Efficacy and Safety of Dulaglutide Monotherapy Compared to Glimepiride in Oral Antihyperglycemic Medication-Naive Chinese patients with Type 2 Diabetes: A Post Hoc Analysis of AWARD-CHN1
Efficacy and Safety of Dulaglutide Monotherapy Compared to Glimepiride in Oral Antihyperglycemic Medication-Naive Chinese patients with Type 2 Diabetes: A Post Hoc Analysis of AWARD-CHN1
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DOI：
10.1007/s13300-020-00799-w
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发表时间：
2020-03-26
期刊：
影响因子：
3.8
通讯作者：
Tong, Nan Wei
中科院分区：
文献类型：
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作者：
Li, Yi Ming;Zhang, Li Hui;Tong, Nan Wei
胰高血糖素样肽(GLP)-1受体激动剂是与减肥、心血管益处和低血糖风险相关的降糖药物，最近的指南推荐将其作为一些2型糖尿病（T2D）患者的一线治疗药物。这项AWARD-CHN1研究的事后分析比较了每周一次的杜拉鲁肽与格列美脲在口服降糖药物（OAM）的中国t2dm患者中的疗效和安全性。方法：awards - chn1是一项3期双盲研究，737例患者以1:1:1的比例随机分配至每周一次的杜拉鲁肽（1.5或0.75 mg）或格列美脲（1-3 mg/天）。这是一项基于混合模型重复测量的AWARD-CHN1事后分析，使用改良的治疗意向分析集，仅针对未患oam的中国人群。结果共纳入264例中国oam初发患者（杜拉鲁肽1.5 mg, n = 87；杜拉鲁肽0.75 mg, n = 90；格列美脲，n = 87）。与格列美脲相比，1.5 mg和0.75 mg的dulaglutide组糖化血红蛋白（HbA1c）较基线有更大的降低（分别为- 2.02%和- 1.84% vs - 1.37%， P均< 0.001）。与格列美脲相比，杜拉鲁肽1.5 mg和0.75 mg组患者达到HbA1c < 7.0%的目标明显更多（86.2%和81.1% vs 65.5%； P分别= 0.002和P = 0.026）。与格列美脲相比，杜拉鲁肽组的β细胞功能显著增加。与格列美脲相比，dulaglutide组的平均体重显著降低1.5 mg和0.75 mg（分别为- 1.40 kg和- 0.96 kg vs + 0.73 kg， P均< 0.001）。26周后，在杜拉鲁肽1.5 mg、0.75 mg和格列美脲组中，分别有7.9%、4.2%和18.2%的患者报告了低血糖，40.4%、23.2%和8.0%的患者报告了至少一次胃肠道治疗紧急不良事件。在这项事后分析中，杜拉鲁肽可有效降低HbA1c和体重，具有良好的耐受性和安全性，这与大型国际杜拉鲁肽单药研究的结果一致。
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)-naive 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-naive Chinese population. Results There were 264 OAM-naive 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.