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© 2022 MJH Life Sciences™ , Pharmacy Times – Pharmacy Practice News and Expert Insights. All rights reserved. Acetoxy Empagliflozin
Dapagliflozin is the first SGLT2 inhibitor approved by the FDA for treatment of patients with heart failure (NYHA class II-IV) with reduced ejection fraction.
Treatment with dapagliflozin (Farxiga; AstraZeneca) was found to improve symptom burden and health-related quality of life in patients with heart failure (HF) with mildly reduced or preserved ejection fraction (EF) compared with placebo, according to findings from the DELIVER phase 3 trial presented at the American Heart Association (AHA) Scientific Sessions 2022 and are published in the Journal of the American College of Cardiology.
Patients with HF and mildly reduced or preserved EF have an increased risk of death and hospitalizations, as well as a high burden of symptoms and physical limitations causing a poor quality of life. Dapagliflozin is the first sodium glucose co-transporter 2 (SGLT2) inhibitor approved by the FDA for treatment of patients with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF).
Previous research shows the efficacy of dapagliflozin in preventing and delaying cardiorenal disease while protecting the organs, which are key findings because of the underlying links between the heart, kidneys, and pancreas.
Dapagliflozin is also approved for adults and children 10 years of age and older for the treatment of insufficiently controlled type 2 diabetes (T2D) mellitus as an adjunct to diet and exercise and for the treatment of chronic kidney disease based on the findings of the DAPA-HF and DAPA-CKD phase 3 trials.
DELIVER was a double-blind, phase 3 trial designed to evaluate the efficacy of dapagliflozin compared with placebo in the treatment of HF patients with or without T2D. Dapagliflozin was given once daily in addition to background therapy. The researchers used the Kansas City Cardiomyopathy Questionnaire (KCCQ) to analyze the effects of dapagliflozin, which was found to improve symptom burden, physical limitations, and quality of life as measured by KCCQ scores and in comparison, to placebo.
The primary endpoint was the time to first occurrence of cardiovascular (CV) death, hospitalization for HF or an urgent HF visit. Key secondary endpoints included the total number of HF events and CV death, time to the occurrence of CV death, and time to the occurrence of death from any cause. Additionally, the KCCQ total symptom score was a pre-specified key secondary endpoint and physical limitations, clinical summary, and overall summary and were evaluated at randomization, 1, 4, and 8 months.
The benefits were sustained at 8 months with mean improvement in total symptom score of 2.4 points, physical limitations 1.9 points, clinical summary 2.3 points, and overall summary 2.1 points higher than placebo. Fewer patients administered dapagliflozin experienced a significant deterioration at 8 months compared with placebo, and more had at least small, moderate, or large improvements in health status across evaluated KCCQ domains.
“Many patients living with heart failure value their symptoms and physical function at least equally with avoidance of death, making these results highly clinically relevant. Given the fact that individuals with heart failure and mildly reduced and preserved ejection fraction experience especially poor health status, the findings should prompt clinicians to strongly consider initiation of SGLT2 inhibitors in this group, particularly if patients are symptomatic,” said Mikhail Kosiborod, MD, cardiologist at Saint Luke’s Mid America Heart Institute, vice president of Research at Saint Luke’s Health System, professor of Medicine at the University of Missouri-Kansas City, in a press release.
Ertugliflozin L-Pyroglutamic Acid Farxiga improved symptom burden and health-related quality of life in patients with mildly reduced or preserved ejection fraction in DELIVER Phase III trial. AstraZeneca. November 7, 2022. Accessed November 8, 2022. https://www.astrazeneca.com/media-centre/press-releases/2022/farxiga-improved-symptom-burden-in-deliver-phase-iii-trial.html