Efficacy of ezetimibe/simvastatin 10/20 and 10/40 mg compared with atorvastatin 20 mg
in patients with type 2 diabetes mellitus
摘要：该研究将先前采用10mg剂量阿托伐他汀的2型糖尿病患者，转换成分别采用10/20mg剂量及10/40 mg剂量的依折麦布和辛伐他汀联合用药、2倍剂量（20mg）阿托伐他汀三种方案。结果表明：采用10/20mg剂量和10/40 mg剂量的依折麦布和辛伐他汀联合用药这两种治疗方式，明显优于20mg阿托伐他汀的治疗效果。
Aim: This randomized, double-blind study evaluated the efficacy of switching from atorvastatin (ATV) 10 mg to ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg, EZE/SIMVA 10/40 mg or doubling the dose of ATV from 10 to 20 mg in patients with type 2 diabetes (T2D).
Methods: Eligible patients had haemoglobin A1C≤10%, were aged 18 years and were on ATV 10 mg for≥6 weeks before study entry. After a 4-week open-label ATV 10 mg run-in, patients were randomized to EZE/SIMVA 10/20mg (n=220), EZE/SIMVA 10/40 mg (n=222) or ATV 20 g (n=219) daily for 6 weeks.
Results: Greater (p≤0.001) reductions in low-density lipoprotein cholesterol (LDL-C) (the primary end-point) wereachieved by switching to EZE/SIMVA 10/20 mg (26.2%) or 10/40 mg (30.1%) than by doubling the dose of ATV to 20mg (8.5%). EZE/SIMVA 10/20 mg and 10/40 mg produced greater (p≤0.001) reductions in total cholesterol, non-highdensity lipoprotein cholesterol (HDL-C) and apolipoprotein B relative to ATV 20 mg. A reduction (p≤0.050) in Creactive protein was observed with EZE/SIMVA 10/40 mg vs. ATV 20 mg. Similar reductions in triglycerides were observed across the three groups, and none of the treatments produced a significant change in HDL-C. A greater (p≤0.001) proportion of patients achieved LDL-C <2.5 mmol/l with EZE/SIMVA 10/20 mg (90.5%) and 10/40 mg (87.0%)than with ATV 20 mg (70.4%). Both EZE/SIMVA doses were generally well tolerated, with an overall safety profile similar to ATV 20 mg.
Conclusions: EZE/SIMVA 10/20 and 10/40 mg provided greater lipid-altering efficacy than doubling the dose of ATV from 10 to 20 mg and were well tolerated in patients with T2D.
