Efficacy and safety of sevelamer hydrochloride and calcium acetate in patients on peritoneal dialysis.
BACKGROUND
Inadequate phosphorus control is associated with increased morbidity and mortality in patients with CKD stage 5. Although phosphate binders are often used in patients on peritoneal dialysis (PD), no large randomized controlled studies evaluating their use solely in this population have previously been reported.


METHODS
In this multicentre, open-label study, adult patients on PD with serum phosphorus >5.5 mg/dl were randomized (2:1) to 12 weeks of treatment with sevelamer hydrochloride or calcium acetate. Doses were titrated to achieve serum phosphorus of 3.0-5.5 mg/dl. Changes in serum phosphorus, calcium, intact parathyroid hormone (iPTH), lipids and plasma biomarkers were assessed.


RESULTS
A total of 253 patients were screened, 143 of whom were randomized (sevelamer hydrochloride, n = 97; calcium acetate, n = 46). Treatment groups were well balanced with regard to baseline demographics. Serum phosphorus levels were significantly reduced after 12 weeks with both sevelamer hydrochloride and calcium acetate (P < 0.001). Serum PTH was also reduced in both groups while serum calcium increased in the calcium acetate group (P = 0.001) but not in the sevelamer hydrochloride group. Sevelamer hydrochloride was also associated with decreases in total cholesterol, low-density lipoprotein cholesterol and uric acid and an increase in bone-specific alkaline phosphatase (all P < 0.001 versus baseline). Both treatments were well tolerated and safety profiles were consistent with previous reports in haemodialysis patients. Hypercalcaemia was experienced by more calcium acetate-treated patients (18 versus 2%; P = 0.001).


CONCLUSIONS
In summary, sevelamer hydrochloride provides a reduction in serum phosphorus compared to that obtained with calcium-based binders in PD patients. The effects of sevelamer hydrochloride appear similar in both PD and haemodialysis populations.
Evenepoel
Pieter
P
1Division of Nephrology, Department of Medicine, University Hospital Gasthuisberg, Leuven, Belgium. pieter.evenepoel@uz.kuleuven.ac.be
Selgas
Rafael
R
Caputo
Flavia
F
Foggensteiner
Lukas
L
Heaf
James G
JG
Ortiz
Alberto
A
Kelly
Alison
A
Chasan-Taber
Scott
S
Duggal
Ajay
A
Fan
Stanley
S
D000085:Acetates / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D017610:Calcium Compounds / Q000009:adverse effects / Q000627:therapeutic use; D002614:Chelating Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D054559:Hyperphosphatemia / Q000188:drug therapy / Q000209:etiology / Q000517:prevention & control; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications / Q000188:drug therapy / Q000628:therapy; D008297:Male; D008875:Middle Aged; D010530:Peritoneal Dialysis / Q000009:adverse effects / Q000379:methods*; D010758:Phosphorus / Q000097:blood; D011073:Polyamines / Q000009:adverse effects / Q000627:therapeutic use*; D000069603:Sevelamer
D000085:Acetates; D017610:Calcium Compounds; D002614:Chelating Agents; D011073:Polyamines; D010758:Phosphorus; D000069603:Sevelamer; C120662:calcium acetate