Real-World Effectiveness of Tirzepatide in Japanese Patients with Type 2 Diabetes: A Multicenter Retrospective Observational Study.

IF 4.2 3区医学 Q2 Medicine

Diabetes Therapy Pub Date : 2026-07-01 Epub Date: 2026-05-30 DOI:10.1007/s13300-026-01877-1

Noriyuki Takahashi, Makoto Ohara, Hiroki Yokoyama, Hiroaki Seino, Munenori Hiromura, Shutaro Ozawa, Takemasa Omachi, Nobuaki Takehana, Tomoki Fujikawa, Ayako Ohara, Shunichiro Irie, Naoya Osaka, Michishige Terasaki, Aya Yoshihara, Yusaku Mori, Tomoyasu Fukui, Sho-Ichi Yamagishi

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引用次数: 0

Abstract

Introduction: Tirzepatide, a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 (GLP-1) receptor agonist, significantly affects glucose and body weight-lowering effects in randomized controlled trials. However, real-world clinical evidence in Japan remains limited. This study aimed to evaluate the real-world effectiveness of tirzepatide on glycemic and metabolic factors in Japanese patients with type 2 diabetes mellitus (T2DM).

Methods: In this multicenter, retrospective, observational study, we included patients with T2DM from seven Japanese institutions who received tirzepatide treatment for at least 24 weeks. Tirzepatide effectiveness was evaluated by comparing clinical and biochemical parameters, including glycated hemoglobin (HbA1c), plasma glucose levels, body weight, blood pressure, lipid profiles, liver enzyme levels, and renal function, before and after 24 weeks of treatment.

Results: We included 324 patients (mean age, 56.8 ± 11.4 years; median body mass index (BMI), 30.4 kg/m² (interquartile range 26.8-34.0)). At 24 weeks, 42 (13.0%), 211 (65.1%), 35 (10.8%), 25 (7.7%), and 11 (3.4%) patients received 2.5 mg, 5 mg, 7.5 mg, 10 mg, and 12.5/15 mg tirzepatide, respectively. HbA1c and body weight significantly decreased after tirzepatide administration; the median HbA1c and body weight reduced from 7.9% [7.2-8.6] to 6.8% [6.1-7.5] and from 82.5 kg [73.5-94.6] to 80.0 kg [70.9-92.5], respectively, whereas the medians of changes in HbA1c and body weight from baseline to week 24 were - 0.9% [- 1.6 to - 0.3] and - 2.0 kg [- 4.0 to 0.0] (p < 0.001). HbA1c reduction was greater in GLP-1 receptor agonist-naïve patients (p < 0.001). Changes in HbA1c levels significantly correlated with baseline HbA1c levels (r_s = - 0.473, p < 0.001), but not BMI.

Conclusions: In real-world clinical practice, tirzepatide was associated with improvements in glycemic control and reductions in body weight in Japanese patients with T2DM, across diverse baseline therapies. These results suggest that tirzepatide may be a useful option across diverse treatment backgrounds, with greater observed benefits in GLP-1RA-naïve individuals with higher baseline HbA1c levels.

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替西帕肽对日本2型糖尿病患者的实际疗效：一项多中心回顾性观察研究

简介：在随机对照试验中，tizepatide是一种双糖依赖性胰岛素型多肽和胰高血糖素样肽-1 （GLP-1）受体激动剂，显著影响血糖和减肥效果。然而，日本的实际临床证据仍然有限。本研究旨在评估替西肽对日本2型糖尿病（T2DM）患者血糖和代谢因子的实际疗效。方法：在这项多中心、回顾性、观察性研究中，我们纳入了来自7家日本机构接受替西帕肽治疗至少24周的T2DM患者。通过比较治疗前后24周的临床和生化参数，包括糖化血红蛋白（HbA1c）、血糖水平、体重、血压、血脂、肝酶水平和肾功能，来评估替西帕肽的有效性。结果：纳入324例患者（平均年龄56.8±11.4岁；中位体重指数（BMI） 30.4 kg/m2（四分位数间距26.8-34.0））。24周时，分别有42例（13.0%）、211例（65.1%）、35例（10.8%）、25例（7.7%）和11例（3.4%）患者接受了2.5 mg、5 mg、7.5 mg、10 mg和12.5/15 mg的替西帕肽治疗。替西帕肽给药后HbA1c和体重明显降低；HbA1c和体重的中位数分别从7.9%[7.2-8.6]降至6.8%[6.1-7.5]，从82.5 kg[73.5-94.6]降至80.0 kg[70.9-92.5]，而HbA1c和体重从基线到第24周的变化中位数分别为- 0.9%[- 1.6 - 0.3]和- 2.0 kg [- 4.0 - 0.0] （p < 0.001）。GLP-1受体agonist-naïve患者的HbA1c降低幅度更大（p < 0.001）。HbA1c水平的变化与基线HbA1c水平显著相关（rs = - 0.473, p < 0.001），但与BMI无关。结论：在现实世界的临床实践中，在不同的基线治疗中，替西帕肽与日本T2DM患者的血糖控制改善和体重降低有关。这些结果表明，替西肽可能是不同治疗背景下的有用选择，对GLP-1RA-naïve基线HbA1c水平较高的个体有更大的疗效。

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来源期刊

Diabetes Therapy Medicine-Endocrinology, Diabetes and Metabolism

CiteScore

6.90

自引率

7.90%

发文量

130

审稿时长

6 weeks

期刊介绍： Diabetes Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all areas of diabetes. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Diabetes Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.