NDT Advance Access originally published online on September 27, 2008
Nephrology Dialysis Transplantation 2009 24(1):278-285; doi:10.1093/ndt/gfn488
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Efficacy and safety of sevelamer hydrochloride and calcium acetate in patients on peritoneal dialysis
1 Division of Nephrology, Department of Medicine, University Hospital Gasthuisberg, Leuven, Belgium 2 Servicio de Nefrologia, Hospital Universitario La Paz, REDinREN Carlos III-RED 16/06, Madrid, Spain 3 Nefrologia 2 con Dialisi e Trapianto, Ospedale Civico e Benfratelli, Palermo, Italy 4 Queen Elizabeth Hospital, Birmingham, UK 5 Department of Nephrology, Copenhagen University Hospital at Herlev, Herlev, Denmark 6 Servicio de Nefrologia Unidad de Diálisis, Fundacion Jiménez Diaz, REDinREN Carlos III-RED 16/06, Madrid, Spain 7 Genzyme Research Europe, Cambridge, UK 8 Biostatistics, Genzyme Corporation, Cambridge, MA, USA 9 The Royal London Hospital, London, UK
Pieter Evenepoel, Department of Medicine, Division of Nephrology, University Hospital Gasthuisberg, Leuven, Belgium. Tel: +32-16-34-45-80; Fax: +32-16-34-45-99; E-mail: pieter.evenepoel{at}uz.kuleuven.ac.be
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Abstract |
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Background. Inadequate phosphorus control is associated with increased morbidity and mortality in patients with CKD stage 5. Although phosphate binders are often used in patients on peritoneal dialysis (PD), no large randomized controlled studies evaluating their use solely in this population have previously been reported.
Methods. In this multicentre, open-label study, adult patients on PD with serum phosphorus >5.5 mg/dl were randomized (2:1) to 12 weeks of treatment with sevelamer hydrochloride or calcium acetate. Doses were titrated to achieve serum phosphorus of 3.0–5.5 mg/dl. Changes in serum phosphorus, calcium, intact parathyroid hormone (iPTH), lipids and plasma biomarkers were assessed.
Results. A total of 253 patients were screened, 143 of whom were randomized (sevelamer hydrochloride, n = 97; calcium acetate, n = 46). Treatment groups were well balanced with regard to baseline demographics. Serum phosphorus levels were significantly reduced after 12 weeks with both sevelamer hydrochloride and calcium acetate (P < 0.001). Serum PTH was also reduced in both groups while serum calcium increased in the calcium acetate group (P = 0.001) but not in the sevelamer hydrochloride group. Sevelamer hydrochloride was also associated with decreases in total cholesterol, low-density lipoprotein cholesterol and uric acid and an increase in bone-specific alkaline phosphatase (all P < 0.001 versus baseline). Both treatments were well tolerated and safety profiles were consistent with previous reports in haemodialysis patients. Hypercalcaemia was experienced by more calcium acetate-treated patients (18 versus 2%; P = 0.001).
Conclusions. In summary, sevelamer hydrochloride provides a reduction in serum phosphorus compared to that obtained with calcium-based binders in PD patients. The effects of sevelamer hydrochloride appear similar in both PD and haemodialysis populations.
Keywords: hyperphosphataemia; peritoneal dialysis; phosphate binders; sevelamer hydrochloride
Received for publication: 20.12.07
Accepted in revised form: 5. 8.08