Tolerability and efficacy of multidose epoetin beta (Reco-Pen®) for subcutaneous administration in patients with anemia due to renal failure

Kidney and Blood Pressure Research

Volumn 26, Issue 3, 2003, Pages 192-198

  Kleophas, W ^a,i   Kult, J ^b   Kreusser, W ^c   Piper, C ^d   Plache, H ^e   Wunderle, P ^f   Fiegel, V ^g   Hartl W ^h  

^a Gemeinschaftspraxis Karlstrasse   (Germany)

^b CARITAS KRANKENHAUS   (Germany)

^c Marien Hospital   (Germany)

^d DR HORST SCHMIDT KLINIKEN   (Germany)

^e Gilead Hospital   (Germany)

^f Dialysepraxis ^*  (Germany)

^g Urologische Praxis   (Germany)

^h KfH Krankhs Missions B   (Germany)

ⁱ Gemeinschaftspraxis Karlstrasse   (Germany)

Author keywords

Epoetin beta; Multidose epoetin beta formulation; Reco Pen ; Renal anemia; Tolerability

Indexed keywords

ERYTHROPOIETIN; HEMOGLOBIN; RECO PEN; RECOMBINANT ERYTHROPOIETIN;

ADULT; AGED; ANEMIA; ARTICLE; BLOOD; BLOOD PRESSURE; BLOOD TRANSFUSION; BRONCHITIS; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEVICE; DRUG DELIVERY SYSTEM; DRUG DOSE; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DRUG SELF ADMINISTRATION; DRUG TOLERABILITY; DYSPEPSIA; FEMALE; HEMATOCRIT; HUMAN; HYPERTENSION; INTRAVENOUS DRUG ADMINISTRATION; KIDNEY FAILURE; MAJOR CLINICAL STUDY; MALE; MEDICAL ASSESSMENT; MEDICAL RECORD; METABOLISM; PERITONITIS; PRIORITY JOURNAL; PROBABILITY; REDUCTION; SUBCUTANEOUS DRUG ADMINISTRATION; UPPER RESPIRATORY TRACT INFECTION; UREMIA;

ADULT; AGED; ANEMIA; BLOOD TRANSFUSION; ERYTHROPOIETIN; ERYTHROPOIETIN, RECOMBINANT; FEMALE; HEMATOCRIT; HEMOGLOBINS; HUMANS; INJECTIONS, INTRAVENOUS; INJECTIONS, SUBCUTANEOUS; KIDNEY FAILURE; MALE; MIDDLE AGED; SELF ADMINISTRATION;

EID: 0042173221     PISSN: 14204096     EISSN: None     Source Type: Journal    
DOI: 10.1159/000071885     Document Type: Article

References (30)

1. Mann JFE: What are the short-term and long-term consequences of anaemia in CRF patients? Nephrol Dial Transplant 1999;14(suppl 2):29-36.
2. Parfrey PS, Foley RN: The clinical epidemiology of cardiac disease in chronic renal failure. J Am Soc Nephrol 1999;10:1606-1615.
3. Winearls CG, Oliver DO, Pippard MJ, Reid C, Downing MR, Cotes PM: Effect of human erythropoietin derived from recombinant DNA on the anaemia of patients maintained by chronic haemodialysis. Lancet 1986;ii:1175-1178.
4. Eschbach JW, Egrie JC, Downing MR, Browne JK, Adamson JW: Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. Results of a combined phase I and II clinical trial. N Engl J Med 1987;316:73-78.
5. Bommer J, Kugel M, Schoeppe W, Brunkhorst R, Samtleben W, Bramsiepe P, Scigalla P: Dose-related effects of recombinant human erythropoietin on erythropoiesis: Results of a multicenter trial in patients with end-stage renal disease. Contrib Nephrol. Basel, Karger, 1988, vol 66, pp 85-93.
6. Bennett WM: A multicenter clinical trial of epoetin beta for anemia of end-stage renal disease. J Am Soc Nephrol 1991;1:990-998.
7. Koch KM, Koene RAP, Messinger D, Quarder O, Scigalla P: The use of epoetin beta in anemic predialysis patients with chronic renal failure. Clin Nephrol 1995;44:201-208.
8. Cannella G, La Canna G, Sandrini M, Gaggiotti M, Nordio G, Movilli E, Mombelloni S, Visioli O, Maiorca R: Reversal of left ventricular hypertrophy following recombinant human erythropoietin treatment of anaemic dialysed uraemic patients. Nephrol Dial Transplant 1991;6:31-37.
9. Pascual J, Teruel JL, Moya JL, Liano F, Jimenez-Mena M, Ortuno J: Regression of left ventricular hypertrophy after partial correction of anemia with erythropoietin in patients on hemodialysis: A prospective study. Clin Nephrol 1991;35:280-287.
10. Wizemann V, Schafer R, Kramer W: Follow-up of cardiac changes induced by anemia compensation in normotensive hemodialysis patients with left-ventricular hypertrophy. Nephron 1993;64:202-206.
11. Foley RN, Parfrey PS, Harnett JD, Kent GM, Murray DC, Barre PE: The prognostic importance of left ventricular geometry in uremic cardiomyopathy. J Am Soc Nephrol 1995;5:2024-2031.
12. Dunn CJ, Markham A: Epoetin beta. A review of its pharmacological properties and clinical use in the management of anaemia associated with chronic renal failure. Drugs 1996;51:299-318.
13. Sowade B, Sowade O, Möcks J, Franke W, Warnke H: The safety of treatment with recombinant human erythropoietin in clinical use: A review of controlled studies. Int J Mol Med 1998;1:303-314.
14. European Best Practice Guidelines for the Management of Anaemia in Patients with Chronic Renal Failure. Nephrol Dial Transplant 1999;14(suppl 5):1-50.
15. National Kidney Foundation-K/DOQI: Clinical practice guidelines for the management of anemia of chronic kidney disease: Update 2000. Am J Kidney Dis 2001;14(suppl 5):182-238.
16. McClellan WM, Frankenfield DL, Wish JB, Rocco MV, Johnson CA, Owen WF Jr, End-Stage Renal Disease Core Indicators Work Group: Subcutaneous erythropoietin results in lower dose and equivalent hematocrit levels among adult hemodialysis patients: Results from the 1998 End-Stage Renal Disease Core Indicators Project. Am J Kidney Dis 2001;37:1-8.
17. Besarab A, Reyes CM, Hornberger J: Meta-analysis of subcutaneous versus intravenous epoetin in maintenance treatment of anemia in hemodialysis patients. Am J Kidney Res 2002;40:439-446.
18. Kaufman JS, Reda DJ, Fye CL, Goldfarb DS, Henderson WG, Kleinman JG, Vaamonde CA, for the Department of Veterans Affairs Cooperative Study Group on Erythropoietin in Hemodialysis Patients: Subcutaneous compared with intravenous epoetin in patients receiving hemodialysis. N Engl J Med 1998;339:578-583.
19. Hynes DM, Stroupe KT, Greer JW, Reda DJ, Frankenfield DL, Kaufman JS, Henderson WG, Owen WF, Rocco MV, Wish JB, Kang J, Feussner JR. Potential cost savings of erythropoietin administration in end-stage renal disease. Am J Med 2002;112:169-175.
20. Franke W, Scherhag R: Tolerability and efficacy of multidose formulations of epoetin beta. Clin Drug Invest 1997;13:199-206.
21. Raftery MJ, Auinger M, Hertlova M, on behalf of the Collaborative Study Group: Safety and tolerability of a multidose formulation of epoetin beta in dialysis patients. Clin Nephrol 2000; 54:240-245.
22. Gallar Ruiz P, Balcke P, Montenegro Martinez J, Harris K, on behalf of the Collaborative Study Group: Tolerability of the epoetin beta multidose formulation (Reco-Pen®) in patients with renal anaemia. Clin Drug Invest 2000;20:151-158.
23. Kientsch-Engel R, Hallermayer K, Dessauer A, Wieczorek L: New enzyme-linked immunosorbent assay methods for measurement of serum erythropoietin levels and erythropoietin antibodies. Blood Purif 1990;8:255-259.
24. Urra JM, de la Torre M, Alcazar R, Peces R: Rapid method for detection of anti-recombinant human erythropoietin antibodies as a new form of erythropoietin resistance. Clin Chem 1997;43:848-849.
25. Frenken LA, van Lier HJ, Gerlag PG, den Hartog M, Koene RA: Assessment of pain after subcutaneous injection of erythropoietin in patients receiving haemodialysis. BMJ 1991;303:288.
26. Granolleras C, Leskopf W, Shaldon S, Fourcade J: Experience of pain after subcutaneous administration of different preparations of recombinant human erythropoietin: A randomized, double-blind crossover study. Clin Nephrol 1995;36:294-298.
27. Lui SF, Leung CB, Li PK, Lai KN: Pain after subcutaneous injection of erythropoietin. BMJ 1991;303:856.
28. Veys N, Vanholder R, Lameire N: Pain at the injection site of subcutaneously administered erythropoietin in maintenance hemodialysis patients: A comparison of two brands of erythropoietin. Am J Nephrol 1992;12:68-72.
29. Veys N, Dhondt A, Lameire N: Pain at the injection site of subcutaneously-administered erythropoietin: Phosphate-buffered epoetin alpha compared to citrate-buffered epoetin alpha and epoetin beta. Clin Nephrol 1998;49:41-44.
30. Lafferty ME, Hall G, Strachan J, Jones MC, McGregor E, Henderson IS: 25% reduction of erythropoietin dose in haemodialysis patients with the Reco-Pen®; in Program and Abstracts of the 35th ERA-EDTA Congress, Madrid 1999, p 339.