Effect of Newly Approved Medications Sacubitril/Valsartan, Empagliflozin and Dapagliflozin on the Quality of Life in Patients with Heart Failure with Reduced Ejection Fraction
Authors: Setouhi Amr , Taha Asmaa , Farrag Hazem M A , Asklany Hany T 
Published: September 2023

ABSTRACT

Background
Per the guidelines established by the European Society of Cardiology (ESC) guidelines for diagnosing and managing chronic and acute heart failure, Sacubitril/Valsartan, Empagliflozin, and Dapagliflozin are suggested to replace an angiotensin-converting enzyme (ACE) inhibitor to significantly minimize the heart failure (HF) associated risks including hospitalization and possible death of HF ambulatory patients with reduced ejection fraction that remain symptomatic.

Objective
This work aimed to evaluate the health-related quality of life (HRQOL) changes in HFrEF patients throughout treatment with newly approved medications sacubitril/valsartan, Dapagliflozin, and empagliflozin using Minnesota living with heart failure questionnaire (MLHFQ) and Kansas City Cardiomyopathy Questionnaire (KCCQ) -12 at baseline, 3 months, and 6 months of treatment.

Methods
This prospective study was conducted on 500 patients with chronic HF with 35% or less LVEF, New York Heart Association class III or IV symptoms who visited Minia university cardiothorasic hospital, cardiology outpatient clinic from period of March 2022 to May 2023. Patients were treated using maximum tolerated doses of guideline-directed medical therapy; angiotensin-converting enzyme inhibitors (ACEIs), ß-blocker (BB), mineralocorticoid receptor antagonist (MRA), and systolic blood pressure greater than 105 mmHg. A total of 3 visits were done (baseline visit, months 3 and 6). At the baseline visit, patients were on ACEIs, BB, MRA, and diuretics and quality of life (QOL) was assessed for this regimen by MLHFQ and KCCQ.12 Then dapagliflozin or empagliflozin was added to the previous regimen, and a reevaluation of patients' QOL was done at 3 months. The ACEI or ARBs was replaced by sacubitril/valsartan, and the reevaluation of QOL was evaluated at 6 months.

Results
Systolic blood pressure (SBP), diastolic blood pressure (DBP), left ventricular end-diastolic volume (LVEDV), left ventricular end-systolic volume (LVESV), E/e′ ratio, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) were remarkably decreased at 6 months compared to baseline (P value &lt;0.001), at 6 months compared to 3 months (P value &lt;0.001), and at 3 months compared to baseline (P value &lt;0.001). Left ventricular ejection fraction (LVEF), global longitudinal strain (GLS), and potassium were significantly increased at 6 months compared to baseline (P value &lt;0.001), at 6 months compared to 3 months (P value &lt;0.001), and at 3 months compared to baseline (P value &lt;0.001). MLHFQ and KCCQ-23 scores were significantly improved at 6 months compared to baseline (P value &lt;0.001), compared to 3 months (P value &lt;0.001), and at 3 months compared to baseline (P value &lt;0.001). 28 (5.6%) patients had stopped the medications due to adverse events (AEs).

Conclusions
Treatment of HFrEF patients with sodium-glucose Co-transporter-2 inhibitors (SGLT2i) and/or sacubitril/valsartan is associated with rapid and significant improvement in patients' QOL according to both KCCQ and MLHFQ scores.