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Abstract: TH-OR026

Prognostic Evaluation by Different Target Hemoglobin Levels During Treatment with Epoetin Beta Pegol in Hemodialysis Patients with ESA Hyporesponsiveness: PARAMOUNT-HD Study

Session Information

Category: Anemia and Iron Metabolism

  • 202 Anemia and Iron Metabolism: Clinical

Authors

  • Tsuchiya, Ken, Tokyo Women's Medical University, Shinjuku-ku, Japan
  • Kuragano, Takahiro, Hyogo College of Medicine, Nishinomiya, Japan
  • Joki, Nobuhiko, TOHO University Ohashi Medical Center, Tokyo, Japan
  • Tsuruya, Kazuhiko, Nara Medical University, Kashihara, Japan
  • Honda, Hirokazu, Showa University Koto Toyosu Hospital, Tokyo, Japan
  • Hamano, Takayuki, Osaka University Graduate School of Medicine, Suita, OSAKA-FU, Japan
  • Fujii, Hideki, Kobe University Graduate School of Medicine, Kobe, Japan
  • Uemura, Yukari, Tokyo University Hospital, Tokyo, Japan
  • Ohashi, Yasuo, Chuo University, Tokyo, Japan
  • Nitta, Kosaku, Tokyo Women's Medical University, Shinjuku-ku, Japan
Background


The incidence of cardiovascular (CV) events is especially high in HD patients in association with hyporesponsive to erythropoiesis stimulating agents (ESAs). However, there is no recommended target ranges of hemoglobin for patients with ESA hyporesponsiveness.

Methods


We randomly assigned 304 HD, ESA-treated, patients with ESA hyporesponsiveness to a proactive treatment group (target hemoglobin [Hb] level; 11g/dL) and a maintenance treatment group (target Hb level; 9-10g/dL) by the use of epoetin beta pegol (CERA). The time from the date of study treatment initiation to the earliest CV event was evaluated as the primary endpoint. The CV events included cardiac death, heart failure requiring hospitalization, and acute coronary syndrome requiring hospitalization. The patients were followed for 24 months.

Results

The proactive and maintenance groups had a mean baseline Hb level of 9.34 and 9.32g/dL, respectively. Mean Hb levels during the observation period were 10.58 and 10.26g/dL (p=0.001) and mean length of Hb level of over 10.5g/dL were 11.5 and 8.6 months (p=0.0002), respectively. Median doses of CERA for 6 months after study treatment were 166.7 and 150.0μg/4 weeks (p=0.298). However, there was a significant difference in frequency CERA administration (once every 4 weeks: 10.9% and 26.4%; once every 2 weeks: 86.5% and 72.3% [p=0.0006], respectively). Kaplan-Meier analysis showed a significant difference in the primary endpoint between the two groups (9 and 18 events; log-rank test, p=0.033). Cox proportional hazards analysis showed a significant lower risk of CV events in the proactive group (Hazard ratio [HR], 0.429; 95% CI; 0.193-0.955). Also, the longer length of Hb level of over 10.5g/dL was associated with lower risk of CV events (HR, 0.919 per month; 95% CI; 0.865-0.977).

Conclusion


Our results suggest that targeting Hb level of 11g/dL with CERA reduces the incidence of CV events in HD patients with ESA hyporesponsiveness. Twice-monthly administration of CERA can maintain adequate Hb levels in these patients.

Funding

  • Commercial Support