There are 6 million Italians with chronic kidney disease, from Aifa ok new drug

Nephrologist Gesualdo: “New treatment will change the natural history of the disease”

In Italy about 10% of the population is affected by chronic kidney disease. About 6 million people are therefore affected by this serious and progressive condition which, in the more advanced stages, can be very disabling and lethal. There are few therapeutic options for these patients, at least up to now: AIFA has in fact just approved the reimbursement of a new drug, dapagliflozin, for the treatment of chronic kidney disease in adult patients irrespective of the presence of type 2 diabetes (T2DM) and heart failure. Publication in the Official Gazette is expected in the next few days. “It is a drug that will change the natural history of the disease“, he claims Loreto Gesualdo, professor of nephrology at the Aldo Moro University of Bari and Past President of the Italian Kidney Foundation, in a press event taking place in Rome.

“The Dapa-Ckd study – continues the nephrologist – has shown that, in addition to standard of care, dapagliflozin reduced the risk of all-cause mortality by 31% and the relative risk of worsening kidney function by 39% compared with standard of care, the occurrence of end-stage renal disease, or the risk of cardiovascular and renal death in patients with stage 2-4 chronic kidney disease with albuminuria”. The approval of dapagliflozin, according to experts, therefore represents an epochal turning point in the treatment of chronic kidney disease, “a pathology with a high mortality rate – specifies Gesualdo – which for the patient on dialysis is 50% at 5 years, higher than that of lymphomas, prostate and breast cancer. This drug is able to modify the progressive evolution of renal and cardiovascular damage, with a simple daily oral intake”.

The approval positions dapagliflozin as the first treatment to have a specific indication for chronic kidney disease and the only treatment option, together with early diagnosis, which allows for slowing disease progression and entry into dialysis. “Dapagliflozin has been shown to have reno- and cardioprotective efficacy in patients with and without diabetes,” he said Luca De Nicola, Professor of Nephrology at the Luigi Vanvitelli University of Naples –. It is able to slow down the entry into dialysis by up to 10 years, because it acts by antagonizing the main mechanism of worsening of renal disease, i.e. glomerular hyperfiltration, present both in diabetics and in patients with reduced renal function with and without diabetes” .

In addition to unmet clinical need and high prevalence, the healthcare costs associated with chronic kidney disease are very significant, especially as it progresses to its terminal stages. “Chronic kidney disease – he says Francesco Saverio Mennini, professor of microeconomics and health economics, University of Rome Tor Vergata, president of the Italian Society of Health Technology Assessment (Sihta) – in addition to the increase in mortality, it is associated with a consumption of health resources, direct and indirect health costs, which increase in relation to the severity of the disease. In 2021, in Italy – recalls Mennini – expenditure for chronic kidney disease represented 3.2% of the total health expenditure borne by the NHS, for a total of around 4 billion euros and, based on the results of the Inside study Ckd, an increase in annual costs for this pathology of 10.8% by 2026 has been estimated, of which 53% attributable to renal replacement therapy”.

“From these data it emerges how much an intervention on early diagnosis, the use of new specific therapies and the treatment of the initial stages of the disease – underlines – can contribute, having an impact on the patient’s clinical outcomes by preventing and / or delaying the progression towards his terminal stage to a significant saving of resources and costs for the NHS and the welfare system as a whole”. “Dapagliflozin – underlines De Nicola – it also has a significant impact on healthcare spending: it reduces cardiovascular complications and the need for dialysis (high-cost therapy) and, consequently, hospitalizations. A data projection presented by the Italian Society of Nephrology demonstrated that, at 3 years, about $200 million can be saved182 on dialysis and 14 in heart failure hospitalizations”.

“Approval of dapagliflozin based on unprecedented results from Dapa-Ckd trial,” he said Raffaela Fede, medical director of AstraZeneca Italy – represents a revolutionary opportunity for patients with chronic kidney disease, who now have a specific treatment available that can slow disease progression, prolong and improve survival and reduce dialysis access, aspects for which dapagliflozin, especially if associated with an early diagnosis, it represents the only truly valid option for patients”.