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Table 5 Entry criteria and outcomes in trials of fibrates

From: The need for a large-scale trial of fibrate therapy in diabetes: the rationale and design of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. [ISRCTN64783481]

Study Demographic entry criteria Lipid entry criteria Outcomes
SENDCAP men and women, 35–65 years, no cardiovascular disease • serum cholesterol ≥ 5.2 mmol/L • triglyceride ≥ 1.8 mmol/L • HDL ≤ 1.1 mmol/L • total/HDL ≥ 4.7 change in carotid intima-media thickness, lipid changes, CHD events, at 3 years
VA-HIT men, <74 years, documented history of CHD • HDL ≤ 1.0 mmol/L • LDL ≤ 3.6 mmol/L • triglyceride ≤ 3.4 mmol/L nonfatal MI or CHD death over median 5.1 years
BIP men and women, 45–74 years, MI 6 months to 5 years before, no insulin-dependent diabetes • serum cholesterol 4.7-6.5 mmol/L • LDL ≤ 4.7 mmol/L • HDL ≤ 1.2 mmol/L • triglyceride ≤ 3.4 mmol/L fatal or nonfatal MI or sudden death over mean 6.2 years
DAIS men and women, 40–65 years, type 2 diabetes • total/HDL ≥ 4 • LDL 3.5–4.5 mmol/L + triglyceride ≤ 5.2 mol/L or LDL ≤ 4.5 mmol/L + triglyceride 1.7–5.2 mol/L change in coronary artery lumen diameters, by angiography, and lipid changes after 3 years
LEADER men with lower-extremity arterial disease, no lipid-lowering drug • serum cholesterol 3.5–8.0 mmol/L CHD events and stroke over median 4.6 years
HHS men, 40–55 years, asymptomatic • non-HDL cholesterol >5.2 mmol/L lipid changes, MI, cardiac death at 5 years
  1. CHD = coronary heart disease, MI = myocardial infarction, HDL = high-density lipoprotein, LDL = low-density lipoprotein