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Odkazy a zdroje - Studie - VA-HIT


Veterans Affairs High-density lipoprotein cholesterol Intervention Trial

(a) Rubins HB, Robins SJ, Iwane MK, Boden W, Elam MB, Fye CL, Gordon DJ, Schaefer EJ, Schectman G, Wittes J
(b) Rubins HB, Robins SJ, Collins D, Fye CL, Anderson JW, Elam MB, Faas FH, Linares E, Schaefer EJ, Schectman G, Wilt TJ, Wittes J

(a) Rationale and design of the Department of Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial (HIT) for secondary prevention of coronary artery disease in men with low high-density lipoprotein cholesterol and desirable low-density lipoprotein cholesterol
(b) Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol

(a) Am J Cardiol 1993;71:45-52
(b) N Engl J Med 1999;341:410-8

Coronary heart disease, dyslipidaemia

To examine the effects of treatment for low HDL cholesterol in men with coronary heart disease and normal LDL cholesterol on their risk of experiencing a cardiovascular event

Study design
Randomised, double-blind, placebo-controlled

Median 5.1 years (range 0-6.9)

2531 men (1264 gemfibrozil, 1267 placebo), mean age 64 ± 7 years, with documented coronary heart disease and HDL cholesterol ≤ 40 mg/dl (mean 32 mg/dl), LDL cholesterol ≤ 140 mg/dl (mean 111 mg/dl), and triglycerides ≤ 300 mg/dl (mean 160 mg/dl)

Treatment regimen
Gemfibrozil slow release, 1200 mg once daily (later replaced with gemfibrozil, 600 mg bid), or placebo

Concomitant therapy

After 1 year, mean HDL cholesterol was significantly higher in the gemfibrozil group than in the placebo group (34 mg/dl vs 32 mg/dl; p < 0.001). LDL cholesterol did not differ between groups, but mean total cholesterol was 4% lower (p < 0.001) and triglycerides were 31% lower (p < 0.001) with gemfibrozil. The incidence of death from coronary heart disease or a nonfatal MI was significantly lower in the gemfibrozil group than in the placebo group (17.3% vs 21.7%, relative risk reduction 22%; p = 0.006). When stroke was included in this aggregate endpoint, relative risk reduction was 24% with gemfibrozil (p < 0.001)