ツチヤ　ケン   TSUCHIYA Ken   土谷　健    所属   医学部 医学科（東京女子医科大学病院）    職種   特任教授
論文種別	原著
言語種別	英語
査読の有無	査読なし
表題	Cardiovascular events by different target hemoglobin levels in ESA-hyporesponsive hemodialysis patients: a multicenter, open-label, randomized controlled study
掲載誌名	正式名：Renal Replacement Therapy 略　 称：RRT ISSNコード：2059-1381
巻・号・頁	8,pp.online
著者・共著者	Nitta Kosaku, Kuragano Takahiro, Joki Nobuhiko, Tsuruya Kazuhiko, Honda Hirokazu, Hamano Takayuki, Fujii Hideki, Uemura Yukari, Tsuchiya Ken and the PARAMOUNT-HD Study Investigators
担当区分	最終著者
発行年月	2022/12/16
概要	Background The incidence of cardiovascular (CV) events is high in hemodialysis (HD) patients and is associated with hyporesponsiveness to erythropoiesis-stimulating agents (ESAs). However, there are no recommended target hemoglobin ranges for ESA-hyporesponsive patients. Methods We randomly assigned 304 ESA-treated HD patients with ESA hyporesponsiveness to a proactive treatment group (target hemoglobin level 11 g/dL) or maintenance treatment group (target hemoglobin level 9–10 g/dL), both of which received epoetin beta pegol. The primary outcome was time to the first CV event. CV events included cardiac death, heart failure, and acute coronary syndrome requiring hospitalization. The patients were followed for 24 months. Results The proactive and maintenance treatment groups had mean baseline hemoglobin levels of 9.34 and 9.32 g/dL, respectively. Mean hemoglobin levels during the observation period were 10.58 and 10.26 g/dL (P < 0.001), and mean durations of hemoglobin level > 10.5 g/dL were 11.5 and 8.6 months (P < 0.001), respectively. Cox proportional hazards analysis demonstrated a significantly lower risk of CV events in the proactive group (hazard ratio [HR], 0.43; 95% confidence interval [CI], 0.19–0.96). This lower risk was driven by lower incidence of hospitalization-required congestive heart failure. A longer duration of hemoglobin level > 10.5 g/dL was associated with a lower risk of CV events (HR, 0.92/month; 95% CI, 0.87–0.98). Conclusions Targeting hemoglobin levels of 11 g/dL with epoetin beta pegol reduces CV risk in Japanese HD patients with ESA hyporesponsiveness. Trial registration: University Hospital Medical Information Network (UMIN) database (UMIN000010138), registered on March 1, 2013.
DOI	https://doi.org/10.1186/s41100-022-00450-3