Dapagliflozin (Farxiga) won FDA approval for use for patients with chronic kidney disease who are at risk of disease progression. The oral tablets showed efficacy in a multicenter, double-blind study for the improvement of kidney outcomes and reduction of cardiovascular death in this patient population.
“In this study, 4,304 patients were randomly assigned to receive either [dapagliflozin] or a placebo,” the FDA noted in a statement. “The study compared the two groups for the number of patients whose disease progressed to a composite (or combined) endpoint that included at least a 50% reduction in kidney function, progression to kidney failure, or cardiovascular or kidney death. Results showed that 197 of the 2,152 patients who received [dapagliflozin] had at least one of the composite endpoint events compared to 312 of the 2,152 patients who received a placebo. The study also compared the two groups for the number of patients who were hospitalized for heart failure or died from cardiovascular disease. A total of 100 patients who received [dapagliflozin] were hospitalized or died compared to 138 patients who received a placebo.”
The regulatory agency noted that dapagliflozin was not studied in patients with autosomal dominant or recessive polycystic kidney disease and is not expected to be effective for these patients. The same goes for kidney disease patients who are on or have recently used immuosuppressive therapy.
The FDA also noted the following:
- Patients should not use dapagliflozin is they have a serious hypersensitivity reaction to the medication or if they are on dialysis.
- Some patients have developed “serious, life threatening cases of Fournier’s Gangrene” when taking dapagliflozin.
- Patients taking insulin or insulin secretagogue should consider a lower dose of insulin in order to reduce the risk of hypoglycemia when taking dapagliflozin.
- Dehydration, serious urinary tract infections, genital yeast infections, and metabolic acidosis or ketoacidosis can occur when taking dapagliflozin.
- Before starting dapagliflozin patients should be assessed for volume status and kidney function.
Dapagliflozin was originally approved as a treatment to improve glycemic control in adults with type 2 diabetes in 2014.
AstraZeneca is the manufacturer of dapagliflozin and garnered the FDA approval.
Candace Hoffmann, Managing Editor, BreakingMED™
Cat ID: 127
Topic ID: 81,127,730,914,12,187,127,192,669,918,925