Efficacy and side-effect profile of sevelamer hydrochloride used in combination with conventional phosphate binders

Sturtevant, Joanna M., Hawley, Carmel M., Reiger, Kylie, Johnson, David W., Campbell, Scott B., Burke, John R., Bofinger, Andrew and Isbel, Nicole M. (2004) Efficacy and side-effect profile of sevelamer hydrochloride used in combination with conventional phosphate binders. Nephrology, 9 6: 406-413. doi:10.1111/j.1440-1797.2004.00338.x

Author Sturtevant, Joanna M.
Hawley, Carmel M.
Reiger, Kylie
Johnson, David W.
Campbell, Scott B.
Burke, John R.
Bofinger, Andrew
Isbel, Nicole M.
Title Efficacy and side-effect profile of sevelamer hydrochloride used in combination with conventional phosphate binders
Journal name Nephrology   Check publisher's open access policy
ISSN 1320-5358
Publication date 2004-12
Sub-type Article (original research)
DOI 10.1111/j.1440-1797.2004.00338.x
Volume 9
Issue 6
Start page 406
End page 413
Total pages 8
Editor D. C. H. Harris
Place of publication Carlton, Vic.
Publisher Blackwell Science
Collection year 2004
Language eng
Subject C1
730118 Organs, diseases and abnormal conditions not elsewhere classified
110312 Nephrology and Urology
Formatted abstract
Background: Poor phosphate control is common among patients with end-stage renal disease. Sevelamer hydrochloride has been demonstrated to be a safe and effective phosphate binder when used as a monotherapy. However, cost limits its usefulness in many countries. Data assessing its effectiveness and safety in combination with conventional phosphate binders are lacking.

: Dialysis patients meeting the following inclusion criteria participated in this study: (i) hyperphosphataemia >1.8 mmol/L (5.6 mg/dL); and (ii) an inability to tolerate currently available binders. The trial was conducted in three phases each lasting 3 months: (i) an observation phase (patients continued on their regular phosphate binders); (ii) a titration phase (sevelamer was added at a dose of 403 mg three times daily with meals, titrated to a maximum of 1209 mg three times daily); and (iii) a maintenance phase.

Results: Twenty-five patients were recruited into the study. Eighteen patients completed all three trial phases. Mean serum phosphate dropped from 2.11 ± 0.06 mmol/L (6.6 ± 0.2 mg/dL) during the observation period to 1.91 ± 0.01 mmol/L (5.9 ± 0.003 mg/dL) during the maintenance phase (P = 0.02). Calcium × phosphate product fell from 5.49 ± 0.17 mmol2/L2 (68.64 ± 2.11 mg2 dL2) to 4.89 ± 0.27 mmol2/L2 (61.36 ± 3.35 mg2 dL2) (P = 0.02). There was no significant change in serum calcium or parathyroid hormone. Total serum cholesterol fell from 3.8 mmol/L (3.4–4.37) 147 mg/dL (131–169) to 3.55 mmol/L (2.97–4.2) 137 mg/dL (115–162) (P = 0.02). Serum low-density lipoprotein cholesterol also fell significantly from 1.67 ± 0.10 mmol/L (65 ± 4 mg/dL) to 1.52 ± 0.11 mmol/L (59 ± 4 mg/dL) (P = 0.04). The average prescribed dose of sevelamer was 2.4 g/day. Elemental calcium dropped from 3.4 g/day (1.4 to 4.6) to 1.2 g/day (0.6–2.4) (P = 0.04). Seventy-two per cent of patients reported mild flatulence, nausea and indigestion. Three patients discontinued treatment because of adverse effects.

Conclusions: Sevelamer in combination with conventional phosphate binders is effective in lowering serum phosphate and calcium-phosphate product in patients with refractory hyperphosphataemia. Beneficial effects on lipid profile were also observed. Mild gastrointestinal upset is common.
Keyword Urology & Nephrology
Calcium X Phosphate Product
Parathyroid Hormone
Sevelamer Hydrochloride
Decreases Bicarbonate Levels
Dialysis Patients
Serum Phosphorus
Q-Index Code C1

Document type: Journal Article
Sub-type: Article (original research)
Collections: Excellence in Research Australia (ERA) - Collection
2005 Higher Education Research Data Collection
School of Medicine Publications
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Citation counts: TR Web of Science Citation Count  Cited 10 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 12 times in Scopus Article | Citations
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Created: Wed, 15 Aug 2007, 03:53:05 EST