Empagliflozin significantly increased serum activity of SOD and GPx and reduced MDA levels compared to placebo in patients with T2DM and HFrEF over 12 weeks.
RCT (n=80)
Double-blind
randomized
No
Does empagliflozin improve oxidative stress parameters in patients with T2DM and HFrEF?
Empagliflozin improves oxidative stress markers and NYHA functional class in patients with T2DM and HFrEF, providing mechanistic insight into its cardioprotective benefits.
INTRODUCTION: In the present study, we evaluated the impact of empagliflozin on serum levels of oxidative stress parameters in individuals with type 2 diabetes (T2DM) who also suffer from heart failure with Reduced Ejection Fraction (HFrEF). METHODS: In this prospective, single-center clinical trial, 80 patients with T2DM and HFrEF, stabilized on guideline-directed heart failure therapy and classified as New York Heart Association functional (NYHA) functional classes II or III, were randomized to receive either empagliflozin (10 mg/daily) or a matching placebo for a duration of 12 weeks. Serum levels of malondialdehyde (MDA), along with the activity of superoxide dismutase (SOD) and glutathione peroxidase (GPx), were measured at baseline and after the 12-week treatment period. RESULTS: The baseline demographic and clinical characteristics of the randomized patients were comparable across the study groups. As anticipated, empagliflozin demonstrated a significant reduction in fasting blood glucose (FBG) and glycated hemoglobin (HbA1c) compared to the placebo after 12 weeks of treatment. Additionally, in comparison to the placebo, empagliflozin significantly increased the antioxidant capacity by elevating serum activity of SOD and GPx, while reducing oxidative damage, as evidenced by diminished MDA levels. Empagliflozin-treated patients also experienced greater improvement in their NYHA functional classes by week 12, though no significant changes in Left Ventricular Ejection Fraction (LVEF) were observed. CONCLUSION: The findings of this study shed light on the potential mechanisms through which SGLT2 inhibitors exert their beneficial effects on clinical outcomes in diabetic patients with HFrEF. This provides compelling evidence supporting the cardio-protective of SGLT2 inhibitors in this patient population. CLINICAL TRIAL REGISTRATION NUMBER: The trial was registered at the Iranian Registry of Clinical Trials (https://irct.behdasht.gov.ir/trial/72825, identifier code: IRCT20120215009014N484). Registration date: 2022-09-30.
Eshraghi et al. (Wed,) conducted a rct in Type 2 diabetes and heart failure with reduced ejection fraction (n=80). empagliflozin vs. placebo was evaluated on Serum levels of malondialdehyde (MDA), superoxide dismutase (SOD) and glutathione peroxidase (GPx). Empagliflozin significantly increased serum activity of SOD and GPx and reduced MDA levels compared to placebo in patients with T2DM and HFrEF over 12 weeks.