University of California, San Francisco, Arteriosclerosis Specialized Center of Research (SCOR) Intervention Trial - SCOR

Description:

LDL reduction for atherosclerotic progression in CAD.

Hypothesis:

Reduction of plasma levels of LDL inhibits progression of coronary atherosclerosis and may promote regression of existing lesions.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 72
Mean Follow Up: 2 years
Mean Patient Age: 42
Female: 57

Patient Populations:

Between the ages of 19 and 72 years
Clinical features compatible with heterozygous familial hypercholesterolemia
Tendon xanthomas
Mean LDL cholesterol levels above 5.17 mmol/L (200 mg/dL), and total triglyceride levels below 3.1 mmol/L (275 mg/dL) while consuming a diet restricted in saturated fats and cholesterol (Patients without tendon xanthomas were included if they had an LDL cholesterol level above 6.46 mmol/L [250 mg/dL] or an LDL cholesterol level greater than 5.17 mmol/L [200 mg/dL] and a first-degree relative with tendon xanthomas.)

Exclusions:

Previous angioplasty, coronary artery bypass graft, or multiple infarcts
Systemic diseases other than atherosclerosis or hypertension
Disorders known to produce secondary hyperlipidemia
Homozygous for apolipoprotein E-2

Primary Endpoints:

Change in cross-sectional percent area stenosis.

Drug/Procedures Used:

Diet; colestipol, initially 30 g/day; niacin, 7.5 g/day; lovastatin, 40 to 60 mg/day in binary or ternary drug combinations.

Concomitant Medications:

Thiazide; calcium channel blocker; beta-antagonist

Principal Findings:

Mean low-density lipoprotein cholesterol levels decreased from 7.32 ±1.5 to 4.45 ±1.6 mmol/L. The mean change in percent area stenosis among controls was +0.80, indicating progression. At the same time, the mean change for the treatment group was -1.53, indicating regression (P = .039 by two-tailed t test for the difference between groups).

Regression among women, analyzed separately, was also significant. The change in percent area stenosis was correlated with low-density lipoprotein levels on trial.

Interpretation:

We conclude that reduction of low-density lipoprotein cholesterol levels can induce regression of atherosclerotic lesions of the coronary arteries in patients with familial hypercholesterolemia. The anticipation of benefit from treatment applies to women and men alike.

References:

1. JAMA 1990;264:3007-12. Final results

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Lipid Metabolism, Nonstatins, Primary Hyperlipidemia, Statins, Diet

Keywords: Coronary Artery Disease, Xanthomatosis, Food Habits, Cholesterol, LDL, Lovastatin, Hyperlipoproteinemia Type II, Tendons, Constriction, Pathologic, Drug Combinations, Heterozygote, Colestipol, Diet, Niacin, Triglycerides


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