Nephrol Dial Transplant (2003) 18: 582-589
© 2003 European Renal Association-European Dialysis and Transplant Association
Sevelamer hydrochloride with or without alphacalcidol or higher dialysate calcium vs calcium carbonate in dialysis patients: an open-label, randomized study
1 Department of Nephrology, 2 Department of Nuclear Medicine and 3 Biochemistry Laboratory, Amiens CHU, Amiens, France
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 CaCO3 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: CaCO3 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 CaCO3 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 PO4 levels. The following parameters were monitored: serum Ca, PO4, 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 CaCO3. The transient decrease of serum bicarbonate after discontinuation of CaCO3 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.
Keywords: bicarbonate; calcium carbonate; LDL cholesterol; parathyroid hormone; sevelamer hydrochloride; 25-OH vitamin D
Correspondence and offprint requests to: Professor Albert Fournier, Hôpital Sud, Department of Nephrology, F-80054 Amiens cedex 1, France. Email: Fournier.Albert{at}chu-amiens.fr
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