Heart failure is the second cause of hospitalization in Italy; an often underestimated disease that has a very strong impact also in terms of related pathologies and mortality. For patients who suffer from it, in particular those who have symptomatic chronic heart failure, there is now the possibility of resorting to a drug, dapagliflozin, previously reserved only for some patients. “Heart failure is classified into different categories based on the ejection fraction, which is an index of contractile capacity, of the left ventricle and about half of patients with heart failure have a slightly reduced or preserved ejection fraction,” says Michele Senni , director of Cardiology 1 and of the Cardiovascular Department of the Papa Giovanni XXIII Hospital in Bergamo. Well, dapagliflozin has now obtained reimbursement for the entire ejection fraction spectrum from the Italian Medicines Agency. And it therefore becomes the first and only selective inhibitor of the renal sodium and glucose co-transporter (SGLT2) to be reimbursed not only for all cases of heart failure but also for the treatment of type 2 diabetes and chronic kidney disease.
The effectiveness of the drug
Heart failure is a chronic disease that worsens over time causing reduced oxygenation of organs and tissues and compromised quality of life: it is associated with high comorbidities and a mortality rate of up to 20% and 50% at 1 year and 50% respectively. 5 years from diagnosis. The clinical studies on which the approval is based show how dapagliflozin works across the entire ejection fraction spectrum: compared to placebo, it significantly reduced the risk of all-cause mortality by 10%, the risk of cardiovascular mortality by 14% and the risk of hospitalization for heart failure of 29%.
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In particular, the benefits in terms of efficacy of dapagliflozin regarding the reduction of cardiovascular mortality and worsening of heart failure were already visible 13 days and 28 days after the start of therapy, respectively for patients with slightly reduced ejection fraction or preserved and for patients with reduced ejection fraction. “Every new therapy that scientific research and the National Health System make available for the treatment of a chronic, disabling disease characterized by co-morbidities such as heart failure, is certainly excellent news for us patients who daily face the challenges also related to the management and complexity of the treatment”, states Rossana Bordoni, President of AISC Italian Association of Heart Failure Patients.
The experience in diabetes
Before being approved for the treatment of symptomatic chronic heart failure, dapagliflozin obtained the indication for the treatment of type 2 diabetes mellitus, also in terms of cardiovascular and renal prevention.
“The publication of the results of the DECLARE Study showed, for the first time in a population mostly undergoing primary prevention, a 27% decrease in the risk of hospitalizations for heart failure and a 47% decrease in the risk of loss of renal function compared to to placebo – underlines Riccardo Candido, President of the AMD Italian Association of Diabetologists –. Considering that in Italy the use of SGLT2i for the treatment of patients suffering from diabetes stands at 29%, we imagine how, in light of all the new evidence and indications, this reimbursement could impact the diabetes community and how this class of drugs can represent the basic therapy in the management of people with diabetes to prevent the onset of complications”.
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Protection of the kidneys
Diabetes and chronic kidney disease are pathologies that have a strong impact on the quality of life of patients and are interconnected with each other, so much so that it is estimated that, globally, one in three people with kidney, cardiovascular or metabolic diseases currently lives with one or more of these pathologies, demonstrating the importance of identifying, diagnosing and consequently treating patients in a more timely and effective manner.
“The approval and use of dapagliflozin also represented an epochal turning point for nephrology – continues Loreto Gesualdo, Professor of Nephrology at the Aldo Moro University of Bari and President of FISM (Italian Federation of Medical-Scientific Societies). It was the first treatment to have a specific indication for this pathology and the only therapeutic option, together with early diagnosis, to allow a slowdown in the progression of the disease and entry into dialysis. Before resorting to treatment, however, it is important to act with a view to prevention and identify patients at risk to subject them to two simple tests, GFR and ACR, which allow a diagnosis of the pathology and prompt intervention. This would allow a reduction in the need for complex therapies with a high impact on quality of life, such as dialysis and transplants. In particular, dapagliflozin has nephro- and cardio-protective efficacy in patients with and without diabetes and is able to slow down entry into dialysis by up to 10 years”.
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A drug to use immediately
Chronic heart failure is the leading cause of hospitalization in people over the age of 65 and constitutes a significant clinical and economic burden.
“It is essential to have a drug available for heart failure that can be used already in the first phase of hospitalization, because it is a time window of unique action,” declares Claudio Borghi, Professor of Internal Medicine at the University of Bologna, Director of the Internal Medicine Unit, Policlinico S.Orsola Malpighi University Hospital, Bologna. Dapagliflozin can in fact be administered before the patient is discharged and the more quickly the person is treated, the sooner the results are visible. Every day we see patients who can present the three pathologies individually but very often also simultaneously; therefore, having a single drug like dapagliflozin available that is effective and safe in these clinical contexts really makes it possible to impact the quality of life of patients and improve the management of these pathologies”.
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– 2024-03-16 09:53:50
