Dapagliflozin treatment decreases the risk of kidney disease progression in patients with type 2 diabetes mellitus, according to new data presented at the American Diabetes Association’s 79th Scientific Sessions in San Francisco.
Analysis of data from the phase 3 DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 trial revealed that dapaglflozin-treated patients experienced a significant 24% decreased risk of the study’s primary composite renal outcome of a sustained 40% decline in estimated glomerular filtration rate (eGFR, in mL/min/1.73 m2) to below 60, end-stage renal disease (ESRD), or death from renal or cardiovascular causes compared with placebo recipients. Dapagliflozin treatment also was associated with a 47% decreased risk of a secondary composite renal outcome, which included all the criteria in the primary composite outcome except for cardiovascular death, Ofri Mosenzon, MD, of Hadassah University Hospital in Jerusalem, and colleagues reported.
These differences were driven mainly by a sustained 40% decline in eGFR to below 60, which occurred in 120 dapagliflozin-treated patients (1.4%) compared with 221 placebo recipients (2.6%). Dapagliflozin was associated with a significant 46% decreased risk of a sustained 40% decline in eGFR to below 60. Development of ESRD was rare, but dapagliflozin-treated patients had a significant 69% decreased risk of progressing to it.
In the DECLARE-TIMI 58 trial, investigators randomly assigned 17,160 patients with type 2 diabetes mellitus to receive either dapagliflozin—a sodium glucose co-transporter 2 inhibitor—at a dosage of 10 mg per day, or placebo. The study population included 8162 patients with an eGFR of 90 or higher, 7732 with an eGFR of 60 or higher but less than 90, and 1265 with an eGFR below 60.
Dapagliflozin is marketed by AstraZeneca as Farxiga.
Mosenzon O, Wiviott SD, Zelniker TA, et al. Effects of dapaflilozin on progression of diabetic kidney disease: Analysis from DECLARE-TIMI 58 trial. Presented at the American Diabetes Association annual meeting in San Francisco, June 7 to 11. Abstract 236-OR.