| Methods |
Study design: double blind, randomised, placebo‐controlled trial.
Method of randomisation: not stated.
Method of allocation: trial co‐ordinating centre.
Exclusions post randomisation: none.
Losses to follow up: bezafibrate 369 (47.1%); placebo 403 (51.3%).
Intention to treat: yes. |
| Participants |
Country: UK.
Setting: 85 general practices and 9 hospital vascular clinics.
No: 1568, bezafibrate 783; placebo: 785.
Age: bezafibrate (mean) 68.4 (SD 8.9); placebo (mean) 68.0 (SD 8.8).
Sex : all male.
Inclusion criteria: lower extremity arterial disease confirmed with the Edinburgh Claudication questionnaire.
Exclusion criteria: Men with PAD were ineligible for the following reasons: unstable angina, unless or until it was controlled; total serum cholesterol less than 3.5 mmol/l or more than 8.0 mmol/l; significant renal or hepatic disease; a known hepatitis B or C or HIV positive status; malignant disease (other than non‐melanoma skin cancer) within the past 5 years; they were taking or likely to need lipid‐lowering agents or monamine oxidase inhibitors; they were unlikely to comply with trial treatment or procedures; they were in another trial; or at the discretion of the general practitioner for other reasons. |
| Interventions |
Treatment: bezafibrate 400 mg daily.
Control: placebo tablets.
Duration: minimum 3 years, maximum 4 years. |
| Outcomes |
Primary: combination of coronary heart disease and/or stroke.
Secondary: all coronary events, fatal and non‐fatal coronary events separately, and strokes alone. |
| Notes |
Haematological and biochemical parameters measured. Active treatment associated with reduced tChol, LDL and TG and increased HDL. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
