Insull William, Ghali Jalal K, Hassman David R, Y As Joseph W, Gandhi Sanjay K, Miller Elinor
Baylor College of Medicine and The Methodist Hospital, Houston, TX, 77030-3411, USA.
Mayo Clin Proc. 2007 May;82(5):543-50. doi: 10.4065/82.5.543.
To evaluate attainment of the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III low-density lipoprotein cholesterol (LDL-C) goal of less than 100 mg/dL with statin treatments in managed care patients at high risk for coronary heart disease.
In a randomized, open-label, multicenter trial (SOLAR [Satisfying Optimal LDL-C ATP III goals with Rosuvastatin]) performed at 145 US clinical centers from June 5, 2002 to July 12, 2004, high-risk men and women in a managed care population received typical starting doses of rosuvastatin (10 mg/d), atorvastatin (10 mg/d), or simvastatin (20 mg/d) for 6 weeks. Those who did not meet the LDL-C target of less than 100 mg/dL at 6 weeks had their dose titrated (doubled), and all patients were followed up for another 6 weeks.
A total of 1632 patients were randomized to 1 of the 3 treatment regimens. After 6 weeks, 65% of patients taking rosuvastatin reached the LDL-C target of less than 100 mg/dL vs 41% with atorvastatin and 39% with simvastatin (P<.001 vs rosuvastatin for both). After 12 weeks, 76% of patients taking rosuvastatin reached the LDL-C target of less than 100 mg/dL vs 58% with atorvastatin and 53% with simvastatin (P<.001 vs rosuvastatin for both). Reductions in the LDL-C level, total cholesterol level, non-high-density lipoprotein cholesterol (non-HDL-C) level, and non-HDL-C/HDL-C ratio were significantly greater with rosuvastatin at both 6 and 12 weeks compared with the other statins. Adverse events were similar in type and frequency in all treatment groups, and only 3% of all patients discontinued treatment because of adverse events. No myopathy was observed, no clinically important impact on renal function was attributed to study medications, and clinically important increases in serum transaminases were rare.
In a managed care population, 10 mg of rosuvastatin treatment resulted in more patients reaching the NCEP ATP III LDL-C goal compared with 10 mg of atorvastatin and 20 mg of simvastatin, potentially reducing the need for titration visits.
评估在冠心病高危的管理式医疗患者中，使用他汀类药物治疗达到美国国家胆固醇教育计划（NCEP）成人治疗小组（ATP）III低密度脂蛋白胆固醇（LDL-C）低于100mg/dL目标的情况。
在2002年6月5日至2004年7月12日于美国145个临床中心进行的一项随机、开放标签、多中心试验（SOLAR[瑞舒伐他汀实现ATP III LDL-C最佳目标]）中，管理式医疗人群中的高危男性和女性接受瑞舒伐他汀（10mg/d）、阿托伐他汀（10mg/d）或辛伐他汀（20mg/d）的典型起始剂量治疗6周。那些在6周时未达到LDL-C低于100mg/dL目标的患者进行剂量滴定（加倍），所有患者再随访6周。
共1632例患者被随机分配至3种治疗方案中的1种。6周后，服用瑞舒伐他汀的患者中有65%达到LDL-C低于100mg/dL的目标，而服用阿托伐他汀的为41%，服用辛伐他汀的为39%（与瑞舒伐他汀相比，两者P<0.001）。12周后，服用瑞舒伐他汀的患者中有76%达到LDL-C低于100mg/dL的目标，而服用阿托伐他汀的为58%，服用辛伐他汀的为53%（与瑞舒伐他汀相比，两者P<0.001）。与其他他汀类药物相比，瑞舒伐他汀在6周和12周时LDL-C水平、总胆固醇水平、非高密度脂蛋白胆固醇（non-HDL-C）水平以及non-HDL-C/HDL-C比值的降低幅度均显著更大。所有治疗组不良事件的类型和频率相似，所有患者中仅3%因不良事件停药。未观察到肌病，研究药物未对肾功能产生临床重要影响，血清转氨酶的临床重要升高也很罕见。
在管理式医疗人群中，与10mg阿托伐他汀和20mg辛伐他汀相比，10mg瑞舒伐他汀治疗使更多患者达到NCEP ATP III LDL-C目标，可能减少滴定访视的需求。
