Cardiovascular outcome trial · N Engl J Med 1999
VA-HIT trial
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.
The bottom line
In men with coronary heart disease and low HDL cholesterol but not high LDL, gemfibrozil reduced the risk of major cardiovascular events despite not lowering LDL cholesterol.
BenefitUS status: US-approved
At a glance
- Medicine
- Gemfibrozil (1200 mg per day)
- Compared with
- Placebo
- People
- 2,531
- Who took part
- Men with coronary heart disease, HDL cholesterol level of 40 mg per deciliter (1.0 mmol per liter) or less, and LDL cholesterol level of 140 mg per deciliter (3.6 mmol per liter) or less
- Design
- double-blind trial
- Follow-up
- median follow-up was 5.1 years
- Main question
- Nonfatal myocardial infarction or death from coronary causes
Main result
A primary event occurred in 275 of the 1267 patients assigned to placebo (21.7 percent) and in 219 of the 1264 patients assigned to gemfibrozil (17.3 percent); the reduction in relative risk was 22 percent (95 percent confidence interval, 7 to 35 percent; P=0.006)
Effect on LDL cholesterol
LDL cholesterol levels did not differ significantly between the groups
Other results
There were no significant differences in the rates of coronary revascularization, hospitalization for unstable angina, death from any cause, and cancer. We observed a 24 percent reduction in the combined outcome of death from coronary heart disease, nonfatal myocardial infarction, and stroke (P< 0.001).
Safety
There were no significant differences in the rates of coronary revascularization, hospitalization for unstable angina, death from any cause, and cancer.
In the trial's own words
“A primary event occurred in 275 of the 1267 patients assigned to placebo (21.7 percent) and in 219 of the 1264 patients assigned to gemfibrozil (17.3 percent). The overall reduction in the risk of an event was 4.4 percentage points, and the reduction in relative risk was 22 percent (95 percent confidence interval, 7 to 35 percent; P=0.006).”
Quoted from the abstract of N Engl J Med 1999, checked word for word against PubMed. PubMed 10438259 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Fibrates (fenofibrate)
Common questions
What did the VA-HIT trial find?
In men with coronary heart disease and low HDL cholesterol but not high LDL, gemfibrozil reduced the risk of major cardiovascular events despite not lowering LDL cholesterol.
Who was in VA-HIT?
2,531 people. Men with coronary heart disease, HDL cholesterol level of 40 mg per deciliter (1.0 mmol per liter) or less, and LDL cholesterol level of 140 mg per deciliter (3.6 mmol per liter) or less.
What was VA-HIT's main result?
A primary event occurred in 275 of the 1267 patients assigned to placebo (21.7 percent) and in 219 of the 1264 patients assigned to gemfibrozil (17.3 percent); the reduction in relative risk was 22 percent (95 percent confidence interval, 7 to 35 percent; P=0.006)
How much did LDL cholesterol change in VA-HIT?
LDL cholesterol levels did not differ significantly between the groups
Related trials
- FIELD (2005)In patients with type 2 diabetes not on statins, fenofibrate did not significantly reduce coronary events but did reduce total cardiovascular events, driven by fewer nonfatal heart attacks and revascularizations, with a small increase in pancreatitis and pulmonary embolism.
- JELIS (2007)Adding EPA to statin therapy modestly reduced major coronary events, mainly non-fatal events, in hypercholesterolaemic Japanese patients, without a significant effect on sudden cardiac or coronary death.
- ACCORD Lipid (2010)Adding fenofibrate to simvastatin did not reduce cardiovascular events or death compared with simvastatin alone in high-risk patients with type 2 diabetes, so routine combination therapy is not supported.
- Helsinki Heart Study (1987)In middle-aged men with dyslipidemia, gemfibrozil raised HDL and lowered non-HDL cholesterol and significantly reduced coronary heart disease incidence over five years without affecting total mortality or cancer rates.
Get your LDL treated to a goal
Preval Health's protocols follow trials like this one. Licensed clinicians set your goal, prescribe and recheck until you reach it.
Get startedEducation only, not medical advice. Results describe the people in this trial and can differ for you. Talk with your clinician before starting or stopping any medicine. Back to all 106 trials.