Effect of sitagliptin on tissue characteristics of the carotid wall in patients with type 2 diabetes: a post hoc sub-analysis of the sitagliptin preventive study of intima-media thickness evaluation (SPIKE).

Effect of sitagliptin on tissue characteristics of the carotid wall in patients with type 2 diabetes: a post hoc sub-analysis of the sitagliptin preventive study of intima-media thickness evaluation (SPIKE).
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DOI:
10.1186/s12933-018-0666-3
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发表时间:
2018-02-05
影响因子:
9.3
通讯作者:
Sitagliptin Preventive study of Intima-media thickness Evaluation (SPIKE) Collaborators
Sitagliptin Preventive study of Intima-media thickness Evaluation (SPIKE) Collaborators
中科院分区:
医学1区
文献类型:
--
作者:
Katakami N;Mita T;Irie Y;Takahara M;Matsuoka TA;Gosho M;Watada H;Shimomura I;Sitagliptin Preventive study of Intima-media thickness Evaluation (SPIKE) Collaborators

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颈动脉壁的超声灰度中值(GSM)反映了其组成,低GSM的颈动脉斑块被认为是脆弱的。本研究旨在评估西格列汀(一种二肽基肽酶-4抑制剂)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试验数据的事后亚分析,该试验是一项随机对照试验,证明西格列汀对T2DM患者颈动脉内膜-中膜厚度的进展有有益作用。本研究共纳入274例无明显心血管病史的T2DM患者(西格列汀治疗组137例,常规治疗组137例)。主要结局是104周治疗期间平均GSM-CCA从基线的变化。西格列汀治疗组GSM-CCA均值显著升高(调整ΔGSM = 2.40±1.19 [mean±SE], p = 0.044),常规治疗组无显著升高(调整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。事后亚分析表明,在104周的治疗期间,西格列汀治疗组颈动脉壁的组织特征得到改善,而常规治疗组则没有。但两组间GSM值变化无组间差异。为了证实我们的发现,预先指定的大样本量研究是必要的。试验注册号为UMIN000028664, 2017年8月15日注册(“追溯注册”)
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”)
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发表时间: 2016-12-03
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