Recommended doses of
bile-acid binding resins have an established hypocholesterolemic effect, but data on responses to low doses, especially in women and subjects with moderate
hypercholesterolemia, are sparse. A double-blind, placebo-controlled, randomized trial of 3 low doses of
colestipol hydrochloride was conducted in women and men with moderate
hypercholesterolemia. Men and women with plasma
low-density lipoprotein (
LDL) cholesterol concentrations greater than 4 mmol/liter (155 mg/dl) and
triglyceride concentrations less than 2.82 mmol/liter (250 mg/dl) were recruited for the study. Eligible patients (54 women and 98 men) were placed on the American Heart Association step I diet 6 weeks before randomization. Participants were subsequently assigned to 1 of 4
drug treatment groups (placebo, and 5, 10 and 15 g/day of
colestipol in 2 divided doses) for an additional 12 weeks. Of the 152 patients randomized, 141 completed all aspects of the study. For the treatment groups--placebo, and 5, 10 and 15 g of
colestipol--
LDL cholesterol reductions (mmol/liter) were observed respectively (n = 141): 0.10 +/- 0.49 (2.7%), 0.65 +/- 0.41 (16.3%), 0.98 +/- 0.36 (22.8%) and 1.17 +/- 0.47 (27.2%) (p less than 0.001). Similar changes were observed in total
cholesterol and
apolipoprotein B concentrations. The
apolipoprotein B/
LDL cholesterol ratio increased significantly with increasing
colestipol dosage. Modest but insignificant changes in plasma
triglyceride levels occurred, and
high-density lipoprotein cholesterol levels remained unchanged. A dose of 5 g/day of
colestipol achieved 51% of the
LDL cholesterol reduction noted with 15 g/day. Low-dose
colestipol therapy is effective in the treatment of patients with moderate
hypercholesterolemia.(ABSTRACT TRUNCATED AT 250 WORDS)