#3382 REASONS FOR DIALYSIS INITIATION AND SAFETY OF DAPAGLIFLOZIN AMONG DIALYSIS PARTICIPANTS: NEW INSIGHTS FROM DAPA-CKD

Abstract

Abstract Background and Aims The DAPA-CKD trial demonstrated that dapagliflozin reduced the risk of kidney failure in patients with chronic kidney disease (CKD) with or without type 2 diabetes. In contrast to most other trials, participants who reached dialysis were allowed to continue study medication with dapagliflozin or placebo. In this pre-specified analysis of the DAPA-CKD trial, we assessed reasons for dialysis initiation and serious adverse events (SAEs) among participants who initiated dialysis and continued the study medication. Method The DAPA-CKD trial randomized 4304 patients with CKD (estimated glomerular filtration rate [eGFR] 25−75 mL/min/1.73m2) and albuminuria (urinary albumin-to-creatinine ratio 200−5000 mg/g) to dapagliflozin 10 mg daily or placebo in addition to standard of care. Chronic dialysis was defined as the need for dialysis for at least 28 days. Investigator reported reasons for dialysis and SAEs were summarized by treatment groups. Results During median 2.4 years follow-up, 68/2152 (3.2%) and 99/2152 (4.6%) participants in the dapaglifozin and placebo groups respectively required chronic dialysis. Reasons for dialysis initiation are shown in the Table below, with volume overload being the most frequently reported. Roughly one-third of patients in both groups had discontinued study drug in advance of dialysis initiation; in the dapagliflozin and placebo groups, 25/68 (37%) and 41/99 (41%) continued the blinded study medication while receiving chronic dialysis. Among these, SAEs were reported in 8/25 (32%) and 11/41 (27%), respectively. Conclusion Participants who continued dapagliflozin or placebo after dialysis initiation experienced similar rates of SAEs. To determine whether dapagliflozin provides cardiovascular or other benefits to patients with kidney failure on chronic dialysis, will require a dedicated prospective trial. Based on our prespecified exploratory analysis, we observed no safety concerns that might discourage the conduct of such a trial. Funding This study was funded by AstraZeneca