AstraZeneca’s (AZ) Farixga (dapagliflozin) improved symptom burden and health-related quality of life in patients with heart failure and mildly reduced or preserved ejection fraction compared with placebo, according to a prespecified analysis of a phase 3 trial.
DELIVER was an international, randomised, double-blind phase 3 trial evaluating the efficacy of the SGLT2 inhibitor, compared with placebo, in the treatment of heart failure patients with left ventricular ejection fraction greater than 40%, with or without type 2 diabetes.
Heart failure affects approximately 64 million people globally and is associated with substantial morbidity and mortality, with chronic heart failure the leading cause of hospitalisation for those over the age of 65.
Of the estimated 64 million heart failure patients, roughly half have reduced ejection fraction – the measurement of the heart’s ability to pump oxygen-rich blood into the body – which is equal to or less than 40%. The remainder have mildly reduced or preserved ejection fraction.
As well as the greater risk of death and hospitalisations, patients with heart failure and mildly reduced or preserved ejection fraction experience an especially high burden of symptoms and physical limitations.
The analysis of DELIVER demonstrated that Farixga, in addition to standard care compared with placebo, improved symptom burden, physical limitations and quality of life as measured by mean Kansas City Cardiomyopathy Questionnaire (KCCQ) scores, with benefits achieved from as early as one month and sustained at eight.
Also at eight months, fewer patients treated with Farixga had a significant deterioration compared to placebo, and more had at least small, moderate and large improvements in health status across evaluated KCCQ domains.
The benefits of Farxiga on cardiovascular death and worsening heart failure in patients with mildly reduced or preserved ejection fraction appeared especially pronounced in those with greater degree of symptomatic impairment at baseline.
The company reported that the safety and tolerability profile of Farxiga was consistent with the well-established safety profile of the medicine.
“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,” said Dr Mikhail Kosiborod, 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.
He continued: “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.”