Department of Nephrology, Kokura Memorial Hospital, Fukuoka, Japan.
Division of Nephrology and Endocrinology, The University of Tokyo, Graduate School of Medicine, Tokyo, Japan.
Ther Apher Dial. 2021 Dec;25(6):979-987. doi: 10.1111/1744-9987.13686. Epub 2021 May 25.
Daprodustat is a hypoxia-inducible factor-prolyl hydroxylase inhibitor for the treatment of anemia of chronic kidney disease. This phase 3 study evaluated the efficacy and safety of daprodustat in an uncontrolled cohort of 56 Japanese peritoneal dialysis patients with anemia over 52 weeks. Subjects received daprodustat 4 mg orally once daily for 4 weeks and the dose was subsequently adjusted every 4 weeks. Mean baseline hemoglobin was 10.9 g/dL (95% CI 10.59, 11.12). Mean hemoglobin reached the target range (11.0-13.0 g/dL) at week 12 and was maintained until week 52. Mean hemoglobin during weeks 40-52 was 12.1 g/dL (95% CI 12.0, 12.2). The most frequent adverse events included nasopharyngitis (29%), catheter-site infection (18%), peritonitis (16%), diarrhea (14%), and nausea (11%). No deaths were reported. Once-daily oral daprodustat treatment was generally well tolerated and mean hemoglobin was achieved and maintained within the target range in Japanese peritoneal dialysis participants.
达普司他是一种低氧诱导因子脯氨酰羟化酶抑制剂，用于治疗慢性肾脏病引起的贫血。这项 3 期研究评估了达普司他在 56 名日本腹膜透析伴贫血患者中的疗效和安全性，这些患者未经控制，研究时间为 52 周。患者接受达普司他 4mg 口服，每日一次，持续 4 周，随后每 4 周调整一次剂量。平均基线血红蛋白为 10.9g/dL（95%CI 10.59,11.12）。在第 12 周时，平均血红蛋白达到目标范围（11.0-13.0g/dL），并一直维持到第 52 周。第 40-52 周的平均血红蛋白为 12.1g/dL（95%CI 12.0,12.2）。最常见的不良事件包括鼻咽炎（29%）、导管部位感染（18%）、腹膜炎（16%）、腹泻（14%）和恶心（11%）。没有死亡报告。达普司他每日一次口服治疗一般耐受性良好，日本腹膜透析患者的平均血红蛋白达到并维持在目标范围内。
