Comparative Study of Recombinant Human Erythropoietin (rhEPO) Products on CKD (Chronic Kidney Disease) Patients.

PURPOSE: This study was conducted to evaluate whether the efficacy and safety profile of recombinant human erythropoietin (rhEPO) manufactured by Daewoong Pharmaceutical Co., Ltd was similar to biological products approved by the drug safety regulatory authority. PATIENTS AND METHODS: It was an open-label, randomized, comparative, parallel, multi-center study in hemodialysis patients with anemia. The reference product at an individualized dose 3 times a week was given in 4-8 weeks of titration period and hemoglobin (Hb) level was controlled to reach the range of 10-12 g/dL. Then, the subjects were randomly administered with reference or test product with the same dose regimen. The primary endpoints were to demonstrate the Hb level change between baseline and evaluation period in both treatment groups, while the secondary endpoints were the mean change in weekly dosage per kg body weight and the instability rate of Hb level during maintenance and evaluation period. The safety was evaluated based on the adverse events incidence. RESULTS: There was no statistical difference in the change of Hb between test and reference (0.14 g/dL and 0.75 g/dL respectively, with p>0.05), also for the mean changes of weekly dosage between groups (1091.40 IU and 570.15 IU respectively, with p>0.05). The instability rate of Hb in both test and reference was not statistically significantly different as well (26 and 15% respectively, with p>0.05). CONCLUSION: This study proves that the efficacy indicated by the change instability of Hb and safety indicated by adverse event incidence of Epodion and the reference product on chronic kidney disease were similar.

Vascular calcification of the aortic arch and peripheral artery in haemodialysis patients with and without diabetes mellitus.

AIM: to look for differences in clinical characteristics, and differences in the role of mineral metabolism disorders and inflammation in diabetic and non diabetic patients. METHODS: subjects were 127 patients on maintenance haemodialysis: 46 with DM and 81 without. Vascular calcification of the aortic arch and peripheral artery were recorded qualitatively using x-ray of the chest and lower extremities. Clinical characteristics and laboratory values were taken from the medical records. RESULTS: the overall prevalence of vascular calcification was similar in our haemodialysis patients, with or without DM (26.1% vs 25.9%). The diabetic patients were in general of older age (58.5+10.3 vs 51.6+12.6 years, p<0.05), had lower diastolic BP (80+14 vs 86+14 mmHg, p<0.05), and higher prevalence of isolated peripheral artery calcification (13% vs 2.5%, p<0.05). Vascular calcification in diabetic haemodialysis patients occurred at the same rate in spite of a lower serum P, (5.7+1.5 vs 6.9+1.5 mg/dl, p<0.05), and Ca X P product (52.3+14.5 vs 60.7+14.5, p<0.05), and shorter HD vintage (1.3+0.9 vs 3.2+3.3 years, p<0.05). In a sub analysis comparing patients according to presence and location of vascular calcification, patients with vascular calcification of the peripheral artery only were mostly diabetics (75%), had lower serum Ca (8.6+0.5mg/dl), P (6.7+0.6mg/dl), Ca x P product (57.4+5.10 mg2/dl2), and higher serum CRP (1.70+1.59mg/dl). CONCLUSION: diabetic patients on HD may be at higher risk for peripheral artery calcification, at lower serum Ca, P, and Ca X P product. The higher CRP may indicate a higher inflammatory status, which is probably the major risk factor for vascular calcification of the peripheral artery.