The Effect of the combination therapy of statin and dapagliflozin, a selective inhibitor of sodium_glucose Co-transporter type 2, in the treatment of Ischemic heart disease with heart failure: A randomized controlled trial

Abstract

PURPOSE: Gliflozins (SGLT2 inhibitors) and statins are key treatments commonly used in patients with ischemic heart failure. Although both are well known for diminishing cardiovascular risk and heart failure-related mortality, the possible synergistic benefits of using them together have not been thoroughly investigated. This study aimed to correlate serum levels of Statins and SGLT2i in addition to estimate the ejection fraction and selected laboratory parameters to indicate the synergistic effect of their combination in ischemic heart disease patients. METHODS: In this prospective, randomized, controlled trial, 81participating patients with ischemic heart disease at department of cardiology, Fayoum University, were randomly enrolled into three groups: SGLT2i group (GPI) (n = 26) who took Dapagliflozin (10 mg) daily, Statin group (GPII) (n = 34) who administrated Atorvastatin (40 mg) or Rosuvastatin (40 mg) daily and Combination group (GPIII) (n = 21) who took both Statin and Dapagliflozin. They had been on treatment for three months before blood sampling. The trough plasma concentrations of the included patients were assessed by ultra-performance liquid chromatography (UPLC). Ejection fraction was assessed by echocardiography, laboratory tests were performed, and data were analyzed with SPSS v22 (p < 0.05). RESULTS: Group: III showed no adverse effects, maintained stable drug levels as the mean was 7.3 ng/ml and SD was 4.4 ng/ml (p-value 0.66), demonstrated improved ejection fraction, lipid profiles and additional metabolic benefits from SGLT2i. CONCLUSION: Dapagliflozin-statin combination therapy appears potentially beneficial for heart disease patients without affecting drug levels, though larger studies are needed to confirm.