胰高血糖素样肽-1 类似物与他汀类药物治疗的 2 型糖尿病冠心病患者冠状动脉粥样斑块的脱脂作用：OPTIMAL 随机临床试验的预设子分析

IF 1.4 Q3 PERIPHERAL VASCULAR DISEASE Atherosclerosis plus Pub Date : 2024-04-04 DOI:10.1016/j.athplu.2024.03.001

Yu Kataoka , Satoshi Kitahara , Sayaka Funabashi , Hisashi Makino , Masaki Matsubara , Miki Matsuo , Yoko Omura-Ohata , Ryo Koezuka , Mayu Tochiya , Tamiko Tamanaha , Tsutomu Tomita , Kyoko Honda-Kohmo , Michio Noguchi , Kota Murai , Kenichiro Sawada , Takamasa Iwai , Hideo Matama , Satoshi Honda , Masashi Fujino , Kazuhiro Nakao , Teruo Noguchi

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引用次数: 0

摘要

背景和目的随机临床试验证明，胰高血糖素样肽-1类似物（GLP-1RA）能够减少2型糖尿病（T2D）患者的动脉粥样硬化性心血管疾病事件。方法OPTIMAL研究是一项前瞻性随机对照研究，目的是在94名经他汀治疗的T2D患者中比较48周连续血糖监测和HbA1c指导的血糖控制对近红外光谱（NIRS）/血管内超声（IVUS）得出的斑块测量结果的疗效（jRCT1052180152，UMIN000036721）。结果所有患者都接受了他汀类药物治疗，两组患者治疗时的 LDL-C 水平相似（66.9 ± 11.6 vs. 68.1 ± 23.2 mg/dL，p = 0.84）。接受 GLP-1RAs 治疗的患者 HbA1c 下降幅度更大 [-1.0 (-1.4 to -0.5) vs. -0.4 (-0.6 to -0.2)%，p = 0.02]，出现血糖水平 >180 mg/dL [-7.5 (-14.9 to -0.1) vs. 1.1 (-2.0 - 4.2)%, p = 0.04]，同时残余胆固醇水平显著下降[-3.8 (-6.3 to -1.3) vs. -0.1 (-0.8 - 1.1)mg/dL, p = 0.008]。在 NIRS/IVUS 成像分析中，两组之间动脉粥样斑块体积百分比的变化没有差异（-0.9 ± 0.25 vs. -0.2 ± 0.2%，p = 0.23）。然而，GLP-1RA 治疗患者的 maxLCBI4mm 回归率更高（85.6 ± 0.1 vs. 42.0 ± 0.6%，p = 0.01）。多变量分析表明，GLP-1RA 的使用与 maxLCBI4mm 的消退独立相关（几率比 = 4.41，95%CI = 1.19-16.30，p = 0.02）。

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Glucagon-like Peptide-1 analogues and delipidation of coronary atheroma in statin-treated type 2 diabetic patients with coronary artery disease: The prespecified sub-analysis of the OPTIMAL randomized clinical trial

Background and aims

Randomized clinical trials have demonstrated the ability of glucagon-like peptide-1 analogues (GLP-1RAs) to reduce atherosclerotic cardiovascular disease events in patients with type 2 diabetes (T2D). How GLP-1RAs modulate diabetic atherosclerosis remains to be determined yet.

Methods

The OPTIMAL study was a prospective randomized controlled study to compare the efficacy of 48-week continuous glucose monitoring- and HbA1c-guided glycemic control on near infrared spectroscopty (NIRS)/intravascular ultrasound (IVUS)-derived plaque measures in 94 statin-treated patients with T2D (jRCT1052180152, UMIN000036721). Of these, 78 patients with evaluable serial NIRS/IVUS images were analyzed to compare plaque measures between those treated with (n = 16) and without GLP-1RAs (n = 72).

Results

All patients received a statin, and on-treatment LDL-C levels were similar between the groups (66.9 ± 11.6 vs. 68.1 ± 23.2 mg/dL, p = 0.84). Patients receiving GLP-1RAs demonstrated a greater reduction of HbA1c [-1.0 (-1.4 to −0.5) vs. −0.4 (-0.6 to −0.2)%, p = 0.02] and were less likely to demonstrate a glucose level >180 mg/dL [-7.5 (-14.9 to −0.1) vs. 1.1 (-2.0 - 4.2)%, p = 0.04], accompanied by a significant decrease in remnant cholesterol levels [-3.8 (-6.3 to −1.3) vs. −0.1 (-0.8 - 1.1)mg/dL, p = 0.008]. On NIRS/IVUS imaging analysis, the change in percent atheroma volume did not differ between the groups (−0.9 ± 0.25 vs. −0.2 ± 0.2%, p = 0.23). However, GLP-1RA treated patients demonstrated a greater frequency of maxLCBI_4mm regression (85.6 ± 0.1 vs. 42.0 ± 0.6%, p = 0.01). Multivariate analysis demonstrated that the GLP-1RA use was independently associated with maxLCBI_4mm regression (odds ratio = 4.41, 95%CI = 1.19–16.30, p = 0.02).