1. ¹Clinical Research Division, Denver Nephrology, Denver, CO, USA
2. ²Department of Cardiology, Emory University, Atlanta, GA, USA
3. ³Department of Nephrology, San Paolo Hospital, University of Milano, Italy
4. ⁴Department of Nephrology, University of Colorado Health Sciences Center, Denver, CO, USA

Correspondence: GA Block, Clinical Research Division, Denver Nephrology, CCRI, 130 Rampart Way Suite 300B, Denver, CO 80230, USA. E-mail: gablock@denverneph.net

Received 4 September 2006; Revised 27 October 2006; Accepted 7 November 2006; Published online 3 January 2007.

Abstract

The risk of death in hemodialysis patients treated with calcium-containing phosphate binders or sevelamer is not known. We assessed all-cause mortality in 127 patients new to hemodialysis assigned to calcium-containing binders or sevelamer after a median follow-up of 44 months from randomization. This was a predetermined secondary end point of a randomized clinical trial designed to assess progression of coronary artery calcium (CAC) scores in the two treatment arms. Thirty-four deaths occurred during the follow-up period: 23 in subjects randomized to calcium-containing phosphate binders and 11 in subjects randomized to sevelamer. Baseline CAC score was a significant predictor of mortality after adjustment for age, race, gender, and diabetes with increased mortality proportional to baseline score (P=0.002). Mortality was borderline significantly lower in subjects randomized to sevelamer (5.3/100 patient years, confidence interval (CI) (2.2–8.5) compared to those randomized to calcium-containing binders (10.6/100 patient years, CI 6.3–14.9) (P=0.05). The greater risk of death for patients treated with calcium-containing phosphate binders persisted after full multivariable adjustment (P=0.016, hazard ratio 3.1, CI 1.23–7.61). In subjects new to hemodialysis baseline CAC score was a significant predictor of all-cause mortality. Treatment with sevelamer was associated with a significant survival benefit as compared to the use of calcium-containing phosphate binders.