FATS (Familial Atherosclerosis Treatment Study)

18 Mar, 14

Regression of coronary artery disease as a result of intensive lipid lowering therapy in men with high levels of apolipoprotein B.

Purpose

To assess the effect of intensive lipid lowering therapy on coronary atherosclerosis among high risk men.

Design

Randomized, double blind, placebo (or colestipol) controlled, multicenter

146 men, 62 years of age, with plasma levels of apolipoprotein b 125 mg/dL, documented coronary artery disease (1 lesion of 50% stenosis, or 3 lesions of 30% stenosis), and a positive family history of vascular disease.

Follow-up

Clinical evaluation, plasma lipid levels, and coronary angiography at baseline and at 30 months.

Treatment Regimen

Lovastatin 20 mg twice daily, and colestipol 10 g thrice daily
Niacin 1g four times daily, and colestipol 10 g thrice daily
Placebo or colestipol (if LDL cholesterol exceeded the 90th percentile for age).

Additional Therapy

American Heart Association phase I and II diet.

Results

The levels of LDL and HDL cholesterol changed only slightly in the control group (mean change 7% and +5%, respectively). However they were improved with the lovastatin + colestipol (-46% and +15%) or niacin + colestipol (-32% and +43%) arms.
In the control group 46% of the patients had definite lesion progression, while 11% had regression. Progression was observed in only 21% and 25% of the lovastatin + colestipol and niacin + colestipol patients, while regression was observed in 32% and 39%, respectively (p for trend =0.005).
Multivariate regression analysis revealed that reduction in the apolipoprotein b levels, and in systolic blood pressure, and an increase in HDL cholesterol were associated with regression of coronary lesions.
Death, myocardial infarction, or revascularization due to worsening symptoms occurred in 10 of the 52 patients with conventional therapy, as compared to 3 of 46 and 2 of 48 of the lovastatin + colestipol and niacin + colestipol-treated patients (p=0.01). Overall, intensive lipid lowering therapy reduces the incidence of clinical events by 73%.

Conclusion

In men with coronary artery disease who are at high risk, intensive lipid lowering therapy reduced the frequency of progression and increased regression of atherosclerotic coronary lesions, and reduced the incidence of cardiovascular events.

N Engl J Med 1990;323:1289-98