S M Sprague1, E A Ross, S D Nath, P Zhang, R D Pratt, R Krause. 1. NorthShore University HealthSystem, Northwestern University Feinberg School of Medicine, Evanston, IL 60201, USA. stuartmsprague@gmail.com
Abstract
AIMS: The aim of this crossover study was to compare the reduction of serum phosphorus (SP) with fixed doses of the non-calcium-containing phosphate binderslanthanum carbonate (LC) and sevelamer hydrochloride (SH) in hemodialysis patients. METHODS: Following washout (2 - 3 weeks), 182 patients withSP >or= 6.0 mg/dl and calcium >or= 8.4 mg/dl were randomized (1:1) to receive LC (2,250 to 3,000 mg/day) or SH (4,800 to 6,400 mg/day) for 4 weeks. Patients underwent a second washout (2 weeks) and switched to the alternative binder for 4 weeks. RESULTS: At the end of treatment, LC had reduced SP by 1.7 +/- 0.1 mg/dl, compared with 1.4 +/- 0.1 mg/dl for SH; the difference was not statistically significant in the primary analysis (LOCF, p = 0.133). However, the reduction with LC was significantly greater than with SH in a prespecified key secondary analysis of patients who completed 4 weeks of treatment with each binder (0.5 mg/dl difference, p = 0.007). The reduction of SP was also greater with LC than SH after 1 week of treatment (p = 0.024). CONCLUSIONS: Although the primary analysis found no difference between LC and SH in the reduction of SP, a significant difference in favor of LC was observed in patients who completed treatment. The results of this study show interesting trends with respect to onset and duration of action that warrant further investigation in longer-term studies.
RCT Entities:
AIMS: The aim of this crossover study was to compare the reduction of serum phosphorus (SP) with fixed doses of the non-calcium-containing phosphate binders lanthanum carbonate (LC) and sevelamer hydrochloride (SH) in hemodialysis patients. METHODS: Following washout (2 - 3 weeks), 182 patients with SP >or= 6.0 mg/dl and calcium >or= 8.4 mg/dl were randomized (1:1) to receive LC (2,250 to 3,000 mg/day) or SH (4,800 to 6,400 mg/day) for 4 weeks. Patients underwent a second washout (2 weeks) and switched to the alternative binder for 4 weeks. RESULTS: At the end of treatment, LC had reduced SP by 1.7 +/- 0.1 mg/dl, compared with 1.4 +/- 0.1 mg/dl for SH; the difference was not statistically significant in the primary analysis (LOCF, p = 0.133). However, the reduction with LC was significantly greater than with SH in a prespecified key secondary analysis of patients who completed 4 weeks of treatment with each binder (0.5 mg/dl difference, p = 0.007). The reduction of SP was also greater with LC than SH after 1 week of treatment (p = 0.024). CONCLUSIONS: Although the primary analysis found no difference between LC and SH in the reduction of SP, a significant difference in favor of LC was observed in patients who completed treatment. The results of this study show interesting trends with respect to onset and duration of action that warrant further investigation in longer-term studies.
Authors: Geoffrey A Block; David P Rosenbaum; Maria Leonsson-Zachrisson; Magnus Åstrand; Susanne Johansson; Mikael Knutsson; Anna Maria Langkilde; Glenn M Chertow Journal: J Am Soc Nephrol Date: 2017-02-03 Impact factor: 10.121
Authors: Alastair Hutchison; Andrew Whelton; Ravi Thadhani; Heinrich Achenbach; Andrea Vergani; Jingyang Wu; Gillian Hall Journal: Nephron Date: 2018-10-23 Impact factor: 2.847