The VA HDL Intervention Trial (HIT): Secondary Prevention of Coronary Heart Disease in Men With Low HDL-Cholesterol and Desirable LDL-Cholesterol
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any - 73 |
| Updated: | 4/21/2016 |
| Start Date: | June 1991 |
| End Date: | August 1999 |
CSP #363 - The VA HDL Intervention Trial (HIT): Secondary Prevention of Coronary Heart Disease in Men With Low HDL-Cholesterol and Desirable LDL-Cholesterol
This was a double-blind randomized trial comparing 1200 mg per day of gemfibrozil with
placebo in 2531 men with coronary heart disease, an HDL-C of 40mg/dl or less, an LDL-C of
140 mg/dl or less, and triglycerides of 300mg/dl or less. The primary outcome was nonfatal
myocardial infarction(MI) or death from coronary causes. The median follow-up was 5.1 years.
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. The rate of events was reduced by
raising HDL-C and lowering triglycerides without lowering LDL-C (N Engl J Med
1999;341:410-418).
placebo in 2531 men with coronary heart disease, an HDL-C of 40mg/dl or less, an LDL-C of
140 mg/dl or less, and triglycerides of 300mg/dl or less. The primary outcome was nonfatal
myocardial infarction(MI) or death from coronary causes. The median follow-up was 5.1 years.
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. The rate of events was reduced by
raising HDL-C and lowering triglycerides without lowering LDL-C (N Engl J Med
1999;341:410-418).
Primary Hypothesis:
To determine if drug treatment aimed at raising HDL-cholesterol and lowering triglycerides
will reduce the rate of heart attack and death in veterans with coronary heart disease (CHD)
and a specific lipid profile characterized by normal levels of LDL-cholesterol and low
levels of HDL-cholesterol.
Secondary Hypotheses:
To determine the effect of treatment on total mortality, unstable angina, CABG, PTCA,
strokes and PVD, and to determine whether there is an association between changes in plasma
lipid levels and outcomes.
Primary Outcomes:
Myocardial infarction (MI), silent MI, and CHD death.
Interventions:
Gemfibrozil (1200 mg per day) versus matching placebo.
Study Abstract:
A double-blind trial was conducted comparing gemfibrozil with placebo in 2531 men with
coronary heart disease, an HDL cholesterol level of 40 mg/dL or less, and an LDL cholesterol
level of 140 mg/dL or less.
The median follow-up was 5.1 years. At one year, the mean HDL was 6% higher, the mean
triglyceride were 31% lower, and the mean total cholesterol was 4% lower in the gemfibrozil
group than in the placebo group. LDL levels did not differ between the groups.
A primary event (MI or death) occurred in 275 of the 1267 placebo patients (21.7%) and in
219 of the 1264 gemfibrozil patients (17.3%). The overall reduction in the risk of an event
was 4.4 percentage points, and the reduction in relative risk was 22% (95% confidence
interval, 7% to 35%; p=0.006). A 24% relative risk reduction occurred in the combined
outcome of death from coronary heart disease, nonfatal myocardial infarction, and stroke
(p<0.001). Gemfibrozil therapy resulted in a significant reduction in the risk of major
cardiovascular events in patients with coronary disease whose primary lipid abnormality was
a low HDL cholesterol level. The findings suggest that the rate of coronary events is
reduced by raising HDL cholesterol levels and lowering levels of triglycerides without
lowering LDL cholesterol levels.
The major findings were published in the New England Journal of Medicine in August, 1999. A
paper on lipid screening was published in the Journal of Clinical Epidemiology in July, 1999
and one on clinical implications was published in the European Heart Journal. Our cost
analysis shows that gemfibrozil therapy is highly cost-effective if not cost-saving, thus
providing a strong rationale for incorporating results into clinical practice. A manuscript
about lipids as predictors of endpoints was published in JAMA in March, 2001. Another paper
on stroke was published in Circulation in June, 2001. Dr. Robins presented data on diabetics
in November, 2000 at the AHA. A paper on cost-effectiveness was published in the Archives of
Internal Medicine in January 2002. A manuscript on diabetes has been accepted by the
Archives of Internal Medicine.
A NHLBI grant for continuing analysis has been funded for two years. Other papers in
progress include homocysteines in diabetics, fasting plasma insulin as a predictor of
outcome, and the effect of lipoprotein subclass particle size on coronary events.
To determine if drug treatment aimed at raising HDL-cholesterol and lowering triglycerides
will reduce the rate of heart attack and death in veterans with coronary heart disease (CHD)
and a specific lipid profile characterized by normal levels of LDL-cholesterol and low
levels of HDL-cholesterol.
Secondary Hypotheses:
To determine the effect of treatment on total mortality, unstable angina, CABG, PTCA,
strokes and PVD, and to determine whether there is an association between changes in plasma
lipid levels and outcomes.
Primary Outcomes:
Myocardial infarction (MI), silent MI, and CHD death.
Interventions:
Gemfibrozil (1200 mg per day) versus matching placebo.
Study Abstract:
A double-blind trial was conducted comparing gemfibrozil with placebo in 2531 men with
coronary heart disease, an HDL cholesterol level of 40 mg/dL or less, and an LDL cholesterol
level of 140 mg/dL or less.
The median follow-up was 5.1 years. At one year, the mean HDL was 6% higher, the mean
triglyceride were 31% lower, and the mean total cholesterol was 4% lower in the gemfibrozil
group than in the placebo group. LDL levels did not differ between the groups.
A primary event (MI or death) occurred in 275 of the 1267 placebo patients (21.7%) and in
219 of the 1264 gemfibrozil patients (17.3%). The overall reduction in the risk of an event
was 4.4 percentage points, and the reduction in relative risk was 22% (95% confidence
interval, 7% to 35%; p=0.006). A 24% relative risk reduction occurred in the combined
outcome of death from coronary heart disease, nonfatal myocardial infarction, and stroke
(p<0.001). Gemfibrozil therapy resulted in a significant reduction in the risk of major
cardiovascular events in patients with coronary disease whose primary lipid abnormality was
a low HDL cholesterol level. The findings suggest that the rate of coronary events is
reduced by raising HDL cholesterol levels and lowering levels of triglycerides without
lowering LDL cholesterol levels.
The major findings were published in the New England Journal of Medicine in August, 1999. A
paper on lipid screening was published in the Journal of Clinical Epidemiology in July, 1999
and one on clinical implications was published in the European Heart Journal. Our cost
analysis shows that gemfibrozil therapy is highly cost-effective if not cost-saving, thus
providing a strong rationale for incorporating results into clinical practice. A manuscript
about lipids as predictors of endpoints was published in JAMA in March, 2001. Another paper
on stroke was published in Circulation in June, 2001. Dr. Robins presented data on diabetics
in November, 2000 at the AHA. A paper on cost-effectiveness was published in the Archives of
Internal Medicine in January 2002. A manuscript on diabetes has been accepted by the
Archives of Internal Medicine.
A NHLBI grant for continuing analysis has been funded for two years. Other papers in
progress include homocysteines in diabetics, fasting plasma insulin as a predictor of
outcome, and the effect of lipoprotein subclass particle size on coronary events.
Inclusion Criteria:
Inclusion criteria:
1. male gender
2. age 73 or younger
3. presence of CHD
4. HDL-C le 40 mg/dl
5. LDL-C le 140 mg/dl
6. triglycerides le 300 mg/dl
Exclusion Criteria:
Exclusion criteria:
1. significant medical illness
2. alcohol or substance abuse
3. evidence of cholecystitis or cholelithiasis
4. ejection fraction of lt 35%
5. current use of steroids, estrogens, immunosuppressive agents, oral coagulants, or
lipid modifying drug.
6. allergic to gemfibrozil or fibric acid
7. refused informed consent
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