Chertow, Burke, Dillon
Dec 1, 1999
Citations
8
Influential Citations
269
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Quality indicators
Journal
Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association
Abstract
Background. Short-term studies have suggested that sevelamer hydrochloride, a non-aluminium- and non-calcium-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 × 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 × 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 × phosphate product and lipid profile of haemodialysis patients.