#4471 CHARACTERISTICS OF PATIENTS WITH CKD WHO USE HYPOXIA-INDUCIBLE FACTOR PROLYL HYDROXYLASE INHIBITORS: A JAPAN MEDICAL DATA CENTER DATABASE STUDY
Authors: Pham Timothy , Mu George , Hunnicutt Jake , Ma Liyuan 
Published: June 2023

Abstract

Background and Aims
Anemia is common among patients with chronic kidney disease (CKD) and is reported to be associated with increased cardiovascular disease and all-cause mortality, as well as reduced quality of life. The incidence of anemia increases as kidney function declines and affects approximately 32% of Japanese patients with stage 3–5 CKD [1]. Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) have been approved in the Japan since Sept 2019 for patients with anemia of chronic kidney disease. Available HIF-PHIs include roxadustat (approved Sept 2019), daprodustat (approved June 2020), vadadustat (approved June 2020), enarodustat (approved Sept 2020) and molidustat (approved Jan 2021). This analysis aims to provide a real-world account of patient characteristics of those initiating HIF-PHIs since the approval of HIF-PHIs in Japan, overall and by individual treatments.

Method
This retrospective cohort study leveraged data from the Japan Medical Data Center (JMDC) database from Nov 2018 – May 2022 and included patients over 18 years of age with documented CKD who initiated any HIF-PHI from Nov 2019 – Nov 2021. JMDC is a health insurance database aggregating administrative claims data, medical examination data, and ledger information of patients who are on employer-based insurance and &lt;75 years of age. The study index date was defined as the first observed claim for any HIF-PHI during the identification period. Patients were required to have baseline period of 1 year prior to the index date and a minimum of six months of follow-up after the index date, with continuous insurance enrollment. This study assessed patient demographics, clinical characteristics, and previous anemia of CKD treatment in the baseline period.

Results
Overall, 500 patients initiated HIF-PHIs, with 47.8% (n = 239) patients initiating daprodustat, 40.8% (n = 204) patients initiating roxadustat, and 11.4% (n = 57) patients initiating other HIF-PHIs. Table 1 illustrates the patient demographic characteristics overall and by index HIF-PHI. Overall, 60.2% (n = 301) of patients were male; the mean age was 55.7 years (SD = 10.8). More than a third (37.2%) of overall patients received dialysis in the baseline period. Within the 184 patients on specified types of dialysis, 67.9% (n = 125) had received hemodialysis and 32.1% (n = 59) had received peritoneal dialysis. In terms of prior anemia of CKD treatments, 61.8% (n = 309) of patients had any rhEPO use in the baseline period. Further break down is in Table 2. Nearly a third (31.6%, n = 158) of patients received any iron treatment in the baseline period, with 19.2% (n = 96) receiving oral iron and 13.8% (n = 69) receiving injectable iron. At baseline, almost all of patients initiating on HIF-PHIs had baseline comorbidities of hypertension (95.8%; n = 479) and diabetes (77.0%; n = 385).

Conclusion
Evaluating a real-world database for patients initiating HIF-PHIs within Japan allows for a more comprehensive picture of patient clinical and demographic characteristics. Our analysis found most patients initiating on HIF-PHIs were male, had previous rhEPO use, and had history of hypertension and diabetes. Understanding patient profiles in a real-world setting may guide treatment decisions in clinical practice.