Fonseca Francisco A H, Ruiz Alvaro, Cardona-Muñoz Ernesto G, Silva Jose M, Fuenmayor Nery, Marotti Marcelo
Disciplina de Cardiologia, Universidade Federal de São Paulo, São Paulo, Brazil.
Curr Med Res Opin. 2005 Aug;21(8):1307-15. doi: 10.1185/030079905X56529.
International guidelines emphasize the need to achieve recommended low-density lipoprotein cholesterol (LDL-C) levels in order to reduce morbidity and mortality associated with coronary heart disease (CHD). However, many patients with hypercholesterolemia fail to achieve LDL-C goals on treatment.
The primary objective was to compare the efficacy of rosuvastatin and atorvastatin for enabling patients to achieve National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) LDL-C goals. Secondary objectives were European LDL-C goal achievement, changes in the lipid profile, and safety.
This 12-week, multicenter, multinational, randomized, open-label trial compared the efficacy and safety of rosuvastatin 10 mg with atorvastatin 10 mg in statin-naïve and switched patients with primary hypercholesterolemia from Brazil, Colombia, Mexico, Portugal, and Venezuela.
A total of 1124 patients with similar baseline characteristics were randomized to the two treatment groups. After 12 weeks of treatment, a significantly greater percentage of patients receiving rosuvastatin 10 mg compared with atorvastatin 10 mg achieved NCEP ATP III LDL-C goals (71.2% vs 61.4%, p < 0.001), 1998 European LDL-C goals (73.5% vs 59.2%, p < 0.001) and 2003 European LDL-C goals (58.9% vs 44.6%, p < 0.001). Rosuvastatin treatment was associated with significant reductions in LDL-C and total cholesterol (TC) and, in statin-naïve patients, a significant increase in high-density lipoprotein cholesterol (HDL-C) compared with atorvastatin treatment. Both treatments were well tolerated with a similar incidence of adverse events. Clinically significant elevations in creatinine, creatine kinase or hepatic transaminases were low and similar between treatment groups.
Rosuvastatin 10 mg is significantly more effective at achieving NCEP ATP III and European LDL-C goals, lowering LDL-C and TC in both naïve and switched patients and increasing HDL-C in naïve patients than atorvastatin 10mg, with a similar safety and tolerability profile. This study also provides evidence regarding the comparative effects of rosuvastatin versus atorvastatin in Latin American and Portuguese populations.
国际指南强调需达到推荐的低密度脂蛋白胆固醇（LDL-C）水平，以降低与冠心病（CHD）相关的发病率和死亡率。然而，许多高胆固醇血症患者在治疗中未能达到LDL-C目标。
主要目的是比较瑞舒伐他汀和阿托伐他汀使患者达到美国国家胆固醇教育计划成人治疗组第三次报告（NCEP ATP III）LDL-C目标的疗效。次要目的是达到欧洲LDL-C目标、血脂谱变化及安全性。
这项为期12周的多中心、跨国、随机、开放标签试验，比较了10毫克瑞舒伐他汀与10毫克阿托伐他汀在来自巴西、哥伦比亚、墨西哥、葡萄牙和委内瑞拉的初治及换药的原发性高胆固醇血症患者中的疗效和安全性。
共1124例具有相似基线特征的患者被随机分为两个治疗组。治疗12周后，与10毫克阿托伐他汀相比，接受10毫克瑞舒伐他汀治疗的患者达到NCEP ATP III LDL-C目标的比例显著更高（71.2%对61.4%，p<0.001）、达到1998年欧洲LDL-C目标的比例显著更高（73.5%对59.2%，p<0.001）以及达到2003年欧洲LDL-C目标的比例显著更高（58.9%对44.6%，p<0.001）。与阿托伐他汀治疗相比，瑞舒伐他汀治疗使LDL-C和总胆固醇（TC）显著降低，且在初治患者中，高密度脂蛋白胆固醇（HDL-C）显著升高。两种治疗耐受性均良好，不良事件发生率相似。治疗组间肌酐、肌酸激酶或肝转氨酶的临床显著升高较低且相似。
与10毫克阿托伐他汀相比，10毫克瑞舒伐他汀在达到NCEP ATP III和欧洲LDL-C目标、降低初治及换药患者的LDL-C和TC以及提高初治患者的HDL-C方面显著更有效，且安全性和耐受性相似。本研究还提供了瑞舒伐他汀与阿托伐他汀在拉丁美洲和葡萄牙人群中的比较效果的证据。
