Fras Zlatko, Mikhailidis Dimitri P
Department for Vascular Medicine, Division for Internal Medicine, University Medical Centre, Ljubljana, Slovenia.
Curr Med Res Opin. 2008 Sep;24(9):2467-76. doi: 10.1185/03007990802303772. Epub 2008 Jul 24.
Poor results from lipid-lowering therapy are mainly due to inadequate dosing and increased adverse effects with high-dose statin monotherapy or drug combinations.
The SI-SPECT (Slovenia (SI) Statin Plus Ezetimibe in Cholesterol Treatment) study evaluated the effectiveness of either ezetimibe (EZE) 10 mg as monotherapy or co-administered with on-going statin treatment (S + EZE) in clinical practice.
A total of 1053 dyslipidaemic patients (52% men, age 60.3 years, 42.9% with CHD, 32.0% with diabetes mellitus and 69.6% with hypertension) were enrolled. The majority (n=986; 93.6%) were treated with EZE as 'add-on' to their already prescribed statin, the rest only received EZE (n=67).
Baseline lipid levels were compared with those obtained 16 weeks after initiating treatment.
Total (TC) and low density lipoprotein cholesterol (LDL-C), as well as triglycerides (TG) decreased significantly with S + EZE (by 25.3%, 31.4% and 28.9%, respectively; p<0.0001 for all comparisons), while monotherapy with EZE resulted in a decrease of 20.8% for TC (p<0.0001), 28.0% for LDL-C (p<0.0001) and 28.8% for TG (p=0.016). At the end of the study 43.9% of patients achieved target TC (<5.0 mmol/L for primary prevention and <4.5 mmol/L for secondary prevention), 50.5% target LDL-C (<3.0 mmol/L for primary prevention and <2.5 mmol/L for secondary prevention) and 61.6% target TG (<2.0 mmol/L). The overall incidence of adverse effects during the treatment period, and probably related to EZE use, was low (n=6, 0.6% of patients).
(1) S + EZE combination therapy was effective and safe irrespective of the statin used, (2) the S + EZE combination resulted in significantly more patients reaching their recommended target lipid levels and (3) the lipid-lowering efficacy of EZE in monotherapy as well as of the S + EZE combination was related to initial lipid values. The much greater decrease of TG than expected could be, at least in part, due to better control/compliance regarding diet and drug treatment during the study and adherence to the need for an overnight fast before sampling.
降脂治疗效果不佳主要是由于剂量不足以及高剂量他汀类单药治疗或联合用药导致不良反应增加。
SI-SPECT（斯洛文尼亚（SI）他汀联合依折麦布治疗胆固醇）研究评估了在临床实践中，依折麦布（EZE）10mg单药治疗或与正在进行的他汀治疗联合使用（S+EZE）的有效性。
共纳入1053例血脂异常患者（52%为男性，年龄60.3岁，42.9%患有冠心病，32.0%患有糖尿病，69.6%患有高血压）。大多数患者（n=986；93.6%）接受EZE作为已处方他汀的“附加”治疗，其余患者仅接受EZE治疗（n=67）。
将基线血脂水平与开始治疗16周后测得的血脂水平进行比较。
S+EZE组的总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）以及甘油三酯（TG）显著降低（分别降低25.3%、31.4%和28.9%；所有比较的p<0.0001），而EZE单药治疗使TC降低20.8%（p<0.0001），LDL-C降低28.0%（p<0.0001），TG降低28.8%（p=0.016）。在研究结束时，43.9%的患者达到TC目标值（一级预防<5.0mmol/L，二级预防<4.5mmol/L），50.5%达到LDL-C目标值（一级预防<3.0mmol/L，二级预防<2.5mmol/L），61.6%达到TG目标值（<2.0mmol/L）。治疗期间不良反应的总体发生率较低（n=6，占患者的0.6%），可能与使用EZE有关。
（1）无论使用何种他汀，S+EZE联合治疗均有效且安全；（2）S+EZE联合治疗使更多患者达到推荐的血脂目标水平；（3）EZE单药治疗以及S+EZE联合治疗的降脂疗效与初始血脂值有关。TG下降幅度远超预期，至少部分原因可能是研究期间饮食和药物治疗得到了更好的控制/依从性，以及采样前坚持空腹过夜。
