Empagliflozin Leads to a Rapid and Sustained Improvement of Left Ventricular Filling Pressure in Patients With Type 2 Diabetes: a Randomized Controlled Study
Abstract
BackgroundIn the EMPA-REG OUTCOME trial (Empagliflozin Cardiovascular Outcome Event Trial) treatment with the sodium-glucose cotransporter-2 (SGLT2) inhibitor empagliflozin significantly reduced heart failure hospitalization (HHF) in patients with type 2 diabetes mellitus (T2D) and established cardiovascular disease. The early separation of the HHF event curves within the first 3 months of the trial suggest that early hemodynamic effects may play a role, potentially mediated by direct diuretic effects of the drug. In this study we examined immediate and more delayed effects of empagliflozin on urinary volume excretion, left ventricular filling pressure and function in addition to hemodynamic parameters.MethodsIn this placebo-controlled, randomized, double blind, exploratory study patients with T2D were randomized to empagliflozin 10 mg or placebo for a period of 3 months. Urinary volume excretion, echocardiographic and hemodynamic parameters were assessed after 1 day, 3 days and 3 months of treatment.ResultsBaseline characteristics were comparable in the empagliflozin (n = 20) and placebo (n = 22) group. Empagliflozin led to a significant increase of urinary glucose excretion (baseline: 7.3 ± 22.7 g/24 hrs; day 1: 48.4 ± 34.7 g/24 hrs; p < 0.001) as well as urinary volume (1740 ± 601 mL/24 hrs to 2112 ± 837 mL/24 hrs; p = 0.011) at day one of treatment which remained significant after 3 months. In addition empagliflozin significantly improved left ventricular filling…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 22 participants or records.
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