EFFECTS OF CALCIUM CARBONATE AND SEVELAMER ON EVENTS IN PATIENTS WITH CKD NOT ON DIALYSIS. THE INDEPENDENT-CKD STUDY

Introduction. Coronary artery calcifications reflect the atherosclerotic disease burden and are strongly associated to events in all stages of CKD. There is no study showing that a reduction of coronary artery calcifications may improve events rate in non-dialysed CKD-patients. Methods. The present study evaluates potential difference in the rate of events in n. 212 non-dialysed CKD-patients randomized to either sevelamer (n.107) or calcium carbonate (n.105) and followed up for 36 months. Asymptomatic middle-aged patients with CKD stages 3-4 were enrolled and fully evaluated; males were prevalent; diabetics were 28%. Phosphate binder dose and changes in lifestyle or other medications used were freely adjusted by clinicians according to everyday clinic routine and to K-DOQI guidelines, the only ones available at study initiation. Sudden death, fatal and not fatal myocardial infarction, othercause of mortality, and inception of dialysis were recorded till 36th month. Coronary artery calcifications were assessed by a multi-slice computed tomography at study entry, on 6th, 12th, 24th month. Results. Two independent readers unaware of undergoing binder treatment scored the scans. Mineral metabolism, extent of baseline coronary artery calcifications and its progression, dyslipidemia, C-reactive protein, and baseline renal function were not predictive factors of events rate. Choice of binder predicted events; rate of all cause-mortality, cardiovascular mortality, and inception of dialysis was lower in patients treated with sevelamer. Conclusions. Larger studies are needed to confirm that sevelamer compared to calcium carbonate provides benefit on survival of non-dialysed CKD-patients.