Some time ago, at the congress of the Italian Society of Cardiology, experts predicted the short-term availability of new treatments for heart failure, a disease that can have a fatal outcome in 50% of patients within five years of diagnosis, if not adequately treated. In Italy, heart failure is the main cause of hospitalization in the over 65s. Experts speculated for the future a much improved prognosis of this condition, thanks to research developments.
On this front, good news comes from the European Commission, which has approved the extension of the indication of a drug of the glyphozine family (dapagliflozin) to the entire spectrum of patients with left ventricular ejection fraction, including heart failure with of preserved and slightly reduced ejection. This is an important step forward, considering that there are several categories of heart failure classified according to the left ventricular ejection fraction (LVEF), which is the measurement of the percentage of blood that leaves the heart each time it contracts. On the basis of the amount of blood that is “pushed” one can therefore consider HFrEF (LVEF less than or equal to 40%), HFmrEF (LVEF 41-49%) and HFpEF (LVEF greater than or equal to 50%). About half of heart failure patients have HFmrEF or HFpEF, clinical conditions with limited treatment options.
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What the clinical studies say
The Commission approval is based on positive results from the Phase III DELIVER1 study, which showed dapagliflozin significantly reduced the composite outcome by 18% of cardiovascular death or worsening heart failure in patients with heart failure with slightly reduced or preserved ejection fraction compared to placebo, also being associated with an improvement in the quality of life of treated patients.
Results from the Phase III DELIVER and DAPA-HF trials also established dapagliflozin as the first heart failure drug to demonstrate a benefit in reducing mortality across the ejection fraction spectrum2. Considering the results of a particular way of reading the data (pooled analysis) of the Phase III Studies DAPA-HF and DELIVER presented at the Congress of the ESC (European Society of Cardiology) dapagliflozin showed a reduction in the risk of cardiovascular death by 14% and the risk of all-cause mortality by 10%.
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An answer to the needs of patients
Second Michele SenniDirector of Cardiology 1 and of the Cardiovascular Department of the Papa Giovanni XXIII Hospital in Bergamo and Professor of Cardiology at the University of Milan Bicocca, “in the field of cardiovascular medicine, heart failure with a slightly reduced or preserved ejection fraction represents today unmet clinical need, primarily due to limited treatment options available.The European approval of dapagliflozin’s indication extension for the treatment of symptomatic chronic heart failure across the ejection fraction spectrum is therefore an important milestone for patients affected by this pathology, allowing a wider population of patients to benefit from a treatment that is well tolerated and indicated by international guidelines.
The DELIVER study, the largest ever conducted in heart failure patients with mildly reduced, preserved, and improved ejection fraction, demonstrated that dapagliflozin significantly reduces the risk of cardiovascular death or worsening of cardiovascular disease compared with placebo. heart failure, highlighting the efficacy of dapagliflozin and reinforcing the latest international guidelines, which advocate wider use of the class of SGLT2i in clinical practice”.
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Positive action on kidneys and diabetes
Glyphozines, it should always be remembered, were born as drugs for the treatment of type 2 diabetes and chronic renal failure. In this sense, considering the situation and the frequent comorbidities of subjects with heart failure, the data appear even more interesting. “Dapagliflozin – continues Senni – has also shown clear protective effects against chronic kidney disease and type 2 diabetes mellitus, two chronic diseases often related to heart failure. The European approval of dapagliflozin in heart failure regardless of ejection fraction represents therefore an important opportunity to improve the management of patients affected by this pathology and we hope as soon as possible to be able to prescribe this drug also in this patient setting”. “In Italy, heart failure is the first cause of hospitalization after childbirth and affects over one million people – he comments Raffaela Faith, Medical Director of AstraZeneca Italy. Of these, approximately 50% have heart failure with mildly reduced or preserved ejection fraction, a disease characterized by a high unmet clinical need with few treatment options available to patients.”
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