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European Heart Journal 2003 24(8):717-728; doi:10.1016/S0195-668X(02)00803-5
Copyright © 2003 by the European Society of Cardiology.
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Efficacy and safety of ezetimibe coadministered with pravastatin in patients with primary hypercholesterolemia: a prospective, randomized, double-blind trial

Lorenzo Melania,*, Richard Millsb, David Hassmanc, Robert Lipetzd, Leslie Lipkaa, Alexandre LeBeauta, Ramachandran Suresha, Pabak Mukhopadhyaya and Enrico Veltria for the Ezetimibe Study Group1

a Schering-Plough Research Institute, Kenilworth, NJ, USA
b Coastal Carolina Research Center, Mount Pleasant, SC, USA
c Comprehensive Clinical Research, Berlin, NJ, USA
d Encompass Clinical Research, Spring Valley, CA, USA

* Corresponding author. Tel.: +1-908-740-7405; fax: +1-908-740-4070
E-mail address: lorenzo.melani{at}spcorp.com

Received 8 October 2002; accepted 16 October 2002

Aims To evaluate the efficacy and safety of ezetimibe 10mg administered with pravastatin in patients with primary hypercholesterolemia.

Methods and results After dietary stabilization, 2–12 week screening/washout period, and 4-week, single-blind, placebo lead-in period, 538 patients with baseline LDL-C ≥3.8 to ≤6.5mmol/l and TG ≤4.0mmol/l were randomized to one of eight possible treatments administered daily for 12 weeks: ezetimibe 10mg; pravastatin 10, 20, or 40mg; ezetimibe 10mg plus pravastatin 10, 20, or 40mg; or placebo. The primary efficacy endpoint was percent reduction in LDL-C from baseline to study endpoint for ezetimibe 10mg plus pravastatin (pooled doses) compared to pravastatin alone (pooled doses) and ezetimibe alone. The combined use of ezetimibe and pravastatin resulted in significant incremental reductions in LDL-C and TG compared to pooled pravastatin alone . Coadministration therapy reduced LDL-C by 34–41%, TG by 21–23%, and increased HDL-C by 7.8–8.4%, depending on the dose of pravastatin. The combined regimen was well tolerated, with a safety profile similar to pravastatin alone and placebo.

Conclusions When coadministered with pravastatin, ezetimibe provided significant incremental reductions in LDL-C and TG and was well tolerated with a safety profile similar to pravastatin alone.

Key Words: Ezetimibe • Pravastatin • Hypercholesterolemia • Cholesterol absorption inhibitor • Coadministration • LDL-cholesterol


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