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New Cholesterol Absorption Inhibitor Appears Safe, Effective for Hypercholesterolemia

Ezetimibe, a new cholesterol absorption inhibitor, appears safe and effective for lowering low density lipid cholesterol and improving other key lipid parameters.

Carlos A. Dujovne, MD, at the Kansas Foundation for Clinical Pharmacology, Overland Park, Kansas, United States, and colleagues conducted a randomised, double-blind, placebo-controlled trial to evaluate the safety and efficacy of the new drug.

The study involved 892 patients with primary hypercholesterolemia, with low density lipid (LDL) cholesterol levels between 130 to 250 mg/dL and triglycerides at 350 mg/dL or less.

After two weeks on the National Cholesterol Education Program (NCEP) Step I or a stricter diet, and a four- to eight-week single-blind placebo lead-in, the patients were randomised 3-1 to receive ezetimibe 10 mg or placebo orally each morning for 12 weeks.

The primary efficacy end point was the percent reduction in direct plasma low density lipid cholesterol from baseline. A total of 434 men and 458 women (ages 18 to 85 years) received randomized treatment (666 ezetimibe 10 mg, 226 placebo). Demographics and baseline characteristics of the ezetimibe and placebo groups were similar, the researchers noted.

Ezetimibe significantly reduced direct low density lipid cholesterol by a mean of 16.9 percent, compared with an increase of 0.4 percent for placebo (p < .01). Subgroup analysis indicated that response to ezetimibe was generally consistent across all subgroups, regardless of risk-factor status, gender, age, race or baseline lipid profile. Ezetimibe effects on low density lipid cholesterol occurred by the second week and persisted throughout the 12-week treatment period, the investigators reported.

Compared with placebo, ezetimibe 10 mg also significantly improved calculated LDL cholesterol, apolipoprotein B, total cholesterol, triglycerides, high-density lipoprotein cholesterol, and high density lipid-3 cholesterol (p < 0.01).

There were no differences in laboratory or clinical safety parameters, or gastrointestinal, liver or muscle side effects between the drug and placebo groups.

"Ezetimibe 10 mg/day is well tolerated, reduces LDL cholesterol approximately 17 percent and improves other key lipid parameters," the researchers concluded.
Am J Cardiol 2002; 90: 1092-1097. "Efficacy and safety of a potent new selective cholesterol absorption inhibitor, ezetimibe , in patients with primary hypercholesterolemia"

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