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Entry criteria and outcomes in trials of fibrates |
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| Study |
Demographic entry criteria |
Lipid entry criteria |
Outcomes |
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| 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 |
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CHD = coronary heart disease, MI = myocardial infarction, HDL = high-density lipoprotein, LDL = low-density lipoprotein | |||
The FIELD Study Investigators Cardiovascular Diabetology 2004 3:9 doi:10.1186/1475-2840-3-9 |
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