Empagliflozin Ameliorates the Oxidative Stress Profile in Type 2 Diabetic Patients with Heart Failure and Reduced Ejection Fraction: Results of a Randomized, Double-blind, Placebo-controlled Study
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 80 participants or records.
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