Integrated Value Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.
Department of Health Policy and Management, School of Medicine, Keio University, Tokyo, Japan.
Curr Med Res Opin. 2022 Dec;38(12):2175-2182. doi: 10.1080/03007995.2022.2125256. Epub 2022 Oct 11.
Anemia is a common complication of chronic kidney disease (CKD). The aim of this study was to evaluate hemoglobin levels at the initiation of erythropoiesis stimulating agent (ESA) therapy in patients with non-dialysis-dependent CKD (NDD-CKD) and anemia using a large-scale administrative database in Japan.
The longitudinal data of adult patients who initiated ESA therapy between April 2008 and December 2018 were extracted from a hospital-based administrative database. The primary outcome was hemoglobin level at the initiation of ESA therapy, whereas the exploratory outcome was hemoglobin level recorded 6 months after the onset of the ESA therapy.
A total of 4939 patients were included in the primary analysis. The mean hemoglobin level at the initiation of ESA therapy was 9.1 g/dL, which was lower than the level (11 g/dL) recommended for the initiation of treatment by the current Japanese treatment guidelines. Moreover, 42.1% and 15.0% of the patients had hemoglobin levels <9.0 and <8.0 g/dL, respectively, at the initiation of ESA therapy. In 2964 patients for whom hemoglobin levels at 6 months after the initiation of ESA therapy were available, the mean hemoglobin level increased to 10.3 g/dL, and 61.9% and 31.1% of these patients had hemoglobin levels ≥10.0 and ≥11.0 g/dL, respectively.
This real-world database study revealed that hemoglobin levels at the initiation of ESA therapy in new users of ESA were lower than those recommended by treatment guidelines in Japan.
贫血是慢性肾脏病(CKD)的常见并发症。本研究旨在使用日本大型行政数据库评估非透析依赖性慢性肾脏病(NDD-CKD)伴贫血患者开始使用促红细胞生成刺激剂(ESA)治疗时的血红蛋白水平。
从医院行政数据库中提取 2008 年 4 月至 2018 年 12 月期间开始接受 ESA 治疗的成年患者的纵向数据。主要结局为 ESA 治疗开始时的血红蛋白水平,探索性结局为 ESA 治疗开始后 6 个月时记录的血红蛋白水平。
共有 4939 例患者纳入主要分析。ESA 治疗开始时的平均血红蛋白水平为 9.1g/dL,低于当前日本治疗指南推荐的治疗起始水平(11g/dL)。此外,42.1%和 15.0%的患者在开始 ESA 治疗时血红蛋白水平<9.0 和<8.0g/dL。在 2964 例可获得 ESA 治疗开始后 6 个月时血红蛋白水平的患者中,平均血红蛋白水平增加至 10.3g/dL,其中 61.9%和 31.1%的患者血红蛋白水平分别≥10.0 和≥11.0g/dL。
本真实世界数据库研究表明,ESA 新使用者开始 ESA 治疗时的血红蛋白水平低于日本治疗指南推荐的水平。