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恩格列净对特立尼达稳定型冠状动脉疾病患者血小板功能谱的影响:EFFECT试点研究。

The Effect of Empagliflozin on Platelet Function Profiles in Patients with Stable Coronary Artery Disease in Trinidad: The EFFECT Pilot Study.

作者信息

Seecheran Naveen, Ramdeen Arvinash, Debideen Niranjan, Ali Kabeer, Grimaldos Kathryn, Grimaldos Gabriella, Karan Abhinav, Seecheran Rajeev, Seecheran Valmiki, Persad Sangeeta, Abdullah Harun, Peram Lakshmipathi, Giddings Stanley, Motilal Shastri, Tello-Montoliu Antonio, Schneider David

机构信息

The University of the West Indies, St. Augustine, Trinidad and Tobago.

North Central Regional Health Authority, Mount Hope, Trinidad and Tobago.

出版信息

Cardiol Ther. 2021 Jun;10(1):189-199. doi: 10.1007/s40119-020-00208-0. Epub 2020 Dec 11.

Abstract

INTRODUCTION

This prospective pharmacodynamic (PD) study aimed to assess the effect of the sodium-glucose cotransporter 2 inhibitor (SGLT2i) empagliflozin on platelet reactivity.

METHODS

Patients with stable coronary artery disease (CAD) and type 2 diabetes mellitus (T2DM) (n = 20) who were actively treated with dual antiplatelet therapy (DAPT) of aspirin 81 mg daily and clopidogrel 75 mg daily were recruited. Platelet function was measured with the VerifyNow™ P2Y assay (Instrumentation Laboratory, Massachusetts, USA) and assessed before the initiation of and after 10 days of treatment with empagliflozin 25 mg once daily maintenance dose regimen. Results were compared with a paired t test.

RESULTS

The mean P2Y reaction units (PRU) on empagliflozin was significantly less than without empagliflozin at baseline (187.35, 95% confidence interval (CI) 155.38-219.32 vs. 217.25, CI 180.60-253.90; p < 0.030). The mean difference in PRU was 29.90 (95% CI 3.17-56.63). No patients experienced any serious adverse events (SAEs).

CONCLUSIONS

Significantly attenuated platelet reactivity was observed on empagliflozin as compared to without empagliflozin. This dedicated pharmacodynamic study could be clinically pertinent for Trinidadian patients with stable CAD and T2DM on DAPT. Further studies are required to confirm these exploratory findings. (Funded by the University of the West Indies, St. Augustine; EFFECT).

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov number NCT04342819.

摘要

引言

这项前瞻性药效学(PD)研究旨在评估钠-葡萄糖协同转运蛋白2抑制剂(SGLT2i)恩格列净对血小板反应性的影响。

方法

招募了20例接受每日81毫克阿司匹林和每日75毫克氯吡格雷双重抗血小板治疗(DAPT)的稳定型冠状动脉疾病(CAD)和2型糖尿病(T2DM)患者。使用VerifyNow™ P2Y检测法(美国马萨诸塞州仪器实验室)测量血小板功能,并在开始使用恩格列净每日25毫克维持剂量方案治疗前及治疗10天后进行评估。结果采用配对t检验进行比较。

结果

在基线时,使用恩格列净时的平均P2Y反应单位(PRU)显著低于未使用恩格列净时(187.35,95%置信区间(CI)155.38 - 219.32 vs. 217.25,CI 180.60 - 253.90;p < 0.030)。PRU的平均差异为29.90(95% CI 3.17 - 56.63)。没有患者发生任何严重不良事件(SAE)。

结论

与未使用恩格列净相比,使用恩格列净时观察到血小板反应性显著降低。这项专门的药效学研究对于特立尼达接受DAPT治疗的稳定型CAD和T2DM患者可能具有临床相关性。需要进一步研究来证实这些探索性发现。(由西印度群岛大学圣奥古斯丁分校资助;EFFECT)。

临床试验注册

ClinicalTrials.gov编号NCT04342819。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9203/8126525/93800a8f44b9/40119_2020_208_Fig1_HTML.jpg

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