Biomedical and clinical sciences; Cardiovascular medicine and haematology; Clinical sciences; ATORVASTATIN; BEZAFIBRATE; Cardiac & Cardiovascular Systems; Cardiovascular System & Cardiology; CARDIOVASCULAR-DISEASE; CHOLESTEROL; CORONARY-HEART-DISEASE; Endocrinology & Metabolism; HIGH-DENSITY-LIPOPROTEIN; INSULIN; Life Sciences & Biomedicine; MYOCARDIAL-INFARCTION; PLASMA; Science & Technology; SECONDARY PREVENTION
Description:
Objective The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study is examining the effects of long-term fibrate therapy on coronary heart disease (CHD) event rates in patients with diabetes mellitus. This article describes the trial's run-in phase and patients' baseline characteristics. Research design and methods FIELD is a double-blind, placebo-controlled trial in 63 centres in 3 countries evaluating the effects of fenofibrate versus placebo on CHD morbidity and mortality in 9795 patients with type 2 diabetes mellitus. Patients were to have no indication for lipid-lowering therapy on randomization, but could start these or other drugs at any time after randomization. Follow-up in the study was to be for a median duration of not less than 5 years and until 500 major coronary events (fatal coronary heart disease plus nonfatal myocardial infarction) had occurred. Results About 2100 patients (22%) had some manifestation of cardiovascular disease (CVD) at baseline and thus high risk status. Less than 25% of patients without CVD had a (UKPDS determined) calculated 5-year CHD risk of