Recently was confirmed, that treatment with dapagliflozin (Farxiga; AstraZeneca) reduced the risk of kidney failure and cardiovascular (CV) or renal death in patients with chronic kidney disease (CKD). The study was confirmed according to results from a phase 3 clinical study.
“Detailed results from the ground-breaking Phase III DAPA-CKD trial showed that dapagliflozin on top of standard of care reduced the composite measure of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% compared to placebo (p<0.0001) in patients with chronic kidney disease (CKD) Stages 2-4 and elevated urinary albumin excretion. The results were consistent in patients both with and without type 2 diabetes (T2D),” – AstraZeneca said.
700M people worldwide have CKD
CKD (chronic kidney disease) is a serious, progressive condition defined by decreased kidney function affecting nearly 700 million people worldwide, many of them still undiagnosed, and the most common causes are diabetes, hypertension and glomerulonephritis.
Dapagliflozin was approved by FDA at May 5, 2020. Volunteers (4.744 people) with average age 66 years and older, with man’s prevalence (77%) were randomly assigned to receive a once-daily dose of either 10 milligrams of Farxiga or a placebo (inactive treatment). According to FDA – “After about 18 months, people who received Farxiga had fewer cardiovascular deaths, hospitalizations for heart failure, and urgent heart failure visits than those receiving the placebo.”
In addition, Farxida were approved to improve glycemic control in adults with type 2 diabetes in addition to diet and exercise, and to reduce the risk of hospitalization for heart failure among adults with type 2 diabetes and known cardiovascular disease or other risk factors.
Dapagliflozin Indications And Limitations
Indications:
- as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
- to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and established cardiovascular (CV) disease or multiple CV risk factors
- to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction
- FARXIGA is not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Contraindications
- Prior serious hypersensitivity reaction to FARXIGA
- Patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) being treated for glycemic control without established CV disease or multiple CV risk factors
- Patients on dialysis
“With today’s results, FARXIGA becomes the first SGLT2 inhibitor proven to significantly prolong the survival of patients with chronic kidney disease with and without type 2 diabetes and we look forward to sharing these data with regulatory authorities around the world. FARXIGA is also the first medicine in its class to demonstrate benefit in treating both heart failure and chronic kidney disease in patients with and without type 2 diabetes, and reduce the risk of hospitalization for heart failure and nephropathy in type 2 diabetes,” Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D concluded.
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