Dapagliflozin reduces risks of kidney failure, cardiovascular or renal death
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Dapagliflozin reduced the worsening of kidney function and the risk of cardiovascular or renal death in patients with chronic kidney disease irrespective of the underlying cause of kidney disease, according to recently presented data.
“In this pre-specified analysis, we’ve shown that these renal, cardiovascular and mortality benefits are present regardless of the underlying cause of chronic kidney disease and regardless of the presence or absence of type 2 diabetes. Dapagliflozin was well tolerated with a safety profile that is consistent with that seen on other patient populations,” David C. Wheeler, MD, said.
Wheeler presented results of a pre-specified secondary analysis of phase 3 data of the Dapagliflozin and Prevention of Adverse outcomes in Chronic Kidney Disease trial at ASN Kidney Week.
Researchers enrolled 4,304 adult patients from 386 sites in 21 countries. Patients had either diabetic nephropathy, chronic glomerulonephritides, ischemic/hypertensive CKD or CKD due to unknown or other causes. Patients had eGFR of 25 mL/min/1.73 m2 to 75 mL/min/1.73 m2 and urine albumin-to-creatinine ratio of 200 mg/g to 5,000 mg/g. Two-thirds of the patients had type 2 diabetes at baseline. Patients with type 1 diabetes, polycystic kidney disease, lupus nephritis or antineutrophil cytoplasmic antibody-associated vasculitis were excluded. Patients on immunosuppressive therapy within 6 months prior to enrollment were also excluded.
Patients were randomized 1:1 to receive either dapagliflozin 10 mg once daily or placebo. Primary outcomes were a composite of sustained decline in eGFR greater than or equal to 50%; end-stage kidney disease; or death from cardiovascular or kidney causes. Secondary outcomes were composite of sustained decline in eGFR greater than or equal to 50%, ESKD or renal death, kidney causes; cardiovascular death or hospitalizations for heart failure; and all-cause mortality. Median follow-up was 2.4 years.
Researchers reported patients who received dapagliflozin had relative risk reductions of 37% for those whose CKD was from diabetic kidney disease; 25% for high blood pressure; 57% for glomerulonephritis; and 42% for CKD of other or unknown causes. Patients who received dapagliflozin also had a reduction in all-cause mortality compared to patients in the placebo group, regardless of the underlying etiology of CKD. The safety and tolerability profile of dapagliflozin was consistent with established safety profiles.
Earlier this month, the FDA granted dapagliflozin a breakthrough therapy designation for patients with CKD with and without type 2 diabetes. In May, the FDA approved the drug to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction with or without type 2 diabetes.
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Wheeler DC, et al. Paper FR-OR58. Presented at: ASN Kidney Week. Oct. 22-25, 2020 (virtual meeting).
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