Compliance with guidelines and predictors of mortality in hemodialysis. Learning from Serbia patients.

OBJECTIVES: The aims of the study were to determine the percentage of patients on regular hemodialysis (HD) in Serbia failing to meet KDOQI guidelines targets and find out factors associated with the risk of time to death and the association between guidelines adherence and patient outcome. METHODS: A cohort of 2153 patients on regular HD in 24 centers (55.7% of overall HD population) in Serbia were followed from January 2010 to December 2012. The percentage of patients failing to meet KDOQI guidelines targets of dialysis dose (Kt/V>1.2), hemoglobin (>110g/L), serum phosphorus (1.1-1.8mmol/L), calcium (2.1-2.4mmol/L) and iPTH (150-300pg/mL) was determined. Cox proportional hazards analysis was used to select variables significantly associated with the risk of time to death. RESULTS: The patients were on regular HD for 5.3±5.3 years, dialyzed 11.8±1.9h/week. Kt/V<1.2 had 42.4% of patients, hemoglobin <110g/L had 66.1%, s-phosphorus <1.1mmol/L had 21.7% and >1.8mmol/L 28.6%, s-calcium <2.1mmol/L had 11.7% and >2.4mmol/L 25.3%, iPTH <150pg/mL had 40% and >300pg/mL 39.7% of patients. Using Cox model (adjustment for patient age, gender, duration of HD treatment) age, duration of HD treatment, hemoglobin, iPTH and diabetic nephropathy were selected as significant independent predictors of time to death. When targets of five examined parameters were included in Cox model, target for KtV, hemoglobin and iPTH were found to be significant independent predictors of time to death. CONCLUSION: Substantial proportion of patients examined failed to meet KDOQI guidelines targets. The relative risk of time to death was associated with being outside the targets for Kt/V, hemoglobin and iPTH.

COMPLETE CORRECTION OF ANEMIA WITH RECORMON® (ERYTHROPOIETIN ß) IN PATIENTS ON CHRONIC HEMODIALYSIS.

INTRODUCTION: Suboptimal correction of anemia is associated with increased prevalence of cardiovascular diseases and increased morbidity and mortality of pre-dialysis and dialysis patients. The aim of the study was to compare the effect of optimal vs. suboptimal correction of anemia in hemodialysis patients with left ventricular hypertrophy. MATERIAL AND METHODS: The study included 50 patients, 32 males and 18 females, their mean age being 49.4±11.8 years, from five hemodialysis centers (Clinical Hospital Center Zvezdara, Beograd, Clinical Center Novi Sad, hospitals in Krusevac, Pirot and Zrenjanin). The patients had suboptimal hemoglobin level in spite of therapy (7.8±3.8 g/dl). In addition, the most important inclusion criteria was the left ventricular mass index above 160 g/m2 and the primary efficacy parameter was a decrease in the left ventricular mass index during 12 month study period. RESULTS: During the study, the number of patients who reached their hemoglobin >12 g/dl increased and the target hemoglobin (12-13 g/dl) was achieved in 24 (52%) of patients at the end of the study. At the same time, the left ventricular mass index significantly decreased as compared with the initial values (p=0.014). The left ventricular mass index was not significantly decreased in the patients who did not achieve the target hemoglobin level (207±65 vs. 217±38 g, p=ns) as compared with the patients who achieved the target hemoglobin (179±32 g/ m2 vs. 197±38 g/m2, p=0.007). The left ventricular ejection fraction did not change significantly during the study period. CONCLUSION: Anemia correction with erythropoietin ß resulted in the significantly corrected left ventricular hypertrophy in hemodialysis patients who had had a suboptimal hemoglobin level. Our results have shown that correction of left ventricular hypertrophy

Epidemiology of end-stage renal disease and hemodialysis treatment in Serbia at the turn of the millennium.

The study presents the epidemiological features of patients treated with renal replacement therapy (RRT) in Serbia from 1997 to 2009 and compares the results of hemodialysis treatment in 1999 and 2009. Epidemiological data were obtained from the National Registry of RRT patients and data on hemodialysis treatment from special surveys conducted in 1999 and 2009. Within the period 1997-2009 the incidence of patients on RRT increased from 108 to 179 per million population (pmp), prevalence rose from 435 to 699 pmp, while mortality rate fell from 20.7% to 16.7%. The frequency of patients with glomerulonephritis decreased, while that of patients with diabetes and hypertensive nephropathy increased. In late 2009 there were 5208 patients receiving RRT in Serbia. Within the examined period new hemodialysis and reverse osmosis equipment were purchased, high-flux dialyzers with synthetic membranes were increasingly used and the number of patients receiving hemodiafiltration increased to 17.6%. Kt/V greater than 1.2 was recorded in 16% of the patients in 1999 but 52% in 2009. Options for correction of anemia and mineral disorders have also improved. The percentage of patients with HbsAg (13.8% vs. 4.8%) as well as anti-hepatitis C virus antibodies positive patients (23.2% vs. 12.7%) was significantly lower in 2009 than in 1999. Both the incidence and prevalence of RRT patients in Serbia are rising continuously, while the mortality rate is falling. More favorable conditions for dialysis treatment have brought about significant improvement in the results over the last 10 years.

[Comparative study of the efficacy of different regimens of intermittent subcutaneous dosing of erythropoietin beta in treatment of renal anemia in chronic dialysis patients].

INTRODUCTION: The use of erythropoietin (EPO) in the treatment of renal anemia is justified by more than 15 years of experience. Clinical trials have shown that subcutaneous erythropoietin beta (Recormon - F. Hoffmann-La Roche) therapy once weekly, or even once every two weeks has proven successful. The aim of this study was to evaluate the efficacy of different regimes of Recormon therapy in maintaining stable levels of hemoglobin (Hb) and hematocrit (HCT) in hemodialysis patients. MATERIAL AND METHODS: An open, comparative, multicenter study was divided into three arms of patients and lasted for 24 weeks. 98 patients with stable Hb level (>100 g/l), were treated with a stable dose of Recormon, and had a ferritin level > 200 microg/l and transferrin saturation >20%. During the first 8 weeks all were on the usual 2-3 times weekly epo dosage. 8 weeks later, 70 patients received epo once weekly, while 28 patients (group 1) maintained the same regimen for the entire study period. After another 8 weeks, 21 of those 70 patients receiving epo once weekly, received it once every two weeks (group 3), while 49 patients continued once weekly regimen to the end of the trial (group 2). The primary efficacy parameter was the percentage of patients maintaining their target Hb and HCT levels (>100 g/l and >30% for HB and HCT respectively). RESULTS: 86 patients (87.75%) completed the study (25 from group 1, 42 from group 2 and 19 from group 3). One patient was excluded because he was transplated during the study, one due to uncontrolled hypertension, while 10 patients, all from the same center, were excluded due to protocol violation (4-week gap in epo therapy due to problems with epo supply). Efficacy analysis included per-protocol population (86 patients). Hb levels remained stable (>100 g/l) in all three groups. Although there were statistically significant differences in Hb levels between visits (p=0,026), there were no statistically significant differences between groups throughout the study (p=0,439). HCT levels remained stable (>30%) in all three groups throughout the study, without statistically significant differences between visits (p=0,053) and between groups (p=0,155). The average epo doses were not statistically significantly different between visits (p=0,676) or between groups (p=0,512). The main tolerability parameters: sitting systolic (SSBP) and diastolic (SDBP) blood pressures were monitored at all visits. Statistical analysis showed that there were no differences in SSBP or SDBP between visits or groups of patients throughout the study. CONCLUSION: All three dosing regimens of subcutaneous epo beta were statistically equivalent in maintaining target Hb and HCT levels. Once weekly or once every two weeks administration of epo beta does not lead to dose increase, and provides greater opportunities to individualize treatment for every single patient and may lead to better compliance.