Sevelamer hydrochloride with or without alphacalcidol or higher dialysate calcium vs calcium carbonate in dialysis patients: an open-label, randomized study.
BACKGROUND
Sevelamer hydrochloride was recently proposed as a phosphate binder to prevent hypercalcaemia in place of calcium alkaline salts in dialysis patients. So far, it has been evaluated only in patients receiving calcitriol, without comparison with CaCO(3) alone, although the latter was found to be as effective as the combination of calcitriol and Al(OH)(3) in suppressing parathyroid hormone (PTH) without inducing hypercalcaemia and to have a better lowering effect on serum phosphate. Moreover, this bile salt binder may decrease serum 25-OH vitamin D. Therefore, we compared for 5 months two strategies for controlling moderate hyperparathyroidism: CaCO(3) alone vs sevelamer in conjunction with measures to increase calcium balance.


METHODS
Forty-two patients were randomized: 21 continued their treatment with 4.8 g/day CaCO(3) and 21 were switched to sevelamer (initial dose: 2.4 g/day, increased to 4.4 g/day). Each month, when serum-corrected calcium decreased below 2.30 mmol/l, dialysate calcium was increased or alphacalcidol was given at each dialysis session, according to serum PO(4) levels. The following parameters were monitored: serum Ca, PO(4), bicarbonate and protein, weekly; and serum PTH, 25-OH vitamin D and total, LDL and HDL cholesterol monthly.


RESULTS
Except for higher serum phosphate at month 1, lower serum bicarbonate at month 2 and lower LDL cholesterol at month 5 in the sevelamer group, no difference was found between the two groups. Compared with baseline levels, PTH increased and 25-OH vitamin D decreased significantly in both groups, these two parameters being inversely correlated.


CONCLUSIONS
Given comparable control of plasma calcium, phosphate and 25-OH vitamin D, PTH control is comparable in both strategies. Sevelamer does not induce greater vitamin D depletion than CaCO(3). The transient decrease of serum bicarbonate after discontinuation of CaCO(3) in the sevelamer group suggests a less optimal prevention of acidosis. The sevelamer-induced decrease in LDL cholesterol gives this drug a potential advantage in cardiovascular prevention.
Sadek
Tarek
T
Department of Nephrology,, Amiens CHU, Amiens, France.
Mazouz
Hakim
H
Bahloul
Hedi
H
Oprisiu
Roxana
R
El Esper
Najeh
N
El Esper
Isabelle
I
Boitte
Francis
F
Brazier
Michel
M
Moriniere
Philippe
P
Fournier
Albert
A
D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000627:therapeutic use*; D000863:Antacids / Q000008:administration & dosage* / Q000627:therapeutic use*; D002118:Calcium / Q000008:administration & dosage* / Q000627:therapeutic use*; D002119:Calcium Carbonate / Q000008:administration & dosage* / Q000627:therapeutic use*; D015314:Dialysis Solutions / Q000008:administration & dosage* / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004852:Epoxy Compounds / Q000008:administration & dosage* / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D006887:Hydroxycholecalciferols / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use*; D006934:Hypercalcemia / Q000097:blood / Q000209:etiology* / Q000517:prevention & control*; D006961:Hyperparathyroidism / Q000097:blood / Q000209:etiology* / Q000517:prevention & control*; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications* / Q000628:therapy*; D011073:Polyamines; D011095:Polyethylenes / Q000008:administration & dosage* / Q000627:therapeutic use*; D006435:Renal Dialysis / Q000009:adverse effects*; D000069603:Sevelamer; D013997:Time Factors
D000276:Adjuvants, Immunologic; D000863:Antacids; D015314:Dialysis Solutions; D004852:Epoxy Compounds; D006887:Hydroxycholecalciferols; D011073:Polyamines; D011095:Polyethylenes; D000069603:Sevelamer; D002119:Calcium Carbonate; D002118:Calcium; C008088:alfacalcidol