Fumika Maruyama, Hiroya Kitsunai, Naoyuki Kitao, Yoshinori Wakabayashi, Miki Ito, Hiroyoshi Kurihara, Kohei Yamamoto, Jun Takeuchi, Atsuko Abiko, Reiko Homma, Yoshihiro Miyamoto, Kazuo Yamagata, Asuka Miyazaki, Akinobu Nakamura, Hiroshi Nomoto, the Hokkaido‐TZP Study Group
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.