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Home > News > Manufacturer News > Farxiga improved with mildly reduced ejection fraction in DELIVER Phase III trial

Farxiga improved with mildly reduced ejection fraction in DELIVER Phase III trial

Author: Magicure Date: 2022-11-10

New findings from a pre-specified analysis of DELIVER Phase III trial data show that AstraZeneca’s Farxiga (dapagliflozin) improved symptom burden and health-related quality of life in patients with heart failure (HF) and mildly reduced or preserved ejection fraction (EF) compared with placebo. The results were presented today at the American Heart Association (AHA) Scientific Sessions 2022 in Chicago, Illinois, US, and are currently in press in the Journal of the American College of Cardiology.

In the analysis, Farxiga, in addition to standard care compared with placebo, improved symptom burden, physical limitations and quality of life as measured by mean KCCQ scores, with benefits achieved as early as one month.

Benefits were sustained at eight 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 (all p <0.001).

Also at eight months, fewer patients treated with Farxiga compared to placebo had a significant deterioration, and more had at least small, moderate and large (at least 5-, at least 10- and at least 15-point, respectively) improvements in health status across evaluated KCCQ domains.

The benefits of Farxiga on cardiovascular (CV) death and worsening HF in patients with mildly reduced or preserved EF appeared especially pronounced in those with greater degree of symptomatic impairment at baseline.

The results support the 2022 joint HF guidelines issued by the American College of Cardiology, the American Heart Association and the Heart Failure Society of America, recommending broader use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in clinical practice and earlier initiation of guideline-directed medical therapy.

The safety and tolerability profile of Farxiga in the DELIVER Phase III trial was consistent with the well-established safety profile of the medicine.

Farxiga

Farxiga (dapagliflozin) is a first-in-class, oral, once-daily SGLT2 inhibitor. Research has shown Farxiga’s efficacy in preventing and delaying cardiorenal disease, while also protecting the organs – important findings given the underlying links between the heart, kidneys and pancreas.

May 05, 2020, the U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization for heart failure. Heart failure occurs when the heart does not pump enough blood to support the body’s needs, and this type of heart failure happens when the heart’s main pumping chamber, the left ventricle, is weakened. 

With the approval, Farxiga is the first in this particular drug class, sodium-glucose co-transporter 2 (SGLT2) inhibitors, to be approved to treat adults with New York Heart Association’s functional class II-IV heart failure with reduced ejection fraction.

April 30, 2021, the U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression.  

Disclaimer: The services of Hong Kong Magicure Medical Center do not replace a physician-patient relationship and are not intended as medical advice. Hong Kong Magicure Medical Center provides patients and physicians with new medicine options by providing safe and secure access to approved medicines from other countries. We only provide this service after the patient and physician have made a professional decision on the treatment.

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