Safety and efficacy of sevelamer in the treatment of uncontrolled hyperphosphataemia of haemodialysis patients

Jaume Almirall, Thaïs Lopez, Montserrat Vallve, Ana Ruiz, Joan Llibre, Angels Betriu
Nephron. Clinical Practice 2004, 97 (1): c17-22

BACKGROUND/AIM: The treatment of hyperphosphataemia is of major importance in the management of patients on dialysis. Traditional phosphate binders can be associated with undesirable effects. Recently, a new non-absorbable phosphate-binding polymer, sevelamer hydrochloride, has been available. Clinical information is scarce, and its cost could be a limiting factor for its wider use. No studies have evaluated its usefulness in uncontrolled hyperphosphataemic patients.

METHODS: We identified 34 patients with a maintained serum phosphorus concentration >6.5 mg/dl and/or toxicity related to standard phosphorus-binding treatment (aluminium or calcium based). Sevelamer was added and titrated up fortnightly to achieve phosphorus control. Previous phosphate binders were decreased, whenever possible. The period of the study was 6 months.

RESULTS: Thirteen patients (38%) dropped out because of side effects, mainly related to the gastro-intestinal tract. The efficacy analysis disclosed that the phosphorus concentration decreased from 2.39 +/- 0.48 to 1.84 +/- 0.48 mmol/l (p < 0.001). The mean dose of sevelamer was stabilised at 3.4 +/- 1.8 g/day. The amount of calcium- and aluminium-based phosphate binders could be decreased from 5.1 +/- 3.5 to 3.1 +/- 2.7 g/day (38% decrease) and from 2.4 +/- 1.5 to 1.5 +/- 1.7 g/day (36% decrease), respectively. The Ca x P product was significantly decreased from 5.83 +/- 1.19 to 4.36 +/- 1.12 mmol/l2 (p < 0.001). The total cholesterol concentration decreased from 4.34 +/- 0.9 to 3.98 +/- 0.9 mmol/l (p < 0.01) and the low-density lipoprotein cholesterol level from 2.61 +/- 0.98 to 2.20 +/- 0.77 mmol/l (p < 0.03).

CONCLUSIONS: Sevelamer is an effective phosphate binder that allows a better serum phosphorus control, while allowing a decrease in the dose of calcium- and aluminium-based phosphate binders in these difficult patients. The drawbacks are the high intolerance rate and the price of the product.

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