Authors' objectives:

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.

Authors' results and conclusions: 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.

Authors' recommendations: Sevelamer is an effective drug to control the metabolic calcium-phosphorus product alterations present in chronic renal failure. The extent of control is similar to that observed with calcium binders, but it has the advantage of inducing less hypercalcemia, which is important since it reduces the incidence of ectopic calcifications. It is associated to a decrease in vascular calcifications scores. In addition, it reduces total cholesterol and LDL cholesterol levels up to 30%. However, up to one fifth of the patients treated cannot continue treatment due to intolerance or lack of compliance. To date, there is no information on overall mortality and survival, nor data on the rate of reduction of hospitalizations for sevelamer. There are also no studies related to quality of life. The cost of the treatment in our country is 6 to 19 times higher than conventional treatments. Although sevelamer shows some additional benefits, it has not yet been demonstrated that these benefits would have a significant clinical impact. For these reasons, and its high cost, sevelamer cannot be presented as a replacement to conventional treatments, specially when there is no severe hypercalcemia.

Authors' methods: Overview

Project Status: Completed

URL for project: http://www.iecs.org.ar/

Year Published: 2006

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Argentina

Organisation Name: Institute for Clinical Effectiveness and Health Policy

Contact Address: Dr. Emilio Ravignani 2024, Buenos Aires - Argentina, C1414 CABA

Contact Name: info@iecs.org.ar

Contact Email: info@iecs.org.ar

Copyright: Institute for Clinical Effectiveness and Health Policy (IECS)