Sevelamer for the treatment of hyperphosphatemia in patients with chronic renal failure

BARDACH, ARIEL; PICHON-RIVIERE A,; AUGUSTOVSKI, F; ALCARAZ A; GARCIA MARTÍ, SEBASTIAN; GLUJOVSKY, D; LOPEZ, A; REGUEIRO, A

Documentos de Evaluación de Tecnologías Sanitarias

IECS

Año: 2006 p. 1 - 30

1668-2793

The aim of this overview is to assess the usefulness of sevelamer in patients with end-stage renal failure, both for hemodialysis and pre-dialysis patients.Ten narrative revisions, 1 systematic revision, 11 controlled clinical trials, 2 economic evaluations, 3 case series and documents from the U.S. FDA were identified. The evidence comes mainly from controlled, open-label clinical trials, with a less than one year follow-up, using heterogeneous populations of hemodialysis patients. The sevelamer doses used and the control treatments were variable. In the randomized controlled trial (RCT) "Treat to Goal", the results obtained with sevelamer are compared with those of calcium binders in 200 patients. The patients treated with calcium acetate and calcium carbonate had higher serum calcium concentrations and more frequent episodes of hypercalcemia. A slight increase of serum calcium was observed for both treatments (+0.1 sevelamer vs +0.4 mg/dL calcium binders, p<0.001. Serum phosphate, PxCa product and iPTH decreased with both treatments. This study has also shown a decrease the progression of coronary and aortic calcifications in hemodialysis patients for the sevelamer arm. The CARE study (Calcium Acetate Renagel Evaluation), is another double blind RCT, with 8 weeks of follow-up, which included 100 hemodialysis patients. Calcium acetate was more efficient than sevelamer as phosphate binder, achieving lower phosphatemia (a 1.08 mg/dL difference, p<0.001) and calcium-phosphorus product (6.1 mg2/dl2 difference, p=0.02) values.Several other RCTs carried out on different populations agree with these findings. Besides, patients treated with sevelamer experienced significant reductions in total cholesterol and LDL cholesterol levels (10-30%).Adverse and limiting effects to its use: Up to 20% of the patients treated discontinued the medication due to side effects and the number of daily tablets to be taken.In Argentina, the monthly cost of the treatment with sevelamer is approximately $770, on the other hand, with calcium acetate it is $130 per month. However, calcium carbonate costs $30-44 (argentine pesos 2006) per month.