ABSTRACT
Background: prior to the availability of recombinant human erythropoietin [r-EPO, epoetin], patients on dialysis frequently demanded blood transfusions and excessive iron therapy, exposing them to the risks of iron overload, transmission of viral hepatitis, and sensitization, which reduced the chances of successful transplantation . Recombinant human erythropoietin has been used for more than 20 years for the treatment of renal anemia, Epoetin-Alfa and -beta representing the common traditional preparations. By the modification of the molecule's carbohydrate moiety or structure a longer duration of erythropoietin receptor stimulation was achieved. The continuous erythropoietin receptor activator C.E.R.A. once or twice a month was found sufficient to achieve serum hemoglobin target levels. This study was aimed to identify the efficacy of C.E.R.A [Methoxy polyethylene glycol-epoetin beta in achieving and maintenance of hemoglobin level in patients with chronic kidney disease and patients on regular Hemodialysis therapy
Patients and methods: 145 patients with either CKD stage 4 and 5 [e GFR < 45 ml/min] on follow up in nephrology outpatient department or on regular Hemodialysis in nephrology unit Dubai hospital. In this center, the CERA approved by the local pharmacy authority was used for treatment of anemia in chronic kidney disease monthly dose of [100 mg for 70 kg patient] and adjusted according to monthly HB level during the trial period for reaching and maintaining target HB level of 11-12.5 g/dl
Results: Patients on HD 78 patients [53.8%] and CKD patients 67 patients the mean HB level at the end of study period showed statistically significant rise in whole patient cohort with HB START [8.882 +/- 1.272 g/dl] and at the end of 24month [11.119 +/- 1017 g/dl] With P-value [< 0.001]. HB at start was [9.013 +/- 1.298 g/dl] and [8.769 +/- 1.246] g/dl for CKD and HD respectively slightly higher in CKD group however without statistical difference [P-value 0.250]. HB level at the 24 month period [end of trial period] was found statically higher in HD group [11.305 +/- 1.197g/dl] than CKD group [10.903 +/- 1.116g/dl] again without statistical significance P value [0.038]
Conclusion: It could be concluded that the long acting erythropoietin stimulating therapy using continuous erythrpoeitin receptor activator [CERA] as once monthly dose is effective and safe in maintaining target HB level in both CKD patients and patients on maintenance hemodialysis and there was no recorded side effects of its use either by intravenous or subcutaneous use
Subject(s)
Humans , Male , Female , Middle Aged , Aged , Polyethylene Glycols , Renal Insufficiency, Chronic , Renal Dialysis , AnemiaABSTRACT
Background: secondary hyperparathyroidism [SHPT], a complication of chronic kidney disease [CKD] and is characterized by not only increased serum levels of intact parathyroid hormone [iPTH], but also may cause skeletal and cardiovascular complications. Deficiency of calcitriol [1, 25-hydroxy vitamin D] caused by impaired renal function, a main factor in the pathogenesis and pathophysiology of secondary hyperparathyroidism [SHPT] is associated with poor outcomes in hemodialysis patients. Therapy with vitamin D receptor [VDR] activators, including calcitriol or the selective VDR activator paricalcitol, has been associated with improved survival in patients with CKD on hemodialysis
Patients and Methods: single center cross over observational study of 28 patients on regular Hemodialysis in nephrology unit in Dubai hospital, the patient stopped all vitamin-D supplementations and calcium containing phosphate binder for 2 weeks prior to initiation and for the whole study period, non calcium based phosphate binder was continued. Initial dose of selective VDRA [PARICALCITOL] is 0.04 to 0.1 mcg/kg body weight [average total dose 2.8-7 mcg] administered as a bolus dose post hemodialysis twice to three times per week according to initial parathyroid hormone level Titration weekly dose [micrograms] calculated by dividing most recent i-PTH level [pg/ml]/80
Results: analyzing the data at start and end of trial period 48 weeks showed that there was significant reduction of serum I-PTH from [491.210 +/- 144.690 pg/dl] at start of the trial to [142.610 +/- 41.519pg/dl] at 48 weeks with P- value [<0.001] . Serum calcium increased from [8.343 +/- 0.654mg/dl] at the start of the study to [8.629 +/- 0.534mg/dl] at 48 weeks but without statistical significance P- value [0.006], same occurred with serum phosphate which showed insignificant rise with phosphate level at start of the test[7.264 +/- 1.695mg/dl] and at 48 weeks [7.279 +/- 1.800mg/dl] with P-value[0.975]
Conclusion: It could be concluded that use of intravenous vitamin D selective receptor activator [Paricalcitol] is effective in reducing serum I-PTH level in hemodialysis patients. Serum Ca++ and phosphorus levels were statistically insignificant