在日本 2 型糖尿病患者中，胰高血糖素样肽-1 受体激动剂利拉鲁肽与一种口服抗糖尿病药物联合使用的安全性和有效性：一项随机、52 周、开放性、平行组试验的事后分析。
Safety and efficacy of the combination of the glucagon-like peptide-1 receptor agonist liraglutide with an oral antidiabetic drug in Japanese patients with type 2 diabetes: Post-hoc analysis of a randomized, 52-week, open-label, parallel-group trial.
机构信息
Department of Internal Medicine, Tokyo-Eki Center-Building Clinic, Tokyo, Japan.
Kansai Electric Power Hospital, Osaka, Japan.
出版信息
J Diabetes Investig. 2018 Jul;9(4):831-839. doi: 10.1111/jdi.12759. Epub 2017 Nov 24.
AIMS/INTRODUCTION: The aim of the present post-hoc analysis was to investigate the safety and efficacy of liraglutide in combination with one oral antidiabetic drug (OAD) across different OAD classes.
MATERIALS AND METHODS
This was a post-hoc analysis using data from a 52-week, open-label, parallel-group trial, in which patients with type 2 diabetes inadequately controlled with a single OAD (α-glucosidase inhibitor, glinide, metformin or thiazolidinedione) were randomized to either pretrial OAD in combination with liraglutide 0.9 mg/day (liraglutide group) or pretrial OAD in combination with an additional OAD (additional OAD group). The primary outcome investigated in this post-hoc analysis was the incidence of adverse events.
RESULTS
The proportions of patients experiencing adverse events across the different groups of pretrial OADs were comparable between liraglutide and additional OAD (α-glucosidase inhibitor 74.6 vs 70.0%; glinide 93.1 vs 87.1%; metformin 91.8 vs 87.1%; thiazolidinedione 86.2 vs 96.4%, respectively). Minor hypoglycemia was infrequent (seven episodes in two patients randomized to liraglutide, and two episodes in two patients randomized to additional OAD). The mean reduction in glycated hemoglobin appeared greater with liraglutide therapy, with the estimated mean treatment difference (95% confidence interval [CI]) for liraglutide vs additional OAD ranging from -0.14%, 95% CI: -0.48 to 0.21 (-1.5 mmol/mol, 95 CI: -5.2 to 2.3) to -0.44%, 95% CI:-0.79 to -0.09 (-4.8 mmol/mol, 95% CI: -8.6 to -1.0).
CONCLUSIONS
The present analysis suggests that Japanese patients on OAD monotherapy might benefit from a greater improvement in glycemic control, without impacting tolerability, by combining their OAD with liraglutide rather than another OAD, regardless of which OAD monotherapy they are receiving.
目的/引言：本事后分析旨在研究利拉鲁肽联合不同口服降糖药（OAD）类别的安全性和疗效。
材料和方法
这是一项事后分析，使用了一项 52 周、开放性、平行组试验的数据，其中接受单一 OAD（α-葡萄糖苷酶抑制剂、格列奈类、二甲双胍或噻唑烷二酮）治疗但血糖控制不佳的 2 型糖尿病患者被随机分配至接受预治疗 OAD 联合利拉鲁肽 0.9mg/天（利拉鲁肽组）或预治疗 OAD 联合另一种 OAD（附加 OAD 组）。本事后分析的主要结局是不良事件的发生率。
结果
不同预治疗 OAD 组的患者发生不良事件的比例在利拉鲁肽和附加 OAD 之间相似（α-葡萄糖苷酶抑制剂 74.6% vs 70.0%；格列奈类 93.1% vs 87.1%；二甲双胍 91.8% vs 87.1%；噻唑烷二酮 86.2% vs 96.4%）。轻度低血糖罕见（两名随机分配至利拉鲁肽的患者发生七次，两名随机分配至附加 OAD 的患者发生两次）。利拉鲁肽治疗时糖化血红蛋白的平均降幅似乎更大，利拉鲁肽与附加 OAD 的估计平均治疗差异（95%置信区间[CI]）范围为-0.14%，95%CI：-0.48 至 0.21（-1.5mmol/mol，95%CI：-5.2 至 2.3）至-0.44%，95%CI：-0.79 至 -0.09（-4.8mmol/mol，95%CI：-8.6 至 -1.0）。
结论
本分析表明，接受 OAD 单药治疗的日本患者通过联合其 OAD 与利拉鲁肽而非另一种 OAD 治疗，可能会在不影响耐受性的情况下，血糖控制得到更大改善，无论他们正在接受哪种 OAD 单药治疗。
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