Real-World Clinical Evidence of Tirzepatide for Metabolic Abnormalities in Subjects With Type 2 Diabetes: The Multicenter Retrospective Observational Hokkaido-TZP Study.

AIMS: Tirzepatide has demonstrated potent glucose-lowering efficacy and metabolic benefits in subjects with type 2 diabetes (T2D) in Phase III clinical trials. However, its efficacy in real-world clinical practice, particularly among patients receiving various antidiabetic therapies, remains to be elucidated. MATERIALS AND METHODS: This multicenter retrospective observational study evaluated subjects with T2D who were treated with tirzepatide for ≥ 6 months across 10 medical centers in Hokkaido, Japan. Primary endpoints included changes in glycated haemoglobin and other metabolic parameters after 6 months of treatment with tirzepatide, alongside adverse events leading to discontinuation of tirzepatide. RESULTS: Of the 828 subjects analysed (mean age 55.6 ± 12.5 years; mean body mass index 30.6 ± 5.8), 81.3% were treated with incretin-based medications at baseline. Tirzepatide was discontinued in 45 subjects because of adverse events, personal preference or other clinical reasons. Significant improvements were observed in both glycated haemoglobin (-1.07%, 95% CI -1.16, -0.98; baseline 7.82% ± 1.59%, p < 0.001) and body weight (-3.1 kg, 95% CI -3.4, -2.8; baseline 83.8 ± 18.5 kg, p < 0.001). This efficacy was consistent even in patients switching from incretin-based medications. CONCLUSIONS: Tirzepatide demonstrated robust clinical efficacy and a favourable safety profile in a real-world clinical setting, regardless of whether incretin-based therapy had been administered previously.