Whitby Group Practice, Spring Vale Medical Centre, Whitby, UK.
Int J Clin Pract. 2010 Jul;64(8):1052-61. doi: 10.1111/j.1742-1241.2010.02429.x. Epub 2010 May 12.
AIM: The aim of this study was to compare ezetimibe/simvastatin combination therapy with intensified statin monotherapy as alternative treatment strategies to achieve the Joint British Societies (JBS)-2 and National Institute for Health and Clinical Excellence low-density-lipoprotein cholesterol (LDL-C) target of < 2 mmol/l for secondary prevention or JBS-2 LDL-C target of < 2 mmol/l for primary prevention in high-risk patients who have failed to reach target with simvastatin 40 mg. METHODS: This is a prospective, double-blind study conducted in 34 UK primary care centres; 1748 patients with established cardiovascular disease (CVD), diabetes or high risk of CVD who had been taking simvastatin 40 mg for > or = 6 weeks were screened and 786 (45%) with fasting LDL-C > or = 2.0 mmol/l (and < 4.2 mmol/l) at screening and after a further 6-week run-in period on simvastatin 40 mg were randomised to ezetimibe/simvastatin 10/40 mg (as a combination tablet; n = 261), atorvastatin 40 mg (n = 263) or rosuvastatin 5 mg (n = 73) or 10 mg (n = 189) once daily for 6 weeks. Rosuvastatin dose was based on UK prescribing instructions. The primary outcome measure was the proportion of patients achieving LDL-C < 2 mmol/l at the end of the study. RESULTS: The percentage of patients (adjusted for baseline differences) achieving LDL-C < 2 mmol/l was 69.4% with ezetimibe/simvastatin 10/40 mg, compared with 33.5% for atorvastatin 40 mg [odds ratio 4.5 (95% CI: 3.0-6.8); p < 0.001] and 14.3% for rosuvastatin 5 or 10 mg [odds ratio 13.6 (95% CI: 8.6-21.6); p < 0.001]. Similar results were observed for achievement of total cholesterol < 4.0 mmol/l. All study treatments were well tolerated. CONCLUSION: Approximately 45% of patients screened had not achieved LDL-C < 2 mmol/l after > or = 12 weeks of treatment with simvastatin 40 mg. In this group, treatment with ezetimibe/simvastatin 10/40 mg achieved target LDL-C levels in a significantly higher proportion of patients during a 6-week period than switching to either atorvastatin 40 mg or rosuvastatin 5-10 mg.
目的：本研究旨在比较依折麦布/辛伐他汀联合治疗与强化他汀类药物单药治疗作为替代治疗策略，以实现联合英国学会（JBS）-2 和国家卫生与临床优化研究所（NICE）的低密度脂蛋白胆固醇（LDL-C）目标<2mmol/L 用于二级预防或 JBS-2 LDL-C 目标<2mmol/L 用于高危患者，这些患者在服用辛伐他汀 40mg 后未能达到目标。
方法：这是一项在 34 个英国初级保健中心进行的前瞻性、双盲研究；筛选了 1748 例患有已确诊心血管疾病（CVD）、糖尿病或 CVD 高风险的患者，这些患者已服用辛伐他汀 40mg> =6 周，其中 786 例（45%）在筛查时和在进一步的 6 周辛伐他汀 40mg 洗脱期后空腹 LDL-C> =2.0mmol/L（<4.2mmol/L）随机分为依折麦布/辛伐他汀 10/40mg（作为联合片剂；n=261）、阿托伐他汀 40mg（n=263）或瑞舒伐他汀 5mg（n=73）或 10mg（n=189），每日一次，持续 6 周。瑞舒伐他汀的剂量基于英国处方说明。主要观察指标是研究结束时 LDL-C<2mmol/L 的患者比例。
结果：依折麦布/辛伐他汀 10/40mg 治疗的患者（根据基线差异调整）中 LDL-C<2mmol/L 的百分比为 69.4%，而阿托伐他汀 40mg 为 33.5%[比值比 4.5（95%CI：3.0-6.8）；p<0.001]，瑞舒伐他汀 5 或 10mg 为 14.3%[比值比 13.6（95%CI：8.6-21.6）；p<0.001]。总胆固醇<4.0mmol/L 的结果类似。所有研究治疗均耐受良好。
结论：筛选出的患者中约有 45%在服用辛伐他汀 40mg> =12 周后 LDL-C<2mmol/L。在这组患者中，依折麦布/辛伐他汀 10/40mg 治疗在 6 周内使 LDL-C 目标水平达到目标的患者比例明显高于转换为阿托伐他汀 40mg 或瑞舒伐他汀 5-10mg。
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