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Efficacy and side-effect profile of sevelamer hydrochloride used in combination with conventional phosphate binders.
Nephrology (Carlton). 2004 Dec; 9(6):406-13.N

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.

METHODS

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 x 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.

Authors+Show Affiliations

Department of Nephrology, Princess Alexandra Hospital, Brisbane, Queensland, Australia. jo_sturtevant@health.qld.gov.auNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

15663645

Citation

Sturtevant, Joanna M., et al. "Efficacy and Side-effect Profile of Sevelamer Hydrochloride Used in Combination With Conventional Phosphate Binders." Nephrology (Carlton, Vic.), vol. 9, no. 6, 2004, pp. 406-13.
Sturtevant JM, Hawley CM, Reiger K, et al. Efficacy and side-effect profile of sevelamer hydrochloride used in combination with conventional phosphate binders. Nephrology (Carlton). 2004;9(6):406-13.
Sturtevant, J. M., Hawley, C. M., Reiger, K., Johnson, D. W., Campbell, S. B., Burke, J. R., Bofinger, A., & Isbel, N. M. (2004). Efficacy and side-effect profile of sevelamer hydrochloride used in combination with conventional phosphate binders. Nephrology (Carlton, Vic.), 9(6), 406-13.
Sturtevant JM, et al. Efficacy and Side-effect Profile of Sevelamer Hydrochloride Used in Combination With Conventional Phosphate Binders. Nephrology (Carlton). 2004;9(6):406-13. PubMed PMID: 15663645.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and side-effect profile of sevelamer hydrochloride used in combination with conventional phosphate binders. AU - Sturtevant,Joanna M, AU - Hawley,Carmel M, AU - Reiger,Kylie, AU - Johnson,David W, AU - Campbell,Scott B, AU - Burke,John R, AU - Bofinger,Andrew, AU - Isbel,Nicole M, PY - 2005/1/25/pubmed PY - 2005/4/9/medline PY - 2005/1/25/entrez SP - 406 EP - 13 JF - Nephrology (Carlton, Vic.) JO - Nephrology (Carlton) VL - 9 IS - 6 N2 - 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. METHODS: 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 x 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. SN - 1320-5358 UR - https://www.unboundmedicine.com/medline/citation/15663645/Efficacy_and_side_effect_profile_of_sevelamer_hydrochloride_used_in_combination_with_conventional_phosphate_binders_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=1320-5358&date=2004&volume=9&issue=6&spage=406 DB - PRIME DP - Unbound Medicine ER -