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Gemfibrozil for the Secondary Prevention of Coronary Heart Disease in Men with Low Levels of High-Density Lipoprotein Cholesterol VA-HIT . Rubins, HB, et al, for the Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group.

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slide1

Gemfibrozil for the Secondary Prevention of Coronary Heart Disease in Menwith Low Levels of High-Density Lipoprotein Cholesterol VA-HIT

Rubins, HB, et al, for the Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group

N Eng J Med, August 5, 1999 Vol. 341:410-418

va hit background
VA-HIT: Background
  • It is generally accepted that lowering LDL cholesterol in patients with CHD is beneficial.
  • Few data exist, however, to guide the treatment of patients whose primary lipid abnormality is low HDL.

N Eng J Med, August 5, 1999 Vol. 341:410-418

va hit hypothesis
VA-HIT: Hypothesis
  • Treatment of men with CHD whose primary lipid abnormality is low HDL-C will reduce the endpoint of CHD death and non-fatal M.I.
  • Gemfibrozil is the drug most likely to favorably affect HDL-C and triglycerides with the least effect on LDL-cholesterol.

N Eng J Med, August 5, 1999 Vol. 341:410-418

va hit study design
VA-HIT: Study Design
  • 2,531 men with coronary heart disease
    • average age: 64yrs
    • 90% white, 57% with hypertension, 25% diabetic, 61% prior MI, 22% current smokers
  • Double-blind trial comparing:
    • Gemfibrozil 1200 mg/d
    • placebo
  • HDL < 40 mg/dL (average: ~ 32 mg/dL)
  • LDL-C < 140 mg/dL (average: ~ 111 mg/dL)
  • TG < 300 mg/dL (average: ~ 161 mg/dL)

N Eng J Med, August 5, 1999 Vol. 341:410-418

va hit study design1
VA-HIT: Study Design
  • Primary endpoint: nonfatal MI or death from coronary heart disease
  • Secondary endpoints: stroke, death from any cause, TIA, revascularization procedures, carotid endarterectomy, and hospitalization for unstable angina or CHF.
  • Median follow-up 5.1 years

N Eng J Med, August 5, 1999 Vol. 341:410-418

va hit mean plasma lipid changes year one
VA-HIT: Mean Plasma Lipid Changes, Year One

4% decrease

p<0.001

31% decrease

p<0.001

P=NS

6% increase

p<0.001

N Eng J Med, August 5, 1999 Vol. 341:410-418

va hit lipid effects
VA-HIT: Lipid Effects

N Eng J Med, August 5, 1999 Vol. 341:410-418

va hit lipid effects1
VA-HIT: Lipid Effects

N Eng J Med, August 5, 1999 Vol. 341:410-418

va hit results
VA-HIT: Results
  • Increased HDL 6%
  • Decreased TG 31%
  • Decreased TC 4%
  • No change in LDL
  • Primary event (death from CHD or nonfatal M.I.) occurred in:
    • 275 of 1267 patients on placebo (21.7%)
    • 219 of 1264 patients on gemfibrozil (17.3%)

N Eng J Med, August 5, 1999 Vol. 341:410-418

va hit results1
VA-HIT: Results
  • Primary endpoint:
    • 22 % risk reduction in nonfatal MI or death from CHD (p=0.006)
  • Secondary endpoints:
    • 24% risk reduction in CHD death, nonfatal MI and confirmed stroke combined (p< 0.001)
    • 22% risk reduction in CHD death (p = 0.07)
    • 23% risk reduction in nonfatal MI (p = 0.02)
    • 25% risk reduction in confirmed stroke (p = 0.10)
    • 59% risk reduction in TIA (p<0.001)
    • 65% risk reduction in carotid endarterectomy (p<0.001)

N Eng J Med, August 5, 1999 Vol. 341:410-418

va hit results2
VA-HIT: Results
  • There was no significant difference in rates of coronary revascularization, hospitalization for unstable angina, death from any cause, and cancer between patients randomized to gemfibrozil or placebo.
  • Gemfibrozil was generally well tolerated. Dyspepsia occurred in 40% of patients taking gemfibrozil and 34% of patients taking placebo (p=0.002)
  • The beneficial effects of gemfibrozil did not become apparent until 2 years after randomization.

N Eng J Med, August 5, 1999 Vol. 341:410-418

va hit primary endpoint results
VA-HIT:Primary Endpoint Results

22% Relative Risk Reduction (p = 0.006)

Nonfatal M.I. or CHD Death, %

N Eng J Med, August 5, 1999 Vol. 341:410-418

va hit results by baseline hdl c death due to chd nonfatal mi or confirmed stroke
VA-HIT: Results by Baseline HDL-CDeath due to CHD, Nonfatal MI or Confirmed Stroke

30% risk reduction

p=0.003

24% risk reduction

p=0.03

N Eng J Med, August 5, 1999 Vol. 341:410-418

slide14

VA-HIT: Results by Baseline LDL-C Death due to CHD, Nonfatal MI or Confirmed Stroke

P< 0.008

P< 0.003

P< 0.02

P< 0.46

P< 0.04

N Eng J Med, August 5, 1999 Vol. 341:410-418

slide15

VA-HIT: Results by Prespecified SubgroupCHD Death, Nonfatal MI, or Confirmed Stroke

Risk Reduction (%): 22 26 24 27 25 24

P value: 0.04 0.007 0.002 0.20 0.11 0.004

N Eng J Med, August 5, 1999 Vol. 341:410-418

slide16

VA-HIT: Results by Prespecified SubgroupCHD Death, Nonfatal MI, or Confirmed Stroke

Risk Reduction (%): -16 34 24 24 17 34

P value: 0.41 0.001 0.05 0.009 0.09 0.002

N Eng J Med, August 5, 1999 Vol. 341:410-418

slide17

VA-HIT: Results by Prespecified SubgroupCHD Death, Nonfatal MI, or Confirmed Stroke

Risk Reduction (%): 27 19 20 42 14 31

P value: 0.002 0.17 0.02 0.007 0.24 0.001

N Eng J Med, August 5, 1999 Vol. 341:410-418

va hit conclusions
VA-HIT:Conclusions
  • The results of this study suggest that raising HDL cholesterol and lowering levels of TG, without lowering LDL cholesterol level, reduces major coronary events in patients whose primary lipid abnormality is a low HDL cholesterol level
  • A 6% increase in HDL and a 31% decrease in TG resulted in 24% decrease in CHD death, nonfatal MI and stroke combined.

N Eng J Med, August 5, 1999 Vol. 341:410-418