New drug approved in Europe for the treatment of chronic kidney disease

by time news

This is the most significant advance in the fight against chronic kidney disease in the past 20 years, particularly for patients with and without type 2 diabetes.

Dapagliflozin, a sodium glucose co-transporter inhibitor (SGLT2i), has been approved in the European Union (EU) for the treatment of chronic kidney disease (CKD) in adult patients regardless of whether they have type 2 diabetes (DT2).

European Commission approval is based on positive results from the Phase III DAPA-CKD Study and the decision follows the recommendation of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)..

Chronic kidney disease is a serious and progressive condition defined by worsening of kidney function and is often associated with an increased risk of cardiovascular disease or stroke1-3. Chronic kidney disease affects 840 million people worldwide and around 47 million people in Europe3,4. Despite this, the percentage of diagnoses remains low and up to 90% of patients are unaware of being affected by this disease3.

This new indication represents an epochal turning point in the treatment of patients with chronic kidney disease, defining dapagliflozin as the first SGLT2 inhibitor approved in the European Union for the treatment of chronic kidney disease regardless of the presence of type 2 diabetes ” – commented Loreto Gesualdo Full Professor of Nephrology at the Aldo Moro University of Bari. “The approval of dapagliflozin for the treatment of chronic kidney disease in patients with and without type 2 diabetes represents a great opportunity for the management of patients suffering from this disease, which we hope will soon become a concrete reality in Italy as well.

The Phase III DAPA-CKD study demonstrated that Dapagliflozin, in addition to standard of care with an angiotensin converting enzyme inhibitor (ACE inhibitor) or angiotensin receptor antagonist, reduced, compared to placebo, 39% relative risk of worsening of renal function, development of end-stage renal disease (ESKD), or risk of cardiovascular and renal death (the primary composite endpoint) in patients with stage 2 chronic kidney disease -4 with high urinary albumin excretion5 (absolute risk reduction [ARR]=5.3%, p<0.0001)

READ Also:  "Possible link with rare thrombosis, but benefits outweigh the risks" - time.news

Dapagliflozin also showed a significant reduction compared to placebo of 31% in the relative risk of death from all causes.5 (ARR = 2.1%, p = 0.0035). The safety and tolerability of dapagliflozin were found to be consistent with the already known safety profile of the drug.

Dapagliflozin was recently approved in the United States for the treatment of chronic kidney disease in adult patients with or without type 2 diabetes and is currently under regulatory review in several other countries around the world. Dapagliflozin is also indicated, as an adjunct to diet and exercise, to improve glycemic control in adult patients with type 2 diabetes and for the treatment of symptomatic chronic heart failure (HF) with reduced ejection fraction (HFrEF) in adults, regardless of the presence of diabetes.

Information on chronic kidney disease

Chronic kidney disease can be a severe and progressive condition defined by decreased kidney function (demonstrated through a decrease in estimated glomerular filtrate (eGFR) or markers of kidney damage, or both, for at least three months)3. The most common causes of CKD are diabetes, hypertension and glomerulonephritis6. Chronic kidney disease is associated with significant comorbidities and an increased risk of cardiovascular events, such as HF and premature death. In its most severe form, known as end-stage renal disease (ESKD), kidney damage and deterioration of its function progress to the stage where dialysis or kidney transplant is needed1. Most CKD patients die from CV causes before reaching the form of ESKD7.

About the DAPA-CKD study

DAPA-CKD is an international, multicenter, randomized, double-blind study including 4,304 patients designed to evaluate the efficacy of dapagliflozin 10mg, compared to placebo, in patients with stage 2 to 4 chronic kidney disease with excretion. albumin urinary tract and with or without type 2 diabetes. Dapagliflozin is given once daily in addition to standard of care. The primary composite endpoint is determined by worsening of renal function or risk of death (defined as a composite endpoint of an eGFR decline of ≥50%, onset of end-stage renal disease and death from cardiovascular or renal causes). Secondary endpoints included time from first episode of the renal composite (sustained decline in eGFR ≥50%, ESKD and renal death), the composite of cardiovascular death or hospitalization for HF (hHF), and death for all. the causes. The study was conducted in 21 countries and detailed results were published in the The New England Journal of Medicine8.

READ Also:  panic is contagious, but there are strategies »- Corriere.it

About dapagliflozin

Dapagliflozin is an innovative drug belonging to the class of selective renal sodium and glucose co-transporter inhibitors (SGLT2), with oral once-daily administration, indicated both as monotherapy and in combination therapy to improve glycemic control. Studies have shown the efficacy of dapagliflozin in preventing and delaying cardiorenal disease, while protecting organs – relevant results, considering the interconnections between the heart, kidneys and pancreas8-10. Damage to one of these organs can cause damage to others, contributing to leading causes of death worldwide, including type 2 diabetes, heart failure and chronic kidney disease.11-13.

Based on the results of the DECLARE-TIMI 58 Phase III CV Outcome Study, dapagliflozin is approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes and type 2 diabetes for reduce the risk of hHF or cardiovascular death when given in addition to standard of care9. Dapagliflozin, based on the Phase III Studies DAPA-HF and DAPA-CKD is also approved for the treatment of heart failure with reduced ejection fraction and for the treatment of chronic kidney disease.8,10.

DapaCare is a robust clinical trial program to evaluate the potential CV, kidney, and organ protection benefits of dapagliflozin. It includes over 35 completed and ongoing Phase IIb / III studies and over 35,000 patients, plus extensive experience of over 2.5 million patients treated per year. Dapagliflozin is currently being investigated in patients without type 2 diabetes who have had an acute myocardial infarction (MI) or heart attack in the Phase III DAPA-MI study – this study is the first of its kind as it is randomized and controlled, based on registers and with the purpose of extension of indication.

READ Also:  Covid Italy, no region above critical intensive care threshold

You may also like

Leave a Comment

This site uses Akismet to reduce spam. Learn how your comment data is processed.