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IF 6.1 3区医学 Q1 ENDOCRINOLOGY & METABOLISM

Diabetes research and clinical practice Pub Date : 2024-12-13 DOI:10.1016/j.diabres.2024.111959

Lixin Guo, Jing Wang, Li Li, Lin Yuan, Sheng Chen, Hui Wang, Tonghuan Li, Lin Qi, Hong Yang

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引用次数: 0

摘要

目的：DONATE（NCT03156985）是一项大规模真实世界研究，调查达帕格列净在中国2型糖尿病（T2DM）患者中的安全性。这项事后分析旨在进一步评估达帕格列净联合二甲双胍的实际安全性：方法：对同时接受达帕格列净和二甲双胍治疗的患者进行安全性评估。此外，还分析了达帕格列净双疗法和达帕格列净与二甲双胍三疗法的安全性：在DONATE的2990名患者中，有2165人（72.4%）同时服用二甲双胍。在这2165名患者中，780人（36.0%）发生过≥1次不良事件（AE），129人（6.0%）发生过严重不良事件（SAE），96人（4.4%）发生过导致达帕格列净停药的不良事件。最常见的不良反应是上呼吸道感染（4.0%）、尿路感染（UTI，2.1%）和便秘（1.5%）。达帕格列净最常见的特殊不良反应是UTI（2.3%）、生殖道感染（1.5%）和低血糖（1.1%）。在达帕格列净和二甲双胍双重疗法亚组中，导致停用达帕格列净的AE、SAE和AE发生率分别为26.7%、2.5%和1.9%，在数量上低于总人群和大多数其他双重疗法亚组。这些患者的代谢结果也比基线有所改善：结论：达帕格列净和二甲双胍联合疗法在现实世界的中国T2DM患者中耐受性良好。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Real-world safety of dapagliflozin plus metformin in patients of type 2 diabetes mellitus in China: Post-hoc analysis of the DONATE study.

Aim: DONATE (NCT03156985) is a large-scale real-world study investigating the safety of dapagliflozin in Chinese type 2 diabetes mellitus (T2DM) patients. This post-hoc analysis aims to further evaluate the real-world safety of dapagliflozin plus metformin.

Methods: Safety outcomes were assessed in patients receiving concomitant dapagliflozin and metformin, with or without other antidiabetics. The safety of dapagliflozin-based dual-therapies and dapagliflozin and metformin-based triple-therapies were also analysed.

Results: Among the 2,990 patients in DONATE, 2,165 (72.4 %) received concomitant metformin. Among these 2,165 patients, 780 (36.0 %) experienced ≥ 1 adverse event (AE), 129 (6.0 %) experienced serious AE (SAE), and 96 (4.4 %) experienced AE leading to dapagliflozin discontinuation. The most common AEs were upper respiratory tract infection (4.0 %), urinary tract infection (UTI, 2.1 %) and constipation (1.5 %). The most common AEs of special interest of dapagliflozin were UTI (2.3 %), genital tract infection (1.5 %) and hypoglycaemia (1.1 %). In the dapagliflozin and metformin dual-therapy subgroup, the incidences of AE, SAE and AE leading to dapagliflozin discontinuation were 26.7 %, 2.5 %, and 1.9 %, respectively, numerically lower than that of the total population and most other dual-therapy subgroups. These patients also had numerically improved metabolic outcomes than baseline.

Conclusion: Dapagliflozin and metformin combination therapy is well-tolerated in real-world Chinese T2DM patients.

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来源期刊

Diabetes research and clinical practice 医学-内分泌学与代谢

CiteScore

10.30

自引率

3.90%

发文量

862

审稿时长

32 days

期刊介绍： Diabetes Research and Clinical Practice is an international journal for health-care providers and clinically oriented researchers that publishes high-quality original research articles and expert reviews in diabetes and related areas. The role of the journal is to provide a venue for dissemination of knowledge and discussion of topics related to diabetes clinical research and patient care. Topics of focus include translational science, genetics, immunology, nutrition, psychosocial research, epidemiology, prevention, socio-economic research, complications, new treatments, technologies and therapy.