Lilly Korea Ltd., Seoul, Korea.
Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Diabetes Metab J. 2024 May;48(3):418-428. doi: 10.4093/dmj.2023.0030. Epub 2024 Feb 2.
To investigate the real-world safety and effectiveness of dulaglutide in Korean adults with type 2 diabetes mellitus (T2DM).
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.
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).
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.
研究度拉糖肽在韩国 2 型糖尿病（T2DM）成年患者中的真实世界安全性和有效性。
这是一项于 2015 年 5 月 26 日至 2021 年 5 月 25 日在 85 家韩国医疗机构进行的真实世界、前瞻性、非干预性上市后安全性研究，使用电子病历数据。收集并汇总了使用度拉糖肽 0.75mg/0.5mL 或度拉糖肽 1.5mg/0.5mL 预充式笔的患者的数据。主要目的是报告发生的不良事件和严重不良事件的频率和比例。次要目的是通过评估糖化血红蛋白（HbA1c）、空腹血糖和体重的变化来监测 12 周和 24 周时度拉糖肽的有效性。
共收集了 3067 例患者的数据，3022 例接受了至少 1 剂（任何剂量）度拉糖肽的患者纳入安全性分析集（53%为女性，平均年龄 56 岁；糖尿病病程 11.2 年，平均 HbA1c 8.8%）。报告了 819 例不良事件，其中 68 例（8.3%）为严重不良事件。报告了 1 例死亡。不良事件大多为轻度；60.81%的不良事件被认为与度拉糖肽有关。该研究由 3022 例患者中的 72.73%（2198 例）完成。在 12 周/24 周时，与基线相比，最小二乘均数 HbA1c（0.96%/0.95%）、空腹血糖（26.24/24.43mg/dL）和体重（0.75/1.21kg）均显著降低（P<0.0001）。
度拉糖肽在韩国真实世界的 2 型糖尿病患者中总体耐受良好且有效。本研究结果为该人群中使用度拉糖肽提供了更多证据。
