Evaluation Effects of Colchicine and Empagliflozin in Heart Failure with Reduced Ejection Fraction: A Randomized Clinical Trial

Abstract

Introduction: Data supported the potential therapeutic benefits of empagliflozin in individuals with acute myocardial infarction (MI). Colchicine administration may confer a reduction in the incidence of MI and mortality among patients with cardiovascular disease. However, there is lacking data regarding the effects of empagliflozin with colchicine and empagliflozin 25mg/day monotherapy in this population.Objective: To assess the potential effects of empagliflozin and colchicine in non-diabetic individuals with reduced left ventricular ejection fraction (LVEF) following ST-elevation myocardial infarction (STEMI).Methods: A total of 106 individuals with reduced LVEF following STEMI were randomized to empagliflozin 10mg/day, empagliflozin 10 mg/day with colchicine, or empagliflozin 25mg/day groups. The randomization occured within 72 hours after PCI. The primary outcomes were changes in New York Heart Association (NYHA) functional class and levels of high-sensitivity C-reactive protein (hs-CRP) over a period of 12 weeks.Results: The baseline characteristics of the individuals enrolled in the study were found to be statistically similar across all study groups. The changes observed in the NYHA functional class did not show any significant differences between the groups. The levels of hs-CRP significantly decreased in all groups. Nevertheless, there were no significant differences in hs-CRP levels between the groups during the study period. The changes in tumor necrosis factor-alpha, LVEF, and left ventricular end-diastolic dimension during the research period did not exhibit statistically significant differences between the study groups.Conclusion: In conclusion, the findings of this study indicate that neither the combination treatment of empagliflozin 10 mg/day with colchicine nor the monotherapy of empagliflozin 25 mg/day demonstrated superiority over empagliflozin 10 mg/day alone in terms of changes observed in clinical, inflammatory, and echocardiographic outcome parameters among patients with recent MI and reduced LVEF. It is recommended that further studies be conducted to validate these findings.