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利拉鲁肽治疗日本急性心肌梗死后2型糖尿病患者的安全性和有效性:一项非随机干预性试验。

Safety and efficacy of liraglutide treatment in Japanese type 2 diabetes patients after acute myocardial infarction: A non-randomized interventional pilot trial.

作者信息

Kajiwara Masataka, Tanaka Atsushi, Kawasaki Tomohiro, Nakao Koichi, Sakamoto Tomohiro, Toyoda Shigeru, Inoue Teruo, Koga Nobuhiko, Node Koichi

机构信息

Division of Cardiology, Saiseikai Kumamoto Hospital Cardiovascular Center, Kumamoto, Japan.

Department of Cardiovascular Medicine, Saga University, Saga, Japan.

出版信息

J Cardiol. 2017 Mar;69(3):511-517. doi: 10.1016/j.jjcc.2016.10.009. Epub 2016 Nov 25.

DOI:10.1016/j.jjcc.2016.10.009
PMID:27894787
Abstract

BACKGROUND

Glucagon-like peptide 1 analogs are expected to exert a cardio-protective action due to their effective glucose-lowering action and favorable potency on multifactorial metabolic pathways. However, the safety and tolerability of liraglutide treatment after a recent acute coronary syndrome (ACS) in Japanese patients with type 2 diabetes mellitus (T2DM) have yet to be fully established.

METHODS

A total of eight T2DM patients were recruited within 2 weeks after the onset of a ST-elevation myocardial infarction (STEMI) followed by successful percutaneous coronary intervention (PCI). The patients continued to receive liraglutide (up to 0.9mg once daily) for 24 weeks after the ACS combined with standard treatment such as a statin or beta-blocker. Changes in various metabolic parameters from pre-liraglutide treatment values were evaluated 24 weeks after liraglutide treatment, and included glycemic and lipid profiles, and cardiac systolic and diastolic function assessed by cardiac ultrasonography.

RESULTS

Twenty-four weeks of treatment with liraglutide reduced body weight (67.0±5.8kg to 62.0±7.8kg, p=0.003) and HbA1c level (6.6±0.5% to 5.9±0.5%, p=0.006) and increased the level of 1,5-anhydroglucitol (12.8±6.9μg/mL to 18.7±8.2μg/mL, p=0.008) without development of hypoglycemia. There were no significant changes over 24 weeks in left ventricular systolic or diastolic function assessed by cardiac ultrasonography. No participant developed a major adverse cardiac event during the 24 weeks of liraglutide treatment, defined as cardiac death, new onset or recurrence of myocardial infarction, or needing target lesion revascularization.

CONCLUSIONS

The present trial demonstrated that liraglutide treatment after onset of STEMI was well-tolerated in Japanese patients with T2DM over 24 weeks, and provided the first evidence to support clinical application of liraglutide treatment even just after ACS in Japanese high-risk T2DM patients.

摘要

背景

胰高血糖素样肽1类似物因其有效的降糖作用以及对多因素代谢途径的良好作用效果,有望发挥心脏保护作用。然而,在日本2型糖尿病(T2DM)患者近期发生急性冠状动脉综合征(ACS)后,利拉鲁肽治疗的安全性和耐受性尚未完全确立。

方法

共招募了8例在ST段抬高型心肌梗死(STEMI)发作后2周内接受成功经皮冠状动脉介入治疗(PCI)的T2DM患者。这些患者在ACS后继续接受利拉鲁肽治疗(每日一次,剂量高达0.9mg),持续24周,并联合使用他汀类药物或β受体阻滞剂等标准治疗。在利拉鲁肽治疗24周后,评估各种代谢参数相对于利拉鲁肽治疗前值的变化,包括血糖和血脂谱,以及通过心脏超声评估的心脏收缩和舒张功能。

结果

利拉鲁肽治疗24周可降低体重(从67.0±5.8kg降至62.0±7.8kg,p=0.003)和糖化血红蛋白水平(从6.6±0.5%降至5.9±0.5%,p=0.006),并提高1,5-脱水葡萄糖醇水平(从12.8±6.9μg/mL升至18.7±8.2μg/mL,p=0.008),且未发生低血糖。通过心脏超声评估,左心室收缩或舒张功能在24周内无显著变化。在利拉鲁肽治疗的24周内,没有参与者发生主要不良心脏事件,主要不良心脏事件定义为心源性死亡、新发或复发性心肌梗死,或需要进行靶病变血运重建。

结论

本试验表明,STEMI发作后使用利拉鲁肽治疗在日本T2DM患者中24周内耐受性良好,并提供了首个证据支持利拉鲁肽治疗在日本高危T2DM患者ACS后即可临床应用。

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