Initial responsiveness to darbepoetin alfa and its contributing factors in non-dialysis chronic kidney disease patients in Japan View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2020-09-19

AUTHORS

Terumasa Hayashi, Hideki Kato, Kenichiro Tanabe, Masaomi Nangaku, Hideki Hirakata, Takashi Wada, Hiroshi Sato, Yasushi Yamazaki, Takao Masaki, Tatsuo Kagimura, Hiroyasu Yamamoto, Hiroki Hase, Masahiro Kamouchi, Enyu Imai, Kyoichi Mizuno, Manabu Iwasaki, Tadao Akizawa, Yoshiharu Tsubakihara, Shoichi Maruyama, Ichiei Narita

ABSTRACT

BackgroundHyporesponsiveness to erythropoiesis-stimulating agents (ESAs) is associated with cardiovascular events and poor renal outcome in patients with chronic kidney disease (CKD). This study aimed to investigate the initial responsiveness to darbepoetin alfa (DA) and its contributing factors using the data from the BRIGHTEN.MethodsOf 1980 patients enrolled at 168 facilities, 1695 were included in this analysis [285 patients were excluded mainly due to lack of hemoglobin (Hb) values]. The initial ESA response index (iEResI) was defined as a ratio of Hb changes over 12 weeks after DA administration per weight-adjusted total DA dose and contributing factors to iEResI were analyzed.ResultsThe mean age was 70 ± 12 years (male 58.8%; diabetic nephropathy 27.6%). The median creatinine and mean Hb levels at DA initiation were 2.62 mg/dL and 9.8 g/dL, respectively. The most frequent number of DA administration during 12 weeks was 3 times (41.1%), followed by 4 (15.6%) times with a wide distribution of the total DA dose (15–900 μg). Remarkably, 225 patients (13.3%) did not respond to DA. Multivariate analysis showed that male gender, hypoglycemic agent use, iron supplementation, high eGFR, low Hb, low CRP, low NT-proBNP, and low urinary protein–creatinine ratio were independently associated with better initial response to DA (P = < 0.0001, 0.0108, < 0.0001, 0.0476, < 0.0001, 0.0004, 0.0435, and 0.0009, respectively).ConclusionsNon-responder to DA accounted for 13.3% of patients with non-dialysis CKD. Iron supplementation, low CRP, low NT-proBNP, and less proteinuria were predictive and modifiable factors associated with better initial response to DA. More... »

PAGES

110-119

Journal

TITLE

Clinical and Experimental Nephrology

ISSUE

2

VOLUME

25

Author Affiliations

  • Department of Kidney Disease and Hypertension, Osaka General Medical Center, Osaka, Japan
  • Division of Nephrology and Endocrinology, The University of Tokyo Graduate School of Medicine, Tokyo, Japan
  • Translational Research Center for Medical Innovation, Kobe, Japan
  • Fukuoka Renal Clinic, Fukuoka, Japan
  • Department of Nephrology and Laboratory Medicine, Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa, Japan
  • Division of Clinical Pharmacology and Therapeutics, Tohoku University Graduate School of Pharmaceutical Sciences and Faculty of Pharmaceutical Sciences, Sendai, Japan
  • Department of Nephrology and Rheumatology, Kagawa Prefectural Central Hospital, Takamatsu, Japan
  • Department of Nephrology, Hiroshima University Hospital, Hiroshima, Japan
  • Division of Nephrology and Hypertension, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan
  • Division of Nephrology, Toho University Ohashi Medical Center, Tokyo, Japan
  • Department of Health Care Administration and Management, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
  • Nakayamadera Imai Clinic, Takarazuka, Japan
  • Mitsukoshi Health and Welfare Foundation, Tokyo, Japan
  • School of Data Science, Yokohama City University, Yokohama, Japan
  • Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan
  • Course of Safety Management in Health Care Sciences, Graduate School of Health Care Sciences, Jikei Institute, Osaka, Japan
  • Department of Nephrology, Nagoya University Graduate School of Medicine, Nagoya, Japan
  • Division of Clinical Nephrology and Rheumatology, Niigata University Graduate School of Medical and Dental Sciences, 757 Ichibancho Asahimachidori Chuo-ku, 951-8510, Niigata, Japan
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s10157-020-01969-7

    DOI

    http://dx.doi.org/10.1007/s10157-020-01969-7

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1130966119

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/32949295


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        "description": "BackgroundHyporesponsiveness to erythropoiesis-stimulating agents (ESAs) is associated with cardiovascular events and poor renal outcome in patients with chronic kidney disease (CKD). This study aimed to investigate the initial responsiveness to darbepoetin alfa (DA) and its contributing factors using the data from the BRIGHTEN.MethodsOf 1980 patients enrolled at 168 facilities, 1695 were included in this analysis [285 patients were excluded mainly due to lack of hemoglobin (Hb) values]. The initial ESA response index (iEResI) was defined as a ratio of Hb changes over 12\u00a0weeks after DA administration per weight-adjusted total DA dose and contributing factors to iEResI were analyzed.ResultsThe mean age was 70\u2009\u00b1\u200912\u00a0years (male 58.8%; diabetic nephropathy 27.6%). The median creatinine and mean Hb levels at DA initiation were 2.62\u00a0mg/dL and 9.8\u00a0g/dL, respectively. The most frequent number of DA administration during 12\u00a0weeks was 3 times (41.1%), followed by 4 (15.6%) times with a wide distribution of the total DA dose (15\u2013900\u00a0\u03bcg). Remarkably, 225 patients (13.3%) did not respond to DA. Multivariate analysis showed that male gender, hypoglycemic agent use, iron supplementation, high eGFR, low Hb, low CRP, low NT-proBNP, and low urinary protein\u2013creatinine ratio were independently associated with better initial response to DA (P\u2009=\u2009\u2009<\u20090.0001, 0.0108,\u2009<\u20090.0001, 0.0476,\u2009<\u20090.0001, 0.0004, 0.0435, and 0.0009, respectively).ConclusionsNon-responder to DA accounted for 13.3% of patients with non-dialysis CKD. Iron supplementation, low CRP, low NT-proBNP, and less proteinuria were predictive and modifiable factors associated with better initial response to DA.", 
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