瑞舒伐他汀与阿托伐他汀在高胆固醇血症患者52周治疗期内的疗效比较。

Effects of rosuvastatin and atorvastatin compared over 52 weeks of treatment in patients with hypercholesterolemia.

作者信息

Olsson Anders G, Istad Helge, Luurila Olavi, Ose Leiv, Stender Steen, Tuomilehto Jaakko, Wiklund Olov, Southworth Harry, Pears John, Wilpshaar J W

机构信息

Department of Medicine and Care, University Hospital, Linköping, Sweden.

出版信息

Am Heart J. 2002 Dec;144(6):1044-51. doi: 10.1067/mhj.2002.128049.

DOI:10.1067/mhj.2002.128049

PMID:12486429

Abstract

BACKGROUND

Despite the demonstrated benefits of low-density lipoprotein cholesterol (LDL-C) reduction in reducing the risk of coronary heart disease, many patients receiving lipid-lowering therapy fail to achieve LDL-C goals. We compared the effects of rosuvastatin and atorvastatin in reducing LDL-C and achieving LDL-C goals in patients with primary hypercholesterolemia.

METHODS AND RESULTS

In this 52-week, randomized, double-blind, multicenter trial (4522IL/0026), 412 patients with LDL-C 160 to <250 mg/dL received a 5-mg dose of rosuvastatin (n = 138), a 10-mg dose of rosuvastatin (n = 134), or a 10-mg dose of atorvastatin (n = 140) for 12 weeks; during the following 40 weeks, dosages could be sequentially doubled up to 80 mg if National Cholesterol Education Program Adult Treatment Panel II (ATP-II) LDL-C goals were not achieved. At 12 weeks, 5- and 10-mg doses of rosuvastatin were associated with significantly greater LDL-C reductions than 10-mg doses of atorvastatin (46% and 50% vs 39%, both P <.001). At 12 weeks, both rosuvastatin dosages brought more patients to within ATP-II and European LDL-C goals than atorvastatin (86% and 89% vs 73% and 75%, and 86% vs 55%, respectively). At 52 weeks, compared with atorvastatin, both initial rosuvastatin treatment groups significantly reduced LDL-C (47% and 53% vs 44%, P <.05 and P <.001). Overall, more patients in the initial rosuvastatin 10-mg group achieved their ATP-II LDL-C goal than those in the initial atorvastatin 10-mg group (98% vs 87%), with 82% of patients treated with rosuvastatin achieving their goal at the 10-mg starting dosage without the need for titration, compared with 59% of patients treated with atorvastatin. Both treatments were well tolerated over 52 weeks.

CONCLUSION

Compared with atorvastatin, rosuvastatin produced greater reductions in LDL-C, which may offer advantages in LDL-C goal attainment over existing lipid-lowering therapies.

摘要

背景

尽管降低低密度脂蛋白胆固醇（LDL-C）已证实对降低冠心病风险有益，但许多接受降脂治疗的患者仍未达到LDL-C目标。我们比较了瑞舒伐他汀和阿托伐他汀在降低原发性高胆固醇血症患者LDL-C及实现LDL-C目标方面的效果。

方法与结果

在这项为期52周的随机、双盲、多中心试验（4522IL/0026）中，412例LDL-C为160至<250mg/dL的患者接受5mg剂量瑞舒伐他汀（n = 138）、10mg剂量瑞舒伐他汀（n = 134）或10mg剂量阿托伐他汀（n = 140）治疗12周；在接下来的40周内，如果未达到美国国家胆固醇教育计划成人治疗小组第二次报告（ATP-II）的LDL-C目标，剂量可依次加倍至80mg。12周时，5mg和10mg剂量的瑞舒伐他汀使LDL-C降低的幅度显著大于10mg剂量的阿托伐他汀（分别为46%和50%对39%，P均<.001）。12周时，两种剂量的瑞舒伐他汀使更多患者达到ATP-II及欧洲LDL-C目标，高于阿托伐他汀（分别为86%和89%对73%和75%，以及86%对55%）。52周时，与阿托伐他汀相比，两个初始瑞舒伐他汀治疗组均显著降低了LDL-C（分别为47%和53%对44%，P<.05和P<.001）。总体而言，初始10mg瑞舒伐他汀组中达到ATP-II LDL-C目标的患者多于初始10mg阿托伐他汀组（98%对87%），82%接受瑞舒伐他汀治疗的患者在起始10mg剂量时即达到目标，无需调整剂量，而接受阿托伐他汀治疗的患者这一比例为59%。两种治疗在52周内耐受性均良好。