Department of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.
Department of Metabolism and Atherosclerosis, Osaka University Graduate School of Medicine, 2-2, Yamadaoka, Suita, Osaka, 565-0871, Japan.
Cardiovasc Diabetol. 2018 Feb 5;17(1):24. doi: 10.1186/s12933-018-0666-3.
Ultrasonic gray-scale median (GSM) of the carotid wall reflects its composition and low-GSM carotid plaque is considered to be vulnerable. This study aimed to evaluate the effect of sitagliptin, 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 mellitus (T2DM).
This is a post hoc sub-analysis using data obtained from the SPIKE trial, a randomized controlled trial that demonstrated the beneficial effect of sitagliptin on the progression of carotid intima-media thickness in patients with T2DM. A total of 274 T2DM patients with no past history of apparent cardiovascular disease (137 in the sitagliptin treatment group and 137 in the conventional treatment group) were enrolled. The primary outcome was the change from baseline in mean GSM-CCA during the 104-week treatment period.
The mean GSM-CCA significantly increased in the sitagliptin treatment group (adjusted ΔGSM = 2.40 ± 1.19 [mean ± SE], p = 0.044) but not in the conventional treatment group (adjusted ΔGSM = 1.32 ± 1.19, p = 0.27). However, there was no significant difference in changes in mean GSM-CCA between the treatment groups.
A post hoc sub-analysis suggests that the tissue characteristics of the carotid arterial wall were improved in the sitagliptin treatment group during the 104-week treatment period, but not in the conventional treatment group. However, there was no between-group difference in the changes of GSM values between the two treatment groups. Prespecified studies with large sample sizes would be necessary to confirm our findings. Trial registration UMIN000028664, Registered 15 August 2017 ("retrospectively registered").
颈动脉壁的超声灰阶均值（GSM）反映了其组成，低 GSM 颈动脉斑块被认为是易损的。本研究旨在评估二肽基肽酶-4 抑制剂西格列汀对 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。
这是一项使用 SPIKE 试验数据进行的事后亚分析，该试验是一项随机对照试验，表明西格列汀对 T2DM 患者颈动脉内膜中层厚度进展有有益作用。共纳入 274 例无明显心血管疾病既往史的 T2DM 患者（西格列汀治疗组 137 例，常规治疗组 137 例）。主要结局是在 104 周治疗期间，颈动脉总分叉处平均 GSM-CCA 的基线变化。
西格列汀治疗组平均 GSM-CCA 显著增加（调整后的 ΔGSM=2.40±1.19[均值±SE]，p=0.044），而常规治疗组无显著变化（调整后的 ΔGSM=1.32±1.19，p=0.27）。然而，两组间平均 GSM-CCA 的变化无显著差异。
事后亚分析提示，在 104 周治疗期间，西格列汀治疗组颈动脉壁组织特征得到改善，但常规治疗组无改善。然而，两组间 GSM 值变化无组间差异。需要进行大样本量的预设研究来证实我们的发现。试验注册号 UMIN000028664，注册日期 2017 年 8 月 15 日（回顾性注册）。
