Control of Hyperphosphataemia – Translating the Kidney Disease Improving Global Outcomes Guidelines on Chronic Kidney Disease–Mineral and Bone Disorder into Clinical Practice
Other studies have investigated the benefits of calcium-based phosphate binders in terms of hospitalisation, patient outcomes, mortality and cost-efficacy, compared with the more recently introduced calcium-free phosphate binders, in particular sevelamer-HCL. The Dialysis clinical outcomes revisited (DCOR) study specifically addressed the issue of mortality; a comparison of sevelamer-HCL with calcium-based phosphate binders in 2,103 patients with stage 5D CKD revealed that there was no difference in the incidence of death between groups treated with sevelamer-HCL or a calcium-based phosphate binder. Only in a post-hoc analysis of patients over 65 years of age was there evidence for a survival benefit with sevelamer-HCL; a secondary analysis also found a trend towards reduction in all-cause hospitalisations over a follow-up period of up to 45 months.44,45
The Cochrane review of phosphate binders for treating bone disease in CKD concludes that the newer phosphate binders, such as sevelamer-HCL and lanthanum carbonate, have an unknown impact on morbidity and mortality.32 It also concludes that avoiding calcium-based binding agents could theoretically reduce the risk of vascular calcification and cardiovascular disease. The review suggests that further research is needed to compare the effects of sevelamer-HCL, lanthanum carbonate and calcium salts on parameters including all-cause and cardiovascular mortality. The KDIGO guidelines state that there is a paucity of high quality studies evaluating the clinical benefit of treatments given to patients with CKD-MBD.1 KDIGO recommend that research should determine which phosphate binders and other phosphate-lowering treatments are able to improve survival in patients with CKD stages 3–5D. This is a matter of great importance and urgency for the nephrology community worldwide, since we must be able to demonstrate patient benefit and cost-effectiveness in our management of CKD-MBD.
The cost effectiveness of the non-calcium phosphate binders is also controversial. These treatments are substantially more expensive than the traditional treatments and have yet to demonstrate overall advantages in reducing phosphate levels or reducing mortality. A health economic evaluation in Canada on database information from a sample of 37 % of patients with CKD initiating renal replacement (n=7,034) showed that the incremental cost of sevelamer-HCL was C$17,000/patient (assuming no survival or hospitalisation advantage for sevelamer-HCL). The cost per quality-adjusted life year (QALY) was C$77,600 (excluding costs of dialysis and transplantation). The authors concluded this was not cost effective even in elderly patients for whom a lower mortality risk with sevelamer-HCL has been suggested.46
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