Epoetin theta: Efficacy and safety of subcutaneous administration in anemic pre-dialysis patients in the maintenance phase in comparison to epoetin beta

Current Medical Research and Opinion

Volumn 28, Issue 7, 2012, Pages 1101-1110

  Gertz, B ^a   Kes, P ^b   Essaian, A ^c   Bias, P ^d   Buchner, A ^d   Zellner, D ^d  

^a Department of Preclinical and Clinical Research   (Germany)

^b KBC Zagreb   (Croatia)

^c PAVLOV FIRST SAINT PETERSBURG STATE MEDICAL UNIVERSITY   (Russian Federation)

^d TEVA PHARMACEUTICALS   (Israel)

Author keywords

Anemia; Chronic kidney disease; Epoetin beta; Epoetin theta; Once weekly; Pre dialysis; Subcutaneous

Indexed keywords

HEMOGLOBIN; RECOMBINANT ERYTHROPOIETIN;

ADULT; AGED; ANALYSIS OF COVARIANCE; ANEMIA; ARTICLE; CHRONIC KIDNEY DISEASE; CHRONIC KIDNEY FAILURE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; EVALUATION; FEMALE; HUMAN; HYPERKALEMIA; HYPERTENSION; IMMUNOGENICITY; KIDNEY DISEASE; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION;

AGED; ANEMIA; DOUBLE-BLIND METHOD; ERYTHROPOIETIN; FEMALE; HEMOGLOBINS; HUMANS; INJECTIONS, SUBCUTANEOUS; KIDNEY FAILURE, CHRONIC; MALE; RECOMBINANT PROTEINS; RENAL DIALYSIS;

EID: 84863609425     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007995.2012.688736     Document Type: Article

References (19)

1. Levin A. Identification of patients and risk factors in chronic kidney disease-evaluating risk factors and therapeutic strategies. Nephrol Dial Transplant 2001;16:57-60 (Pubitemid 33062125)
2. National Kidney Foundation-Dialysis Outcomes Quality Initiative. NKF-K/DOQI clinical practice guidelines for anemia of chronic kidney disease: update 2000. Am J Kidney Dis 2001;37:182-238
3. Working Party for European Best Practice Guidelines for the Management of Anaemia in Patients with Chronic Renal Failure. European best practice guidelines for the management of anaemia in patients with chronic renal failure. Nephrol Dial Transplant 1999;14:1-50
4. Locatelli F, Aljama P, Bárány P, et al. Revised European best practice guidelines for the management of anaemia in patients with chronic renal failure. Nephrol Dial Transplant 2004;19:1-47
5. Eschbach JW, Egrie JC, Downing MR, et al. Correction of the anemia of endstage renal disease with recombinant human erythropoietin: results of a combined phase I and II clinical trial. N Engl J Med 1987;316:73-8 (Pubitemid 17052741)
6. Winearls CG, Oliver DO, Pippard MJ, et al. Effect of human erythropoietin derived from recombinant DNA on the anaemia of patients maintained by chronic haemodialysis. Lancet 1986;2:1175-8
7. Tjulandin SA, Bias P, Elsässer R, et al. Epoetin theta in anaemic cancer patients receiving platinum-based chemotherapy. Arch Drug Info 2010;3; 45-53
8. Tjulandin SA, Bias P, Elsässer R, et al. Epoetin theta with a new dosing schedule in anaemic cancer patients receiving nonplatinum-based chemotherapy. Arch Drug Info 2011;4;33-41
9. Gertz B, Kohler E, Kes P, et al. Epoetin theta: efficacy and safety of IV administration in anaemic haemodialysis patients in the maintenance phase in comparison to epoetin beta. Curr Med Res Opin 2010;26:2393-402
10. FDA: Darbepoetin alfa, Summary Basis of Approval, 2001
11. Hörl WH, Holzer H, Mayer GJ. Treatment of renal anaemia with darbepoetin alfa-Results of an Austrian multicentre study. Wien Klin Wochenschr 2002;114:967-71. German (Pubitemid 36105540)
12. EMA, Epoetin beta, Summary of Product Characteristics, revised 11 May 2010
13. Provenzano R, Bhaduri S, Singh AK for the PROMPT Study Group. Extended epoetin alfa dosing as maintenance treatment for the anemia of chronic kidney disease: the PROMPT study. Clin Nephrol 2005;64:113-23 (Pubitemid 41079007)
14. Drüeke TB, Locatelli F, Clyne N, et al. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Eng J Med 2006; 335:2071-84 (Pubitemid 44749316)
15. Provenzano R, Garcia-Mayol L, Suchinda P, et al. Once-weekly epoetin alfa for treating the anemia of chronic kidney disease. Clin Nephrol 2004; 61:392-405 (Pubitemid 38787334)
16. Hoggard J, Crouch T, McMurray S, et al. Preference for monthly darbepoetin alfa dosing in patients with chronic kidney disease not receiving dialysis. Cur Med Res Opin 2006;22:2023-30 (Pubitemid 44663406)
17. Wizemann V, Rutkowski B, Baldamus C, et al. Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment. Cur Med Res Opin 2008;24:625-37 (Pubitemid 351428973)
18. Haag-Weber M, Vetter A, Thyroff-Friesinger U, et al. Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving haemodialysis. Clin Nephrol 2009;72:380-90
19. Haag-Weber M, Eckhardt K-U, Hörl WH, et al. Safety, immunogenicity and efficacy of subcutaneous biosimilar epoetin-a (HX575) in non-dialysis patients with renal anemia. Clin Nephrol 2012;77:8-17