Nozue Tsuyoshi, Michishita Ichiro, Mizuguchi Ichiro
Department of Internal Medicine, Yokohama Sakae Kyosai Hospital, Federation of National Public Service Personnel Mutual Associations, Yokohama, Japan.
Curr Ther Res Clin Exp. 2010 Aug;71(4):252-8. doi: 10.1016/j.curtheres.2010.08.002.
A potential effect of ezetimibe, a novel cholesterol-absorption inhibitor, on insulin resistance has been reported in an animal model.
The aim of this study was to evaluate the effects of ezetimibe on glucose metabolism in patients with type 2 diabetes mellitus (T2DM).
Between March and June 2008, outpatients with T2DM who were being treated at Yokohama Sakae Kyosai Hospital, Yokohama, Japan, were enrolled in this pilot study if they had not achieved the target lipid levels recommended by the Japan Atherosclerosis Society Guidelines despite diet and exercise or a statin therapy for ≥3 months. At baseline and at 4 and 12 weeks after open-label treatment with ezetimibe 10 mg/d, the levels of lipid parameters, fasting plasma glucose (FPG), glycosylated hemoglobin (HbA1c), and high-sensitivity C-reactive protein were measured. Adverse effects (AEs) were assessed at each study visit by patient interviews and laboratory testing.
A total of 21 consecutive patients (10 men, 11 women; mean [SD] age, 72 [9] years; weight, 63.4 [10.5] kg; body mass index, 25.5 [3.2] kg/m(2)) were enrolled in this study. The mean (SD) level of LDL-C decreased significantly from 146 (31) to 114 (27) mg/dL (-21%; P < 0.001) after 12 weeks of treatment with ezetimibe. The mean level of remnant-like particle cholesterol also decreased significantly from 6.5 (3.8) to 4.8 (2.2) mg/dL (-15%; P = 0.03). Treatment with ezetimibe was associated with a reduction in FPG level from 127 (31) to 119 (30) mg/dL (P = 0.02), and HbAlc from 6.3% (0.6%) to 6.1% (0.7%) (P = 0.003). No AEs were observed or reported during the study period.
In this small, open-label, uncontrolled, pilot study, ezetimibe was associated with a significant decrease in lipid parameters and improvement in glucose metabolism in these patients with T2DM.
在动物模型中，已报道新型胆固醇吸收抑制剂依折麦布对胰岛素抵抗有潜在影响。
本研究旨在评估依折麦布对2型糖尿病（T2DM）患者糖代谢的影响。
2008年3月至6月期间，在日本横滨荣祭共济医院接受治疗的T2DM门诊患者，若尽管进行了饮食和运动或他汀类药物治疗≥3个月仍未达到日本动脉粥样硬化协会指南推荐的目标血脂水平，则纳入本初步研究。在基线以及接受10 mg/d依折麦布开放标签治疗4周和12周后，测量血脂参数、空腹血糖（FPG）、糖化血红蛋白（HbA1c）和高敏C反应蛋白水平。每次研究访视时通过患者访谈和实验室检测评估不良反应（AE）。
本研究共纳入21例连续患者（10例男性，11例女性；平均[标准差]年龄，72[9]岁；体重，63.4[10.5]kg；体重指数，25.5[3.2]kg/m²）。依折麦布治疗12周后，低密度脂蛋白胆固醇（LDL-C）的平均（标准差）水平从146（31）显著降至114（27）mg/dL（-21%；P<0.001）。残留样颗粒胆固醇的平均水平也从6.5（3.8）显著降至4.8（2.2）mg/dL（-15%；P = 0.03）。依折麦布治疗使FPG水平从127（31）降至119（30）mg/dL（P = 0.02），HbA1c从6.3%（0.6%）降至6.1%（0.7%）（P = 0.003）。研究期间未观察到或报告任何AE。
在这项小型、开放标签、非对照的初步研究中，依折麦布与这些T2DM患者血脂参数的显著降低和糖代谢的改善相关。
