Familial Atherosclerosis Treatment Study
Condition: Cardiovascular Diseases; Coronary Arteriosclerosis; Coronary Disease; Heart Diseases; Myocardial Ischemia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Arteriosclerosis; Ischemia
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the effects of two intensive lipid-lowering regimens with conventional therapy on
      coronary atherosclerosis as assessed by arteriography.
    

Detailed description: 
      BACKGROUND:

      For several decades, clinical trials have addressed the question of whether treatment of
      hyperlipidemia reduces the risk of cardiovascular events. Substantial evidence supports the
      idea that cardiovascular benefits are related to the degree of reduction in low-density
      lipoprotein cholesterol level and perhaps to the degree of increase in the high-density
      lipoprotein cholesterol level. In these trials, changes in lipid levels have usually been
      small and the overall clinical benefits have been limited. The appearance in the 1980s of
      more effective treatments for hyperlipidemia, new arteriographic methods for assessing
      atherosclerosis, and new insights into atherogenesis permitted an objective investigation
      into whether the progression of atherosclerosis was retarded or reversed by lipid-lowering
      agents.

      The clinical trial was supported by a subproject within a program project grant.

      DESIGN NARRATIVE:

      Randomized, double-blind, placebo-controlled. Baseline arteriograms were performed and
      fasting lipid samples drawn before heparinization. Patients were stratified for age below 45
      years, cigarette smoking within the previous month, and lipid patterns including familial
      hypercholesterolemia and triglyceride levels. Patients were given dietary counseling and
      randomly assigned to one of three treatments: lovastatin (20 mg twice a day) and colestipol
      (10 g three times a day); niacin (1 g four times a day) and colestipol (10 g three times a
      day): or conventional therapy with placebo (or colestipol if the LDL cholesterol level was
      elevated). The primary endpoint was a measure of change in the severity of disease in the
      proximal coronary arteries as measured by quantitative arteriography.
    

Intervention name(s): lovastatin; colestipol; niacin; Placebo for colestipol; Placebo for lovastatin
Intervention type(s): Drug; Drug; Drug; Other; Other
Intervention description(s): Lovastatin was begun at a dose of 20 mg twice a day (in the morning and at bedtime). If the LDL cholesterol level did not fall below 3.1 mmol per liter after three months, the dose of lovastatin was increased to 40 mg twice a day.; Colestipol was begun at a dose of 5 g three times a day with meals and increased to 10 g three times a day after 10 days, unless side effects delayed the increase. Psyllium hydrophic mucilloid (Metamucil) was provided if dietary bran was insufficient to control constipation.; Niacin was started at 125 mg twice a day and gradually increased to 500 mg four times a day (with meals and at bedtime) at one month and 1 g four times a day at two months. If the LDL cholesterol level did not fall below 3.1 mmol per liter (120 mg per deciliter) after three months, the dose of niacin was increased to 1.5 g (three tablets) four times a day, but no further.; Placebo for colestipol.; Placebo for lovastatin
Other intervention name(s): Mevacor; Colestid; nicotinic acid
Intervention MeSH terms: Niacin; Nicotinic Acids; Lovastatin; L 647318; Dihydromevinolin; Colestipol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment