Original Paper
Nephron 1992;61:399-403
Austrian Multicenter Study Group o f r-HuEPO in Predialysis Patients
Effectiveness and Safety of Recombinant Human Erythropoietin in Predialysis Patients
Key Words Recombinant human erythropoietin Predialysis patients Renal anemia
Abstract Experience with erythropoietin in the treatment of anemia in predialysis patients is limited. A practical treatment regimen which minimized the number of outpatient visits was investigated. The Austrian multicenter study included 123 patients. At baseline, the treatment protocol mandated once weekly the adminis tration of 10,000 U recombinant human erythropoietin (r-HuEPO) subcuta neously. The follow-up period was 3 months, and dose adjustments were made at monthly intervals. At baseline, the mean values for creatinine were 6.2 ±0.2 mg/dl, and for hemoglobin ( Hb) 9.0 g/dl. During 3 months of therapy, mean Hb increased to 10.8 g/dl and creatinine to 6.6 mg/dl. The initial r-HuEPO weekly dose was 10,000 U. The mean dose after 3 months was 9,000 ± 4,000 U. There was no significant alteration of the slope of the reciprocal creatinine curve or of blood pressure values. No side effects occurred during the 3-month treatment period. In conclusion, the results of this multicenter trial demonstrate that using a simple once-weekly subcutaneous treatment regime, r-HuEPO can be administered safely and effectively in predialysis patients.
Introduction
H. Graf, U. Bamas, S. Stifter, J. Kovarik, M. Franz, 2nd Department of Medicine, University of Vienna; P. Balcke, F. Stockenhuber, 1st Department of Medicine, University of Vienna; E. Zimmermann, Lainz Hospital Vienna; M. Pöschek, Kaiser Franz Josef Hospital. Vienna; R. Puchegger, Hanusch Hos pital, Vienna; M. Huspeck, Bad Ischl Hospital; W. Pronai, Eisenstadl Hospital; A. Heiser, Deaconesses Hospital, Salzburg; F. Krempler, Salzburg Hospital; H. Pogglilsch, J. Horina, University Clinic, Graz; G. Puhr, Oberwart Hospital; W.F. Pinggera, Amstetten Hospital; J. Zazgomik, Linz Hospital; H.K. Stummvoll. Elisabethinen Hospital, Linz; U. Never, Feldkirch Hospital: W. Frilzer, Lienz Hospital: P. König, Department of Medicine, University of Innsbruck; I. Neugebauer, O. Paul, Wiener Neustadt Hospital: R. Kramar, Weis Hospital. G. Höltl, Wörgl Hospital: R. Vikvdal, Steyr Hospital; N. Kaiser, St. Johann Hospital, Tirol.
Accepted: December 17,1991
Recombinant human erythropoietin (r-HuEPO) is well established in the treatment of anemia of patients on chronic hemodialysis. The effectiveness and safety are well documented on the basis of multicenter trials [1-4], The effects of r-HuEPO in the treatment of anemia of pro gressive renal failure, however, has only been studied in limited numbers of patients [5-9]. Additionally, in contrast to patients on maintainance dialysis therapy, the patients with progressive renal failure do not attend medical fa cilities as regularly, and therefore, more practical treatment strategies have to be developed.
Helmut Graf. M l) 2nd Department of Medicine University of Vienna, Gamisongassc 13 A-1090 Vienna ( Austria)
© I992S. Karger AG. Basel 0028 -2766/92/ 0614-0399S2.75/0
Downloaded by: Univ. of California Santa Barbara 128.111.121.42 - 3/13/2018 11:19:43 PM
Study participants:
T a b le -!. Charac teristics of patients participating in the Austrian multicenter trial of r-HuEPO in predialysis patients
123 patients
64 female 59 male
Mean age 56,6 years, range 18-84 Mean body weight 68.4 kg (±1.25 SEM) Creatinine 6.2 mg/dl (±0.2 SEM) Underlying disease
n
Glomerulonephritis Interstitial nephritis Diabetic nephropathy Polycystic kidney disease Analgetic nephropathy Amyloidosis
33 12 16 8 8 2 Fig. 1. Hemoglobin (H b ;— ) and hematocrit (H c t;— ) values during 3 months of r-HuEPO treatment. Values are means + SEM, n = I23. The distribution of the r-HuEPO dose is reported in table 2. *p
Nephron 1992;61:399-403
Austrian Multicenter Study Group o f r-HuEPO in Predialysis Patients
Effectiveness and Safety of Recombinant Human Erythropoietin in Predialysis Patients
Key Words Recombinant human erythropoietin Predialysis patients Renal anemia
Abstract Experience with erythropoietin in the treatment of anemia in predialysis patients is limited. A practical treatment regimen which minimized the number of outpatient visits was investigated. The Austrian multicenter study included 123 patients. At baseline, the treatment protocol mandated once weekly the adminis tration of 10,000 U recombinant human erythropoietin (r-HuEPO) subcuta neously. The follow-up period was 3 months, and dose adjustments were made at monthly intervals. At baseline, the mean values for creatinine were 6.2 ±0.2 mg/dl, and for hemoglobin ( Hb) 9.0 g/dl. During 3 months of therapy, mean Hb increased to 10.8 g/dl and creatinine to 6.6 mg/dl. The initial r-HuEPO weekly dose was 10,000 U. The mean dose after 3 months was 9,000 ± 4,000 U. There was no significant alteration of the slope of the reciprocal creatinine curve or of blood pressure values. No side effects occurred during the 3-month treatment period. In conclusion, the results of this multicenter trial demonstrate that using a simple once-weekly subcutaneous treatment regime, r-HuEPO can be administered safely and effectively in predialysis patients.
Introduction
H. Graf, U. Bamas, S. Stifter, J. Kovarik, M. Franz, 2nd Department of Medicine, University of Vienna; P. Balcke, F. Stockenhuber, 1st Department of Medicine, University of Vienna; E. Zimmermann, Lainz Hospital Vienna; M. Pöschek, Kaiser Franz Josef Hospital. Vienna; R. Puchegger, Hanusch Hos pital, Vienna; M. Huspeck, Bad Ischl Hospital; W. Pronai, Eisenstadl Hospital; A. Heiser, Deaconesses Hospital, Salzburg; F. Krempler, Salzburg Hospital; H. Pogglilsch, J. Horina, University Clinic, Graz; G. Puhr, Oberwart Hospital; W.F. Pinggera, Amstetten Hospital; J. Zazgomik, Linz Hospital; H.K. Stummvoll. Elisabethinen Hospital, Linz; U. Never, Feldkirch Hospital: W. Frilzer, Lienz Hospital: P. König, Department of Medicine, University of Innsbruck; I. Neugebauer, O. Paul, Wiener Neustadt Hospital: R. Kramar, Weis Hospital. G. Höltl, Wörgl Hospital: R. Vikvdal, Steyr Hospital; N. Kaiser, St. Johann Hospital, Tirol.
Accepted: December 17,1991
Recombinant human erythropoietin (r-HuEPO) is well established in the treatment of anemia of patients on chronic hemodialysis. The effectiveness and safety are well documented on the basis of multicenter trials [1-4], The effects of r-HuEPO in the treatment of anemia of pro gressive renal failure, however, has only been studied in limited numbers of patients [5-9]. Additionally, in contrast to patients on maintainance dialysis therapy, the patients with progressive renal failure do not attend medical fa cilities as regularly, and therefore, more practical treatment strategies have to be developed.
Helmut Graf. M l) 2nd Department of Medicine University of Vienna, Gamisongassc 13 A-1090 Vienna ( Austria)
© I992S. Karger AG. Basel 0028 -2766/92/ 0614-0399S2.75/0
Downloaded by: Univ. of California Santa Barbara 128.111.121.42 - 3/13/2018 11:19:43 PM
Study participants:
T a b le -!. Charac teristics of patients participating in the Austrian multicenter trial of r-HuEPO in predialysis patients
123 patients
64 female 59 male
Mean age 56,6 years, range 18-84 Mean body weight 68.4 kg (±1.25 SEM) Creatinine 6.2 mg/dl (±0.2 SEM) Underlying disease
n
Glomerulonephritis Interstitial nephritis Diabetic nephropathy Polycystic kidney disease Analgetic nephropathy Amyloidosis
33 12 16 8 8 2 Fig. 1. Hemoglobin (H b ;— ) and hematocrit (H c t;— ) values during 3 months of r-HuEPO treatment. Values are means + SEM, n = I23. The distribution of the r-HuEPO dose is reported in table 2. *p
