SEVELAMER ATTENUATES CV MORTALITY IN INCIDENT HEMODIALYSIS PATIENTS: OPEN LABEL, RANDOMIZED CLINICAL TRIAL OF EFFICACY AND SAFETY (INDEPENDENT STUDY)

INTRODUCTION AND AIMS: Whether the choice of sevelamer (SV) compared to calcium-based phosphate binder improves cardiovascular (CV) survival in patients receiving dialysis still remains to be elucidated. We herein report on an open label, blocked-randomized, multi-centered controlled trial with masked allocation, aimed at evaluating the impact of SV on CV survival in incident dialysis patients. METHODS: A total of 466 individuals were randomized to receive either SV or calcium salts (CS) as phosphate binders (figure 1). All individuals were followed until study completion or CV death occurrence. All-cause mortality and non-CV mortality were investigated as secondary endpoints. The Independent study was registered on ClinicalTrials.Gov as the Reduce Cardiovascular Calcifications to Reduce QT Interval in Dialysis (INDEPENDENT) Study, number NCT00710788 RESULTS: Overall, we recruited middle-age (mean age 65+14 years) men (49%) and women (51%). Hypertension (79%), CV disease (36%) and diabetes (29%) were the most common comorbid conditions. At baseline, patients allocated to SV had higher serum phosphorus levels and lower CAC scores (CACS) compared to patients allocated to CS. After a mean follow-up of 28 (10) months, SV treated patients experienced a 10-fold lower CV mortality compared to patients treated with CS as binders (p