Abstract：
Oral semaglutide has potent anti-hyperglycemic efficacy in phase III trials. However, the complicated dosing instructions hamper to use this drug; therefore, we evaluated the efficacy and safety of oral semaglutide in subjects with type 2 diabetes in a real-world clinical setting. In this multi-center retrospective observational study, we analyzed subjects with type 2 diabetes newly treated with an oral semaglutide for >6 months at four medical centers located in Sapporo, Japan. The changes in glycated hemoglobin, body weight, and other metabolic parameters were evaluated and any adverse event leading to semaglutide discontinuation were recorded from February 2021 to December 2022. This study was registered with the University Hospital Medical Information Network Center (UMIN000050583). Of 543 subjects who met the inclusion criteria, data for 434 subjects (age 55.5 ± 12.6 years; body mass index 29.6 ± 6.0 kg/m2) were analyzed. After a 6 months of observation period, semaglutide 3 mg, 7 mg, or 14 mg was used by 55 (12.7%), 241 (55.5%), and 138 (31.8%) of subjects, respectively. Both glycated hemoglobin and body weight significantly improved: 7.65 ± 1.11% to 6.88 ± 0.91% (p < 0.001) and 80.2 ± 19.2 kg to 77.6 ± 19.2 kg (p < 0.001), respectively. Efficacy was also confirmed in the subgroup switched from other anti-hyperglycemic agents, including dipeptidyl peptidase-4 inhibitors. In total, 154 subjects had symptomatic gastrointestinal symptoms and 39 (7.2%) were discontinued semaglutide due to the adverse events. None of the participants experienced severe hypoglycemic events. Oral semaglutide in subjects with type 2 diabetes improved glycemic control and body weight in a real-world clinical setting.
摘要：
在III期试验中，口服司马鲁肽具有有效的抗高血糖功效。然而,复杂的给药说明妨碍使用这种药物；因此，我们在真实世界的临床环境中评估了口服司美鲁肽在2型糖尿病患者中的疗效和安全性.在这项多中心回顾性观察研究中，我们分析了在位于札幌的四个医疗中心新使用口服司美鲁肽治疗6个月以上的2型糖尿病患者，日本。糖化血红蛋白的变化，体重,和其他代谢参数进行了评估,并记录了2021年2月至2022年12月期间导致司美鲁肽停药的任何不良事件.本研究在大学医院医学信息网络中心（UMIN000050583）注册。在符合纳入标准的543名受试者中，我们分析了434名受试者(年龄55.5±12.6岁;体重指数29.6±6.0kg/m2)的数据.经过6个月的观察期，司马鲁肽3毫克，7毫克，或55毫克（12.7%）使用了14毫克，241（55.5%），和138名(31.8%)科目，分别。糖化血红蛋白和体重均显着改善：7.65±1.11％至6.88±0.91％（p<0.001）和80.2±19.2kg至77.6±19.2kg（p<0.001），分别。在从其他抗高血糖药物转换的亚组中也证实了疗效，包括二肽基肽酶-4抑制剂。总的来说,154名受试者出现有症状的胃肠道症状，39名（7.2%）因不良事件停用司马鲁肽。没有参与者经历严重的低血糖事件。2型糖尿病患者口服司马鲁肽改善了实际临床环境中的血糖控制和体重。
