Gottfried Rudofsky, Hanan Amadid, Uffe Christian Braae, Sergiu-Bogdan Catrina, Anastas Kick, Kabirdev Mandavya, Klaus Roslind, Ponnusamy Saravanan, William van Houtum, Akshay B Jain
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Here, data from Canada, Denmark, Italy, the Netherlands, Sweden, Switzerland, and the UK are pooled and analyzed to address treatment satisfaction as well as glycated hemoglobin (HbA<sub>1C</sub>) and body weight changes in relevant subgroup analyses.</p><p><strong>Methods: </strong>This pooled analysis encompasses seven country-specific, non-interventional, multicenter, phase 4, prospective, single-arm clinical studies assessing the use of oral semaglutide in adults with T2D. Primary endpoint was the change in HbA<sub>1C</sub> from baseline to end of study (EOS), and secondary endpoints included changes in body weight and treatment satisfaction. For the analyses, results were stratified by age, T2D duration, and oral semaglutide dose at EOS as well as baseline HbA<sub>1C</sub>, body weight, and body mass index.</p><p><strong>Results: </strong>Oral semaglutide treatment was initiated by 1615 participants. At EOS, 1222 (76%) participants out of the 1483 (92%) who completed the study were on treatment. Estimated changes in HbA<sub>1C</sub> and body weight from baseline to week 38 were - 1.0%-point (95% CI - 1.08 to - 0.97; P < 0.0001) and - 5.0% (CI - 5.37 to - 4.72; P < 0.0001). Treatment satisfaction increased significantly during the study. Shorter T2D duration interacted with higher HbA<sub>1C</sub> reduction and body weight loss. Interaction was also observed between higher baseline HbA<sub>1C</sub> and more pronounced decrease in HbA<sub>1C</sub>. No significant interactions were detected between clinical outcomes and age or physician setting.</p><p><strong>Conclusion: </strong>The PIONEER REAL pooled analysis shows that people initiating oral semaglutide treatment experience improved glycemic control and body weight loss across age groups and T2D duration. This occurs regardless of specialist or primary care practice setting and is accompanied by an increased treatment satisfaction.</p><p><strong>Clinical trial registrations: </strong>NCT04559815 (Canada), NCT04537637 (Denmark), NCT05230615 (Italy), NCT04601740 (the Netherlands), NCT04601753 (Sweden), NCT04537624 (Switzerland), NCT04862923 (UK).</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8000,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Oral Semaglutide Use in Type 2 Diabetes: A Pooled Analysis of Clinical and Patient-Reported Outcomes from Seven PIONEER REAL Prospective Real-World Studies.\",\"authors\":\"Gottfried Rudofsky, Hanan Amadid, Uffe Christian Braae, Sergiu-Bogdan Catrina, Anastas Kick, Kabirdev Mandavya, Klaus Roslind, Ponnusamy Saravanan, William van Houtum, Akshay B Jain\",\"doi\":\"10.1007/s13300-024-01668-6\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Oral semaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1RA) approved for improving glycemic control in adults with type 2 diabetes (T2D). 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引用次数: 0
摘要
简介口服塞马鲁肽是一种胰高血糖素样肽 1 受体激动剂 (GLP-1RA)，已被批准用于改善成人 2 型糖尿病 (T2D) 患者的血糖控制。PIONEER REAL 计划对 13 个国家的常规临床实践中口服塞马鲁肽治疗的临床和患者报告结果进行了评估。在此，我们汇总并分析了来自加拿大、丹麦、意大利、荷兰、瑞典、瑞士和英国的数据，在相关亚组分析中探讨了治疗满意度以及糖化血红蛋白（HbA1C）和体重变化：本汇总分析包括七项针对特定国家的非干预、多中心、4 期、前瞻性、单臂临床研究，这些研究评估了口服塞马鲁肽在成人 T2D 患者中的应用。主要终点是 HbA1C 从基线到研究结束（EOS）的变化，次要终点包括体重变化和治疗满意度。分析结果按年龄、T2D持续时间、研究结束时的口服塞马鲁肽剂量以及基线HbA1C、体重和体重指数进行分层：1615名参与者开始了口服塞马鲁肽治疗。在 EOS 阶段，完成研究的 1483 人（92%）中有 1222 人（76%）仍在接受治疗。从基线到第38周，HbA1C和体重的估计变化为-1.0%点（95% CI - 1.08至-0.97；P 1C降低和体重减轻）。基线 HbA1C 较高与 HbA1C 下降更明显之间也存在相互作用。临床结果与年龄或医生环境之间没有发现明显的相互作用：PIONEER REAL 的汇总分析表明，开始口服塞马鲁肽治疗的患者在不同年龄组和 T2D 病程中的血糖控制和体重减轻情况都有所改善。这种情况的出现与专科或初级医疗机构无关，同时治疗满意度也有所提高：临床试验注册：NCT04559815（加拿大）、NCT04537637（丹麦）、NCT05230615（意大利）、NCT04601740（荷兰）、NCT04601753（瑞典）、NCT04537624（瑞士）、NCT04862923（英国）。
Oral Semaglutide Use in Type 2 Diabetes: A Pooled Analysis of Clinical and Patient-Reported Outcomes from Seven PIONEER REAL Prospective Real-World Studies.
Introduction: Oral semaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1RA) approved for improving glycemic control in adults with type 2 diabetes (T2D). The PIONEER REAL program evaluates clinical and patient-reported outcomes of oral semaglutide treatment as part of routine clinical practice across 13 countries. Here, data from Canada, Denmark, Italy, the Netherlands, Sweden, Switzerland, and the UK are pooled and analyzed to address treatment satisfaction as well as glycated hemoglobin (HbA1C) and body weight changes in relevant subgroup analyses.
Methods: This pooled analysis encompasses seven country-specific, non-interventional, multicenter, phase 4, prospective, single-arm clinical studies assessing the use of oral semaglutide in adults with T2D. Primary endpoint was the change in HbA1C from baseline to end of study (EOS), and secondary endpoints included changes in body weight and treatment satisfaction. For the analyses, results were stratified by age, T2D duration, and oral semaglutide dose at EOS as well as baseline HbA1C, body weight, and body mass index.
Results: Oral semaglutide treatment was initiated by 1615 participants. At EOS, 1222 (76%) participants out of the 1483 (92%) who completed the study were on treatment. Estimated changes in HbA1C and body weight from baseline to week 38 were - 1.0%-point (95% CI - 1.08 to - 0.97; P < 0.0001) and - 5.0% (CI - 5.37 to - 4.72; P < 0.0001). Treatment satisfaction increased significantly during the study. Shorter T2D duration interacted with higher HbA1C reduction and body weight loss. Interaction was also observed between higher baseline HbA1C and more pronounced decrease in HbA1C. No significant interactions were detected between clinical outcomes and age or physician setting.
Conclusion: The PIONEER REAL pooled analysis shows that people initiating oral semaglutide treatment experience improved glycemic control and body weight loss across age groups and T2D duration. This occurs regardless of specialist or primary care practice setting and is accompanied by an increased treatment satisfaction.
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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