Authors
The FIELD Study Investigators
Title
Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial.
References
Lancet. 2005 Nov 26;366(9500):1849-61.
Background
Patients with type 2 diabetes mellitus are at increased risk of cardiovascular disease, partly owing to dyslipidaemia, which can be amenable to fibrate therapy. No large clinical-endpoint trials of fibrate therapy specifically in people with diabetes had been done to this point.
Purpose
To assess the effect of fenofibrate on cardiovascular disease events in diabetic patients
Design
  • Multinational, randomized controlled trial
  • 9795 participants aged 50-75 years, with type 2 diabetes mellitus - not taking statin therapy
  • Initial total cholesterol 3.0-6.5 mmol/L plus either total cholesterol/HDL > 4 or triglyceride between 1.0-5.0 mmol/L
  • No clear indication for lipid modifying therapy
Exclusion Criteria
  • Serum creatinine ≥ 130 umol/L
  • Chronic liver disease
  • Symptomatic gallbladder disease
  • Cardiovascular event within 3 months prior to recruitment
Follow-Up
Median 5 years
Treatment Regimen
  • Fenofibrate 200 mg or matching placebo
  • 4-6 monthly visits over 5 years: compliance, fasting lipids, creatinine, ALT, HbA1c, lipoproteins, urine albumin, urine creatinine, CK.
Results

Primary Endpoints

  • Coronary heart disease death or non-fatal myocardial infarction
  • Non-significant reduction in coronary events in fenofibrate group: 5.9% (placebo) vs. 5.2% (fenofibrate) - [HR] 0.89, 95% CI 0.75–1.05; p=0.16

Seondary Outcomes and Other Results

  • 24% reduction in non-fatal myocardial infarction (p=0·01) and a non-significant increase in coronary heart disease mortality (HR 1.19, 0.90–1.57; p=0.22) for fenofibrate group
  • Total cardiovascular disease events were significantly reduced from 13.9% to 12.5% (p=0.035) in the fenofibrate group
Summary
Fenofibrate did not significantly reduce the risk of the primary outcome of coronary events. It did reduce total cardiovascular events, mainly due to fewer non-fatal myocardial infarctions and revascularizations. The higher rate of starting statin in the placebo group of patients might have masked a moderately larger treatment benefit.