Long-term effects of sevelamer hydrochloride on the calcium x phosphate product and lipid profile of haemodialysis patients

Background. Short-term studies have suggested that sevelamer hydrochloride, a non-aluminium- and noncalcium-containing hydrogel, is an effective phosphate binder in haemodialysis patients, and may produce favourable changes in the lipid profile. Methods. To determine the long-term effectiveness of sevelamer hydrochloride, we performed an open-label clinical trial in 192 adult patients with end-stage renal disease on haemodialysis. Drug-related changes in the concentrations of serum phosphorus, calcium, calcium x phosphate product, parathyroid hormone, and low- and high-density lipoprotein cholesterol concentrations were the major outcomes of interest. Results. Treatment with sevelamer was associated with a mean change in serum phosphorus of -0.71 +/- 0.77 mmol/l, serum calcium of 0.08 +/- 0.22 mmol/l, and calcium x phosphate product of -1.46 +/- 1.78 mmol/l (P<0.0001 for all comparisons). There were no significant overall treatment-related changes in parathyroid hormone. Serum levels of LDL cholesterol decreased by 0.81 +/- 0.75 mmol/l (mean -30%, P<0.0001) and HDL cholesterol increased by a mean of 0.15 +/- 0.29 mmol/l (mean + 18%, P<0.0001). Drug-related adverse events were infrequent and most were of mild intensity. Conclusion. Sevelamer is a safe and effective phosphate binder that leads to significant improvements in the calcium x phosphate product and lipid profile of haemodialysis patients.