The State Expert Center, the authorized body for state health technology assessment (HTA), recommends including the medicinal product dapagliflozin, in addition to standard therapy for patients with chronic kidney disease, in the National List of Essential Medicines.
The state HTA conclusion has been published on the Center's website: http://surl.li/tiewx
For which patients is this important?
According to WHO estimates, about 850 million people worldwide suffer from kidney diseases, more than 2,5 million people receive dialysis treatment, and this number increases by 7-8% annually.
About the medicinal product under evaluation
Dapagliflozin is a highly potent, selective and reversible inhibitor of sodium-glucose cotransporter type 2. It reduces glucose reabsorption in the proximal renal tubules with a simultaneous decrease in sodium reabsorption. The medicinal product leads to reduced volume overload, lowered blood pressure and reduced preload and afterload, which has a beneficial effect on the myocardium and its diastolic function, and to preservation of renal function.
Dapagliflozin compared with placebo had a statistically and clinically significant advantage in the treatment of patients with chronic kidney disease and an estimated glomerular filtration rate (eGFR) of 25 to 75 mL/min/1,73m2, regardless of the presence or absence of type 2 diabetes mellitus.
Recommendations of the Authorized Body
It is recommended to consider including the medicinal product dapagliflozin (film-coated tablets, 10 mg) in the National List of Essential Medicines for the indication of treatment of adult patients with chronic kidney disease and GFR from 25 to 75 mL/min/1,73m2, regardless of the presence or absence of type 2 diabetes mellitus, in addition to standard therapy, taking into account the conditions specified in the conclusion.
