度拉糖肽单药治疗与格列美脲相比在初治2型糖尿病中国患者中的疗效和安全性：AWARD-CHN1的事后分析
Efficacy and Safety of Dulaglutide Monotherapy Compared to Glimepiride in Oral Antihyperglycemic Medication-Naïve Chinese patients with Type 2 Diabetes: A Post Hoc Analysis of AWARD-CHN1.
作者信息
Li Yi Ming, Zhang Li Hui, Li Xue Jun, Zhang Bin, Hou Jia Ning, Tong Nan Wei
机构信息
Department of Endocrinology, Huashan Hospital, Fudan University, Shanghai, 200040, China.
Department of Endocrinology, The Second Hospital of Hebei Medical University, Hebei, 050000, China.
出版信息
Diabetes Ther. 2020 May;11(5):1077-1090. doi: 10.1007/s13300-020-00799-w. Epub 2020 Mar 26.
INTRODUCTION
Glucagon-like peptide (GLP)-1 receptor agonists are glucose-lowering agents associated with weight loss, cardiovascular benefits, and low hypoglycemic risk and are recommended by recent guidelines as first-line therapy for some patients with type 2 diabetes (T2D). This post hoc analysis of the AWARD-CHN1 study compared the efficacy and safety of once-weekly dulaglutide with glimepiride in oral antihyperglycemic medication (OAM)-naïve Chinese patients with T2D.
METHODS
AWARD-CHN1 was a phase 3, double-blind study with 737 patients randomized 1:1:1 to once-weekly dulaglutide (1.5 or 0.75 mg) or glimepiride (1-3 mg/day). This is a post hoc analysis of AWARD-CHN1 based on mixed-model repeated measures using a modified intent-to-treat analysis set with only the OAM-naïve Chinese population.
RESULTS
There were 264 OAM-naïve Chinese patients included in this analysis (dulaglutide 1.5 mg, n = 87; dulaglutide 0.75 mg, n = 90; glimepiride, n = 87). A greater glycated hemoglobin (HbA1c) reduction from baseline was observed with dulaglutide 1.5 mg and 0.75 mg compared to glimepiride (- 2.02% and - 1.84% vs - 1.37%, respectively; both P < 0.001). Significantly more patients in dulaglutide 1.5 mg and 0.75 mg groups achieved HbA1c targets < 7.0% compared to glimepiride (86.2% and 81.1% vs 65.5%; P = 0.002 and P = 0.026, respectively). Beta cell function was significantly increased for dulaglutide groups compared to glimepiride. Mean body weight was significantly reduced for dulaglutide 1.5 mg and 0.75 mg compared to glimepiride (- 1.40 kg and - 0.96 kg vs + 0.73 kg, respectively; both P < 0.001). Through 26 weeks, 7.9%, 4.2%, and 18.2% of patients reported hypoglycemia, and 40.4%, 23.2%, and 8.0% of patients reported at least one gastrointestinal treatment emergent adverse event, in dulaglutide 1.5 mg, 0.75 mg, and glimepiride groups, respectively.
CONCLUSIONS
In this post hoc analysis, dulaglutide was effective in reducing both HbA1c and weight with favorable tolerability and safety profile, which is consistent with results seen in larger international dulaglutide monotherapy studies.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01644500.
简介
胰高血糖素样肽（GLP）-1受体激动剂是一类降糖药物，具有减轻体重、心血管获益及低血糖风险低的特点，近期指南推荐其作为部分2型糖尿病（T2D）患者的一线治疗药物。这项对AWARD-CHN1研究的事后分析比较了在未使用口服降糖药（OAM）的中国T2D患者中，每周一次度拉糖肽与格列美脲的疗效和安全性。
方法
AWARD-CHN1是一项3期双盲研究，737例患者按1:1:1随机分组，分别接受每周一次的度拉糖肽（1.5或0.75mg）或格列美脲（1 - 3mg/天）治疗。这是基于混合模型重复测量对AWARD-CHN1进行的事后分析，采用改良意向性治疗分析集，仅纳入未使用OAM的中国人群。
结果
本分析纳入了264例未使用OAM的中国患者（度拉糖肽1.5mg组，n = 87；度拉糖肽0.75mg组，n = 90；格列美脲组，n = 87）。与格列美脲相比，度拉糖肽1.5mg组和0.75mg组糖化血红蛋白（HbA1c）从基线的降幅更大（分别为-2.02%和-1.84% vs -1.37%；P均<0.001）。与格列美脲相比，度拉糖肽1.5mg组和0.75mg组达到HbA1c目标<7.0%的患者显著更多（分别为86.2%和81.1% vs 65.5%；P分别为0.002和0.026）。与格列美脲相比，度拉糖肽组的β细胞功能显著增强。与格列美脲相比，度拉糖肽1.5mg组和0.75mg组的平均体重显著降低（分别为-1.40kg和-0.96kg vs +0.73kg；P均<0.001）。在26周期间，度拉糖肽1.5mg组、0.75mg组和格列美脲组分别有7.9%、4.2%和18.2%的患者报告发生低血糖，分别有40.4%、23.2%和8.0%的患者报告至少发生一次胃肠道治疗期间出现的不良事件。
结论
在这项事后分析中，度拉糖肽在降低HbA1c和体重方面有效，且耐受性和安全性良好，这与在更大规模的国际度拉糖肽单药治疗研究中观察到的结果一致。
试验注册
ClinicalTrials.gov NCT01644500
Zotero 插件