Efficacy and safety of exenatide once-weekly vs exenatide twice-daily in Asian patients with type 2 diabetes mellitus.
Efficacy and safety of exenatide once-weekly vs exenatide twice-daily in Asian patients with type 2 diabetes mellitus.
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DOI：
10.1111/j.2040-1124.2012.00238.x
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发表时间：
2013-01-29
影响因子：
3.2
通讯作者：
Boardman MK
中科院分区：
文献类型：
--
作者：
Ji L;Onishi Y;Ahn CW;Agarwal P;Chou CW;Haber H;Guerrettaz K;Boardman MK
在中国、印度、日本、韩国和中国台湾地区的2型糖尿病患者中比较艾塞那肽缓释制剂每周一次（EQW）与艾塞那肽每日两次（EBID）治疗26周的安全性和疗效。一项随机、对照、开放标签研究纳入了681例口服降糖药物（OAM）控制不佳（血红蛋白A1 c [HbA 1c] ≥7且≤11%）的2型糖尿病患者。患者在当前OAM的基础上添加了2 mg EQW或10 μg EBID。末次治疗后10周重新评价安全性。第26周时，EQW在HbA 1c指标方面上级EBID（最小二乘平均治疗差异：−0.31% [95%置信区间−0.49，−0.14%]）。更多EQW治疗患者达到目标HbA 1c ≤7.0%（P = 0.003）、≤6.5%（P < 0.001）或≤6.0%（P = 0.003）。EQW治疗患者的空腹血糖下降幅度更大（P < 0.001）。两个治疗组的血糖曲线均有所改善（P < 0.001）。两种治疗均发生体重减轻，但EBID组更大。不良事件（≥ 10%，任一组）为恶心、注射部位硬结、血脂异常和呕吐。EQW组注射部位硬结更常见，而恶心、呕吐和低血糖发生率较低。报告了严重低血糖（EBID）和胰腺炎（EQW）各发生一次。在该人群中，EQW和EBID显示出有效的血糖和体重控制;安全性和耐受性与非亚洲患者的观察结果一致。本试验在ClinicalTrials.gov上注册（编号NCT 00917267）。
To compare safety and efficacy of the extended‐release formulation exenatide once weekly (EQW) vs exenatide twice daily (EBID) for 26 weeks in type 2 diabetes patients from China, India, Japan, South Korea and Taiwan. A randomized, comparator‐controlled, open‐label study included 681 patients with type 2 diabetes inadequately controlled (hemoglobin A1c [HbA1c] ≥7 and ≤11%) with oral antihyperglycemic medications (OAMs). Patients added 2 mg EQW or 10 μg EBID to current OAMs. Safety was re‐evaluated 10 weeks after last treatment. EQW was superior to EBID on HbA1c measures at week 26 (Least‐squares mean treatment difference: −0.31% [95% confidence interval −0.49, −0.14%]). More EQW‐treated patients achieved target HbA1c ≤7.0% (P = 0.003), ≤6.5% (P < 0.001), or ≤6.0% (P = 0.003). Fasting serum glucose reductions were greater among EQW‐treated patients (P < 0.001). Blood glucose profiles improved in both treatment groups (P < 0.001). Weight loss occurred with both treatments, but was greater with EBID. Adverse events (≥10%, either group) were nausea, injection‐site induration, dyslipidemia and vomiting. Injection‐site induration was more frequent with EQW, whereas nausea, vomiting and hypoglycemia were less frequent. One episode each of major hypoglycemia (EBID) and pancreatitis (EQW) were reported. In this population, EQW and EBID showed efficacious glucose and weight control; safety and tolerability were consistent with observations in non‐Asian patients. This trial was registered with ClinicalTrials.gov (no. NCT00917267).
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影响因子：
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作者：
Linnebjerg, Helle;Park, Soomin;Horowitz, Michael
通讯作者：
Horowitz, Michael
影响因子：
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作者：
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影响因子：
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作者：
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通讯作者：
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通讯作者：
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