Dapagliflozin slows renal disease, reduces death risk regardless of diabetes status
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The SGLT2 inhibitor dapagliflozin was linked to significant reductions in worsening renal function and renal or cardiovascular death in adults with chronic kidney disease irrespective of type 2 diabetes, according to a press release.
Top-line results from the phase 3 DAPA-CKD trial showed that, compared with placebo, the type 2 diabetes drug dapagliflozin (Farxiga, AstraZeneca) slowed time to a sustained decline of at least 50% in estimated glomerular filtration rate, onset of end-stage renal disease, or CV or renal death among approximately 4,300 adults with CKD stages 2 to 4. The study was designed to include least 30% of participants without diabetes and no more than 10% of participants with an eGFR greater than 60 mL/min/1.73 m2 at baseline.
Follow-up was originally planned for 4 years, but the trial was stopped early in March after investigators reported an “overwhelming benefit.”
“The data will be transformative for these patients,” investigators David Wheeler, MD, FRCP, MRCP, MBChB, professor of kidney medicine at University College London, and Hiddo L. Heerspink, PhD, a clinical pharmacologist at in the department of clinical pharmacy and pharmacology at the University Medical Center Groningen, said in the release.
As Healio previously reported, dapagliflozin was granted fast track designation by the FDA last year for an indication to delay the progression of renal failure and prevent CV and renal death in adults with CKD. The SGLT2 inhibitor empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) also received fast track designation for renal indication in March. Dapagliflozin is under priority review with the FDA for the treatment of adults with heart failure.
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