Division of Endocrinology, Keenan Research Centre in the Li Ka Shing Knowledge Institute of St. Michael's Hospital, University of Toronto, Toronto, Canada.
Diabetes Obes Metab. 2011 Jul;13(7):615-28. doi: 10.1111/j.1463-1326.2011.01383.x.
This post hoc analysis compared the lipid-altering efficacy and safety of ezetimibe 10 mg plus statin (EZE/statin) vs. statin monotherapy in hypercholesterolaemic patients with and without diabetes.
A pooled analysis of 27 previously published, randomized, double-blind, active- or placebo-controlled clinical trials comprising 21 794 adult patients with (n = 6541) and without (n = 15253) diabetes receiving EZE/statin or statin alone for 4-24 weeks evaluated percentage change from baseline in lipids and other parameters. Consistency of the treatment effect across the subgroups was tested using treatment × subgroup interaction. No multiplicity adjustments were made.
Treatment effects within both subgroups were generally consistent with the overall population. EZE/statin was more effective than statin alone in improving low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), non-HDL-C, apolipoprotein (apo) B and high-sensitivity C-reactive protein (hs-CRP) in the overall population and both subgroups. Patients with diabetes achieved significantly larger reductions in LDL-C, TC and non-HDL-C compared with non-diabetic patients. Incidences of adverse events or creatine kinase elevations were similar between groups. A small but significantly higher incidence of alanine aminotransferase or aspartate aminotransferase elevations was seen in patients receiving EZE/statin (0.6%) vs. statin monotherapy (0.3%) in the overall population.
Treatment with EZE/statin vs. statin monotherapy provided significantly larger reductions in LDL-C, TC, TG, non-HDL-C, apo B and hs-CRP and significantly greater increases in HDL-C, with a similar safety profile in patients with and without diabetes. Reductions in LDL-C, TC and non-HDL-C were larger in patients with diabetes than in patients without diabetes.
本事后分析比较了依折麦布 10mg 联合他汀类药物（EZE/他汀类药物）与他汀类药物单药治疗在伴有或不伴有糖尿病的高胆固醇血症患者中的降脂疗效和安全性。
对 27 项先前发表的、随机、双盲、活性药物或安慰剂对照的临床试验进行了汇总分析，共纳入 21794 例成年患者（n=6541）和 15253 例不伴糖尿病患者（n=15253），他们在 4-24 周内接受 EZE/他汀类药物或他汀类药物单药治疗，评估从基线到治疗结束时的血脂和其他参数的百分比变化。采用治疗×亚组交互作用检验亚组间治疗效果的一致性。未进行多重性调整。
在亚组内，治疗效果通常与总体人群一致。EZE/他汀类药物与他汀类药物单药治疗相比，在改善低密度脂蛋白胆固醇（LDL-C）、总胆固醇（TC）、高密度脂蛋白胆固醇（HDL-C）、三酰甘油（TGs）、非高密度脂蛋白胆固醇（non-HDL-C）、载脂蛋白（apo）B 和高敏 C 反应蛋白（hs-CRP）方面，在总体人群和两个亚组中均更为有效。与非糖尿病患者相比，糖尿病患者的 LDL-C、TC 和非-HDL-C 降幅更大。各组之间不良事件或肌酸激酶升高的发生率相似。在总体人群中，接受 EZE/他汀类药物治疗的患者（0.6%）较接受他汀类药物单药治疗的患者（0.3%）更易发生丙氨酸氨基转移酶或天门冬氨酸氨基转移酶升高，且发生率虽小但有统计学意义。
与他汀类药物单药治疗相比，EZE/他汀类药物治疗可显著降低 LDL-C、TC、TG、non-HDL-C、apo B 和 hs-CRP，显著升高 HDL-C，且在伴有或不伴有糖尿病的患者中具有相似的安全性。与无糖尿病患者相比，糖尿病患者 LDL-C、TC 和 non-HDL-C 的降幅更大。
