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Sevelamer reduces calcium load and maintains a low calcium-phosphorus ion product in dialysis patients.
J Nephrol. 2001 May-Jun; 14(3):176-83.JN

Abstract

BACKGROUND

Sevelamer HCl, a non-aluminum, non-calcium containing hydrogel, has proved an effective phosphate binder in North American hemodialysis patients. This single-center, open-label, dose titration study assessed the efficacy of sevelamer in a cohort of European hemodialysis patients with different dietary habits, in particular with lower phosphate intake. The aim of the study was to obtain a calcium x phosphate product lower than 60 mg2/dL2 in all patients.

METHODS

Administration of calcium- or aluminum-based phosphate binders was discontinued during a two-week washout period. Nineteen patients whose serum phosphate level at the end of washout was greater than 5.5 mg/dL (1.78 mmol/L) qualified to receive sevelamer for six weeks. Based on the degree of hyperphosphatemia during washout, patients were started on 403 mg sevelamer capsules with a dose schedule different from previous studies. Only one capsule was administered at breakfast, and the rest of the phosphate binder was divided equally at the two main meals. Sevelamer could be increased by two capsules per day every two weeks, if necessary. A second two-week washout period followed.

RESULTS

Mean serum phosphorus rose from a baseline of 5.3 +/- 1.0 to 7.4 +/- 1.4 mg/dL at the end of washout, then declined to 5.4 +/- 0.8 mg/dL (p < 0.001) by the end of the six-week treatment period and rebounded significantly to 7.1 +/- 1.1 mg/dL after the second two-week washout. Calcium x phosphate product showed a similar pattern, decreasing significantly from 64.1 +/- 14.1 to 46.9 +/- 7.4 mg2/dL2 (p < 0.001) after six weeks of sevelamer. A level of less than 50 mg2/dL2 was reached by 68% of patients, and 95% had less than 60 mg2/dL2. The mean dose of sevelamer at the end of treatment was 3.1 +/- 0.6 g per day. As expected, calcium declined from 9.2 +/- 0.5 to 8.7 mg/dL (p < 0.01) during the initial washout after stopping calcium-based phosphate binders, but remained stable thereafter. Ionized calcium did not change significantly throughout the washout and sevelamer treatment. However, interruption of calcium salts led to a 81% reduction of total calcium intake.

CONCLUSIONS

We confirmed in an European sample of hemodialysis patients that sevelamer can reduce phosphate levels without inducing hypercalcemia. The drug can also be successfully used to reduce mean calcium x phosphate levels below 50 mg2/dL2, closer to normal values. Although similar results can be obtained with other phosphate binders, a concomitant accumulation of aluminum, calcium or magnesium could be detrimental to patients.

Authors+Show Affiliations

Renal Unit, San Paolo Hospital, Milan, Italy. nefro@hspsanpaolo.mi.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

11439741

Citation

Gallieni, M, et al. "Sevelamer Reduces Calcium Load and Maintains a Low Calcium-phosphorus Ion Product in Dialysis Patients." Journal of Nephrology, vol. 14, no. 3, 2001, pp. 176-83.
Gallieni M, Cozzolino M, Carpani P, et al. Sevelamer reduces calcium load and maintains a low calcium-phosphorus ion product in dialysis patients. J Nephrol. 2001;14(3):176-83.
Gallieni, M., Cozzolino, M., Carpani, P., Zoni, U., & Brancaccio, D. (2001). Sevelamer reduces calcium load and maintains a low calcium-phosphorus ion product in dialysis patients. Journal of Nephrology, 14(3), 176-83.
Gallieni M, et al. Sevelamer Reduces Calcium Load and Maintains a Low Calcium-phosphorus Ion Product in Dialysis Patients. J Nephrol. 2001 May-Jun;14(3):176-83. PubMed PMID: 11439741.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sevelamer reduces calcium load and maintains a low calcium-phosphorus ion product in dialysis patients. AU - Gallieni,M, AU - Cozzolino,M, AU - Carpani,P, AU - Zoni,U, AU - Brancaccio,D, PY - 2001/7/7/pubmed PY - 2002/6/12/medline PY - 2001/7/7/entrez SP - 176 EP - 83 JF - Journal of nephrology JO - J Nephrol VL - 14 IS - 3 N2 - BACKGROUND: Sevelamer HCl, a non-aluminum, non-calcium containing hydrogel, has proved an effective phosphate binder in North American hemodialysis patients. This single-center, open-label, dose titration study assessed the efficacy of sevelamer in a cohort of European hemodialysis patients with different dietary habits, in particular with lower phosphate intake. The aim of the study was to obtain a calcium x phosphate product lower than 60 mg2/dL2 in all patients. METHODS: Administration of calcium- or aluminum-based phosphate binders was discontinued during a two-week washout period. Nineteen patients whose serum phosphate level at the end of washout was greater than 5.5 mg/dL (1.78 mmol/L) qualified to receive sevelamer for six weeks. Based on the degree of hyperphosphatemia during washout, patients were started on 403 mg sevelamer capsules with a dose schedule different from previous studies. Only one capsule was administered at breakfast, and the rest of the phosphate binder was divided equally at the two main meals. Sevelamer could be increased by two capsules per day every two weeks, if necessary. A second two-week washout period followed. RESULTS: Mean serum phosphorus rose from a baseline of 5.3 +/- 1.0 to 7.4 +/- 1.4 mg/dL at the end of washout, then declined to 5.4 +/- 0.8 mg/dL (p < 0.001) by the end of the six-week treatment period and rebounded significantly to 7.1 +/- 1.1 mg/dL after the second two-week washout. Calcium x phosphate product showed a similar pattern, decreasing significantly from 64.1 +/- 14.1 to 46.9 +/- 7.4 mg2/dL2 (p < 0.001) after six weeks of sevelamer. A level of less than 50 mg2/dL2 was reached by 68% of patients, and 95% had less than 60 mg2/dL2. The mean dose of sevelamer at the end of treatment was 3.1 +/- 0.6 g per day. As expected, calcium declined from 9.2 +/- 0.5 to 8.7 mg/dL (p < 0.01) during the initial washout after stopping calcium-based phosphate binders, but remained stable thereafter. Ionized calcium did not change significantly throughout the washout and sevelamer treatment. However, interruption of calcium salts led to a 81% reduction of total calcium intake. CONCLUSIONS: We confirmed in an European sample of hemodialysis patients that sevelamer can reduce phosphate levels without inducing hypercalcemia. The drug can also be successfully used to reduce mean calcium x phosphate levels below 50 mg2/dL2, closer to normal values. Although similar results can be obtained with other phosphate binders, a concomitant accumulation of aluminum, calcium or magnesium could be detrimental to patients. SN - 1121-8428 UR - https://www.unboundmedicine.com/medline/citation/11439741/Sevelamer_reduces_calcium_load_and_maintains_a_low_calcium_phosphorus_ion_product_in_dialysis_patients_ L2 - https://medlineplus.gov/dialysis.html DB - PRIME DP - Unbound Medicine ER -