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

Meade, Tom ; Zuhrie, Riaz ; Cook, Claire ; Cooper, Jackie

BMJ, 2002-11, Vol.325 (7373), p.1139-1141 [Periódico revisado por pares]

London: British Medical Journal Publishing Group

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Título:
Bezafibrate in men with lower extremity arterial disease: randomised controlled trial
Autor: Meade, Tom ; Zuhrie, Riaz ; Cook, Claire ; Cooper, Jackie
Assuntos: Adult ; Aged ; Aged, 80 and over ; Antifibrinolytic Agents - therapeutic use ; Arteries ; Atherosclerosis ; Bezafibrate - therapeutic use ; Biological and medical sciences ; Blood vessels ; Cardiovascular disease ; Cholesterol ; Clinical outcomes ; Coronary artery disease ; Coronary Disease - prevention & control ; Diabetes ; Disease risk ; Double-Blind Method ; Drug therapy ; Epidemiology ; Experimentation ; General and cellular metabolism. Vitamins ; Heart attacks ; Heart diseases ; Homocysteine ; Humans ; Leg - blood supply ; Lipids ; Lipoproteins ; Lower extremity ; Male ; Medical disorders ; Medical research ; Medical sciences ; Men ; Middle Aged ; Myocardial infarction ; Peripheral Vascular Diseases - complications ; Pharmacology. Drug treatments ; Placebos ; Stroke ; Stroke - prevention & control ; Strokes ; Studies ; Treatment Outcome
É parte de: BMJ, 2002-11, Vol.325 (7373), p.1139-1141
Notas: istex:42B14CF633E7DF7080B3FD519AD8BCC743D680C7
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Correspondence to: T Meade
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Contributors: The trial was designed and implemented by TM (who is also guarantor), RZ, and CC and JC analysed the results. Bianca De Stavola advised on statistical analyses. End point reports were assembled by Katherine Garrow, Christine Knottenbelt, and George Miller and independently assessed by John Dickinson. The data monitoring and ethics committee comprised S Pocock (chair), G Fowkes, and D Julian.
Correspondence to: T Meade Tom.meade@lshtm.ac.uk
Descrição: 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.
Editor: London: British Medical Journal Publishing Group
Idioma: Inglês

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

Meade, Tom ; Zuhrie, Riaz ; Cook, Claire ; Cooper, Jackie

London: British Medical Journal Publishing Group

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