Division of Endocrinology and Metabolism Department of Internal Medicine The Catholic University of Korea Bucheon St. Mary's Hospital Bucheon Korea.
Division of Endocrinology and Metabolism Department of Internal Medicine Inje University Ilsan Paik Hospital Ilsan Korea.
J Diabetes Investig. 2013 Sep 13;4(5):466-74. doi: 10.1111/jdi.12074. Epub 2013 Mar 26.
AIMS/INTRODUCTION: Recently, patient-tailored statin therapy was proven effective for achieving target low-density lipoprotein (LDL) cholesterol levels. It is unclear, however, whether this therapeutic modality would be effective for atherogenic lipid profiles and inflammation in patients with type 2 diabetes.
The present study was an 8-week, multicenter, single-step titration trial of patient-tailored atorvastatin therapy (10, 20 and 40 mg) according to baseline LDL cholesterol levels in 440 patients with type 2 diabetes. We measured the LDL particle size by polyacrylamide gel electrophoresis, and used high-sensitivity C-reactive protein (hsCRP) and adiponectin as surrogate markers of inflammation.
In the intention-to-treat analysis, 91% of the patients achieved their LDL cholesterol targets (<2.6 mmol/L) at week 8. There were significant reductions at week 8 in total cholesterol, triglycerides, non-high-density lipoprotein cholesterol (HDL) cholesterol, and the total cholesterol:HDL cholesterol ratio compared with the baseline values for all of the doses. The mean LDL particle size was significantly increased, and the small, dense LDL cholesterol levels were decreased in a dose-dependent manner over the study period. In addition, the hsCRP levels were decreased in those high-risk patients with baseline hsCRP levels over 3 mg/L (P < 0.001), and the adiponectin levels tended to increase with all of the doses (P = 0.004) at 8 weeks.
Patient-tailored atorvastatin therapy based on LDL cholesterol at baseline was effective in ameliorating atherogenic LDL particle size and inflammation, in addition to achieving the target LDL cholesterol level without an undesirable effect on glycemic control in patients with type 2 diabetes. This trial was registered with ClinicalTrials.gov (no. NCT01239849).
目的/引言：最近，针对患者的他汀类药物治疗在实现目标低密度脂蛋白（LDL）胆固醇水平方面已被证明是有效的。然而，对于 2 型糖尿病患者的致动脉粥样硬化脂质谱和炎症，这种治疗方式是否有效尚不清楚。
本研究是一项为期 8 周、多中心、单步滴定试验，根据 440 例 2 型糖尿病患者的基线 LDL 胆固醇水平，对患者进行个体化阿托伐他汀治疗（10、20 和 40mg）。我们通过聚丙烯酰胺凝胶电泳测量 LDL 颗粒大小，并使用高敏 C 反应蛋白（hsCRP）和脂联素作为炎症的替代标志物。
在意向治疗分析中，91%的患者在第 8 周达到了 LDL 胆固醇目标（<2.6mmol/L）。与所有剂量的基线值相比，第 8 周时总胆固醇、甘油三酯、非高密度脂蛋白胆固醇（HDL-C）和总胆固醇：HDL-C 比值均显著降低。LDL 颗粒大小呈显著增加趋势，小而密 LDL 胆固醇水平呈剂量依赖性降低。此外，对于基线 hsCRP 水平超过 3mg/L 的高危患者，hsCRP 水平降低（P<0.001），并且所有剂量下脂联素水平均呈升高趋势（P=0.004）。
基于基线 LDL 胆固醇的个体化阿托伐他汀治疗除了实现 LDL 胆固醇目标外，还能改善致动脉粥样硬化的 LDL 颗粒大小和炎症，同时对 2 型糖尿病患者的血糖控制没有不良影响。本试验已在 ClinicalTrials.gov 注册（编号 NCT01239849）。
