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Effects of Ezetimibe on Glucose Metabolism in Patients With Type 2 Diabetes: A 12-Week, Open-Label, Uncontrolled, Pilot Study

机译:依泽替米贝对2型糖尿病患者葡萄糖代谢的影响:一项为期12周的开放标签,无对照的先导研究

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BACKGROUND: A potential effect of ezetimibe, a novel cholesterol-absorption inhibitor, on insulin resistance has been reported in an animal model.OBJECTIVE: The aim of this study was to evaluate the effects of ezetimibe on glucose metabolism in patients with type 2 diabetes mellitus (T2DM).METHODS! 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 (HbA_(1c)), and high-sensitivity C-reactive protein were measured. Adverse effects (AEs) were assessed at each study visit by patient interviews and laboratory testing.RESULTS: 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/m2) 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 (HbA_(1c) from 6.3% (0.6%) to 6.1% (0.7%) (P = 0.003). No AEs were observed or reported during the study period.CONCLUSION: 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.
机译:背景:在动物模型中已经报道了新型的胆固醇吸收抑制剂依泽替米贝对胰岛素抵抗的潜在作用。目的:本研究的目的是评估依泽替米贝对2型糖尿病患者葡萄糖代谢的影响(T2DM)。方法!在2008年3月至6月期间,在日本横滨荣京斋市医院接受治疗的T2DM门诊患者,尽管饮食和运动均未达到《日本动脉粥样硬化学会指南》建议的目标血脂水平,但该患者参加了该试验研究。他汀类药物疗法> 3个月。在基线期以及使用依泽替米贝10 mg / d的开放标签治疗后的第4周和第12周,血脂参数,空腹血糖(FPG),糖基化血红蛋白(HbA_(1c))和高敏感性C反应蛋白的水平被测量。结果:共有21位连续患者(10位男性,11位女性;平均[SD]年龄:72 [9]岁;体重:63.4 [10.5])公斤体重;体重指数25.5 [3.2} kg / m2)参加了这项研究。用依折麦布治疗12周后,LDL-C的平均(SD)水平从146(31)mg / dL显着降低至114(27)mg / dL(-21%; P <0.001)。残留物样胆固醇的平均水平也从6.5(3.8)降至4.8(2.2)mg / dL(-15%; P = 0.03)。依泽替米贝治疗可使FPG水平从127(31)降至119(30)mg / dL(P = 0.02)和(HbA_(1c)从6.3%(0.6%)降至6.1%(0.7%) (P = 0.003)。在研究期间未观察到或未报告任何不良事件。结论:在这项小型,开放标签,未经控制的先导研究中,依泽替米贝与这些患者的脂质参数显着降低和葡萄糖代谢改善有关使用T2DM。

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