Study designs of evaluations included in the review
Randomised controlled trials (RCTs) were eligible for inclusion.
Specific interventions included in the review
Studies comparing fibrate lipid-lowering therapy with placebo were eligible for inclusion. The included studies assessed clofibrate, gemfibrozil, clofibric acid, bezafibrate and fenofibrate.
Participants included in the review
Studies of patients with type 2 diabetes mellitus were eligible for inclusion. Both patients with known coronary heart disease (CHD; secondary prevention) and no known pre-existing CHD (primary prevention) were included in the review. Where stated, the proportion of females ranged from 0 to 60%, mean age ranged from 46 to 65 years, and the proportion of current smokers ranged from 9 to 34%.
Outcomes assessed in the review
Studies that prospectively recorded cardiovascular events and included a follow-up of at least 2 years were eligible for inclusion. The primary outcome measure was the incidence of CHD events, defined as a combination of nonfatal myocardial infarction (MI) or death due to CHD. The secondary end points included death due to CHD (e.g. fatal MI, congestive heart failure or sudden death), fatal and nonfatal MI, and fatal and non fatal stroke. Outcome data had to be reported separately for patients with type 2 diabetes mellitus. The duration of follow-up ranged from 2 to 6 years.
How were decisions on the relevance of primary studies made?
Two reviewers independently assessed studies for inclusion. Any discrepancies were resolved through discussion with a third reviewer.