Semaglutide 2.4 mg in French people living with Class 3 obesity and comorbidities: Baseline characteristics and real-world safety data

IF 4.6 2区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes & metabolism Pub Date : 2025-02-17 DOI:10.1016/j.diabet.2025.101625

Emmanuel Disse , Judith Aron-Wisnewsky , David Jacobi , Karine Clément , Martine Laville , Cyril Gauthier , François Pattou , Julie Molleville , Melissa Akerib , Lysiane Jubin , Blandine Gatta-Cherifi , Bénédicte Gaborit , Emilie Montastier , Fabien Stenard , Claire Carette , Najate Achamrah , Antoine Avignon , Sébastien Czernichow

{"title":"Semaglutide 2.4 mg in French people living with Class 3 obesity and comorbidities: Baseline characteristics and real-world safety data","authors":"Emmanuel Disse , Judith Aron-Wisnewsky , David Jacobi , Karine Clément , Martine Laville , Cyril Gauthier , François Pattou , Julie Molleville , Melissa Akerib , Lysiane Jubin , Blandine Gatta-Cherifi , Bénédicte Gaborit , Emilie Montastier , Fabien Stenard , Claire Carette , Najate Achamrah , Antoine Avignon , Sébastien Czernichow","doi":"10.1016/j.diabet.2025.101625","DOIUrl":null,"url":null,"abstract":"<div><h3>Aim</h3><div><em>-</em> To describe baseline characteristics and safety data of real-world use of semaglutide 2.4 mg.</div></div><div><h3>Methods</h3><div><em>-</em> Patients with a body mass index (BMI) ≥40 kg/m<sup>2</sup> and at least one of the following treated weight-related comorbidities (WRC: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease) were eligible to receive treatment through Temporary Utilization Authorization (TUA: March to June 2022) or Early Access Program (EAP: July 2022 to October 2023). Data were collected according to Health Authorities’ requirements. Only descriptive statistics were used.</div></div><div><h3>Results</h3><div><em>-</em> Overall, 5,797 (62.8%) treatment requests were sent by sites specialized in obesity management. In total, 478 and 8,568 patients were treated within TUA and EAP cohorts respectively, with mean follow-up durations of 1.2 and 4.5 months, respectively. Mean (SD) BMI was 48.9 (9.7) and 47.0 (7.4) kg/m<sup>2</sup>, respectively. Age ranged from 18 to 81 years. In the EAP, 57.4%, 26.5%, 12.3% and 3.7% of patients had 1, 2, 3 and 4 WRC. In addition, 15.5% had type 2 diabetes, 18.1% reported depression and 15.4% had osteoarthritis. In the EAP, 247 (2.9%) patients discontinued treatment after a median time of 2.8 months (IQR: 1.2–5.1), mainly due to adverse events (AEs) (47.0%). During TUA, 3 patients discontinued due to AEs. Pancreatitis was reported in 7 cases overall.</div></div><div><h3>Conclusion</h3><div><em>-</em> The high number of treatment prescriptions in a short period highlights the high unmet medical need. No new safety concerns were identified in this population with severe obesity treated in a real-world setting.</div></div>","PeriodicalId":11334,"journal":{"name":"Diabetes & metabolism","volume":"51 3","pages":"Article 101625"},"PeriodicalIF":4.6000,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Diabetes & metabolism","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1262363625000205","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}

引用次数: 0

Abstract

Aim

- To describe baseline characteristics and safety data of real-world use of semaglutide 2.4 mg.

Methods

- Patients with a body mass index (BMI) ≥40 kg/m² and at least one of the following treated weight-related comorbidities (WRC: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease) were eligible to receive treatment through Temporary Utilization Authorization (TUA: March to June 2022) or Early Access Program (EAP: July 2022 to October 2023). Data were collected according to Health Authorities’ requirements. Only descriptive statistics were used.

Results

- Overall, 5,797 (62.8%) treatment requests were sent by sites specialized in obesity management. In total, 478 and 8,568 patients were treated within TUA and EAP cohorts respectively, with mean follow-up durations of 1.2 and 4.5 months, respectively. Mean (SD) BMI was 48.9 (9.7) and 47.0 (7.4) kg/m², respectively. Age ranged from 18 to 81 years. In the EAP, 57.4%, 26.5%, 12.3% and 3.7% of patients had 1, 2, 3 and 4 WRC. In addition, 15.5% had type 2 diabetes, 18.1% reported depression and 15.4% had osteoarthritis. In the EAP, 247 (2.9%) patients discontinued treatment after a median time of 2.8 months (IQR: 1.2–5.1), mainly due to adverse events (AEs) (47.0%). During TUA, 3 patients discontinued due to AEs. Pancreatitis was reported in 7 cases overall.

Conclusion

- The high number of treatment prescriptions in a short period highlights the high unmet medical need. No new safety concerns were identified in this population with severe obesity treated in a real-world setting.

查看原文本刊更多论文

Semaglutide 2.4 mg用于法国3级肥胖和合并症患者：基线特征和现实世界安全性数据

目的：描述实际使用semaglutide 2.4 mg的基线特征和安全性数据。方法：体重指数(BMI)≥40 kg/m2且至少有以下一种已治疗的体重相关合并症（WRC：高血压、血脂异常、阻塞性睡眠呼吸暂停、心血管疾病）的患者有资格通过临时使用授权（TUA: 2022年3月至6月）或早期使用计划（EAP: 2022年7月至2023年10月）接受治疗。数据是根据卫生当局的要求收集的。仅使用描述性统计。结果：总体而言，5797（62.8%）个治疗请求是由肥胖管理专业网站发送的。TUA组和EAP组分别有478例和8568例患者接受了治疗，平均随访时间分别为1.2个月和4.5个月。平均（SD） BMI分别为48.9（9.7）和47.0 (7.4)kg/m2。年龄从18岁到81岁不等。在EAP中，57.4%、26.5%、12.3%和3.7%的患者为1、2、3和4级WRC。此外，15.5%的人患有2型糖尿病，18.1%的人患有抑郁症，15.4%的人患有骨关节炎。在EAP中，247例（2.9%）患者在中位2.8个月后（IQR: 1.2-5.1）停止治疗，主要是由于不良事件（ae）（47.0%）。在TUA期间，有3例患者因ae而停药。胰腺炎共7例。结论：短时间内大量的治疗处方凸显了大量未满足的医疗需求。在现实世界中，没有发现在重度肥胖人群中存在新的安全问题。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Diabetes & metabolism 医学-内分泌学与代谢

CiteScore

12.00

自引率

4.20%

发文量

审稿时长

13 days

期刊介绍： A high quality scientific journal with an international readership Official publication of the SFD, Diabetes & Metabolism, publishes high-quality papers by leading teams, forming a close link between hospital and research units. Diabetes & Metabolism is published in English language and is indexed in all major databases with its impact factor constantly progressing. Diabetes & Metabolism contains original articles, short reports and comprehensive reviews.