Sato Genki, Uchino Hiroshi, Hirose Takahisa
Division of Diabetes, Metabolism, and Endocrinology, Department of Medicine, Toho University Graduate School of Medicine, 6-11-1 Omori-Nishi, Ota-ku, Tokyo, 143-8541, Japan.
Diabetes Ther. 2024 Sep;15(9):2119-2130. doi: 10.1007/s13300-024-01631-5. Epub 2024 Aug 7.
The efficacy and safety of oral semaglutide, the first glucagon-like peptide 1 receptor agonist available in tablet form for the treatment of type 2 diabetes, were established in the phase 3a PIONEER program. However, evidence regarding the titration of oral semaglutide in real-world clinical settings remains insufficient. This study aimed to elucidate the therapeutic advantages of escalating the dose of oral semaglutide from 7 to 14 mg through clinical data analysis.
This retrospective observational study was conducted at a single center in Japan, focusing on adults with type 2 diabetes who were initiated on 14 mg oral semaglutide. The primary endpoint was the alteration in HbA1c levels 24 weeks after the initial prescription of 14 mg oral semaglutide. Secondary endpoints included changes in metabolic parameters and the incidence of adverse events.
Data from 66 patients who met the inclusion criteria were analyzed. The mean change in HbA1c levels from baseline to 24 weeks following dose escalation was - 0.5 ± 0.8% [from 7.4 ± 1.0% at baseline to 7.0 ± 0.9% at 24 weeks (p < 0.01)]. Moreover, a significant reduction in body weight of - 2.0 ± 4.4 kg was observed at 24 weeks [from 90.0 ± 20.5 kg at baseline to 88.2 ± 21.4 kg at 24 weeks (p < 0.01)], with 41% of patients achieving at least a 3% reduction compared to baseline. Gastrointestinal disorders emerged as the most prevalent adverse event (10.6%), particularly nausea (7.6%), although predominantly of mild or moderate severity, with no instances of serious adverse events necessitating drug discontinuation.
Escalating the dose of oral semaglutide to 14 mg could be an effective approach for enhancing glycemic control and managing body weight in individuals with type 2 diabetes.
口服司美格鲁肽是首个以片剂形式用于治疗2型糖尿病的胰高血糖素样肽-1受体激动剂，其疗效和安全性已在3a期先锋项目中得到证实。然而，关于口服司美格鲁肽在实际临床环境中的滴定证据仍然不足。本研究旨在通过临床数据分析阐明将口服司美格鲁肽剂量从7毫克增加到14毫克的治疗优势。
这项回顾性观察研究在日本的一个单一中心进行，重点关注开始使用14毫克口服司美格鲁肽的2型糖尿病成人患者。主要终点是首次开具14毫克口服司美格鲁肽处方后24周时糖化血红蛋白（HbA1c）水平的变化。次要终点包括代谢参数的变化和不良事件的发生率。
分析了66例符合纳入标准患者的数据。剂量增加后从基线到24周时HbA1c水平的平均变化为-0.5±0.8%[从基线时的7.4±1.0%降至24周时的7.0±0.9%（p<0.01）]。此外，在24周时观察到体重显著减轻-2.0±4.4千克[从基线时的90.0±20.5千克降至24周时的88.2±21.4千克（p<0.01）]，41%的患者与基线相比体重减轻至少3%。胃肠道疾病是最常见的不良事件（10.6%），尤其是恶心（7.6%），尽管主要为轻度或中度严重程度，且没有严重不良事件导致停药的情况。
将口服司美格鲁肽剂量增加到14毫克可能是增强2型糖尿病患者血糖控制和管理体重的有效方法。
