{"title":"鲁西格列净对2型糖尿病合并肾功能受损患者肾功能保护的疗效：一项随机开放标签临床试验（RESOLUTION研究）","authors":"Munehiro Kitada, Masao Toyoda, Osamu Sekine, Daisuke Suzuki, Yosuke Okada, Yoshikata Morita, Hideki Nishimura, Hiroaki Satoh, Hideki Kamiya, Toshinari Takamura, Motohide Isono, Takeshi Onoue, Hiroshi Arima, Kenichi Tanaka, Masaji Miyamoto, Yasushi Omura, Daisuke Yabe, Takehiro Kato, Akimichi Asano, Yutaka Wakasa, Satoshi Miyamoto, Shinji Kume, Tomohiko Ito, Shin-Ichi Araki, Atsushi Nakagawa","doi":"10.1111/jdi.70173","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>The renoprotective effects of luseogliflozin, a sodium-glucose cotransporter 2 inhibitor, in patients with renal dysfunction are unexamined. We evaluated the efficacy of luseogliflozin in slowing renal function decline among patients with type 2 diabetes mellitus and moderate to severe renal dysfunction.</p><p><strong>Materials and methods: </strong>In a multicenter, randomized, open-label, controlled clinical trial, patients with type 2 diabetes mellitus and an estimated glomerular filtration rate based on serum creatinine (eGFRcreat) of 15-45 mL/min/1.73 m<sup>2</sup> were randomized into luseogliflozin or control groups. The primary endpoint was the change in eGFRcreat from baseline to 104 weeks. Secondary endpoints included eGFRcreat and eGFRcreat slope changes from 4 to 104 weeks (chronic eGFRcreat slope).</p><p><strong>Results: </strong>Among 152 participants, eGFRcreat change from baseline to 104 weeks did not significantly differ between groups. The luseogliflozin group showed a significant decrease in eGFRcreat from 2 to 12 weeks compared to the control group; the largest decline occurred at 4 weeks (initial eGFR decline). There were no differences between groups thereafter. The chronic eGFRcreat slope was less negative in the luseogliflozin group compared to the control group (not significant). Conversely, subgroup analysis indicated that the difference in chronic eGFRcreat slope between groups was significantly greater (with a less negative or even positive slope observed in the luseogliflozin group compared to the control group) among patients with eGFRcreat <30 mL/min/1.73 m<sup>2</sup>, urinary albumin/creatinine ratio <30 mg/g creatinine, systolic blood pressure <130 mmHg, or females.</p><p><strong>Conclusions: </strong>Although the primary endpoint did not reach statistical significance, luseogliflozin may provide renoprotective benefits in patients with type 2 diabetes mellitus and moderate-to-severe renal impairment, potentially by slowing eGFRcreat decline post-initial decline.</p>","PeriodicalId":190,"journal":{"name":"Journal of Diabetes Investigation","volume":" ","pages":""},"PeriodicalIF":3.0000,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy of luseogliflozin for renal function preservation in patients with type 2 diabetes mellitus and impaired renal function: A randomized open-label clinical trial (RESOLUTION study).\",\"authors\":\"Munehiro Kitada, Masao Toyoda, Osamu Sekine, Daisuke Suzuki, Yosuke Okada, Yoshikata Morita, Hideki Nishimura, Hiroaki Satoh, Hideki Kamiya, Toshinari Takamura, Motohide Isono, Takeshi Onoue, Hiroshi Arima, Kenichi Tanaka, Masaji Miyamoto, Yasushi Omura, Daisuke Yabe, Takehiro Kato, Akimichi Asano, Yutaka Wakasa, Satoshi Miyamoto, Shinji Kume, Tomohiko Ito, Shin-Ichi Araki, Atsushi Nakagawa\",\"doi\":\"10.1111/jdi.70173\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>The renoprotective effects of luseogliflozin, a sodium-glucose cotransporter 2 inhibitor, in patients with renal dysfunction are unexamined. We evaluated the efficacy of luseogliflozin in slowing renal function decline among patients with type 2 diabetes mellitus and moderate to severe renal dysfunction.</p><p><strong>Materials and methods: </strong>In a multicenter, randomized, open-label, controlled clinical trial, patients with type 2 diabetes mellitus and an estimated glomerular filtration rate based on serum creatinine (eGFRcreat) of 15-45 mL/min/1.73 m<sup>2</sup> were randomized into luseogliflozin or control groups. The primary endpoint was the change in eGFRcreat from baseline to 104 weeks. Secondary endpoints included eGFRcreat and eGFRcreat slope changes from 4 to 104 weeks (chronic eGFRcreat slope).</p><p><strong>Results: </strong>Among 152 participants, eGFRcreat change from baseline to 104 weeks did not significantly differ between groups. The luseogliflozin group showed a significant decrease in eGFRcreat from 2 to 12 weeks compared to the control group; the largest decline occurred at 4 weeks (initial eGFR decline). There were no differences between groups thereafter. The chronic eGFRcreat slope was less negative in the luseogliflozin group compared to the control group (not significant). Conversely, subgroup analysis indicated that the difference in chronic eGFRcreat slope between groups was significantly greater (with a less negative or even positive slope observed in the luseogliflozin group compared to the control group) among patients with eGFRcreat <30 mL/min/1.73 m<sup>2</sup>, urinary albumin/creatinine ratio <30 mg/g creatinine, systolic blood pressure <130 mmHg, or females.</p><p><strong>Conclusions: </strong>Although the primary endpoint did not reach statistical significance, luseogliflozin may provide renoprotective benefits in patients with type 2 diabetes mellitus and moderate-to-severe renal impairment, potentially by slowing eGFRcreat decline post-initial decline.</p>\",\"PeriodicalId\":190,\"journal\":{\"name\":\"Journal of Diabetes Investigation\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.0000,\"publicationDate\":\"2025-10-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Diabetes Investigation\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/jdi.70173\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Diabetes Investigation","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/jdi.70173","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Efficacy of luseogliflozin for renal function preservation in patients with type 2 diabetes mellitus and impaired renal function: A randomized open-label clinical trial (RESOLUTION study).
Introduction: The renoprotective effects of luseogliflozin, a sodium-glucose cotransporter 2 inhibitor, in patients with renal dysfunction are unexamined. We evaluated the efficacy of luseogliflozin in slowing renal function decline among patients with type 2 diabetes mellitus and moderate to severe renal dysfunction.
Materials and methods: In a multicenter, randomized, open-label, controlled clinical trial, patients with type 2 diabetes mellitus and an estimated glomerular filtration rate based on serum creatinine (eGFRcreat) of 15-45 mL/min/1.73 m2 were randomized into luseogliflozin or control groups. The primary endpoint was the change in eGFRcreat from baseline to 104 weeks. Secondary endpoints included eGFRcreat and eGFRcreat slope changes from 4 to 104 weeks (chronic eGFRcreat slope).
Results: Among 152 participants, eGFRcreat change from baseline to 104 weeks did not significantly differ between groups. The luseogliflozin group showed a significant decrease in eGFRcreat from 2 to 12 weeks compared to the control group; the largest decline occurred at 4 weeks (initial eGFR decline). There were no differences between groups thereafter. The chronic eGFRcreat slope was less negative in the luseogliflozin group compared to the control group (not significant). Conversely, subgroup analysis indicated that the difference in chronic eGFRcreat slope between groups was significantly greater (with a less negative or even positive slope observed in the luseogliflozin group compared to the control group) among patients with eGFRcreat <30 mL/min/1.73 m2, urinary albumin/creatinine ratio <30 mg/g creatinine, systolic blood pressure <130 mmHg, or females.
Conclusions: Although the primary endpoint did not reach statistical significance, luseogliflozin may provide renoprotective benefits in patients with type 2 diabetes mellitus and moderate-to-severe renal impairment, potentially by slowing eGFRcreat decline post-initial decline.
期刊介绍：
Journal of Diabetes Investigation is your core diabetes journal from Asia; the official journal of the Asian Association for the Study of Diabetes (AASD). The journal publishes original research, country reports, commentaries, reviews, mini-reviews, case reports, letters, as well as editorials and news. Embracing clinical and experimental research in diabetes and related areas, the Journal of Diabetes Investigation includes aspects of prevention, treatment, as well as molecular aspects and pathophysiology. Translational research focused on the exchange of ideas between clinicians and researchers is also welcome. Journal of Diabetes Investigation is indexed by Science Citation Index Expanded (SCIE).
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