Impact of dapagliflozin administration on remodeling marker and clinical outcomes of stemi patients with diabetes mellitus: a controlled clinical trial

Abstract

Background

Cardiac remodeling post-myocardial infarction contributes to adverse outcomes and increased mortality. We aimed to evaluate the impact of Dapagliflozin on remodeling markers, clinical outcomes and quality of life of diabetic ST-elevation myocardial infarction (STEMI) patients. This was an open label, single centered, randomized controlled-clinical trial was conducted at the Cardiology department, Ain Shams University. Eligible diabetic STEMI patients (n = 54) were randomly allocated to receive either 10 mg of dapagliflozin plus standard of care (Test group) or standard of care alone (Control group) for 4 weeks. The primary outcome was to assess the changes in suppression of tumorigenicity 2 (sST2) over time. Secondary outcomes included: echocardiographic evaluations (left ventricular ejection fraction (LVEF), End Diastolic Diameter (EDD), End systolic volume (ESV), End diastolic volume (EDV) and quality of life using EQ-5D-5L questionnaire.

Results

No change was observed in sST2 levels either between or within groups from baseline to 4 weeks. Echocardiographic and quality of life parameters were comparable between groups after 4 weeks. LVEF was significantly increased in the study group at the end of study (42 vs. 47, P < 0.001).

Conclusions

Early administration of dapagliflozin in post-MI diabetic patients had no effect on sST2 and quality of life but improved LVEF after 4 weeks of follow up. More studies are needed with larger sample sizes to further investigate SGLT2-inhibitors potential benefits in such population.

ClinicalTrial.gov registration number: NCT05335629