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使用托格列净治疗的2型糖尿病患者血清肝脏相关参数、尿酸和血红蛋白水平的变化——UTOPIA研究的事后分析

Changes in serum levels of liver-related parameters, uric acid, and hemoglobin in patients with type 2 diabetes mellitus under treatment with tofogliflozin-a post-hoc analysis of the UTOPIA study.

作者信息

Katakami Naoto, Mita Tomoya, Sato Yasunori, Watada Hirotaka, Shimomura Iichiro

机构信息

Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka 565-0871 Japan.

Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Hongo 2-1-1, Bunkyo-Ku, Tokyo 113-8421 Japan.

出版信息

Diabetol Int. 2024 Feb 10;15(3):379-388. doi: 10.1007/s13340-024-00693-x. eCollection 2024 Jul.

DOI:10.1007/s13340-024-00693-x
PMID:39101158
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11291786/
Abstract

AIMS/INTRODUCTION: The aim of the study was to evaluate the effects of tofogliflozin, a selective sodium-glucose cotransporter 2 inhibitor, on circulating levels of hepatic enzymes, uric acid and hemoglobin levels in patients with type 2 diabetes mellitus (T2DM).

MATERIALS AND METHODS

We evaluated longitudinal changes in circulating aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (γ-GTP), uric acid, and hemoglobin levels in tofogliflozin (n = 169) and conventional treatment groups (n = 170) using data obtained from the UTOPIA trial, a randomized prospective study conducted to evaluate the efficacy of tofogliflozin in preventing atherosclerosis.

RESULTS

Within 104 weeks, tofogliflozin treatment, but not conventional treatment, significantly reduced AST, ALT, and γ-GTP levels. This reduction was significantly greater in the tofogliflozin group than in the conventional group. Stratified analysis showed that, in patients with obesity (defined as body mass index (BMI) ≥ 25.0 kg/m), significant differences were observed in AST, ALT, and γ-GTP changes from baseline to 104 weeks between treatment groups. However, in patients without obesity, there were no significant differences in AST and γ-GTP changes from baseline to 104 weeks between treatment groups. Multivariable regression analysis showed that changes in BMI and HbA1c levels were independently associated with changes in AST, ALT, and γ-GTP levels. The reduction of uric acid and the increase of hemoglobin from baseline to 104 weeks were significantly greater in the tofogliflozin group than in the conventional group.

CONCLUSIONS

The beneficial effects of tofogliflozin on circulating levels of hepatic enzymes, uric acid, and Hb lasted for 2 years in patients with T2DM.

CLINICAL TRIAL REGISTRATION

UMIN000017607 (https://www.umin.ac.jp/icdr/index.html).

SUPPLEMENTARY INFORMATION

The online version contains supplementary material available at 10.1007/s13340-024-00693-x.

摘要

目的/引言:本研究旨在评估选择性钠-葡萄糖协同转运蛋白2抑制剂托格列净对2型糖尿病(T2DM)患者循环中肝酶、尿酸水平及血红蛋白水平的影响。

材料与方法

我们利用乌托邦试验(一项旨在评估托格列净预防动脉粥样硬化疗效的随机前瞻性研究)获得的数据,评估了托格列净组(n = 169)和传统治疗组(n = 170)中循环天门冬氨酸氨基转移酶(AST)、丙氨酸氨基转移酶(ALT)、γ-谷氨酰转肽酶(γ-GTP)、尿酸和血红蛋白水平的纵向变化。

结果

在104周内,托格列净治疗组而非传统治疗组显著降低了AST、ALT和γ-GTP水平。托格列净组的这种降低幅度显著大于传统治疗组。分层分析显示,在肥胖患者(定义为体重指数(BMI)≥25.0kg/m²)中,治疗组之间从基线到104周的AST、ALT和γ-GTP变化存在显著差异。然而,在非肥胖患者中,治疗组之间从基线到104周的AST和γ-GTP变化无显著差异。多变量回归分析表明,BMI和糖化血红蛋白(HbA1c)水平的变化与AST、ALT和γ-GTP水平的变化独立相关。从基线到104周,托格列净组的尿酸降低幅度和血红蛋白升高幅度显著大于传统治疗组。

结论

托格列净对T2DM患者循环中肝酶、尿酸和血红蛋白水平的有益影响持续了2年。

临床试验注册

UMIN000017607(https://www.umin.ac.jp/icdr/index.html)。

补充信息

在线版本包含可在10.1007/s13340-024-00693-x获取的补充材料。

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