Short-term efficacy of sevelamer versus calcium acetate in patients with chronic kidney disease stage 3-4.

BACKGROUND

The relative effectiveness and safety of sevelamer, a mineral-free phosphate binder, for treatment of hyperphosphatemia in children with chronic kidney disease is uncertain.

AIM

This study was designed to compare the efficacy and acceptability of sevelamer hydrochloride to calcium acetate as a phosphate binder in pediatric patients with chronic kidney disease.

METHODS

A 12-week open-label trial of sevelamer hydrochloride vs calcium acetate was initiated in 22 patients, aged 2-18, with CKD stages 3 and 4. After a 2-week washout of phosphate binders and vitamin D, patients were randomized to receive sevelamer hydrochloride or calcium acetate. The effect of therapy was adjusted for baseline blood levels of calcium, phosphorus, calcium-phosphate product, alkaline phosphatase, PTH and GFR using ANOVA. The primary end point was the decrease in serum phosphorus levels after 12 weeks of treatment.

RESULTS

Of the 22 patients enrolled, data of 19 patients were used for analysis. The adjusted mean serum phosphate levels at 12 weeks did not differ significantly between calcium acetate- (5.3 mg/dl) and sevelamer-treated subjects (6.1 mg/dl) (P adjusted means = 0.6). The adjusted blood level of calcium at 12 weeks was significantly lower in the sevelamer-treated patients (8.2 mg/dl) compared to those treated with calcium acetate (9.1 mg/dl) (P adjusted means = 0.01). In the sevelamer group, there was a non-significant decrease in serum bicarbonate, whereas the total and LDL cholesterol significantly decreased at 12 weeks (P = 0.04). Sevelamer hydrochloride was well tolerated and without adverse effects related to the drug.

CONCLUSIONS

Compared to calcium acetate, use of sevelamer in children with chronic kidney disease is associated with similar reduction in serum phosphate levels, lower risk of hypercalcemia, and marked decrease in serum lipid levels.