On April 30, 2021, the U.S. Food and Drug Administration approved dapagliflozin oral tablets to lower the chances of the risk of kidney function decline, kidney failure, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression. The FDA granted the approval of dapagliflozin to AstraZeneca¹. 

“Chronic kidney disease is an important public health issue, and there is a significant unmet need for therapies that slow disease progression and improves outcomes. Today’s approval of dapagliflozin for the treatment of chronic kidney disease is an important step forward in helping people living with kidney disease.” -Dr Aliza Thompson, M.D., M.S., deputy director of the Division of Cardiology and Nephrology in the FDA’s center for Drug Evaluation and research¹. 

A multicenter, double-blind study was conducted to assess the efficacy of dapagliflozin to improve kidney outcomes and reduce cardiovascular death in patients with chronic kidney disease. The study included 4304 patients who were randomly allocated to receive either dapagliflozin or a placebo. This study compared the two groups for the number of patients whose disease progressed to a composite endpoint including at least a 50% reduction in kidney function, progression to kidney failure, or cardiovascular or kidney death. The study findings were that 197 of the 2152 patients who received Dapagliflozin had at least one of the composite endpoint events compared to 312 of the 2152 patients who received a placebo. The clinical trial also compared the two groups who were hospitalized for heart failure or died from cardiovascular disease. It was found that 100 patients on dapagliflozin were hospitalized or died compared to 138 patients who received a placebo². 

Dapagliflozin has been noted to be efficacious in improving kidney outcomes and reduce cardiovascular death in patients with chronic kidney disease in a multicenter, double-blind study. It has been suggested that dapagliflozin should not be used if individuals have a history of serious hypersensitivity reactions to the medication or if they are on dialysis treatment¹. 

Reference: 

1. FDA News Release. FDA approves treatment for chronic kidney disease. April 30, 2021. Accessed fromhttps://www.fda.gov/news-events/press-announcements/fda-approves-treatment-chronic-kidney-disease.
2. Heerspink HJL, Stefansson BV, Correa-Rotter R, et al. Dapagliflozin in patients with chronic kidney disease. N Engl J Med. 2020; 383:1436-1446. DOI: 10.1056/NEJMoa2024816