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Cholesterol/Lipid Disorders
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my personal edition > cholesterol/lipid disorders > news
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DGReview
Ezetimibe Safe and Effective in Patients With Hypercholesterolaemia
A DGReview of :"Evaluation of the efficacy, safety, and tolerability of ezetimibe in primary hypercholesterolaemia: a pooled analysis from two controlled phase III clinical studies"
International Journal of Clinical Practice
07/29/2003
By Emma Hitt, PhD
Ezetimibe, a novel cholesterol absorption inhibitor, appears to be safe and effective in improving lipid profiles in patients with hypercholesterolaemia, according to a pooled analysis of over 1700 patients.
Ezetimibe prevents the absorption of dietary and biliary cholesterol across the intestinal wall, without affecting absorption of other nutrients or fat-soluble vitamins. It has a long half-life and is administered once daily, with or without food.
Robert H Knopp, MD, with the Northwest Lipid Research Clinic at the University of Washington, Seattle, United States analysed data from 1719 patients who participated in 2 multi-centre, double-blind studies.
Patients underwent dietary stabilisation, a 2- to 12-week washout period, and a four-week, single-blind, placebo lead-in period. They were then randomised to receive ezetimibe 10 mg or placebo once daily in the morning for 12 consecutive weeks.
Ezetimibe reduced LDL-cholesterol by a mean of 18.2% compared with placebo, which increased LDL-cholesterol by 0.9% (p<0.01). The group taking ezetimibe also experienced significant improvements in HDL-cholesterol, triglycerides and apolipoprotein B.
The response to ezetimibe was consistent across all subgroups analysed, and the drug was well tolerated, with a safety profile similar to placebo, the researchers report.
According to Dr. Knopp and colleagues, the reduction in LDL-cholesterol is similar to that observed in three phase II trials. Furthermore, in all studies, the LDL-cholesterol reduction was apparent at 2 weeks and was maintained to endpoint.
"Ezetimibe has value as monotherapy to treat patients with mild primary hypercholesterolaemia, particularly as an option in patients who are hypersensitive or intolerant to the available cholesterol-lowering agents," the researchers conclude. "Ezetimibe also has great potential for use in combination with statins to increase, with a minimum of side-effects, the percentage of patients attaining LDL-cholesterol goals and, ultimately, reducing risk of coronary heart disease," they add.
Int J Clin Pract 2003;57:5:363-368.
"Evaluation of the efficacy, safety, and tolerability of ezetimibe in primary hypercholesterolaemia: a pooled analysis from two controlled phase III clinical studies"
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