disease or stroke risk in men with peripheral artery disease. However, it may decrease non-fatal coronary events, especially in younger men.
Area of Science:
- Cardiology
- Vascular Medicine
- Pharmacology
Background:
- Lower extremity arterial disease (LEAD) is associated with increased risk of coronary heart disease (CHD) and stroke.
- Fibrates, like bezafibrate, are lipid-lowering agents that may influence cardiovascular outcomes.
Purpose of the Study:
- To evaluate the efficacy of bezafibrate in reducing the risk of major adverse cardiovascular events in men with LEAD.
- To assess the impact of bezafibrate on coronary heart disease and stroke incidence in this patient population.
Main Methods:
- A double-blind, placebo-controlled, randomized trial was conducted across 85 general practices and nine hospital vascular clinics.
- 1568 men with LEAD, with a mean age of 68.2 years, were randomized to receive either bezafibrate 400 mg daily or a placebo.
- The primary outcome was the composite of coronary heart disease and stroke; secondary outcomes included individual coronary events, fatal and non-fatal events, and strokes.
Main Results:
- Bezafibrate did not significantly reduce the combined incidence of coronary heart disease and stroke (relative risk 0.96; 95% CI 0.76 to 1.21).
- A potential reduction in non-fatal coronary events was observed (0.60; 0.36 to 0.99), particularly in men younger than 65 years at entry.
- No significant effect was noted on fatal coronary events, strokes, or all-cause mortality, but bezafibrate improved intermittent claudication severity.
Conclusions:
- Bezafibrate does not appear to reduce the combined risk of coronary heart disease and stroke in men with lower extremity arterial disease.
- A possible benefit in reducing non-fatal coronary events, especially in younger men (<65 years), warrants further investigation.
- Bezafibrate demonstrated a positive effect on the severity of intermittent claudication.
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.
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