Efficacy and Safety of Escalating the Dose of Oral Semaglutide from 7 to 14 mg: A Single-Center, Retrospective Observational Study.

IF 3.8 3区 医学 Q2 Medicine
Diabetes Therapy Pub Date : 2024-09-01 Epub Date: 2024-08-07 DOI:10.1007/s13300-024-01631-5
Genki Sato, Hiroshi Uchino, Takahisa Hirose
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Abstract

Introduction: 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.

Conclusion: 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.

Abstract Image

将塞马鲁肽口服剂量从 7 毫克增至 14 毫克的有效性和安全性:一项单中心回顾性观察研究。
简介口服塞马鲁肽是第一种片剂形式的胰高血糖素样肽 1 受体激动剂,可用于治疗 2 型糖尿病,其疗效和安全性已在 3a 期 PIONEER 项目中得到证实。然而,在实际临床环境中,有关口服塞马鲁肽滴定的证据仍然不足。本研究旨在通过临床数据分析,阐明将口服塞马鲁肽的剂量从7毫克提升至14毫克的治疗优势:这项回顾性观察研究在日本的一个中心进行,主要针对开始口服 14 毫克塞马鲁肽的 2 型糖尿病成人患者。主要终点是首次处方 14 毫克口服塞马鲁肽 24 周后 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:对符合纳入标准的66名患者的数据进行了分析。剂量升级后,HbA1c水平从基线到24周的平均变化为-0.5±0.8%[从基线时的7.4±1.0%降至24周时的7.0±0.9%(p 结论:HbA1c水平的平均变化为-0.5±0.8%]:将口服塞马鲁肽的剂量提高到14毫克可能是加强2型糖尿病患者血糖控制和控制体重的有效方法。
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来源期刊
Diabetes Therapy
Diabetes Therapy Medicine-Endocrinology, Diabetes and Metabolism
CiteScore
6.90
自引率
7.90%
发文量
130
审稿时长
6 weeks
期刊介绍: Diabetes Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all areas of diabetes. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Diabetes Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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