No Increase in Risk With Dapagliflozin in Patients With Stage 4 CKD

For patients with stage 4 chronic kidney disease (CKD), a similar pattern of reduced kidney, cardiovascular, and mortality risks is seen with dapagliflozin versus placebo, with no evidence of increased risks, according to a study published online July 16 in the Journal of the American Society of Nephrology.

Glenn M. Chertow, M.D., M.P.H., from Stanford University School of Medicine in California, and colleagues examined the effect of dapagliflozin in patients with stage 4 CKD (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2). Patients with an eGFR of 25 to 75 mL/min/1.73 m2 and urinary albumin-to-creatinine ratio of 200 to 5,000 mg/g were randomly assigned to either dapagliflozin (293 patients) or placebo (331 patients).

The researchers found a 27 percent reduction in the primary composite end point of sustained decline in eGFR of ≥50 percent, end-stage kidney disease, or kidney or cardiovascular death among patients randomly assigned to dapagliflozin compared with placebo and statistically nonsignificant reductions in the kidney, cardiovascular, and mortality end points. In the dapagliflozin and placebo groups, the decline in eGFR slope was 2.15 and 3.38 mL/min/1.73 m2/year, respectively. Both groups had similar rates of serious adverse events and adverse events of interest.

"This analysis shows that the effects of dapagliflozin in patients with stage 4 CKD are similar to effects in patients with mild to moderate CKD," Chertow said in a statement.

Several authors disclosed financial ties to the pharmaceutical industry.