WESTPORT, CT (Reuters Health) – Colesevelam lowers LDL cholesterol (LDL-C) levels by as much as 18% in patients with primary hypercholesterolemia, according to a recent report. In addition, the drug is well tolerated and associated with no serious adverse events.
Colesevelam, marketed by New York-based Sankyo Pharma, Inc. as WelChol, is a nonsystemic lipid-lowering agent that reduces LDL-C levels by binding to intestinal bile acids. Colesevelam was developed by GelTex Pharmaceuticals, Inc. in Waltham, Massachusetts.
In a study reported in the October issue of Mayo Clinic Proceedings, Dr. Joanne M. Donovan, from GelTex, and colleagues randomized 494 patients with primary hypercholesterolemia to receive placebo or colesevelam for 24 weeks. Patients in the colesevelam group were further randomized to receive 2.3 g, 3.0 g, 3.8 g, or 4.5 g of medication each day.
The researchers found that colesevelam lowered LDL-C levels in a dose-dependent manner, resulting in a mean 9% to 18% reduction. At the highest dosage, the median LDL-C reduction was 20%. A dose-dependent decrease in mean total cholesterol levels and mean apolipoprotein B levels was also noted. Median HDL cholesterol levels increased 3% to 4% with colesevelam therapy.
Colesevelam therapy produced an increase in median triglyceride levels, but a comparable increase was also seen with placebo use. Compliance and adverse event rates for placebo and colesevelam groups were similar, the authors note.
"Colesevelam produced a rapid therapeutic response and was well tolerated in the current trial, suggesting that patient compliance will be affected favorably," the investigators write. "Colesevelam appears to be a useful therapeutic alternative for patients with mild to moderate primary hypercholesterolemia."
Mayo Clin Proc 2001;76:971-982.
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