荷兰 PIONEER REAL 多中心、前瞻性、观察性研究中 2 型糖尿病成人口服塞马鲁肽的实际使用情况。

IF 3.8 3区医学 Q2 Medicine Diabetes Therapy Pub Date : 2024-08-01 Epub Date: 2024-06-11 DOI:10.1007/s13300-024-01588-5

William van Houtum, Patrick Schrömbges, Hanan Amadid, Arianne C van Bon, Uffe C Braae, Charlotte Hoogstraten, Hans Herrings

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引用次数: 0

摘要

简介：在这项4期、多中心、前瞻性、非干预性的荷兰PIONEER REAL研究中，我们评估了在实际临床实践中每日一次口服塞马鲁肽对初次使用注射降糖药物的2型糖尿病（T2D）成人患者的临床疗效：对开始使用口服塞马鲁肽的参与者进行为期 34-44 周的随访。糖化血红蛋白（HbA1c）从基线（BL）到研究结束（EOS）的变化是主要终点；次要终点包括体重（BW）从基线到研究结束的变化、HbA1c结果的参与者比例：187名参与者开始口服塞马鲁肽；94.1%的参与者完成了研究，78.6%的参与者在研究结束时仍在接受治疗。在BL期，54.0%的参与者为男性，平均年龄为58.8岁，平均T2D病程为8.7年，平均体重指数为35.1 kg/m2；平均HbA1c为8.6%，平均体重为103.1 kg。从 BL 到 EOS，HbA1c 和体重均有明显改善（估计变化 [95% 置信区间]：- 1.16% 点 [- 1.48 到 - 0.85]；P 结论：从 EOS 到 BL，HbA1c 和体重均有明显改善：在这一实际人群中，我们发现 HbA1c 和体重均有显著的临床降低，治疗满意度提高，并且没有新的安全问题。本文附有图表摘要：临床试验注册：NCT04601740。

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Real-World Use of Oral Semaglutide in Adults with Type 2 Diabetes in the PIONEER REAL Netherlands Multicentre, Prospective, Observational Study.

Introduction: In this phase 4, multicentre, prospective, non-interventional PIONEER REAL Netherlands study, we assessed clinical outcomes associated with once-daily oral semaglutide use in real-world clinical practice in adults living with type 2 diabetes (T2D) naïve to injectable glucose-lowering medication.

Methods: Participants initiated on oral semaglutide were followed for 34-44 weeks. Change in glycated haemoglobin (HbA1c) from baseline (BL) to end of study (EOS) was the primary endpoint; secondary endpoints included change in body weight (BW) from BL to EOS, the proportion of participants with HbA1c < 7.0% at EOS and the composite endpoints of HbA1c reduction ≥ 1.0%-points with BW reduction ≥ 3% or ≥ 5% at EOS. Treatment satisfaction was assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ status/change). Safety was evaluated in all participants who initiated oral semaglutide treatment.

Results: Oral semaglutide was initiated in 187 participants; 94.1% completed the study and 78.6% remained on treatment at EOS. At BL, 54.0% of participants were male, mean age was 58.8 years, mean duration of T2D was 8.7 years and mean body mass index was 35.1 kg/m²; mean HbA1c was 8.6% and mean BW was 103.1 kg. Significant improvements from BL to EOS were observed for HbA1c and BW (estimated change [95% confidence interval]: - 1.16%-points [- 1.48 to - 0.85]; p < 0.0001, and - 5.84 kg [- 6.88 to - 4.80]; p < 0.0001, respectively). At EOS, 47.5% of participants had an HbA1c level < 7.0%; 41.8% and 35.5% of participants achieved composite endpoints of HbA1c reduction ≥ 1.0%-points plus BW reduction ≥ 3% or ≥ 5%, respectively. DTSQ status and change scores improved by 2.1 (p = 0.0003) and 10.8 points (p < 0.0001), respectively. Oral semaglutide was easy or very easy to consume for 81.5% of participants. Adverse events were mostly mild/moderate, with gastrointestinal disorders being the most common.

Conclusion: In this real-world population, we reported clinically significant reductions in HbA1c and BW, improved treatment satisfaction and no new safety concerns. A graphical abstract is available with this article.

Clinical trial registration: NCT04601740.

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来源期刊

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.