PDF(Pubmed)
Abstract：
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：口服司马鲁肽的疗效和安全性，第一种胰高血糖素样肽1受体激动剂以片剂形式可用于治疗2型糖尿病，是在第3a阶段先锋计划中建立的。然而,关于在现实临床环境中口服司美鲁肽滴定的证据仍然不足.本研究旨在通过临床数据分析阐明将口服司马鲁肽的剂量从7mg提高到14mg的治疗优势。
方法：这项回顾性观察研究是在日本的一个中心进行的，重点关注口服14mg司马鲁肽的2型糖尿病成人。主要终点是14mg口服司马鲁肽初始处方后24周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。
结果：分析66例符合纳入标准的患者的数据。剂量递增后从基线到24周的HbA1c水平的平均变化为-0.5±0.8%[从基线的7.4±1.0%到24周时的7.0±0.9%(p<0.01)]。此外，在24周时观察到体重显着下降-2.0±4.4kg[从基线时的90.0±20.5kg到24周时的88.2±21.4kg（p<0.01）]，41％的患者与基线相比至少减少3％。胃肠道疾病是最常见的不良事件（10.6％），特别是恶心(7.6%)，虽然主要是轻度或中度的严重程度，没有严重不良事件需要停药的情况。
结论：将口服司马鲁肽的剂量提升至14mg可能是2型糖尿病患者血糖控制和体重管理的有效方法。
方法：这项回顾性观察研究是在日本的一个中心进行的，重点关注口服14mg司马鲁肽的2型糖尿病成人。主要终点是14mg口服司马鲁肽初始处方后24周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。
结果：分析66例符合纳入标准的患者的数据。剂量递增后从基线到24周的HbA1c水平的平均变化为-0.5±0.8%[从基线的7.4±1.0%到24周时的7.0±0.9%(p<0.01)]。此外，在24周时观察到体重显着下降-2.0±4.4kg[从基线时的90.0±20.5kg到24周时的88.2±21.4kg（p<0.01）]，41％的患者与基线相比至少减少3％。胃肠道疾病是最常见的不良事件（10.6％），特别是恶心(7.6%)，虽然主要是轻度或中度的严重程度，没有严重不良事件需要停药的情况。
结论：将口服司马鲁肽的剂量提升至14mg可能是2型糖尿病患者血糖控制和体重管理的有效方法。
