2023-07-04 17:57:00
Boehringer Ingelheim and Eli Lilly and Company announced that empagliflozin has been granted extended reimbursement for the treatment of adult patients with symptomatic chronic heart failure with preserved ejection fraction (HFpEF). The drug therefore becomes the first and only treatment currently approved and reimbursed by our National Health Service for adult patients with this pathology. The clinical value of empagliflozin for this extension of the indication – informs a note – was ascertained by the Italian Medicines Agency (Aifa) which recognized its conditional innovativeness on the basis of the important therapeutic need and the high quality of the evidence presented (i.e. the robustness of clinical trials).
This recognition – reads the note – demonstrates the value of empagliflozin compared to the therapies available so far, since Aifa establishes that for the attribution of the character of innovation it is necessary to demonstrate an added therapeutic value in the treatment of a serious pathology, intended such as a life-threatening disease, or which induces repeated hospitalizations, or which is life threatening or causes disability which significantly compromises the quality of life.
Heart failure is responsible for nearly 2 million hospital admissions each year worldwide and is also characterized by a high mortality rate. There are 2 different forms of symptomatic chronic heart failure, with reduced ejection fraction (HFrEF) and with preserved ejection fraction (HFpEF), characterized respectively by a difficulty of the heart to contract normally or to fill with blood adequately. It is precisely for this latter form of heart failure with preserved ejection fraction that there is an unmet clinical need, due to the absence of adequate therapies.
“In Italy about 1.2 million people have a diagnosis of heart failure and this number is constantly increasing given the aging of the population – confirms Francesco Dentali, president of Fadoi, the Federation of Associations of Intern Hospital Managers – About 50% of people hospitalized for symptomatic chronic heart failure have preserved ejection fraction. It is well known that in these patients, hospitalization – which occurs mainly in internal medicine – heavily affects survival and quality of life. In this context, therefore, the possibility of using an extremely effective drug in reducing re-hospitalizations regardless of the ejection fraction represents for all of us healthcare professionals, but above all for our patients, an unprecedented therapeutic opportunity”.
“Symptomatic chronic heart failure with preserved ejection fraction (pEF) is the first and most important unmet clinical need in cardiovascular medicine – underlines Fabrizio Oliva, president of Anmco, National Association of Hospital Cardiologists – Empagliflozin is the first drug to have demonstrated a significant efficacy on hospitalizations or mortality. In fact, the other treatments available to date have no impact on the progression of the disease. Having demonstrated the ability to improve the outcome of these patients, who represent a large population with an important therapeutic need, the drug now constitutes, with a high quality of evidence, the first-line treatment, with an undoubted added value compared to the available therapeutic alternatives”.
The approval is based on results from the groundbreaking Phase III Emperor-Preserved study, which evaluated the effect of empagliflozin 10 mg versus placebo, administered once daily, both as an add-on to standard of care. in 5,988 adults with heart failure with LVEF greater than 40%. In the study, empagliflozin demonstrated a 21% relative risk reduction in the primary composite endpoint of cardiovascular death or hospitalization for heart failure. These results were observed regardless of the more or less elevated age of the patient and the concomitant pathologies, including any diabetic status, or the causes of heart failure. In addition to its cardiovascular effects, empagliflozin has been shown to protect the kidney, an organ often involved in this disease, by significantly reducing the rate of decline in kidney function.
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