A randomized, double-blind, crossover design study of sevelamer hydrochloride and sevelamer carbonate in patients on hemodialysis.
OBJECTIVE
Sevelamer carbonate is an anion exchange resin with the same polymeric structure as sevelamer hydrochloride in which carbonate replaces chloride as the anion. The study investigated the effects of sevelamer carbonate and sevelamer hydrochloride on serum phosphorus, lipids and bicarbonate levels in hemodialysis patients.


METHODS
This was a double-blind, randomized, crossover study. 79 hemodialysis patients were randomly assigned to either sevelamer carbonate or sevelamer hydrochloride for 8 weeks followed by a crossover to the other regimen for an additional 8 weeks of treatment.


RESULTS
The mean serum phosphorus was 4.6+/-0.9 and 4.7+/-0.9 mg/dl during sevelamer carbonate and sevelamer hydrochloride treatment, respectively. Sevelamer carbonate and sevelamer hydrochloride were equivalent in controlling serum phosphorus, the geometric least square mean ratio was 0.99 (90% CI, 0.95-1.03). Mean total and LDL cholesterol were 144.0+/-33.9 and 59.5+/-24.9 mg/dl, respectively, during sevelamer carbonate treatment and 139.0+/-33.6 and 56.0+/-23.3 mg/dl, respectively, during sevelamer hydrochloride treatment. Serum bicarbonate levels increased by 1.3+/-4.1 mEq/l during sevelamer carbonate treatment. There were fewer gastrointestinal adverse events with sevelamer carbonate.


CONCLUSIONS
Sevelamer carbonate and sevelamer hydrochloride were equivalent in controlling serum phosphorus and serum bicarbonate levels increased with sevelamer carbonate. Lipid profiles for both were well-below the levels suggested by KDOQI. Sevelamer carbonate may have advantages over sevelamer hydrochloride in the treatment of hyperphosphatemia in hemodialysis patients.
Delmez
J
J
Washington University School of Medicine, St. Louis, MO 63110, USA. jdelmez@wustl.edu
Block
G
G
Robertson
J
J
Chasan-Taber
S
S
Blair
A
A
Dillon
M
M
Bleyer
A J
AJ
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001639:Bicarbonates / Q000097:blood*; D002614:Chelating Agents / Q000627:therapeutic use*; D002908:Chronic Disease; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007674:Kidney Diseases / Q000097:blood* / Q000628:therapy; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D010758:Phosphorus / Q000097:blood*; D011073:Polyamines / Q000627:therapeutic use*; D006435:Renal Dialysis; D000069603:Sevelamer
D001639:Bicarbonates; D002614:Chelating Agents; D008055:Lipids; D011073:Polyamines; D010758:Phosphorus; D000069603:Sevelamer