Effects of ezetimibe, a new cholesterol absorption inhibitor, on plasma lipids in patients with primary hypercholesterolemia

• Published in: European heart journal 2003-04, Vol.24 (8), p.729-741
• Main Authors: Knopp, R.H., Gitter, H., Truitt, T., Bays, H., Manion, C.V., Lipka, L.J., LeBeaut, A.P., Suresh, R., Yang, B., Veltri, E.P.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Anticholesteremic Agents - therapeutic use; Azetidines - therapeutic use; Cholesterol, LDL - blood; Cosyntropin - blood; Double-Blind Method; Efficacy; Ezetimibe; Female; Humans; Hypercholesterolaemia; Hypercholesterolemia - blood; Hypercholesterolemia - drug therapy; Male; Middle Aged; Safety; Selective cholesterol absorption inhibitor; Single-Blind Method; Triglycerides - blood; Vitamins - blood
• ISSN: 0195-668X; 1522-9645
• DOI: 10.1016/S0195-668X(02)00807-2

Aims This randomized, double-blind, placebo-controlled, parallel-group study evaluated the safety and efficacy of ezetimibe 10mg/day in patients with primary hypercholesterolemia. Methods and results Following dietary stabilization, a 2–12-week washout period, and a 4-week, single-blind, placebo lead-in period, 827 patients with baseline low-density lipoprotein cholesterol (LDL-C) ≥3.36mmol/l (130mg/dl) to ≤6.47mmol/l (250mg/dl) and triglycerides ≤3.95mmol/l (350mg/dl) were randomized 3:1 to receive ezetimibe 10mg or placebo orally once daily in the morning for 12 weeks. The primary efficacy endpoint was percentage reduction in direct plasma LDL-C. Ezetimibe reduced direct LDL-C by a mean of 17.7% from baseline to endpoint, compared with an increase of 0.8% with placebo \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} \((P{