Dose--Response Study of Colestipol Tablets in Patients with Moderate Hypercholesterolemia.
The purpose of the study was to evaluate the efficacy and safety of a new formulation of colestipol provided in table form. This was a randomized, double-blind, placebo-controlled, multicenter, dose-ranging study. A total of 196 patients with primary hypercholesterolemia who were following a low-fat, low-cholesterol diet (NCEP Step I diet), and having mean low-density lipoprotein cholesterol (LDL-C) levels greater-than-or-equal4.14 mmol L(minus sign1) (160 mg dl(minus sign1)) and less-than-or-equal6.46 mmol L(minus sign1) (250 mg dl(minus sign1)) were studied. Study medication was taken twice daily, with breakfast and supper, for 8 weeks. The five parallel treatment groups consisted of colestipol tablets 1, 2, 4, and 8 g BID, and matching placebo tablets BID. The main outcome measures were absolute change and percent change from baseline in selected lipid, lipoprotein, and apolipoprotein measurements; LDL-C was considered primary. Statistically significant (p less-than-or-equal 0.05) dose-dependent reductions in LDL-C from 5.2% to 25.8% and in total cholesterol from 2.8% to 16.8% were observed. Colestipol tablet treatment also resulted in statistically significant dose-dependent increases in LpAl levels reaching 25.8% at 16 g day(minus sign1). The treatment was well tolerated, and no serious adverse events were reported. Colestipol administered in tablet form was efficacious in lowering LDL-C and total cholesterol and was well tolerated in patients with primary hypercholesterolemia.
Hunninghake
Donald B.
DB
University of Minnesota Heart Disease Prevention Clinic, Minneapolis, USA.
Stein
Evan A.
EA
Bremner
W. Fraser
WF
Greenland
Philip
P
Demke
Donald M.
DM
Oliphant
Thomas H.
TH