title: Intravenous Vitamin B6 Increases Resistance to Erythropoiesis-Stimulating Agents in Hemodialysis Patients: A Randomized Controlled Trial.
abstract: Vitamin B6 deficiency is common in hemodialysis patients and may contribute to anemia and abnormal bone metabolism in this population.
  
  
  
  6-month, open-label, randomized controlled parallel-group study in hemodialysis centers.
  
  
  
  Fifty-six maintenance hemodialysis patients with relatively high resistance to erythropoiesis-stimulating agents (ESA).
  
  
  
  Intravenous vitamin B6 (60 mg of intravenous pyridoxal 5'-phosphate after each thrice-weekly hemodialysis session).
  
  
  
  The primary and secondary outcomes were changes over time in ESA resistance index and bone turnover markers, respectively.
  
  
  
  The prevalence of vitamin B6 deficiency was 40% overall. Compared with the control group, the B6 group showed an upward change in ESA resistance index over time (Pinteraction= .038). At week 13 (a priori-defined time point), pyridoxal 5'-phosphate administration was associated with higher ESA resistance index by 0.97 (95% confidence interval, 0.02-1.92) ×10-2μg ⋅darbepoetin-α/kg per g/dL⋅hemoglobin after baseline adjustment, which was not modified by baseline vitamin B6 status. There was a trend toward increase in serum erythropoietin concentrations in the B6 group after adjustment for baseline values, hemoglobin, and weekly ESA dose (Pinteraction= .06). The downward changes of bone-specific alkaline phosphatase and tartrate-resistant acid phosphatase 5b in the B6 group relative to the control group were pronounced in patients without vitamin B6 deficiency (Pinteraction< .001 and .017, respectively), despite nonsignificant between-group difference in 1-84 parathyroid hormone.
  
  
  
  Thrice-weekly intravenous vitamin B6 (60 mg pyridoxal 5'-phosphate hydrate) worsens the response to ESA and may blunt the response of bone to parathyroid hormone in hemodialysis patients.
authors.affiliation: Department of Geriatric Medicine and Nephrology, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Yoshitsugu
authors.initials: Y
authors.lastname: Obi
authors.affiliation: Department of Internal Medicine, Higashikouri Hospital, Osaka, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Mikami
authors.affiliation: Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine, Osaka, Japan. Electronic address: hamatea@kid.med.osaka-u.ac.jp.
authors.forename: Takayuki
authors.initials: T
authors.lastname: Hamano
authors.affiliation: Obi Clinic, Osaka, Japan.
authors.forename: Yasue
authors.initials: Y
authors.lastname: Obi
authors.affiliation: Department of Internal Medicine, Higashikouri Hospital, Osaka, Japan.
authors.forename: Hirotaka
authors.initials: H
authors.lastname: Tanaka
authors.affiliation: Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Shimomura
authors.affiliation: Department of Geriatric Medicine and Nephrology, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Hiromi
authors.initials: H
authors.lastname: Rakugi
authors.affiliation: Department of Internal Medicine, Higashikouri Hospital, Osaka, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Inoue
authors.affiliation: Department of Geriatric Medicine and Nephrology, Osaka University Graduate School of Medicine, Osaka, Japan.
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Isaka
mesh_terms: D000740:Anemia; D001842:Bone and Bones / Q000378:metabolism; D004920:Erythropoiesis / Q000187:drug effects*; D006397:Hematinics / Q000627:therapeutic use*; D006801:Humans; D010281:Parathyroid Hormone / Q000502:physiology; D006435:Renal Dialysis; D025101:Vitamin B 6 / Q000627:therapeutic use*
chemical_list: D006397:Hematinics; D010281:Parathyroid Hormone; D025101:Vitamin B 6