Zibotentan plus dapagliflozin demonstrated significant albuminuria reduction in patients with chronic kidney disease, proteinuria: AstraZeneca
Cambridge: AstraZeneca has announced that the combination of zibotentan with dapagliflozin has shown statistically significant and clinically meaningful reductions in urinary albumin-to-creatinine ratio (UACR), used to assess albuminuria, at 12 weeks compared with dapagliflozin alone.
After 12 weeks of treatment, the Phase IIb ZENITH-CKD trial showed that the UACR difference of zibotentan/dapagliflozin versus dapagliflozin alone (n=177) was –33.7% (90% CI –42.5 to –23.5; p<0.001) for high dose (1.5 mg zibotentan / 10 mg dapagliflozin; n=179) and –27.0% (90% CI –38.4 to –13.6; p=0.002) for low dose (0.25 mg / 10 mg; n=91). The percentage mean change from baseline in UACR was –52.5% (90% CI –59.0 to –44.9) for high-dose and –47.7% (90% CI –55.7 to –38.2) for low-dose combination.
These results were presented at the American Society of Nephrology (ASN) Kidney Week 2023 and simultaneously published in The Lancet.
Previous studies showed endothelin A (ETA) receptor antagonists are associated with high rates of fluid retention. The results from ZENITH-CKD showed low-dose zibotentan/dapagliflozin, but not high-dose, had comparable fluid retention events to dapagliflozin alone, with 18.4% (33/179), 8.8% (8/91) and 7.9% (14/177) of patients experiencing events in high-dose combination, low-dose combination and dapagliflozin groups, respectively.
Reference: Prof Hiddo J L Heerspink, Arihiro Kiyosue, Prof David C Wheeler, Min Lin, Zibotentan in combination with dapagliflozin compared with dapagliflozin in patients with chronic kidney disease (ZENITH-CKD): a multicentre, randomised, active-controlled, phase 2b, clinical trial, the lancet, DOI:https://doi.org/10.1016/S0140-6736(23)02230-4
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