Hydroxypropylmethylcellulose (HPMC) is a food gum having several structural
and functional properties in common with hypocholesterolemic soluble fiber
s. The safety and cholesterol-lowering efficacy of HPMC, incorporated into
a National Cholesterol Education program Step 1 diet, was compared with pla
cebo in patients with mild to moderate hypercholesterolemia. After an 8-wee
k National Cholesterol Education Program Step I dietary lead-in phase, 160
patients with low-density lipoprotein (LDL) cholesterol between 130 and 200
mg/dl and triglycerides <300 mg/dl were randomized to placebo, 2.5, 5.0, o
r 7.5 g/day of HPMC for a 6-week treatment period. Patients returned to the
clinic every 2 weeks for lipid measurements and safety assessments. HPMC s
ignificantly lowered total, LDL, and non-high-density lipoprotein (HDL) cho
lesterol, LDL cholesterol concentrations (overage of weeks 4 and 6) decreas
ed by 3.0% (4.9 mg/dl), 5.9% (10.3 mg/dl), 12.1% (20.4 mg/dl), and 11.7% (2
0.3 mg/dl) from baseline levels in the placebo and 2.5, 5.0, and 7.5 g/day
HPMC treatment groups, respectively. Statistically significant (p < 0.05) r
eductions in LDL cholesterol were observed in the 5.0 and 7.5 g/day HPMC gr
oups compared with placebo and 2.5 g/day HPMC treatment groups, Total and n
on-HDL cholesterol responses paralleled those of LDL cholesterol. There wer
e no significant differences between the treatment groups in HDL cholestero
l or triglyceride responses, incidence of adverse experiences, or gastroint
estinal-related adverse experiences. These results suggest that HPMC is a w
ell-tolerated and effective adjunct to diet for lowering LDL cholesterol in
patients with mild to moderate hypercholesterolemia. (C) 1999 by Excerpta
Medico, Inc.