Cardiovascular events by different target hemoglobin levels in ESA-hyporesponsive hemodialysis patients: a multicenter, open-label, randomized controlled study
Abstract 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...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-12-01
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| Series: | Renal Replacement Therapy |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s41100-022-00450-3 |
| _version_ | 1811291932416016384 |
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| author | Kosaku Nitta Takahiro Kuragano Nobuhiko Joki Kazuhiko Tsuruya Hirokazu Honda Takayuki Hamano Hideki Fujii Yukari Uemura Ken Tsuchiya the PARAMOUNT-HD Study Investigators |
| author_facet | Kosaku Nitta Takahiro Kuragano Nobuhiko Joki Kazuhiko Tsuruya Hirokazu Honda Takayuki Hamano Hideki Fujii Yukari Uemura Ken Tsuchiya the PARAMOUNT-HD Study Investigators |
| author_sort | Kosaku Nitta |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-04-13T04:36:51Z |
| format | Article |
| id | doaj.art-4b385cddc3af4886925e7424d23c89ad |
| institution | Directory Open Access Journal |
| issn | 2059-1381 |
| language | English |
| last_indexed | 2024-04-13T04:36:51Z |
| publishDate | 2022-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Renal Replacement Therapy |
| spelling | doaj.art-4b385cddc3af4886925e7424d23c89ad2022-12-22T03:02:08ZengBMCRenal Replacement Therapy2059-13812022-12-018111010.1186/s41100-022-00450-3Cardiovascular events by different target hemoglobin levels in ESA-hyporesponsive hemodialysis patients: a multicenter, open-label, randomized controlled studyKosaku Nitta0Takahiro Kuragano1Nobuhiko Joki2Kazuhiko Tsuruya3Hirokazu Honda4Takayuki Hamano5Hideki Fujii6Yukari Uemura7Ken Tsuchiya8the PARAMOUNT-HD Study InvestigatorsDepartment of Nephrology, Tokyo Women’s Medical UniversityDivision of Kidney and Dialysis, Department of Internal Medicine, Hyogo College of MedicineDivision of Nephrology, Toho University Ohashi Medical CenterDepartment of Nephrology, Nara Medical UniversityDivision of Nephrology, Department of Medicine, Showa University School of MedicineDepartment of Nephrology, Nagoya City University Graduate School of Medical SciencesDivision of Nephrology and Kidney Center, Kobe University Graduate School of MedicineBiostatistics Section, Department of Data Science, Center for Clinical Sciences, National Center for Global Health and MedicineDepartment of Blood Purification, Tokyo Women’s Medical UniversityAbstract 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.https://doi.org/10.1186/s41100-022-00450-3ESA hyporesponsivenessCardiovascular eventsHemodialysisTarget hemoglobin |
| spellingShingle | Kosaku Nitta Takahiro Kuragano Nobuhiko Joki Kazuhiko Tsuruya Hirokazu Honda Takayuki Hamano Hideki Fujii Yukari Uemura Ken Tsuchiya the PARAMOUNT-HD Study Investigators Cardiovascular events by different target hemoglobin levels in ESA-hyporesponsive hemodialysis patients: a multicenter, open-label, randomized controlled study Renal Replacement Therapy ESA hyporesponsiveness Cardiovascular events Hemodialysis Target hemoglobin |
| title | Cardiovascular events by different target hemoglobin levels in ESA-hyporesponsive hemodialysis patients: a multicenter, open-label, randomized controlled study |
| title_full | Cardiovascular events by different target hemoglobin levels in ESA-hyporesponsive hemodialysis patients: a multicenter, open-label, randomized controlled study |
| title_fullStr | Cardiovascular events by different target hemoglobin levels in ESA-hyporesponsive hemodialysis patients: a multicenter, open-label, randomized controlled study |
| title_full_unstemmed | Cardiovascular events by different target hemoglobin levels in ESA-hyporesponsive hemodialysis patients: a multicenter, open-label, randomized controlled study |
| title_short | Cardiovascular events by different target hemoglobin levels in ESA-hyporesponsive hemodialysis patients: a multicenter, open-label, randomized controlled study |
| title_sort | cardiovascular events by different target hemoglobin levels in esa hyporesponsive hemodialysis patients a multicenter open label randomized controlled study |
| topic | ESA hyporesponsiveness Cardiovascular events Hemodialysis Target hemoglobin |
| url | https://doi.org/10.1186/s41100-022-00450-3 |
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