The renoprotective effect of dapagliflozin in patients with chronic kidney disease (CKD) extends to those with focal segmental glomerulosclerosis (FSGS), according to study data presented at the 58th European Renal Association-European Dialysis and Transplant Association virtual annual meeting.
The data are from a prespecified subgroup analysis of the phase 3 randomized placebo-controlled DAPA-CKD trial, which had a median follow-up duration of 2.4 years. Overall results from that trial showed that dapagliflozin, an oral diabetes drug that increases urinary glucose excretion by inhibiting sodium-dependent glucose cotransporter 2 (SGLT2), decreased the risk for adverse kidney and cardiovascular events and mortality among patients with CKD regardless of diabetes status compared with placebo.
The subgroup analysis included 115 patients with FSGS: 53 in the dapagliflozin group and 62 in the placebo group. The primary composite endpoint (a 50% or greater decrease in estimated glomerular filtration rate [eGFR], need for dialysis, or kidney or cardiovascular death) occurred in 4 patients in the dapagliflozin group and 9 in the placebo group. Dapagliflozin-treated patients had a 55% reduction in the risk of the combined primary endpoint compared with placebo, lead investigator David C. Wheeler, MD, of University College London in London, UK, reported. The dapagliflozin group also had a 48% decreased risk for the kidney-specific composite secondary endpoint (50% or greater decrease in eGFR, need for dialysis, or kidney death).
“These reductions in this subgroup were not statistically significant, but they’re consistent with the overall results of the study,” Dr Wheeler said.
Over the course of the study, dapagliflozin recipients had a slower decline in eGFR compared with the placebo group (-3.6 vs -4.5 mL/min/1.73 m2 per year), he reported.
At week 2 of the study, dapagliflozin-treated patients had a greater reduction in urinary albumin-to-creatinine ratio (UACR) from baseline compared with placebo recipients (-25.1% vs 11.7%). Each 10% reduction in UACR at week 2 was associated with an average -0.58 mL/min/1.73 m2 per year lesser eGFR decline.
Dapagliflozin was well tolerated with no unexpected safety issues.
Dr Wheeler concluded that the data might encourage the use of dapagliflozin in addition to ACE inhibitors and angiotensin receptor blockers in patients with FSGS.
Disclosure: AstraZeneca provided funded the DAPA-CKD trial.
Wheeler DC, Tot RD, Stefansson BV, et al. Effects of dapagliflozin on major adverse kidney events in patients with focal segmental glomerulosclerosis: a prespecified analysis of the DAPA-CKD trial. Presented at: 58th ERA-EDTA 2021 virtual congress. LB003.