SGLT2 inhibitor dapagliflozin safe and effective in patients with advanced kidney disease: Study
The effects of dapagliflozin in patients with stage 4 CKD are similar to effects in patients with mild to moderate CKD.
USA: The benefits of SGLT2 inhibitor are consistent with those observed in the DAPA-CKD trial overall, with no indication of increased risks among patients with stage 4 CKD and albuminuria, reveals a recent study in the Journal of American Society of Nephrology.
Previous studies have shown diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors to provide cardiovascular and kidney-related benefits in patients with or without diabetes and with or without impaired kidney function. The present study provides insights about the efficacy and safety of SGLT2 inhibitors in people with advanced chronic kidney disease (CKD), an especially vulnerable population.
Dapagliflozin And Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) trial enrolled patients with and without type 2 diabetes and with mildly decreased to severely decreased kidney function (stage 4 CKD).
In DAPA-CKD, 624 of 4,304 (14%) patients had stage 4 CKD--with an estimated glomerular filtration rate (eGFR), a measure of kidney function, as low as 25 mL/min/1.73m2--at the start of the study. Patients were randomized to receive daily treatments of the SGLT2 inhibitor dapagliflozin or placebo. Among patients with stage 4 CKD, those randomized to dapagliflozin experienced a 27% reduction in the primary endpoint (a composite of a sustained and large decline in kidney function, kidney failure, or death) and 29%, 17%, and 32% reductions in the kidney, cardiovascular, and mortality endpoints, respectively, compared with those randomized to placebo. Rates of serious side effects were similar in the two groups.
"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," said Dr. Chertow. "While patients with screening eGFR as low as 25 mL/min/1.73m2 were enrolled, it is noteworthy that neither dapagliflozin nor placebo were discontinued when eGFR declined, even to below 15 mL/min/1.73m2. Therefore, a drug initially developed for the treatment of diabetes can benefit patients with CKD with and without diabetes, including patients with moderate to advanced CKD."
The study titled, "Effects of Dapagliflozin in Stage 4 Chronic Kidney Disease," is published in the Journal of American Society of Nephrology.