Faculty of Health, Queensland University of Technology, Brisbane, Australia.
Expert Opin Biol Ther. 2020 May;20(5):489-492. doi: 10.1080/14712598.2020.1724952. Epub 2020 Feb 5.
: The 'glutides,' which stimulate the glucagon-like peptide 1 (GLP-1) receptor to stimulate insulin secretion, are used in the treatment of type 2 diabetes. Semaglutide is the first glutide to be developed in an oral form. The PIONEER series of clinical trials (Peptide Innovation for Early Diabetes Treatment) were undertaken to establish a clinical role for oral semaglutide.: This evaluation is of PIONEER 6 in a non-inferiority phase 3a trial. In PIONEER 6, the primary outcome was the time from randomization to first occurrence of a major adverse cardiovascular event and this was non-inferior with oral semaglutide, compared to placebo.: In my opinion, there are several reasons why once-daily oral semaglutide may not replace once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes. Most importantly, subcutaneous semaglutide has already been shown to be superior to placebo in reducing cardiovascular risk, whereas the study of this with oral semaglutide will not be completed until 2024. Secondly, it is debatable whether subjects will find the daily protocol for taking oral semaglutide more convenient than that for the weekly subcutaneous formulation.
: “谷赖胰岛素”刺激胰高血糖素样肽 1（GLP-1）受体以刺激胰岛素分泌，用于治疗 2 型糖尿病。司美格鲁肽是第一种开发为口服形式的谷赖胰岛素。开展 PIONEER 系列临床试验（早期糖尿病治疗肽类创新）是为了确定口服司美格鲁肽的临床作用。: 这是一项 PIONEER 6 非劣效性 3a 期临床试验的评估。在 PIONEER 6 中，主要结局是从随机分组到首次发生主要不良心血管事件的时间，与安慰剂相比，口服司美格鲁肽无差异。: 在我看来，每日一次的口服司美格鲁肽不太可能替代每周一次的皮下注射司美格鲁肽用于治疗 2 型糖尿病，有几个原因。最重要的是，皮下注射司美格鲁肽已被证明在降低心血管风险方面优于安慰剂，而口服司美格鲁肽的研究要到 2024 年才会完成。其次，对于患者而言，口服司美格鲁肽的每日方案是否比每周皮下制剂更方便，这一点值得商榷。
