Across the individual treatment groups, meanpercentage changes in direct LDL-C from baseline to end point ranged fromapproximately -44% to -57% for coadministration versus -27% to -44% forsimvastatin monotherapy. The incremental mean percentage change resulting fromthe coadministration of ezetimibe with each dose of simvastatin wasstatistically significant (p <0.01) when compared with each correspondingdose of simvastatin monotherapy and between ezetimibe plus simvastatin 10 mgand both simvastatin 20 mg and simvastatin 40 mg alone, and between ezetimibeplus simvastatin 20 mg and simvastatin 40 mg alone.
The meanpercentage change in LDL-C achieved with ezetimibe plus simvastatin 10 mg wasnumerically similar to that with simvastatin 80 mg alone (approximately -44% inboth cases). The incremental LDL-C-lowering effects resulting from thecoadministration of ezetimibe with each dose of simvastatin were observed asearly as Week 2 and maintained for the duration of the study. The incrementalreduction of LDL-C concentrations with coadministration of ezetimibe andsimvastatin (all doses) was generallyconsistent across all subgroups tested, including risk-factor status, gender,age, race, or baseline lipid profile. Results for calculated LDL-C were entirely consistent with thoseobtained for direct LDL-C.
Individually, all coadministration treatmentgroups exhibited consistently greater mean percent changes in calculated LDL-Cfrom baseline to end point (approximately -46%, -46%, -56%, and -58%,respectively) compared with simvastatin alone treatment groups (approximately-27%, -37%, -38%, and -45%).
Thedifference between each dose of simvastatin plus ezetimibe 10 mg versus thesame and the next higher dose of simvastatin alone was statisticallysignificant (p < 0.01). As with direct LDL-C, coadministration of ezetimibewith simvastatin 10 mg resulted in a similar mean percent change as simvastatin80 mg monotherapy (-46% and -45%, respectively). Ezetimibe plus simvastatin(pooled) also significantly improved the following secondary efficacy variablescom- pared with simvastatin alone (pooled): TG and TC, apolipoprotein B,non-HDL-C, direct LDL-C: HDL-C, and TC:HDL-C (p < 0.01); HDL-C (p = 0.03);and HDL3-C (p =0.02). Coadministration of ezetimibe with simvastatin comparedwith simvastatin alone significantly reduced direct LDL-Cat all simvastatindoses (p < 0.01), increased HDL-C at a simvastatin dose of 40 mg (p=0.02), and reduced TG at simvastatin dosesof 10 mg (p =0.01) and 80 mg (p =0.02). Overall, 59% (157/268) of patients whoreceived coadministration therapy compared with 15% (40/261) of patients whoreceived simvastatin monotherapy achieved ≥50% reduction in plasmaconcentrations of direct LDL-C at end point.
meanpercentage通道的变化实现10毫克wasnumerically ezetimibe加辛伐他汀,辛伐他汀类似,仅80毫克(大约-44%里担当情况下)。增量ldl c降低造成的影响thecoadministration ezetimibe每个剂量的辛伐他汀asearly观察作为第2周和维持持续的研究。incrementalreduction浓度的通道与与andsimvastatin ezetimibe(所有剂量)是在所有子组generallyconsistent测试,包括危险因素状况、性别、年龄、种族、或基线血脂。计算结果是完全一致thoseobtained通道直接通道。
单独,所有与treatmentgroups表现出一贯的百分数变化更意味着计算LDL-Cfrom基线结束点(约-46%、-46%、-56%和-58%,分别比单独使用辛伐他汀治疗组(约- 27%,-37%,-38%,和-45%)。
每一剂量的辛伐他汀之间的差异化加上ezetimibe 10毫克与同一和未来更高剂量的辛伐他汀就statisticallysignificant(p < 0.01)。与直接的通道,与ezetimibewith 10毫克辛伐他汀导致类似的平均百分比变化作为单一疗法simvastatin80毫克(分别为-46%和-45%)。Ezetimibe加辛伐他汀(池)可显著提高以下次要疗效variablescom——缩减单独使用辛伐他汀(池):TG、TC、载脂蛋白B、非hdl c,直接通道:高密度脂蛋白胆固醇,酋长:高密度脂蛋白胆固醇(p < 0.01),高密度脂蛋白胆固醇(p = 0.03);HDL3-C(p = 0.02)。与辛伐他汀,辛伐他汀独自ezetimibe控制组显著降低低密度脂蛋白的猫都直接simvastatindoses(p < 0.01),高密度脂蛋白胆固醇的增加在辛伐他汀剂量的40毫克(p = 0.02),并降低TG在辛伐他汀dosesof 10毫克(p = 0.01)和80毫克(p = 0.02)。总体而言,59%(157/268)的患者与治疗whoreceived比例为15%(40/261)的患者whoreceived辛伐他汀单药治疗达到≥50%减少的直接通道plasmaconcentrations在终点。
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