|
Inclusion and exclusion criteria for the FIELD study |
| Individuals were eligible for this study provided they had the following characteristics: |
| • male or female, aged 50–75 years inclusive |
| • non-insulin dependent diabetes mellitus (type 2) with age at diagnosis >35 years (currently using any of diet, tablets or insulin); for Maori, Pacific Islanders, Australian Aborigines and Torres Strait Islanders, the eligible age of diagnosis was >25 years, provided there had been at least 1 year of treatment without insulin |
| • on the basis of diabetes, considered to be at higher risk for coronary heart disease than the general population |
| • no clear indication for any cholesterol-lowering treatment: the patient was not already taking any cholesterol-lowering drug and neither the patient nor the patient's doctor considered there to be any definite need to do so |
| • total cholesterol level 3 to 6.5 mmol/L, plus either |
| a total cholesterol-to-HDL cholesterol ratio of ≥ 4.0 |
| a blood triglyceride level >1.0 mmol/L |
| • no clear contraindication to study therapy in the view of the treating physician |
| • no other predominant medical problem that might limit compliance with 5 years of study treatment or compromise long-term participation and clinic attendance in the trial |
| Individuals were not eligible if they had any of the following characteristics: |
| • serum triglyceride >5 mmol/L in the baseline visit fasting blood sample |
| • concurrent treatment with any other lipid-lowering agent |
| • serum creatinine >130 μmol/L |
| • known chronic liver disease, transaminases >2 × upper limit of normal or symptomatic gall-bladder disease |
| • myocardial infarction or hospital admission for unstable angina within 3 months |
| • female, of child-bearing potential, unless sterilized or on reliable approved methods of contraception, including oral contraceptives |
| • concurrent cyclosporin treatment (or a condition likely to result in organ transplantation and the need for cyclosporin during the next 5 years) |
| • known allergy to any fibrate drug or known photosensitivity |
| • unwilling or unable to consent to enter the study, with the understanding that follow-up was planned to continue for more than 5 years |
The FIELD Study Investigators Cardiovascular Diabetology 2004 3:9 doi:10.1186/1475-2840-3-9 |