Kidney international reports · 2025
Empagliflozin and Ultrafiltration Volume in Patients Undergoing Peritoneal Dialysis.
СтатьяНазвание и аннотация: Перевод в очереди
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Doi Yohei, Shinzawa Maki, Arisato Tetsuya, Oka Hideaki, Ueda Yoshiyasu, Matsumoto Ayumi, Kitamura Harumi, Hamano Takayuki, Nakazono Yumi, Nishiya Yoichi, Hashimoto Nobuhiro, Matsuo Miki, Sonoura Takuryu, Monden Chikako, Kamimura Taro, Hayashi Terumasa, Yoshihara Fumiki, Isaka Yoshitaka, EMPOWERED Investigators
Аннотация
INTRODUCTION: Sodium-glucose cotransporter 2 (SGLT2) is expressed in the human peritoneum, and preclinical studies suggest that SGLT2 inhibitors may enhance ultrafiltration by reducing glucose absorption from peritoneal dialysis (PD) solutions. This study evaluated whether empagliflozin increases ultrafiltration volume (UFV) in patients on PD.
METHODS: In this multicenter, randomized (1:1), double-blind, placebo-controlled crossover trial, patients on PD received empagliflozin (10 mg/d) or placebo for 8 weeks, separated by a 4-week washout period. The primary outcome was the change in daily UFV from baseline to week 8 in each treatment period.
RESULTS: Of 40 randomized patients, 37 received treatment and were analyzed. The median age was 66 years, PD duration was 2.8 years, and 46% were female. At baseline, median daily UFV was 476 ml with 4500 ml of glucose-based dialysate. At week 8, change in UFV did not significantly differ between treatments (-38 ml; 95% confidence interval [CI]: -120 to 44; P = 0.36). No heterogeneity was observed in subgroups by diabetes or peritoneal membrane transport characteristics. Empagliflozin had no significant effect on UFV or dialysate glucose or sodium concentrations, assessed by peritoneal equilibration test (PET). Urinary glucose excretion increased by 2698 mg/d (95% CI: 343-5052), without changes in urine volume, sodium, or protein excretion. Adverse events occurred in 47% with empagliflozin and 29% with placebo; serious adverse events occurred in 11% and 6%, respectively.
CONCLUSION: Empagliflozin did not significantly improve UFV in patients on PD, suggesting limited short-term clinical utility.
METHODS: In this multicenter, randomized (1:1), double-blind, placebo-controlled crossover trial, patients on PD received empagliflozin (10 mg/d) or placebo for 8 weeks, separated by a 4-week washout period. The primary outcome was the change in daily UFV from baseline to week 8 in each treatment period.
RESULTS: Of 40 randomized patients, 37 received treatment and were analyzed. The median age was 66 years, PD duration was 2.8 years, and 46% were female. At baseline, median daily UFV was 476 ml with 4500 ml of glucose-based dialysate. At week 8, change in UFV did not significantly differ between treatments (-38 ml; 95% confidence interval [CI]: -120 to 44; P = 0.36). No heterogeneity was observed in subgroups by diabetes or peritoneal membrane transport characteristics. Empagliflozin had no significant effect on UFV or dialysate glucose or sodium concentrations, assessed by peritoneal equilibration test (PET). Urinary glucose excretion increased by 2698 mg/d (95% CI: 343-5052), without changes in urine volume, sodium, or protein excretion. Adverse events occurred in 47% with empagliflozin and 29% with placebo; serious adverse events occurred in 11% and 6%, respectively.
CONCLUSION: Empagliflozin did not significantly improve UFV in patients on PD, suggesting limited short-term clinical utility.