PURPOSE: This study was undertaken to examine whether differences exist in the hemoglobin variability according to the types of erythropoiesis stimulating agent (ESA) in hemodialysis (HD) patients. METHODS: Clinical data were retrospectively analyzed from 72 patients on maintenance hemodialysis who were using darbepoetin alfa (n=27), epoetin beta (n=27), and epoetin alpha (n=18). As parameters of hemoglobin variability, hemoglobin cycling, the variance of hemoglobin and the SD/mean of hemoglobin were analyzed. Hemoglobin cycling was defined as the presence of cycles with an amplitude >1.5 g/dL and lasting more than 2 months. RESULTS: Hemoglobin cycling was present in 53 (73.6%) out of 72 HD patients. Hemoglobin cycling in patients receiving darbepoetin alfa had greater frequency (1.63+/-0.93 vs. 1.00+/-0.88 times/year, p<0.05), amplitude (2.88+/-1.48 vs. 1.88+/-1.60 g/dL, p<0.05), and velocity (1.21+/-0.74 vs. 0.73+/-0.66 g/dL/month, p<0.05) than that in patients receiving epoetin beta. The variance of hemoglobin in patients receiving epoetin beta (0.79+/-0.53 g/dL) was smaller than that in patients receiving darbepoetin alfa (1.29+/-0.70 g/dL, p<0.05) and epoetin alfa (1.08+/-0.52 g/dL, p<0.05). Also, the ratio of SD/mean of hemoglobin in patients receiving epoetin beta (8.20+/-2.59%) was lower than that in patients receiving darbepoetin alfa (10.81+/-2.10%, p<0.05) and epoetin alfa (10.30+/-2.10%, p<0.05). CONCLUSION: Hemoglobin variability is differential according to various ESAs, and it may be less with epoetin beta compared with darbepoetin alpha and epoetin alpha.
Anemia ; Erythropoiesis ; Erythropoietin ; Hematinics ; Hemoglobins ; Humans ; Recombinant Proteins ; Renal Dialysis ; Retrospective Studies ; Darbepoetin alfa ; Epoetin Alfa

PURPOSE: We aim to compare the erythropoietic effects of epoetin-alpha (EA, 4000 IU SC thrice a week) with those of darbepoetin-alpha (DA, 60ug IV weekly, conversion rate to EA=200:1). METHODS: Forty one stable hemodialysis patients were enrolled in this randomized crossover study. After a washout period of erythropoietin stimulating agents (ESA), the patients with hemoglobin (Hb) level of < or =11.0 g/dL were randomly assigned to DA or EA and we measured Hb and reticulocyte levels. When Hb reached >11.0 g/dL, we stopped ESA. When Hb level decreased to < or =11.0 g/dL again, we switched to alternative ESA and repeated the rest of the steps. RESULTS: Thirty six patients (M:F=20:16, age 62+/-11 years, Kt/V 1.65, nPCR 1.13 g/kg/day) completed the study. No significant differences were observed in baseline parameters between DA and EA during the period of the clinical trial. The rate of Hb level increase (EA 0.29 g/dL/week, DA 0.30 g/dL/week, p=0.76) and decrease (EA 0.45 g/dL/week, DA 0.38 g/dL/week, p=0.14) were not different between two periods. After ESA stopped, the duration of decreased Hb level of < or =11.0 g/dL was not significantly different (4 weeks in EA vs. 3.9 weeks in DA, p=0.86). Erythropoietin resistance index was 10.59 in the EA period. It was not significantly different from 10.97 in DA period (p=0.49). Nine patients (25%) showed a >30% change in EA efficiency relative to DA efficiency. CONCLUSION: There was no significant difference in erythropoietic parameters for both EA and DA.
Anemia ; Cross-Over Studies ; Erythropoietin ; Hemoglobins ; Humans ; Recombinant Proteins ; Renal Dialysis ; Reticulocytes ; Darbepoetin alfa ; Epoetin Alfa

BACKGROUND: Darbepoetin alfa is a new erythropoietic agent with a three fold longer terminal half-life than recombinant human erythropoietin (r- HuEPO). The aim of this randomized, open-label study is to determine whether darbepoetin alfa is as effective as r-HuEPO for the treatment of anemia in hemodialysis patients when administered at a reduced dosing frequency. METHODS: A total 74 Korean hemodialysis patients receiving r-HuEPO therapy by either the intravenous (IV) or subcutaneous (SC) route were randomized to continue r-HuEPO or to receive an equivalent dose of darbepoetin alfa at a reduced dosing frequency. Patients receiving r-HuEPO once weekly changed to once every other week darbepoetin alfa, and those receiving r-HuEPO two or three times weekly changed to once-weekly darbepoetin alfa. The initial dose of darbepoetin alfa was based on the r-HuEPO dose at the time of entry into the study, using a formula equating the peptide mass of the two molecules (200 IU r-HuEPO=1 microgram darbepoetin alfa). The doses of r-HuEPO and darbepoetin alfa were titrated to maintain hemoglobin concentrations within -1.0 to +1.5 g/dL of patients' baseline values and within a range of 8.0 to 13.0 g/ dL for up to 20 weeks (16-week dose-titration period followed by a 4-week evaluation period). The primary end point was change in hemoglobin level between baseline and the evaluation period. RESULTS: The mean change in hemoglobin from baseline to the evaluation period was similar in the darbepoetin alfa (-0.03+/-0.19 g/dL) and r-HuEPO (0.27+/-0.20 g/dL) groups, and the difference between the two treatments was -0.30 g/dL (95% CI, -0.84 to 0.23). This was not a statistically significant or clinically relevant difference, despite the reduced frequency of darbepoetin alfa administration. The safety profiles of darbepoetin alfa and r-HuEPO were similar. CONCLUSION: This study suggests that darbepoetin alfa maintains hemoglobin as effectively as r- HuEPO, but with reduced dose frequency.
Anemia* ; Erythropoietin ; Half-Life ; Hemoglobin A ; Humans ; Renal Dialysis* ; Darbepoetin alfa

BACKGROUND: Anemia is quite common in lung cancer patients and known to decrease the quality of life. Darbepoetin alfa is an erythropoiesis-stimulating protein approved for administration to cancer patients. This study examined the efficacy and safety of darbepoetin alfa in lung cancer patients with a hemoglobin concentration <10 g/dl during chemotherapy. METHODS: Lung cancer patients (n=178) received darbepoetin alfa at doses of 1.91 microgram/kg per week until the hemoglobin concentration increased to >10 g/dl. The efficacy and safety were measured by comparing the hemoglobin concentration and assessing the adverse events. RESULTS: After chemotherapy, the hemoglobin concentration decreased to 9.03+/-0.64 g/dl. With the darbepoetin alfa treatment, the hemoglobin concentration increased to 10.09+/-1.17 g/dl after 4 weeks reaching a peak hemoglobin concentration of 10.45+/-1.18 g/dl. The changes in hemoglobin after 4 and 8 weeks with treatment were 1.08+/-1.24 g/dl and 1.38+/-1.59 g/dl (p<0.01). At least a 1 g/dl or more increase in hemoglobin was observed in 62.4% of patients. There were no serious adverse effects except for some mild reactions. CONCLUSION: Darbepoetin alfa administered to lung cancer patients appears to be an effective, well-tolerated treatment for chemotherapy induced anemia.
Anemia ; Erythropoietin ; Hemoglobins ; Humans ; Lung ; Lung Neoplasms ; Quality of Life ; Darbepoetin alfa

BACKGROUND: The aim of this study was to evaluate the effects of darbepoetin alfa (DA) on hemoglobin (Hb) concentration and the need for transfusions in multiple myeloma (MM) patients receiving chemotherapy with novel agents. METHODS: Of 251 patients with MM who received DA therapy for at least 4 weeks, 142 who did not receive RBC transfusion during 4 weeks after DA initiation and started DA therapy at baseline Hb <10.0 g/dL were analyzed. RESULTS: After 4 weeks of DA therapy, 80 (60.6%) of 132 patients with evaluable data had Hb that increased ≥1.0 g/dL from baseline, while 50 (37.9%) had Hb that increased ≥2.0 g/dL from baseline. Pretreatment Hb level did not correlate with the proportion of patients with increased Hb. The median duration of DA therapy was 9.0 weeks. At the end of DA therapy, of 135 patients with evaluable data, 86 (60.6%) had Hb that increased ≥1.0 g/dL from baseline, while 67 (47.2%) had Hb that increased ≥2.0 g/dL from baseline. Stage III disease according to the International Staging System and absence of myeloma bone disease at diagnosis were independent predictors of higher Hb response during early DA therapy. CONCLUSION: We demonstrated the efficacy of DA therapy in a homogeneous group of MM patients receiving chemotherapy. DA therapy significantly increased Hb concentration, regardless of baseline Hb level.
Anemia ; Bone Diseases ; Darbepoetin alfa* ; Diagnosis ; Drug Therapy* ; Erythropoietin ; Humans ; Multiple Myeloma*

No abstract available.
Erythropoietin*

No abstract available.
Erythropoietin*

BACKGROUND: Recombinant human erythropoietin (rHuEPO) is an established treatment for renal anemia. We aimed to determine that high dose subcutaneous epoetin alfa is as efficient and safe as usual dose for treating anemia in peritoneal dialysis patient. METHODS: Twenty four patients on CAPD were randomly assigned to either 10, 000 IU (high dose group, n=12) or 4, 000 IU (usual dose group, n=12) epoetin alfa regimen with variable interval for 24 weeks. If hematocrit was out of range (30-39%), the interval was changed within 50% of previous interval. RESULTS: Mean hemoglobin levels at randomization and after 12 weeks and 24 weeks were 11.4+/-1.3, 11.3+/-1.1, and 11.6+/-1.2 g/dL in high dose group compared with 10.8+/-0.8, 11.5+/-1.1, and 10.9+/-1.2 g/dL in usual dose group (p<0.05). The mean weekly epoetin alfa dosages at randomization and after 12 and 24 weeks were 93.2+/-45.3, 95.5+/-33.6, and 102.5+/-43.6 IU/kg in high dose group compared with 78.8+/-29.4, 75.9+/-20.6 and 75.5+/-39.7 IU/kg in usual dose group (p<0.05). But, interval in high dose group was two times as longer as usual dose group. Adverse events were generally mild and transient CONCLUSION: This study demonstrates that epoetin alfa 10, 000 IU is as efficient and safe as 4, 000 IU with similar weekly dose in CAPD patients. epoetin alfa 10, 000 IU administration reduces frequency of injections about one half.
Anemia ; Erythropoietin ; Hematocrit ; Humans ; Peritoneal Dialysis ; Peritoneal Dialysis, Continuous Ambulatory* ; Random Allocation ; Epoetin Alfa

STUDY DESIGN: Prospective randomized clinical trial. OBJECTIVES: To determine the minimal effective pretreatment dosage of recombinant human erythropoietin for preoperative autologous donation in lumbar stenosis surgery. SUMMARY OF LITERATURE REVIEW: Preoperative autologous donation is one of the most widely used methods of autotransfusion. However securing predetermined amount may be difficult due to falling hematocrit with repeated donation especially in patients with low basal hematocrit. In this situation recombinant human erythropoietin(Epoetin alfa) may be used. MATERIALS AND METHODS: Forty five lumbar stenosis patients requiring posterior wide decompression and posterolateral fusion with instrumentation, who had basal hematocrit less than 40% were selected and alloted randomly into 3 groups. Group I(n=15) had pretreatment with Epoetin alfa 50 unit/kg. Group II(n=15) was pretreated with 25 unit/kg. Group III(n=15) had no pretreament. Patients were excluded from donation when their hematocrit values were less than 33%. RESULTS: The mean number of units collected per patient(mean+/-SD) was 3 for group I(P<0.05), 2.84 for group II and 2.67 for the control group. The red cell volumes in pretreated groups(347 ml, 325 ml) were greater than in group III(255 ml, P<0.05). The differences between hematocrits of the first and the third preoperative donations were significantly less in group I(1.50) and group II(1.51) than that of control group(3.73). Two patients in group II and 3 patients in group III required additional homologous transfusion postoperatively. And there were no significant differences in the pattern of postoperative changes of hemoglobin among the groups. There were no significant differences in amount of intraoperative saved blood, postoperative reinfused blood, and postoperative drainage. CONCLUSION: Fifty units/kg of Epoetin alfa seems to be more effective than twenty-five units/kg for preoperative autologous donation in patients requiring posterior wide decompression, posterolateral fusion with instrumentation.
Blood Transfusion, Autologous ; Cell Size ; Constriction, Pathologic* ; Decompression ; Drainage ; Erythropoietin* ; Hematocrit ; Humans* ; Prospective Studies ; Epoetin Alfa

BACKGROUND: Recombinant human erythropoietin (rHuEPO) is an essential and well-established treatment for renal anemia. Rcently, clinicians have moved toward administration of high dose rHuEPO to reduce the inconvenience and time efficient.We aimed to determine whether high dose subcutaneous (SC) epoetin alfa is as efficient and safe as the usual dose for treating anemia in continuous ambulatory peritoneal dialysis (CAPD) patients. METHODS: Twenty-four patients on CAPD were randomly assigned to a high-usual dose group (n=12) and an usual-high dose group (n=12) with a variable interval for 48 weeks. Patients received 10 times treatments by scheduled visiting during Period I lasting 24 weeks and received 4 times treatments by scheduled visiting in Period II lasting 24 weeks by cross-over. The high dose was 10,000 IU and the usual dose was 4,000 IU epoetin alfa regimen. If hematocrit was out of the targeted range, 30~39%, the interval of epoetin alfa was changed within 50% of the previous interval. RESULTS: Fifteen patients, out of 24, completed the study (8 patients in the high-usual dose group; 7 patients in the usual-high dose group). Mean hemoglobin levels at randomization and after 12, 24, 36 and 48 weeks were 10.8+/-1.1, 11.5+/-0.9, 11.5+/-1.5, 11.4+/-1.5, 11.5+/-0.8 g/dL, respectively, in high-usual dose group compared with 11.2+/-0.8, 11.4+/-1.2, 11.2+/-0.9, 11.2+/-1.4, 11.4+/-0.9 g/dL, respectively, in usual-high dose group. The mean weekly epoetin alfa dosages at randomization and after 12, 24, 36 and 48 weeks were 83.6+/-38.1, 87.1+/-35.8, 89.4+/-34.2, 60.1+/-25.1, 62.8+/-30.7 IU/kg/week, respectively, in high-usual dose group compared with 69.8+/-31.6, 64.9+/-12.2, 69.9+/-46.1, 78.8+/-29.3, 75.9+/-16.4 IU/kg/week, respectively, in usual-high dose group. No statistically significant differences between the two groups were apparent for hemoglobin levels or mean weekly epoetin alfa dosages. Treatment interval at Period I and Period II were 13.3+/-5.3, 8.2+/-4.3 days in high-usual dose group compared with 7.0+/-2.5, 13.4+/-4.0 days in usual-high dose group with statistically significant differences. Treatment interval in high dose was about two times as longer as usual dose. Adverse events were generally mild and transient, and pain on injection site following subcutaneous administration was rarely reported. CONCLUSIONS: This study demonstrates that epoetin alfa 10,000 IU is as efficient and safe as 4,000 IU with a similar weekly dose in CAPD patients. Epoetin alfa 10,000 IU administration can reduce frequency of injections by about one half.
Anemia ; Cross-Over Studies* ; Erythropoietin ; Hematocrit ; Humans ; Peritoneal Dialysis, Continuous Ambulatory* ; Random Allocation ; Epoetin Alfa