Sevelamer with and without calcium and vitamin D: observations from a long-term open-label clinical trial.
OBJECTIVE
To determine the effects of sevelamer hydrochloride on serum phosphorus, calcium, calcium x phosphate product, and parathyroid hormone (PTH) in patients treated with and without vitamin D metabolites and calcium supplementation.


METHODS
Long-term, open-label clinical trial.


METHODS
Hemodialysis units.


METHODS
One hundred ninety-two adult patients with end-stage renal disease on hemodialysis.


METHODS
An extended treatment period of sevelamer hydrochloride, preceded and followed by phosphate binder washout periods.


METHODS
Treatment-related changes in serum phosphorus, calcium, calcium x phosphate product, and PTH.


RESULTS
Subjects treated with sevelamer alone, sevelamer with vitamin D metabolites (with or without calcium), and sevelamer with calcium without vitamin D experienced significant reductions in mean serum phosphorus (range, 2.1 to -2.9 mg/dL) and the calcium x phosphate product (range, -16.3 to -23.4 mg2/dL2). The mean serum calcium concentration increased in all subgroups except those treated with sevelamer alone (range, +0.3 to +0.5 mg/dL). In contrast, only subjects treated concurrently with vitamin D metabolites experienced a reduction in PTH. Subjects treated with sevelamer alone or sevelamer with calcium without vitamin D experienced an increase in PTH with treatment.


CONCLUSIONS
Sevelamer hydrochloride is a safe and effective phosphate binder in hemodialysis patients. Sevelamer should be used in combination with vitamin D metabolites to jointly control hyperphosphatemia and hyperparathyroidism. Randomized clinical trials will be required to determine the optimal management strategies for metabolic bone disease in end-stage renal disease, as well as less advanced stages of chronic renal insufficiency.
Department of Medicine, University of California, San Francisco 94143-0532, USA.
G M
GM
Chertow
M A
MA
Dillon
N
N
Amin
S K
SK
Burke
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002118:Calcium / Q000008:administration & dosage / Q000097:blood / Q000494:pharmacology*; D004852:Epoxy Compounds / Q000494:pharmacology* / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000188:drug therapy / Q000517:prevention & control*; D007676:Kidney Failure, Chronic / Q000188:drug therapy* / Q000628:therapy; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood; D010710:Phosphates / Q000378:metabolism; D010758:Phosphorus / Q000097:blood; D011073:Polyamines; D011095:Polyethylenes / Q000494:pharmacology* / Q000627:therapeutic use; D006435:Renal Dialysis; D000069603:Sevelamer; D014807:Vitamin D / Q000008:administration & dosage / Q000378:metabolism*
D004852:Epoxy Compounds; D010281:Parathyroid Hormone; D010710:Phosphates; D011073:Polyamines; D011095:Polyethylenes; D014807:Vitamin D; D010758:Phosphorus; D000069603:Sevelamer; D002118:Calcium