艾塞那肽在口服降糖药治疗控制不佳的韩国2型糖尿病患者中的有效性和安全性：一项真实临床实践中的观察性研究
Effectiveness and safety of exenatide in Korean patients with type 2 diabetes inadequately controlled with oral hypoglycemic agents: an observational study in a real clinical practice.
作者信息
Hwang You-Cheol, Kim Ari, Jo Euna, Yang Yeoree, Cho Jae-Hyoung, Lee Byung-Wan
机构信息
Division of Endocrinology and Metabolism, Department of Internal Medicine, Kyung Hee University School of Medicine, Kyung Hee University Hospital at Gangdong, Seoul, South Korea.
AstraZeneca, Seoul, South Korea.
出版信息
BMC Endocr Disord. 2017 Oct 25;17(1):68. doi: 10.1186/s12902-017-0220-4.
BACKGROUND
Randomized clinical trials have shown the efficacy and safety of short-acting exenatide in patients with type 2 diabetes mellitus (T2DM). The aim of this observational study was to investigate the effectiveness and safety of exenatide twice a day in Korean patients with T2DM who are suboptimally controlled with oral hypoglycemic agents.
METHODS
This study was a post hoc analysis of multi-center (71 centers), prospective, observational, single-arm, post-marketing study of short-acting exenatide 5 to 10 μg twice a day from March 2008 to March 2014 and analyzed those who finished the follow-up over 20 weeks of medication. Changes of hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), and body weight values before and after exenatide treatment were analyzed. Adverse events and adverse drug reactions were estimated in patients who were treated with exenatide at least once and for whom follow-up for safety has been completed.
RESULTS
After 20 weeks treatment with exenatide, mean HbA1c and body weight were significantly reduced from 8.4% to 7.7% and from 83.4 kg to 80.2 kg, respectively (both p < 0.001). Subjects with higher baseline glucose and HbA1c levels showed an independent association with a greater reduction in glucose level. In addition, short duration of diabetes less than 5 years was an independent predictor for the improvement in glucose level. The majority of study subjects showed a reduction in both body weight and glucose level (63.3%) after exenatide treatment. In terms of safety profile, exenatide treatment was generally well-tolerated and the incidence of severe adverse event was rare (0.8%). The gastrointestinal side effects were most common and hypoglycemia was reported in 1.7% of subjects.
CONCLUSION
In real clinical practice, 20 weeks treatment with short-acting exenatide was well tolerated and showed a significant body weight and glucose reduction in Korean patients with T2D who are suboptimally controlled with oral hypoglycemic agents.
TRIAL REGISTRATION
ClinicalTirals.gov , number NCT02090673 , registered 14 February 2008.
背景
随机临床试验已证明短效艾塞那肽在2型糖尿病（T2DM）患者中的有效性和安全性。本观察性研究的目的是调查每日两次使用艾塞那肽对口服降糖药控制不佳的韩国T2DM患者的有效性和安全性。
方法
本研究是一项对2008年3月至2014年3月期间71个中心进行的多中心、前瞻性、观察性、单臂、上市后研究的事后分析，该研究为每日两次使用5至10μg短效艾塞那肽，并分析了完成20周以上药物治疗随访的患者。分析了艾塞那肽治疗前后糖化血红蛋白（HbA1c）、空腹血糖（FPG）和体重值的变化。对至少接受过一次艾塞那肽治疗且已完成安全性随访的患者评估不良事件和药物不良反应。
结果
使用艾塞那肽治疗20周后，平均HbA1c和体重分别从8.4%显著降至7.7%，从83.4kg降至80.2kg（均p<0.001）。基线血糖和HbA1c水平较高的受试者与血糖水平更大幅度的降低存在独立关联。此外，糖尿病病程短于5年是血糖水平改善的独立预测因素。大多数研究受试者在接受艾塞那肽治疗后体重和血糖水平均有所降低（63.3%）。在安全性方面，艾塞那肽治疗总体耐受性良好，严重不良事件的发生率很低（0.8%）。胃肠道副作用最为常见，1.7%的受试者报告有低血糖。
结论
在实际临床实践中，每日两次使用短效艾塞那肽治疗20周耐受性良好，对于口服降糖药控制不佳的韩国T2D患者，体重和血糖有显著降低。
试验注册
ClinicalTirals.gov，编号NCT02090673，于2008年2月14日注册。
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