Efficacy and safety of ezetimibe coadministered with pravastatin in patients with primary hypercholesterolemia: a prospective, randomized, double-blind trial

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作者：

L Melani，R Mills，D Hassman，R Lipetz，L Lipka，A Lebeaut，R Suresh，P Mukhopadhyay，E Veltri

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摘要：

AIMS: To evaluate the efficacy and safety of 10 mg administered with in patients with .: After dietary stabilization, 2-12 week screening/washout period, and 4-week, single-blind, placebo lead-in period, 538 patients with baseline LDL-C > or =3.8 to < or =6.5 mmol/l and TG < or =4.0 mmol/l were randomized to one of eight possible treatments administered daily for 12 weeks: 10mg; 10, 20, or 40 mg; 10 mg 10, 20, or 40 mg; or placebo. The primary efficacy endpoint was percent reduction in LDL-C from baseline to study endpoint for 10 mg (pooled doses) compared to alone (pooled doses) and alone. The combined use of and resulted in significant incremental reductions in LDL-C and TG compared to pooled alone (p<0.01). 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 . The combined regimen was well tolerated, with a safety profile similar to alone and placebo.: When coadministered with , provided significant incremental reductions in LDL-C and TG and was well tolerated with a safety profile similar to alone.

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关键词：

ezetimibe pravastatin hypercholesterolemia cholesterol absorption inhibitor coadministration LDL-cholesterol

DOI：

10.1016/S0195-668X(03)00286-0

被引量：

408

年份：

2003