Ponnusamy Saravanan, Heather Bell, Uffe Christian Braae, Edward Collins, Alisa Deinega, Ketan Dhatariya, Alena Machell, Antonia Trent, Anna Strzelecka
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The primary endpoint was change in glycated haemoglobin (HbA<sub>1C</sub>) from baseline to end of study (EOS). Secondary endpoints included change in body weight, proportion of participants with HbA<sub>1C</sub> < 7% (53 mmol/mol) at EOS and proportion of participants with ≥ 1%-point HbA<sub>1C</sub> reduction and body weight reduction of ≥ 3% or ≥ 5% at EOS. Treatment satisfaction was assessed by Diabetes Treatment Satisfaction Questionnaire (DTSQ) status and change.</p><h3>Results</h3><p>Of 333 participants, 299 completed the study and 227 were on treatment at EOS. People treated with oral semaglutide experienced significantly reduced HbA<sub>1C</sub> by an estimated change of – 1.1%-points (95% CI – 1.27 to – 0.96; <i>P</i> < 0.0001) or – 12.2 mmol/mol (CI – 13.87 to – 10.47; <i>P</i> < 0.0001). Estimated change in body weight was – 4.8 kg (CI – 5.47 to – 4.12; <i>P</i> < 0.0001). At EOS, an HbA<sub>1C</sub> level < 7% (53 mmol/mol) was recorded in 46.3% of participants. A ≥ 1%-point reduction in HbA<sub>1C</sub> combined with a ≥ 3% reduction in body weight was observed in 36.4% of participants, and 27.1% had a ≥ 1%-point reduction in HbA<sub>1C</sub> and a ≥ 5% body weight reduction. Treatment satisfaction improved significantly during the study. No new safety concerns or cases of severe hypoglycaemia were reported.</p><h3>Conclusion</h3><p>People living with T2D in the UK experienced a meaningful decrease in HbA<sub>1C</sub> and body weight after initiation of oral semaglutide treatment. 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引用次数: 0
摘要
简介口服塞马鲁肽是注射用胰高血糖素样肽-1受体激动剂（GLP-1RA）治疗2型糖尿病（T2D）的替代药物。PIONEER REAL 研究评估了在实际环境中口服塞马鲁肽治疗 T2D 的临床效果。PIONEER REAL UK 主要针对英国的成年 T2D 患者：这项多中心、前瞻性、非干预性单臂研究共招募了 333 名参与者，并对他们进行了 34-44 周的随访。参与者接受常规临床实践治疗，之前未接受过注射降糖药物治疗。主要终点是糖化血红蛋白（HbA1C）从基线到研究结束（EOS）的变化。次要终点包括体重变化、HbA1C 下降 1C 的参与者比例以及 EOS 时体重下降≥ 3% 或≥ 5%。治疗满意度通过糖尿病治疗满意度问卷（DTSQ）的状态和变化进行评估：在 333 名参与者中，299 人完成了研究，227 人在 EOS 时仍在接受治疗。36.4%的参与者接受了口服司马鲁肽治疗，HbA1C明显降低，估计变化幅度为-1.1%点（95% CI - 1.27 to - 0.96; P 1C level 1C），体重下降≥3%，27.1%的参与者HbA1C下降≥1%点，体重下降≥5%。研究期间，治疗满意度明显提高。没有新的安全问题或严重低血糖病例的报告：结论：英国的 T2D 患者在开始口服司马鲁肽治疗后，HbA1C 和体重均有明显下降。未发现新的安全性问题：试验注册：ClinicalTrials.gov：试验注册：ClinicalTrials.gov：NCT04862923。本文有图形化简明语言摘要。
PIONEER REAL UK: A Multi-Centre, Prospective, Real-World Study of Once-Daily Oral Semaglutide Use in Adults with Type 2 Diabetes
Introduction
Oral semaglutide provides an alternative to injectable glucagon-like peptide-1 receptor agonists (GLP-1RAs) for treatment of type 2 diabetes (T2D). The PIONEER REAL studies evaluate clinical outcomes of oral semaglutide treatment of T2D in a real-world setting. PIONEER REAL UK focused on adults living with T2D in the UK.
Methods
The multi-centre, prospective and non-interventional single-arm study enrolled 333 participants and followed them for 34–44 weeks. Participants were treated as part of routine clinical practice and had not been previously treated with injectable glucose-lowering medication. The primary endpoint was change in glycated haemoglobin (HbA1C) from baseline to end of study (EOS). Secondary endpoints included change in body weight, proportion of participants with HbA1C < 7% (53 mmol/mol) at EOS and proportion of participants with ≥ 1%-point HbA1C reduction and body weight reduction of ≥ 3% or ≥ 5% at EOS. Treatment satisfaction was assessed by Diabetes Treatment Satisfaction Questionnaire (DTSQ) status and change.
Results
Of 333 participants, 299 completed the study and 227 were on treatment at EOS. People treated with oral semaglutide experienced significantly reduced HbA1C by an estimated change of – 1.1%-points (95% CI – 1.27 to – 0.96; P < 0.0001) or – 12.2 mmol/mol (CI – 13.87 to – 10.47; P < 0.0001). Estimated change in body weight was – 4.8 kg (CI – 5.47 to – 4.12; P < 0.0001). At EOS, an HbA1C level < 7% (53 mmol/mol) was recorded in 46.3% of participants. A ≥ 1%-point reduction in HbA1C combined with a ≥ 3% reduction in body weight was observed in 36.4% of participants, and 27.1% had a ≥ 1%-point reduction in HbA1C and a ≥ 5% body weight reduction. Treatment satisfaction improved significantly during the study. No new safety concerns or cases of severe hypoglycaemia were reported.
Conclusion
People living with T2D in the UK experienced a meaningful decrease in HbA1C and body weight after initiation of oral semaglutide treatment. No new safety issues were observed.
Trial Registration
ClinicalTrials.gov: NCT04862923.
Graphical plain language summary available for this article.
期刊介绍：
Advances in 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 therapeutic areas. 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. Advances in 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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