Pearson Thomas, Ballantyne Christie, Sisk Christine, Shah Arvind, Veltri Enrico, Maccubbin Darbie
University of Rochester School of Medicine and Dentistry, Rochester, New York, USA.
Am J Cardiol. 2007 Jun 15;99(12):1706-1713. doi: 10.1016/j.amjcard.2007.01.062. Epub 2007 May 2.
The lowering effects of ezetimibe/simvastatin combination therapy on low-density lipoprotein (LDL) cholesterol and high-sensitivity C-reactive protein (CRP) were compared with those of simvastatin or atorvastatin monotherapy in a large cohort of patients with primary hypercholesterolemia. To compare ezetimibe/simvastatin with simvastatin, data were combined from 3 identical, prospective 12-week trials in which patients were randomized to receive placebo; ezetimibe 10 mg; ezetimibe 10 mg added to simvastatin 10, 20, 40, or 80 mg; or simvastatin 10, 20, 40, or 80 mg. To compare ezetimibe/simvastatin with atorvastatin, data were analyzed from a phase III double-blind, active-controlled study in which patients were randomized equally to receive ezetimibe/simvastatin 10/10, 10/20, 10/40, or 10/80 mg or atorvastatin 10, 20, 40, or 80 mg for 6 weeks. When averaged across doses, ezetimibe/simvastatin produced significantly greater reductions compared with simvastatin alone in LDL cholesterol (52.5% vs 38.0%, respectively) and CRP levels (31.0% vs 14.3%, respectively). At each individual simvastatin dose, co-administration with ezetimibe produced significant further CRP reductions versus simvastatin alone. Ezetimibe/simvastatin was significantly more effective at lowering LDL cholesterol than atorvastatin when pooled across doses (53.4% vs 45.3%, respectively) and in each milligram-equivalent dose comparison. Reductions in CRP of similar magnitude were observed with ezetimibe/simvastatin and atorvastatin when averaged across doses and at each milligram-equivalent statin dose comparison. In conclusion, the lipid-modulating and anti-inflammatory effects of ezetimibe/simvastatin provide additional benefits not realized by statin monotherapy alone.
在一大群原发性高胆固醇血症患者中，比较了依折麦布/辛伐他汀联合疗法与辛伐他汀或阿托伐他汀单药疗法对低密度脂蛋白（LDL）胆固醇和高敏C反应蛋白（CRP）的降低作用。为了比较依折麦布/辛伐他汀与辛伐他汀，将3项相同的前瞻性12周试验的数据合并，在这些试验中，患者被随机分配接受安慰剂；依折麦布10毫克；依折麦布10毫克加辛伐他汀10、20、40或80毫克；或辛伐他汀10、20、40或80毫克。为了比较依折麦布/辛伐他汀与阿托伐他汀，对一项III期双盲、活性对照研究的数据进行了分析，在该研究中，患者被随机均分为接受依折麦布/辛伐他汀10/10、10/20、10/40或10/80毫克或阿托伐他汀10、20、40或80毫克，为期6周。当各剂量平均计算时，与单独使用辛伐他汀相比，依折麦布/辛伐他汀使LDL胆固醇（分别为52.5%对38.0%）和CRP水平（分别为31.0%对14.3%）的降低幅度显著更大。在辛伐他汀的每个单独剂量下，与依折麦布联合使用相对于单独使用辛伐他汀可使CRP进一步显著降低。当各剂量合并计算时以及在每毫克当量剂量比较中，依折麦布/辛伐他汀在降低LDL胆固醇方面比阿托伐他汀显著更有效（分别为53.4%对45.3%）。当各剂量平均计算以及在每毫克当量他汀剂量比较中，依折麦布/辛伐他汀和阿托伐他汀观察到相似程度的CRP降低。总之，依折麦布/辛伐他汀的调脂和抗炎作用提供了单独使用他汀类单药疗法无法实现的额外益处。
