VA-HIT Trial

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Click here to download slides for VA-HIT Trial.

Objective

To determine if the reduction in major CHD events (MI and CHD deaths) with gemfibrozil could be attributed to changes in major plasma lipid levels.

Methods

VA-HIT (Veterans Affairs HDL Intervention Trial) trial is a multicentered, randomized, double-blinded, placebo-controlled trial wherein 2531 patients with CAD along with LDL levels ≤140 mg/dL (mean 111 mg/dL) and HDL ≤40 mg/dL (mean 32 mg/dL) were randomly assigned to treatment with gemfibrozil (1200mg) or placebo. The median follow-up was 5.1 years.

Results

Results At One Year

  • Mean HDL-C level was higher by 6% in the group treated with gemfibrozil.
  • Mean TG concentration was lower by 31% in the group treated with gemfibrozil.
  • Mean total cholesterol was 4% lower in the group treated with gemfibrozil.

Results At Five Year

  • The combined primary end point of cardiac death and non-fatal myocardial infarction occurred in 17.3% versus 21.7% in the group receiving gemfibrozil and the placebo group respectively.
  • There was a risk reduction of 22% in the primary outcome (p=.0006) and 24% risk reduction in the combined endpoint of stroke, MI, and CHD death
  • Acute coronary events were reduced by 11% with gemfibrozil for every 5 mg/dL rise in HDL-C, but the reduction was independent of changes in LDL-C and triglyceride levels.

Conclusion

Low HDL-C levels strongly and independently predict the occurrence of coronary events. Gemfibrozil reduced the rate of coronary events by raising HDL-C and lowering triglycerides without lowering LDL-C.[1][2][3][4][5]

References

  1. Rubins HB, Robins SJ, Collins D, Fye CL, Anderson JW, Elam MB; et al. (1999). "Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group". N Engl J Med. 341 (6): 410–8. doi:10.1056/NEJM199908053410604. PMID 10438259.
  2. Robins SJ, Collins D, Nelson JJ, Bloomfield HE, Asztalos BF (2008). "Cardiovascular events with increased lipoprotein-associated phospholipase A(2) and low high-density lipoprotein-cholesterol: the Veterans Affairs HDL Intervention Trial". Arterioscler. Thromb. Vasc. Biol. 28 (6): 1172–8. doi:10.1161/ATVBAHA.107.160739. PMID 18356553. Unknown parameter |month= ignored (help)
  3. Asztalos BF, Collins D, Horvath KV, Bloomfield HE, Robins SJ, Schaefer EJ (2008). "Relation of gemfibrozil treatment and high-density lipoprotein subpopulation profile with cardiovascular events in the Veterans Affairs High-Density Lipoprotein Intervention Trial". Metab. Clin. Exp. 57 (1): 77–83. doi:10.1016/j.metabol.2007.08.009. PMC 2194640. PMID 18078862. Unknown parameter |month= ignored (help)
  4. Peloso GM, Demissie S, Collins D; et al. (2010). "Common genetic variation in multiple metabolic pathways influences susceptibility to low HDL-cholesterol and coronary heart disease". J. Lipid Res. 51 (12): 3524–32. doi:10.1194/jlr.P008268. PMC 2975725. PMID 20855565. Unknown parameter |month= ignored (help)
  5. Robins SJ, Collins D, McNamara JR, Bloomfield HE (2008). "Body weight, plasma insulin, and coronary events with gemfibrozil in the Veterans Affairs High-Density Lipoprotein Intervention Trial (VA-HIT)". Atherosclerosis. 196 (2): 849–55. doi:10.1016/j.atherosclerosis.2007.01.029. PMID 17335828. Unknown parameter |month= ignored (help)