Department of Clinical Pharmacy, Faculty of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.
Cardiovascular Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.
Eur J Clin Pharmacol. 2024 Jan;80(1):93-104. doi: 10.1007/s00228-023-03582-5. Epub 2023 Oct 28.
There is accumulating evidence regarding the potential benefits of empagliflozin in individuals with acute myocardial infarction (MI). Based on the literature, colchicine could also reduce the risk of MI and death in individuals with cardiovascular disease (CVD). However, trials investigating the effects of the combination of empagliflozin with colchicine and high-dose empagliflozin monotherapy in this setting are lacking.
In this trial, 106 non-diabetic participants with reduced left ventricular ejection fraction (LVEF) following recent ST-elevation MI were randomly assigned to empagliflozin 10 mg/day, empagliflozin 10 mg/day plus colchicine 0.5 mg twice daily, or empagliflozin 25 mg/day groups within 72 h after primary percutaneous coronary intervention (PCI). The study's primary outcomes were the changes in New York Heart Association (NYHA) functional class and high-sensitivity C-reactive protein (hs-CRP) over 12 weeks.
The baseline characteristics of individuals were statistically similar between the study groups. Changes in NYHA functional class over 12 weeks were not significantly different between the study groups. hs-CRP was significantly reduced in all groups (all P < 0.001); however, there was no significant change between the groups over the study period. Changes in tumor necrosis factor-alpha (TNF-α), LVEF, and left ventricular end-diastolic dimension (LVEDD) during the research period did not differ significantly between groups.
This study showed that neither the combination treatment of empagliflozin 10 mg/day with colchicine nor the monotherapy of empagliflozin 25 mg/day was superior to empagliflozin 10 mg/day in terms of changes in clinical, inflammatory, and echocardiographic outcome parameters in patients with recent MI with reduced LVEF over 3 months. Further studies are warranted to confirm the findings.
Clinical trial ID: IRCT20111206008307N39. Registration date: 27 October 2022. https://www.irct.ir/trial/66216.
越来越多的证据表明，恩格列净对急性心肌梗死（MI）患者可能有益。基于文献，秋水仙碱也可以降低心血管疾病（CVD）患者的 MI 和死亡风险。然而，在这种情况下，尚无研究恩格列净与秋水仙碱联合使用以及高剂量恩格列净单药治疗的效果。
本试验纳入了 106 例近期发生 ST 段抬高型心肌梗死并伴有左心室射血分数（LVEF）降低的非糖尿病患者，他们在初次经皮冠状动脉介入治疗（PCI）后 72 小时内被随机分配至恩格列净 10 mg/天组、恩格列净 10 mg/天加秋水仙碱 0.5 mg 每日 2 次组或恩格列净 25 mg/天组。该研究的主要结局是 12 周时纽约心脏协会（NYHA）功能分级和高敏 C 反应蛋白（hs-CRP）的变化。
各组间研究对象的基线特征具有统计学可比性。12 周时 NYHA 功能分级的变化在各组间无显著差异。所有组的 hs-CRP 均显著降低（均 P<0.001）；然而，在研究期间各组间无显著变化。研究期间，肿瘤坏死因子-α（TNF-α）、LVEF 和左心室舒张末期内径（LVEDD）的变化在各组间无显著差异。
本研究表明，恩格列净 10 mg/天加秋水仙碱的联合治疗或恩格列净 25 mg/天的单药治疗与恩格列净 10 mg/天相比，在 3 个月内 LVEF 降低的近期 MI 患者的临床、炎症和超声心动图结局参数的变化方面均不具有优势。需要进一步的研究来证实这些发现。
IRCT20111206008307N39。注册日期：2022 年 10 月 27 日。www.irct.ir/trial/66216。
