A prospective study of combination therapy for hyperphosphataemia with calcium-containing phosphate binders and sevelamer in hypercalcaemic haemodialysis patients.

Abstract

Hyperphosphataemia is predictive of death, in haemodialysis (HD) patients. Sevelamer is a mineral-free phosphate binder not limited by the hypercalcaemia often encountered when utilizing calcium-containing phosphate binders. Highly positive calcium balance is associated with ectopic calcification and potentially accelerated vascular disease. Unfortunately, exclusive use of sevelamer entails a large cost differential, limiting its use in many centres. We report on a strategy of partial replacement of calcium with sevelamer for the management of hyperphosphataemia in hypercalcaemic chronic HD patients. We identified 23 HD patients with serum calcium >2.6 mmol/l. Dietary phosphate and calcium intake were assessed and baseline serum calcium, phosphate and 1alpha calcidol and elemental calcium dose recorded. Fifty per cent of this initial calcium dose was exchanged for sevelamer. Vitamin D doses were left unchanged. If serum calcium was still >2.6 mmol/l after 4 weeks a further 50% of calcium was exchanged. If serum phosphate was >2 mmol/l the sevelamer dose was increased by 25%. The patients were followed up for a further 4 weeks. Seven patients complained of gastrointestinal intolerance of sevelamer. Serum calcium fell from a mean value of 2.8+/-0.04 (2.64-3.54) mmol/l to 2.56+/-0.03 (2.4-2.9) mmol/l, P<0.0005. The hypercalcaemic percentage of patients fell from 100 to 26%. Mean serum phosphate was not significantly changed, 1.59+/-0.1 (0.57-2.6) mmol/l to 1.63+/-0.11 (0.55-2.68) mmol/l, 17-22% of patients having serum phosphate >2 mmol/l. Serum intact parathyroid hormone increased from 166+/-47 (12-933) ng/l to 276+/-104 (20-1013) ng/l, P=0.02. Mean sevelamer dose was 2.77+/-0.36 (0-5.6) g per day. Elemental calcium dose fell from 2.05+/-0.23 (0.5-4.5) g to 1.03+/-0.1 (0.5-2.5) g, P<0.0001. A regimen based on the combination of sevelamer and calcium is capable of effectively managing hyperphosphataemia, without hypercalcaemia, in the majority of hypercalcaemic HD patients. Such a minimally calcaemic approach might reduce the financial burden of sevelamer therapy, and enable a wider range of patients to be treated.