Real-world clinical evidence of oral semaglutide on metabolic abnormalities in subjects with type 2 diabetes: a multicenter retrospective observational study (the Sapporo-Oral SEMA study).

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2024-04-25 DOI:10.1507/endocrj.EJ23-0648

Shoichi Furusawa, H. Nomoto, Chiho Oba-Yamamoto, J. Takeuchi, Miki Ito, Hiroyoshi Kurihara, S. Aoki, A. Miya, H. Kameda, A. Nakamura, Tatsuya Atsumi

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引用次数: 0

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.

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口服塞马鲁肽对 2 型糖尿病患者代谢异常的真实临床证据：一项多中心回顾性观察研究（Sapporo-Oral SEMA 研究）。

在 III 期试验中，口服塞马鲁肽具有很强的降糖疗效。然而，复杂的用药指导妨碍了这种药物的使用；因此，我们在实际临床环境中评估了口服塞马鲁肽对 2 型糖尿病患者的疗效和安全性。在这项多中心回顾性观察研究中，我们分析了日本札幌市四家医疗中心新近使用口服塞马鲁肽治疗超过 6 个月的 2 型糖尿病患者。从 2021 年 2 月到 2022 年 12 月，我们评估了糖化血红蛋白、体重和其他代谢参数的变化，并记录了导致停用塞马鲁肽的任何不良事件。该研究已在大学医院医学信息网络中心注册（UMIN000050583）。在符合纳入标准的 543 名受试者中，分析了 434 名受试者（年龄 55.5 ± 12.6 岁；体重指数 29.6 ± 6.0 kg/m2）的数据。经过 6 个月的观察期后，分别有 55 人（12.7%）、241 人（55.5%）和 138 人（31.8%）使用了 3 毫克、7 毫克或 14 毫克的塞马鲁肽。糖化血红蛋白和体重均有明显改善：从 7.65 ± 1.11% 降至 6.88 ± 0.91%（p < 0.001），从 80.2 ± 19.2 kg 降至 77.6 ± 19.2 kg（p < 0.001）。从包括二肽基肽酶-4 抑制剂在内的其他降糖药物转换而来的亚组的疗效也得到了证实。共有154名受试者出现胃肠道症状，其中39人（7.2%）因不良反应停用了赛马鲁肽。没有任何受试者出现严重的低血糖事件。在实际临床环境中，2型糖尿病患者口服塞马鲁肽可改善血糖控制和体重。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.