{"title":"替西帕肽对2型糖尿病和慢性肾病患者的疗效和安全性：一项前瞻性、两组观察性研究","authors":"Yuki Oe, Hiroshi Nomoto, Kyu Yong Cho, Takashi Omori, Koki Nakamura, Akihiro Takahashi, Yuka Suzuki, Jyunpei Yoshikawa, Akiko Kato-Sato, Shin Furukawa, Taro Nishio, Hirohiko Kitakawa, Aika Miya, Hiraku Kameda, Daigo Nakazawa, Akinobu Nakamura, Kiyoshi Sakai, Tatsuya Atsumi","doi":"10.1177/20420188251378216","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Tirzepatide (TZP) has demonstrated efficacy for glycemic control and weight loss in subjects with type 2 diabetes (T2D). However, previous clinical trials were not conducted under the treatment of glucagon-like peptide-1 receptor agonists (GLP-1RAs) as a background regimen nor were they limited to subjects with chronic kidney disease (CKD).</p><p><strong>Objectives: </strong>We evaluated the glycemic control of tirzepatide switching from conventional GLP-1 receptor agonists in subjects with T2D and CKD.</p><p><strong>Design: </strong>This was a prospective, two-arm, observational study performed at a single center.</p><p><strong>Methods: </strong>Eligible subjects were individuals with T2D and CKD who had been treated with dulaglutide for more than 3 months, with glycated hemoglobin (HbA1c) ⩾7.0%, and an estimated glomerular filtration rate ⩽60 mL/min/1.73 m<sup>2</sup>. Subjects who switched to tirzepatide (TZP group) and those who continued dulaglutide (Dula group) were observed over 6 months. The primary outcome was a change in HbA1c over 6 months between the groups. Additional metabolic parameters, including body weight and the urine albumin-creatinine ratio (UACR), were evaluated. Adverse events in the TZP group were also investigated.</p><p><strong>Results: </strong>Of the 55 participants, 48 completed the study (TZP group, <i>n</i> = 23; Dula group, <i>n</i> = 25). Tirzepatide significantly reduced HbA1c and body weight compared with the Dula group over 6 months (both <i>p</i> < 0.01). UACR levels remained stable in the TZP group throughout the study period and increased significantly in the Dula group (<i>p</i> < 0.05). Gastrointestinal events and hypoglycemia were observed in the TZP group, and those subjects who suffered hypoglycemic symptoms were mostly insulin users.</p><p><strong>Conclusion: </strong>Tirzepatide might be an effective alternative treatment for subjects with T2D and CKD who did not achieve sufficient glycemic control with conventional GLP-1RAs, as well as preventing the progression of nephropathy.</p><p><strong>Trial registration: </strong>This study was registered with the University Hospital Medical Information Network (registration number UMIN 000051344, date: June 16, 2023). https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_his_list.cgi?recptno=R000058576.</p>","PeriodicalId":22998,"journal":{"name":"Therapeutic Advances in Endocrinology and Metabolism","volume":"16 ","pages":"20420188251378216"},"PeriodicalIF":4.6000,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12444058/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of tirzepatide in subjects with type 2 diabetes and chronic kidney disease: a prospective, two-arm observational study.\",\"authors\":\"Yuki Oe, Hiroshi Nomoto, Kyu Yong Cho, Takashi Omori, Koki Nakamura, Akihiro Takahashi, Yuka Suzuki, Jyunpei Yoshikawa, Akiko Kato-Sato, Shin Furukawa, Taro Nishio, Hirohiko Kitakawa, Aika Miya, Hiraku Kameda, Daigo Nakazawa, Akinobu Nakamura, Kiyoshi Sakai, Tatsuya Atsumi\",\"doi\":\"10.1177/20420188251378216\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Tirzepatide (TZP) has demonstrated efficacy for glycemic control and weight loss in subjects with type 2 diabetes (T2D). However, previous clinical trials were not conducted under the treatment of glucagon-like peptide-1 receptor agonists (GLP-1RAs) as a background regimen nor were they limited to subjects with chronic kidney disease (CKD).</p><p><strong>Objectives: </strong>We evaluated the glycemic control of tirzepatide switching from conventional GLP-1 receptor agonists in subjects with T2D and CKD.</p><p><strong>Design: </strong>This was a prospective, two-arm, observational study performed at a single center.</p><p><strong>Methods: </strong>Eligible subjects were individuals with T2D and CKD who had been treated with dulaglutide for more than 3 months, with glycated hemoglobin (HbA1c) ⩾7.0%, and an estimated glomerular filtration rate ⩽60 mL/min/1.73 m<sup>2</sup>. Subjects who switched to tirzepatide (TZP group) and those who continued dulaglutide (Dula group) were observed over 6 months. The primary outcome was a change in HbA1c over 6 months between the groups. Additional metabolic parameters, including body weight and the urine albumin-creatinine ratio (UACR), were evaluated. Adverse events in the TZP group were also investigated.</p><p><strong>Results: </strong>Of the 55 participants, 48 completed the study (TZP group, <i>n</i> = 23; Dula group, <i>n</i> = 25). Tirzepatide significantly reduced HbA1c and body weight compared with the Dula group over 6 months (both <i>p</i> < 0.01). UACR levels remained stable in the TZP group throughout the study period and increased significantly in the Dula group (<i>p</i> < 0.05). Gastrointestinal events and hypoglycemia were observed in the TZP group, and those subjects who suffered hypoglycemic symptoms were mostly insulin users.</p><p><strong>Conclusion: </strong>Tirzepatide might be an effective alternative treatment for subjects with T2D and CKD who did not achieve sufficient glycemic control with conventional GLP-1RAs, as well as preventing the progression of nephropathy.</p><p><strong>Trial registration: </strong>This study was registered with the University Hospital Medical Information Network (registration number UMIN 000051344, date: June 16, 2023). https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_his_list.cgi?recptno=R000058576.</p>\",\"PeriodicalId\":22998,\"journal\":{\"name\":\"Therapeutic Advances in Endocrinology and Metabolism\",\"volume\":\"16 \",\"pages\":\"20420188251378216\"},\"PeriodicalIF\":4.6000,\"publicationDate\":\"2025-09-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12444058/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapeutic Advances in Endocrinology and Metabolism\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/20420188251378216\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q2\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Endocrinology and Metabolism","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/20420188251378216","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
Efficacy and safety of tirzepatide in subjects with type 2 diabetes and chronic kidney disease: a prospective, two-arm observational study.
Background: Tirzepatide (TZP) has demonstrated efficacy for glycemic control and weight loss in subjects with type 2 diabetes (T2D). However, previous clinical trials were not conducted under the treatment of glucagon-like peptide-1 receptor agonists (GLP-1RAs) as a background regimen nor were they limited to subjects with chronic kidney disease (CKD).
Objectives: We evaluated the glycemic control of tirzepatide switching from conventional GLP-1 receptor agonists in subjects with T2D and CKD.
Design: This was a prospective, two-arm, observational study performed at a single center.
Methods: Eligible subjects were individuals with T2D and CKD who had been treated with dulaglutide for more than 3 months, with glycated hemoglobin (HbA1c) ⩾7.0%, and an estimated glomerular filtration rate ⩽60 mL/min/1.73 m2. Subjects who switched to tirzepatide (TZP group) and those who continued dulaglutide (Dula group) were observed over 6 months. The primary outcome was a change in HbA1c over 6 months between the groups. Additional metabolic parameters, including body weight and the urine albumin-creatinine ratio (UACR), were evaluated. Adverse events in the TZP group were also investigated.
Results: Of the 55 participants, 48 completed the study (TZP group, n = 23; Dula group, n = 25). Tirzepatide significantly reduced HbA1c and body weight compared with the Dula group over 6 months (both p < 0.01). UACR levels remained stable in the TZP group throughout the study period and increased significantly in the Dula group (p < 0.05). Gastrointestinal events and hypoglycemia were observed in the TZP group, and those subjects who suffered hypoglycemic symptoms were mostly insulin users.
Conclusion: Tirzepatide might be an effective alternative treatment for subjects with T2D and CKD who did not achieve sufficient glycemic control with conventional GLP-1RAs, as well as preventing the progression of nephropathy.
Trial registration: This study was registered with the University Hospital Medical Information Network (registration number UMIN 000051344, date: June 16, 2023). https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_his_list.cgi?recptno=R000058576.
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