Nephrol Dial Transplant (1999) 14: 2907-2914
© 1999 European Renal Association-European Dialysis and Transplant Association
Long-term effects of sevelamer hydrochloride on the calcium x phosphate product and lipid profile of haemodialysis patients*
1 Divisions of Nephrology, Moffitt-Long Hospitals and UCSF-Mt. Zion Medical Center, Department of Medicine, University of California, San Francisco, 2 GelTex Pharmaceuticals, Inc., Waltham, MA and 3 Renal Division, Department of Internal Medicine, Barnes-Jewish Hospitals, Washington University Medical Center, Washington University School of Medicine, St Louis, MO, USA
Correspondence and offprint requests to: Glenn M. Chertow, MD, MPH, Division of Nephrology, University of California, San Francisco, 672 Health Sciences East, San Francisco, CA 94143-0532, USA.
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, calciumxphosphate 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 calciumxphosphate 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 calciumxphosphate product and lipid profile of haemodialysis patients.
Keywords: end-stage renal disease; hyperphosphataemia; hyperparathyroidism; haemodialysis; cholesterol; phosphate; calcium
* Presented in abstract form at the 31st Annual Meeting of the American Society of Nephrology, October 25–28, 1998, Philadelphia, PA.
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