Yoshitsugu Obi1, Satoshi Mikami2, Takayuki Hamano3, Yasue Obi4, Hirotaka Tanaka2, Akihiro Shimomura5, Hiromi Rakugi1, Toru Inoue2, Yoshitaka Isaka1. 1. Department of Geriatric Medicine and Nephrology, Osaka University Graduate School of Medicine, Osaka, Japan. 2. Department of Internal Medicine, Higashikouri Hospital, Osaka, Japan. 3. Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine, Osaka, Japan. Electronic address: hamatea@kid.med.osaka-u.ac.jp. 4. Obi Clinic, Osaka, Japan. 5. Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine, Osaka, Japan.
Abstract
OBJECTIVE:Vitamin B6 deficiency is common in hemodialysis patients and may contribute to anemia and abnormal bone metabolism in this population. DESIGN: 6-month, open-label, randomized controlled parallel-group study in hemodialysis centers. SUBJECTS:Fifty-six maintenance hemodialysis patients with relatively high resistance to erythropoiesis-stimulating agents (ESA). INTERVENTION: Intravenous vitamin B6 (60 mg of intravenous pyridoxal5'-phosphate after each thrice-weekly hemodialysis session). MAIN OUTCOME MEASURE: The primary and secondary outcomes were changes over time in ESA resistance index and bone turnover markers, respectively. RESULTS: 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) ×10-2 μg⋅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. CONCLUSIONS: 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.
RCT Entities:
OBJECTIVE:Vitamin B6 deficiency is common in hemodialysis patients and may contribute to anemia and abnormal bone metabolism in this population. DESIGN: 6-month, open-label, randomized controlled parallel-group study in hemodialysis centers. SUBJECTS: Fifty-six maintenance hemodialysis patients with relatively high resistance to erythropoiesis-stimulating agents (ESA). INTERVENTION: Intravenous vitamin B6 (60 mg of intravenous pyridoxal 5'-phosphate after each thrice-weekly hemodialysis session). MAIN OUTCOME MEASURE: The primary and secondary outcomes were changes over time in ESA resistance index and bone turnover markers, respectively. RESULTS: 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) ×10-2 μg ⋅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. CONCLUSIONS: 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: Sara Castro-Barquero; Marta Arias-Guillén; Sofia Pi-Oriol; Emilio Sacanella; Barbara Romano-Andrioni; Sandra Vidal-Lletjós; Ana María Ruiz-León; Ramon Estruch; Rosa Casas Journal: J Clin Med Date: 2022-03-16 Impact factor: 4.241