杜拉鲁肽治疗 2 型糖尿病的安全性和有效性:韩国真实世界上市后研究》。

IF 6.8 2区 医学 Q1 ENDOCRINOLOGY & METABOLISM
Diabetes & Metabolism Journal Pub Date : 2024-05-01 Epub Date: 2024-02-02 DOI:10.4093/dmj.2023.0030
Jeonghee Han, Woo Je Lee, Kyu Yeon Hur, Jae Hyoung Cho, Byung Wan Lee, Cheol-Young Park
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引用次数: 0

摘要

背景调查度拉鲁肽在韩国2型糖尿病(T2DM)成人患者中的实际安全性和有效性:这是一项真实世界、前瞻性、非干预性的上市后安全性研究,于2015年5月26日至2021年5月25日在韩国85家医疗中心使用电子病例数据进行。收集并汇总了使用度拉鲁肽 0.75 毫克/0.5 毫升或度拉鲁肽 1.5 毫克/0.5 毫升一次性使用笔的患者数据。首要目标是报告不良和严重不良事件发生的频率和比例。次要目标是通过评估糖化血红蛋白(HbA1c)、空腹血浆葡萄糖和体重的变化,监测度拉鲁肽在12周和24周时的疗效:共收集了3067名受试者的数据,其中有3022名受试者接受了≥1个剂量(任何强度)的度拉鲁肽,这些受试者被纳入了安全性分析集(53%为女性,平均年龄56岁;糖尿病病程11.2年,平均HbA1c为8.8%)。报告的不良事件为 819 例,其中 68 例(8.3%)为严重不良事件。有 1 例死亡报告。不良事件的严重程度大多较轻;60.81%的不良事件被认为与度拉鲁肽有关。72.73%的受试者(2,198/3,022)完成了这项研究。在12/24周的研究中,有显著的(PC结论:在现实世界中,韩国 T2DM 患者对度拉鲁肽的耐受性和有效性普遍良好。这项研究的结果为在这一人群中使用度拉鲁肽提供了更多证据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety and Effectiveness of Dulaglutide in the Treatment of Type 2 Diabetes Mellitus: A Korean Real-World Post-Marketing Study.

Backgruound: To investigate the real-world safety and effectiveness of dulaglutide in Korean adults with type 2 diabetes mellitus (T2DM).

Methods: This was a real-world, prospective, non-interventional post-marketing safety study conducted from May 26, 2015 to May 25, 2021 at 85 Korean healthcare centers using electronic case data. Data on patients using dulaglutide 0.75 mg/0.5 mL or the dulaglutide 1.5 mg/0.5 mL single-use pens were collected and pooled. The primary objective was to report the frequency and proportion of adverse and serious adverse events that occurred. The secondary objective was to monitor the effectiveness of dulaglutide at 12 and 24 weeks by evaluating changes in glycosylated hemoglobin (HbA1c ), fasting plasma glucose, and body weight.

Results: Data were collected from 3,067 subjects, and 3,022 subjects who received ≥1 dose (of any strength) of dulaglutide were included in the safety analysis set (53% female, mean age 56 years; diabetes duration 11.2 years, mean HbA1c 8.8%). The number of adverse events reported was 819; of these, 68 (8.3%) were serious adverse events. One death was reported. Adverse events were mostly mild in severity; 60.81% of adverse events were considered related to dulaglutide. This study was completed by 72.73% (2,198/3,022) of subjects. At 12/24 weeks there were significant (P<0.0001) reductions from baseline in least-squares mean HbA1c (0.96%/0.95%), fasting blood glucose (26.24/24.43 mg/dL), and body weight (0.75/1.21 kg).

Conclusion: Dulaglutide was generally well tolerated and effective in real-world Korean individuals with T2DM. The results from this study contribute to the body of evidence for dulaglutide use in this population.

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来源期刊
Diabetes & Metabolism Journal
Diabetes & Metabolism Journal Medicine-Endocrinology, Diabetes and Metabolism
CiteScore
10.40
自引率
6.80%
发文量
92
审稿时长
52 weeks
期刊介绍: The aims of the Diabetes & Metabolism Journal are to contribute to the cure of and education about diabetes mellitus, and the advancement of diabetology through the sharing of scientific information on the latest developments in diabetology among members of the Korean Diabetes Association and other international societies. The Journal publishes articles on basic and clinical studies, focusing on areas such as metabolism, epidemiology, pathogenesis, complications, and treatments relevant to diabetes mellitus. It also publishes articles covering obesity and cardiovascular disease. Articles on translational research and timely issues including ubiquitous care or new technology in the management of diabetes and metabolic disorders are welcome. In addition, genome research, meta-analysis, and randomized controlled studies are welcome for publication. The editorial board invites articles from international research or clinical study groups. Publication is determined by the editors and peer reviewers, who are experts in their specific fields of diabetology.
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