Sevelamer carbonate lowers serum phosphorus effectively in haemodialysis patients: a randomized, double-blind, placebo-controlled, dose-titration study
| Autor: | Zhaohui Ni, Gengru Jiang, Xiaoqiang Ding, Fan Fan Hou, Bi-Cheng Liu, Xuequing Yu, Xuemei Li, Li Zuo, Yan La, Jianghua Chen, Ping Fu, John Hunter, Li Wang, Changying Xing, Nan Chen, Xiongfei Wu, John Neylan, Chaoxing Huang, Maureen Dillon, Jun-zhou Fu, Melissa Plone, Changlin Mei |
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| Rok vydání: | 2013 |
| Předmět: |
Adult
Male medicine.medical_specialty medicine.drug_class medicine.medical_treatment Urology Sevelamer Placebo Phosphates Hyperphosphatemia Young Adult Double-Blind Method Renal Dialysis Internal medicine medicine Polyamines Humans Adverse effect Dialysis Aged Chelating Agents Transplantation business.industry Phosphorus Cholesterol LDL Middle Aged medicine.disease Phosphate binder Endocrinology Nephrology Kidney Failure Chronic Female Hemodialysis business medicine.drug Kidney disease |
| Zdroj: | Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association. 29(1) |
| ISSN: | 1460-2385 |
| Popis: | BACKGROUND Hyperphosphataemia in patients with advanced chronic kidney disease (CKD) is associated with adverse outcomes, including vascular calcification and higher mortality rates. While phosphate lowering is an integral aspect of CKD management, the efficacy and safety of phosphate binders in a contemporary cohort of Chinese haemodialysis patients (who have different genetics and dietary patterns than other populations) has not been previously described. Moreover, sparse data are available on strategies for optimal dose titration when transitioning from a calcium-based to a polymer-based phosphate binder. METHODS This randomized, double-blind, dose-titration study compared sevelamer carbonate (starting dose 800 mg three times daily) with placebo over 8 weeks' duration in Chinese CKD patients on haemodialysis. Patients were required to be using calcium-based binders prior to study start. RESULTS In all, 205 patients were randomized (sevelamer, n = 135; placebo, n = 70); mean age was 48.6 years, 61% were male and the mean time on dialysis was 4.4 years. The mean serum phosphorus decreased significantly in patients treated with sevelamer carbonate [change -0.69 ± 0.64 mmol/L (-2.14 ± 1.98 mg/dL)] but remained persistently elevated with placebo [change -0.06 ± 0.57 mmol/L (-0.19 ± 1.76 mg/dL)] (P < 0.0001). When compared with placebo, sevelamer carbonate treatment resulted in statistically significant greater mean reductions from baseline in serum total (-17.1 versus -3.3%) and low-density lipoprotein cholesterol (-33.5 versus-7.6%) (P < 0.0001 for both). Sevelamer carbonate was well tolerated with 96% adherence compared with 97% adherence in the placebo arm. Overall, adverse events experienced by patients in the sevelamer carbonate and placebo treatment groups were similar and consistent with their underlying renal disease. CONCLUSIONS This study demonstrated that hyperphosphataemia developed quickly following the cessation of phosphate binders and remained persistently elevated in end-stage CKD in the placebo-treated group. Gradually titrating up sevelamer carbonate from an initial dose of 2.4 g/day to an average daily dose of 7.1 ± 2.5 g/day was well tolerated, safe and efficacious in contemporary Chinese haemodialysis patients. |
| Databáze: | OpenAIRE |
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