A randomized, crossover design study of sevelamer carbonate powder and sevelamer hydrochloride tablets in chronic kidney disease patients on haemodialysis
| Autor: | Calum N. Ross, Sandip Mitra, Jeremy Heaton, Melissa Plone, Stanley Fan, Philip A. Kalra, Nick Pritchard, John Hunter |
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| Rok vydání: | 2009 |
| Předmět: |
Adult
Male medicine.medical_specialty medicine.drug_class medicine.medical_treatment Bicarbonate Urology phosphate binder Sevelamer sevelamer carbonate chemistry.chemical_compound Renal Dialysis Polyamines Humans Medicine Prospective Studies Dialysis Aged Chelating Agents Aged 80 and over Transplantation Cross-Over Studies business.industry clinical trial Middle Aged medicine.disease Crossover study Surgery Phosphate binder haemodialysis patients chemistry Nephrology powder formulation Chronic Disease Carbonate Female Kidney Diseases Hemodialysis Powders business Tablets medicine.drug Kidney disease |
| Zdroj: | Nephrology Dialysis Transplantation |
| ISSN: | 1460-2385 0931-0509 |
| DOI: | 10.1093/ndt/gfp372 |
| Popis: | Background Sevelamer carbonate is an improved, buffered form of sevelamer hydrochloride developed for the treatment of hyperphosphataemia in CKD patients. Sevelamer carbonate formulated as a powder for oral suspension presents a novel, patient-friendly alternative to tablet phosphate binders. This study compared the safety and efficacy of sevelamer carbonate powder with sevelamer hydrochloride tablets in CKD patients on haemodialysis. Methods This was a multi-centre, open-label, randomized, crossover design study. Thirty-one haemodialysis patients were randomly assigned to either sevelamer carbonate powder or sevelamer hydrochloride tablets for 4 weeks followed by a crossover to the other regimen for an additional 4 weeks. Results The mean serum phosphorus was 1.6 +/- 0.5 mmol/L (5.0 +/- 1.5 mg/dL) during sevelamer carbonate powder treatment and 1.7 +/- 0.4 mmol/L (5.2 +/- 1.1 mg/dL) during sevelamer hydrochloride tablet treatment. Sevelamer carbonate powder and sevelamer hydrochloride tablets are equivalent in controlling serum phosphorus; the geometric least square mean ratio was 0.95 (90% CI 0.87-1.03). No statistically significant or clinically meaningful differences were observed in calcium x phosphorus product and lipid levels between sevelamer carbonate powder and sevelamer hydrochloride tablets. Serum bicarbonate levels increased 2.7 +/- 3.7 mmol/L (2.7 +/- 3.7 mEq/L) during sevelamer carbonate treatment. No statistically significant change in bicarbonate was observed during sevelamer hydrochloride treatment. Sevelamer carbonate powder and sevelamer hydrochloride were well tolerated during this study. Conclusions Sevelamer carbonate powder and sevelamer hydrochloride tablets are equivalent in controlling serum phosphorus and well tolerated in CKD patients on haemodialysis. Bicarbonate levels improved only during sevelamer carbonate treatment. Sevelamer carbonate powder should provide a welcomed new option for the treatment of hyperphosphataemia for CKD patients on dialysis. |
| Databáze: | OpenAIRE |
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