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阿格列汀对颈动脉壁组织特征影响的评估:SPEAD-A试验的亚分析

Evaluation of the Effect of Alogliptin on Tissue Characteristics of the Carotid Wall: Subanalysis of the SPEAD-A Trial.

作者信息

Irie Yoko, Katakami Naoto, Mita Tomoya, Takahara Mitsuyoshi, Matsuoka Taka-Aki, Gosho Masahiko, Watada Hirotaka, Shimomura Iichiro

机构信息

Department of Endocrinology and Diabetes, Osaka Police Hospital, 10-31 Kitayamacho, Tennoji-ku, Osaka, 543-0035, Japan.

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

出版信息

Diabetes Ther. 2018 Feb;9(1):317-329. doi: 10.1007/s13300-018-0367-7. Epub 2018 Jan 12.

Abstract

INTRODUCTION

Ultrasonic tissue characterization of the carotid wall using gray-scale median (GSM) reflects its composition and low-GSM plaque is considered to be unstable. The present study evaluated the effect of alogliptin, a dipeptidyl peptidase-4 inhibitor, on the longitudinal change in GSM, an index of the tissue characteristics of the carotid wall, in patients with type 2 diabetes (T2DM).

METHODS

This is a post hoc subanalysis using data obtained from the SPEAD-A trial, a randomized controlled trial that demonstrated the beneficial effect of alogliptin treatment on the progression of carotid intima-media thickness in patients with T2DM with no past history of apparent cardiovascular disease. A total of 322 subjects (161 in the alogliptin treatment group and 161 in the conventional treatment group) were enrolled. The primary outcome was the change from baseline in mean GSM-CCA (common carotid artery) during the 104-week observation period.

RESULTS

Both alogliptin treatment and conventional treatment significantly increased the mean GSM-CCA (from 60.7 ± 12.3 to 65.9 ± 10.1, p < 0.001 and 58.8 ± 14.4-65.2 ± 12.2, p < 0.001, respectively) and there was no significant difference in changes in mean GSM-CCA between the treatment groups (p = 0.95). Additionally, there were no differences in the changes in the left and right GSM-CCA between the groups.

CONCLUSIONS

A post hoc subanalysis revealed an improvement of tissue characteristics in the carotid arterial wall in both the alogliptin treatment group and the conventional treatment group during the 104-week treatment period and that there was no significant difference between the treatment groups.

CLINICAL TRIAL REGISTRATION

UMIN000019951.

摘要

引言

使用灰度中位数(GSM)对颈动脉壁进行超声组织特征分析可反映其成分,低GSM斑块被认为不稳定。本研究评估了二肽基肽酶-4抑制剂阿格列汀对2型糖尿病(T2DM)患者颈动脉壁组织特征指标GSM纵向变化的影响。

方法

这是一项事后亚组分析,使用的是从SPEAD-A试验获得的数据,该试验是一项随机对照试验,证明了阿格列汀治疗对无明显心血管疾病既往史的T2DM患者颈动脉内膜中层厚度进展的有益作用。共纳入322名受试者(阿格列汀治疗组161名,传统治疗组161名)。主要结局是在104周观察期内平均GSM-CCA(颈总动脉)相对于基线的变化。

结果

阿格列汀治疗组和传统治疗组均显著增加了平均GSM-CCA(分别从60.7±12.3增加到65.9±10.1,p<0.001;从58.8±14.4增加到65.2±12.2,p<0.001),治疗组之间平均GSM-CCA的变化无显著差异(p=0.95)。此外,两组之间左右GSM-CCA的变化也无差异。

结论

一项事后亚组分析显示,在104周的治疗期内,阿格列汀治疗组和传统治疗组的颈动脉壁组织特征均有改善,且治疗组之间无显著差异。

临床试验注册

UMIN000019951。

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