瑞典 PIONEER REAL:瑞典临床实践中 2 型糖尿病成人口服塞马鲁肽的多中心、前瞻性、真实世界观察研究。

IF 3.8 3区 医学 Q2 Medicine Diabetes Therapy Pub Date : 2024-09-01 Epub Date: 2024-07-25 DOI:10.1007/s13300-024-01614-6
Sergiu-Bogdan Catrina, Hanan Amadid, Uffe C Braae, Jonatan Dereke, Neda Rajamand Ekberg, Boris Klanger, Stefan Jansson
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引用次数: 0

摘要

简介该研究旨在评估在瑞典临床实践中,每日一次口服塞马鲁肽对初次使用注射降糖药的成人2型糖尿病(T2D)患者的治疗效果:在这项非干预性多中心研究中,参与者开始口服塞马鲁肽,并接受34-44周的随访。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(BW)从基线到研究结束(EOS)的变化、研究结束(EOS)时 HbA1c 1c 降低≥1% 和体重降低≥3% 或≥5% 的参与者比例。参与者填写糖尿病治疗满意度问卷(DTSQ 状态/变化)和用药条件问卷:共有 187 名参与者(平均年龄 62.5 岁)开始口服塞马鲁肽。基线平均 HbA1c 和体重分别为 7.8% (n = 177) 和 96.9 kg (n = 165)。HbA1c 和体重的估计平均变化为- 0.88% 点(95% 置信区间 [CI] - 1.01 至 - 0.75;P 1c 1c 降低≥1%,体重降低≥5%。DTSQ 状态评分和变化评分分别提高了 1.44 分(P = 0.0260)和 12.3 分(P 结论:DTSQ 状态评分和变化评分分别提高了 1.44 分和 12.3 分:在这一真实世界研究人群中,我们观察到,作为瑞典常规临床实践的一部分,T2D患者在服用塞马鲁肽片剂后,HbA1c和体重均显著下降,参与者的治疗满意度提高,且没有新的安全问题:试验注册:NCT04601753。
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PIONEER REAL Sweden: A Multicentre, Prospective, Real-World Observational Study of Oral Semaglutide Use in Adults with Type 2 Diabetes in Swedish Clinical Practice.

Introduction: The study was designed to assess outcomes with once-daily oral semaglutide in adults with type 2 diabetes (T2D) naïve to injectable glucose-lowering agents, in Swedish clinical practice.

Methods: In this non-interventional, multicentre study, participants initiated oral semaglutide and were followed for 34-44 weeks. The primary endpoint was glycated haemoglobin (HbA1c) change from baseline to end of study (EOS). Secondary endpoints included body weight (BW) change from baseline to EOS, proportion of participants achieving HbA1c < 7%, and proportion achieving both a HbA1c reduction ≥ 1% and BW reduction of ≥ 3% or ≥ 5%, at EOS. Participants completed Diabetes Treatment Satisfaction Questionnaires (DTSQ status/change) and a dosing conditions questionnaire.

Results: A total of 187 participants (mean age 62.5 years) initiated oral semaglutide. Baseline mean HbA1c and BW were 7.8% (n = 177) and 96.9 kg (n = 165), respectively. Estimated mean changes in HbA1c and BW were - 0.88%-points (95% confidence interval [CI] - 1.01 to - 0.75; P < 0.0001) and - 4.72% (95% CI - 5.58 to - 3.86; P < 0.0001), respectively. At EOS, 64.6% of participants had HbA1c < 7%, and 22.9% achieved HbA1c reduction of ≥ 1% and BW reduction of ≥ 5%. DTSQ status and change scores improved by 1.44 (P = 0.0260) and 12.3 points (P < 0.0001), respectively. Oral semaglutide was easy or very easy to consume for 86.4% of participants. Most common adverse events (AEs) were gastrointestinal disorders; nine participants (4.8%) had serious AEs; one (0.5%) experienced severe hypoglycaemia.

Conclusion: In this real-world study population, we observed significant reductions in HbA1c and BW in people living with T2D when prescribed semaglutide tablets as part of routine clinical practice in Sweden, with improved treatment satisfaction among participants and no new safety concerns.

Trial registration: NCT04601753.

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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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