Safety and Efficacy of Imeglimin for Type 2 Diabetes Mellitus in Patients With Heart Failure.

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.

Patients and methods: 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.

Results: 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.

Conclusion: Imeglimin demonstrated safety and efficacy in T2DM in patients with coexisting heart failure.