Nishikawa Tomoaki, Higaki Akinori, Kurokawa Keisho, Yoshimoto Kohei, Horie Rikako, Nakao Yasuhisa, Fujisawa Tomoki, Miyazaki Shigehiro, Akazawa Yusuke, Miyoshi Toru, Kawakami Hiroshi, Higashi Haruhiko, Tamaki Shunsuke, Nishimura Kazuhisa, Inoue Katsuji, Ikeda Shuntaro, Yamaguchi Osamu
Department of Cardiology, Pulmonology, Hypertension and Nephrology, Ehime University Graduate School of Medicine, Toon, Japan
Department of Cardiology, Pulmonology, Hypertension and Nephrology, Ehime University Graduate School of Medicine, Toon, Japan.
In Vivo. 2025 Jan-Feb;39(1):375-380. doi: 10.21873/invivo.13838.
BACKGROUND/AIM: Imeglimin, a novel oral antidiabetic agent, was approved in 2021 for the treatment of type 2 diabetes mellitus (T2DM). Phase III clinical trials demonstrated its safety and efficacy in managing T2DM. However, its safety profile in patients with heart failure has not been thoroughly evaluated in real-world clinical settings.
We analyzed cases of patients with heart failure (stage B or higher) who were newly prescribed imeglimin, based on electronic medical records from June 2022 to June 2024. Baseline clinical data at the initiation of imeglimin therapy were collected, and cardiovascular events, adverse effects (e.g., lactic acidosis), and blood test results, including glycated hemoglobin A1c (HbA1c), were assessed as of July 2024.
A total of 21 patients met the inclusion criteria. HbA1c levels significantly decreased after an average of 312.1±205.8 days of imeglimin therapy (baseline vs. on therapy: 8.2±1.0% vs. 7.5±0.7%, p=0.001). Alanine aminotransferase levels were also significantly reduced (baseline vs. on therapy: 30.9±23.8 IU/l vs. 22.0±12.3 IU/l, p=0.022). No adverse drug reactions were observed during the treatment period. Major adverse cardiovascular events occurred in three patients (14%), although a clear association with imeglimin remains uncertain.
Imeglimin demonstrated safety and efficacy in T2DM in patients with coexisting heart failure.
背景/目的：艾美格列明是一种新型口服抗糖尿病药物，于2021年获批用于治疗2型糖尿病（T2DM）。III期临床试验证明了其在管理T2DM方面的安全性和有效性。然而，在真实世界临床环境中，其在心力衰竭患者中的安全性尚未得到充分评估。
我们基于2022年6月至2024年6月的电子病历，分析了新开具艾美格列明处方的心力衰竭（B期或更高阶段）患者的病例。收集了开始艾美格列明治疗时的基线临床数据，并截至2024年7月评估了心血管事件、不良反应（如乳酸性酸中毒）以及血液检测结果，包括糖化血红蛋白A1c（HbA1c）。
共有21名患者符合纳入标准。艾美格列明治疗平均312.1±205.8天后，HbA1c水平显著下降（基线时vs.治疗时：8.2±1.0% vs. 7.5±0.7%，p = 0.001）。丙氨酸转氨酶水平也显著降低（基线时vs.治疗时：30.9±23.8 IU/l vs. 22.0±12.3 IU/l，p = 0.022）。治疗期间未观察到药物不良反应。3名患者（14%）发生了主要不良心血管事件，尽管与艾美格列明的明确关联仍不确定。
艾美格列明在合并心力衰竭的T2DM患者中显示出安全性和有效性。
