Inokuchi Medical Clinic, Fukuoka, Japan.
Department of Auditors, Japan Physicians Association, Tokyo, Japan.
J Diabetes Investig. 2024 Sep;15(9):1202-1210. doi: 10.1111/jdi.14225. Epub 2024 May 3.
Glucagon-like peptide 1 receptor agonists (GLP1Ras) have emerged as pivotal agents in diabetes management and organ protection. However, their use is limited due to the necessity for injectable administration. The advent of the first oral GLP1Ra (oral semaglutide) in Japan since 2021 is expected to expand its usage. The aim of this study is to survey the efficacy and tolerability of oral semaglutide in clinical practice.
We retrospectively analyzed 120 outpatients diagnosed with type 2 diabetes mellitus who had received oral semaglutide for >6 months. Changes in clinical parameters during oral semaglutide treatment from baseline to 12 months were analyzed. The inverse probability weighting method using the propensity score was used to evaluate the differences in clinical parameters at 6 months after treatment, based on the patients' obesity levels.
Body weight (BW), glycated hemoglobin A (HbA), and alanine aminotransferase (ALT) levels at baseline decreased significantly after treatment compared with those at 12 months (P < 0.001, P < 0.001, and P = 0.03, respectively). The patients were divided into two groups using a cutoff baseline body mass index (BMI) of 30.3 kg/m. Although no significant difference was observed, changes in body weight and HbA indicated a potentially greater decrease in the BMI ≧ 30.3 group than that in the BMI < 30.3 group (P = 0.07 and 0.13, respectively). Among 206 registered patients, 25 (12.1%) discontinued oral-semaglutide treatment owing to adverse effects, including gastrointestinal symptoms.
Oral semaglutide treatment demonstrates efficacy and tolerability for managing type 2 diabetes mellitus in Japan. Significant improvements in metabolic factors induced by oral semaglutide are anticipated, particularly in obese patients.
胰高血糖素样肽 1 受体激动剂（GLP1Ras）已成为糖尿病管理和器官保护的重要药物。然而，由于需要注射给药，其应用受到限制。自 2021 年以来，日本首次出现了口服 GLP1Ra（口服司美格鲁肽），预计其应用范围将扩大。本研究旨在调查口服司美格鲁肽在临床实践中的疗效和耐受性。
我们回顾性分析了 120 例接受口服司美格鲁肽治疗>6 个月的 2 型糖尿病门诊患者。分析了口服司美格鲁肽治疗期间从基线到 12 个月时临床参数的变化。基于患者的肥胖程度，采用倾向评分逆概率加权法（Inverse Probability Weighting，IPTW）评估治疗后 6 个月时临床参数的差异。
与治疗 12 个月相比，治疗后体重（body weight，BW）、糖化血红蛋白 A（glycated hemoglobin A，HbA）和丙氨酸氨基转移酶（alanine aminotransferase，ALT）水平显著降低（P<0.001，P<0.001 和 P=0.03）。使用 30.3kg/m2 作为基线体质量指数（body mass index，BMI）的截止值，将患者分为两组。尽管没有显著差异，但 BW 和 HbA 的变化表明 BMI≧30.3 组的下降幅度可能大于 BMI<30.3 组（P=0.07 和 0.13）。在 206 名登记的患者中，有 25 名（12.1%）因胃肠道症状等不良反应而停止口服司美格鲁肽治疗。
口服司美格鲁肽治疗日本 2 型糖尿病的疗效和耐受性良好。口服司美格鲁肽有望显著改善代谢因素，尤其是肥胖患者。
