Catapano Alberico, Brady William E, King Thomas R, Palmisano Joanne
Marie Curie Training Centre for Cardiovascular Diseases, Milan, Italy.
Curr Med Res Opin. 2005 Jul;21(7):1123-30. doi: 10.1185/030079905X50642.
Results of direct comparative studies between ezetimibe/simvastatin and rosuvastatin therapies have not been reported. Both of these treatment options offer significant reductions in LDL-C. To evaluate the lipid efficacy of each of these therapies relative to each other, a meta-analysis of data from 14 randomized, double-blind clinical trials that compared the effectiveness of two new options for cholesterol lowering was performed.
PubMed, EMBASE and BIOSIS databases were searched up to March 14, 2004.
Efficacy results from clinical trials with the co-administration of ezetimibe 10 mg with simvastatin or with the ezetimibe/simvastatin combination product (ezetimibe/simvastatin 10/10 mg, 10/20 mg, 10/40 mg, and 10/80 mg) were compared with efficacy results from clinical trials of rosuvastatin 5 mg, 10 mg, 20 mg, and 40 mg in patients with primary hypercholesterolemia. Trials in healthy patients, heterozygous familial hypercholesterolemia or combined hyperlipidemia, and pharmacokinetic trials were excluded.
This analysis used pooled data for LDL-C, HDL-C, non-HDL-C, triglycerides, total cholesterol, apolipoprotein (apo) A-I, and apo B for the two therapies at their lowest doses (ezetimibe/simvastatin 10/10 mg and rosuvastatin 5 mg) through their highest doses (ezetimibe/simvastatin 10/80 mg and rosuvastatin 40 mg), and estimated within-treatment percentage changes in these parameters. Percentage reductions from baseline in LDL-C for the pooled data were 46.2% and 41.8% for ezetimibe/simvastatin 10/10 mg and rosuvastatin 5 mg, respectively; 50.6% and 47.4% for ezetimibe/simvastatin 10/20 mg and rosuvastatin 10 mg, respectively; 55.9% and 52.1% for ezetimibe/simvastatin 10/40 mg and rosuvastatin 20 mg, respectively; and 59.7% and 58.5% for ezetimibe/simvastatin 10/80 mg and rosuvastatin 40 mg, respectively.
The results of this meta-analysis suggest greater LDL-C lowering with ezetimibe/simvastatin compared with rosuvastatin. These results need to be confirmed in a head-to-head comparison of both therapies.
依折麦布/辛伐他汀与瑞舒伐他汀治疗之间的直接对比研究结果尚未见报道。这两种治疗方案均可使低密度脂蛋白胆固醇（LDL-C）显著降低。为评估这两种疗法相对于彼此的降脂疗效，对14项比较两种新型降胆固醇方案有效性的随机双盲临床试验数据进行了荟萃分析。
检索了截至2004年3月14日的PubMed、EMBASE和BIOSIS数据库。
将依折麦布10 mg与辛伐他汀联合应用或依折麦布/辛伐他汀复方制剂（依折麦布/辛伐他汀10/10 mg、10/20 mg、10/40 mg和10/80 mg）的临床试验疗效结果，与瑞舒伐他汀5 mg、10 mg、20 mg和40 mg治疗原发性高胆固醇血症患者的临床试验疗效结果进行比较。排除健康患者、杂合子家族性高胆固醇血症或混合性高脂血症患者的试验以及药代动力学试验。
本分析使用了两种疗法在最低剂量（依折麦布/辛伐他汀10/10 mg和瑞舒伐他汀5 mg）至最高剂量（依折麦布/辛伐他汀10/80 mg和瑞舒伐他汀40 mg）时LDL-C、高密度脂蛋白胆固醇（HDL-C）、非HDL-C、甘油三酯、总胆固醇、载脂蛋白（apo）A-I和apo B的汇总数据，并估计了这些参数在治疗期间的百分比变化。依折麦布/辛伐他汀10/1 mg和瑞舒伐他汀5 mg的汇总数据中，LDL-C从基线水平降低的百分比分别为46.2%和41.8%；依折麦布/辛伐他汀10/20 mg和瑞舒伐他汀10 mg分别为50.6%和47.4%；依折麦布/辛伐他汀10/40 mg和瑞舒伐他汀20 mg分别为55.9%和52.1%；依折麦布/辛伐他汀10/80 mg和瑞舒伐他汀40 mg分别为59.7%和58.5%。
这项荟萃分析的结果表明，与瑞舒伐他汀相比，依折麦布/辛伐他汀降低LDL-C的效果更佳。这些结果需要在两种疗法的直接对比研究中得到证实。
