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Odkazy a zdroje - Studie - VA-HIT



VA-HIT

Veterans Affairs High-density lipoprotein cholesterol Intervention Trial

Author(s)
(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

Title(s)
(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

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

Disease
Coronary heart disease, dyslipidaemia

Purpose
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

Follow-up
Median 5.1 years (range 0-6.9)

Patients
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
-

Results
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)