Departments of Epidemiology & Medicine, University of Iowa College of Public Health, Iowa City, IA 52242, USA.
J Clin Lipidol. 2011 Nov-Dec;5(6):474-82. doi: 10.1016/j.jacl.2011.06.004. Epub 2011 Jun 15.
Metabolic syndrome (MetS) and atherosclerotic vascular disease (AVD) are associated with increased coronary heart disease risk.
To assess percent change from baseline in lipids and high-sensitivity C-reactive protein (hs-CRP) levels and the proportion of subjects reaching specified low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (HDL-C) and apolipoprotein B (Apo B) single, dual, and triple targets and hs-CRP <2 mg/L among subjects with and without AVD treated with ezetimibe/simvastatin or atorvastatin for 6 weeks.
Adults (N = 1143) with MetS and hypercholesterolemia were randomized to starting and next higher doses of ezetimibe/simvastatin (10/20 or 10/40 mg) or atorvastatin (10, 20, or 40 mg).
Ezetimibe/simvastatin produced significantly greater reductions in evaluated lipids than atorvastatin for most prespecified dose comparisons. More subjects without AVD achieved LDL-C levels <100 mg/dL, non-HDL-C levels <130 mg/dL, and dual LDL-C/non-HDL targets (83%-92% vs 62%-76%) and Apo B <90 mg/dL or triple targets (65%-75% vs 41%-49%) with 40 mg of atorvastatin or 10/20-40 mg of ezetimibe/simvastatin compared with 10 or 20 mg of atorvastatin, respectively. More subjects with AVD achieved LDL-C<70 mg/dL and non-HDL-C<100 mg/dL single and dual targets (65%-80%) and Apo B <80 mg/dL (53%-63%) with 10/20-40 mg of ezetimibe/simvastatin than with 40 mg of atorvastatin (40%-49%). More subjects achieved triple lipid targets with 10/20-40 mg of ezetimibe/simvastatin versus 10-40 mg of atorvastatin (50%-63% vs 24%-40%). Achievement of hs-CRP <2 mg/L was similar across all doses regardless of AVD status.
More intensive therapy was required for >80% of subjects to achieve LDL-C <100 mg/dL and non-HDL-C <130 mg/dL and for the majority of subjects to achieve lower levels of LDL-C <70 mg/dL, non-HDL-C <100 mg/dL, and/or Apo B <90 mg/dL. The effect of ezetimibe on cardiovascular risk reduction has yet to be established. (Clintrials.gov no: NCT00409773).
代谢综合征（MetS）和动脉粥样硬化性血管疾病（AVD）与冠心病风险增加相关。
评估基线时血脂和高敏 C 反应蛋白（hs-CRP）水平的变化百分比，以及在接受依折麦布/辛伐他汀或阿托伐他汀治疗的伴有和不伴有 AVD 的患者中，达到特定低密度脂蛋白胆固醇（LDL-C）、非高密度脂蛋白胆固醇（HDL-C）和载脂蛋白 B（Apo B）单、双和三靶点以及 hs-CRP<2mg/L 的比例，治疗 6 周。
患有 MetS 和高胆固醇血症的成年人（N=1143）被随机分配至起始剂量和下一较高剂量的依折麦布/辛伐他汀（10/20 或 10/40mg）或阿托伐他汀（10、20 或 40mg）。
与阿托伐他汀相比，依折麦布/辛伐他汀在大多数预设剂量比较中产生了更显著的降脂作用。更多不伴有 AVD 的患者达到 LDL-C<100mg/dL、非 HDL-C<130mg/dL、双 LDL-C/非 HDL 靶点（83%-92%比 62%-76%）和 Apo B<90mg/dL 或三靶点（65%-75%比 41%-49%），用 40mg 阿托伐他汀或 10/20-40mg 依折麦布/辛伐他汀，而分别用 10 或 20mg 阿托伐他汀。更多伴有 AVD 的患者达到 LDL-C<70mg/dL 和非 HDL-C<100mg/dL 的单和双靶点（65%-80%）和 Apo B<80mg/dL（53%-63%），用 10/20-40mg 依折麦布/辛伐他汀，而不是 40mg 阿托伐他汀（40%-49%）。与用 10-40mg 阿托伐他汀相比，用 10/20-40mg 依折麦布/辛伐他汀的患者达到三脂靶点的比例更高（50%-63%比 24%-40%）。无论 AVD 状态如何，hs-CRP<2mg/L 的达标率在所有剂量中均相似。
对于大多数患者来说，需要更强化的治疗才能达到 LDL-C<100mg/dL 和非 HDL-C<130mg/dL，并且对于大多数患者来说，需要达到更低的 LDL-C<70mg/dL、非 HDL-C<100mg/dL 和/或 Apo B<90mg/dL。依折麦布对心血管风险降低的影响尚未确定。（Clintrials.gov 编号：NCT00409773）。
