Darbepoetin alfa: review in the management of anemia in patients with chronic kidney disease

Authors

  • Hanmant Barkate Department of Medical Affairs, Wockhardt Limited, Mumbai, Maharashtra, India
  • Jatin Kothari Department of Nephrology and Transplant, Hinduja Hospital, Mumbai, Maharashtra, India
  • Himanshu Patel Department of Nephrology and Renal Transplantation, Zydus Hospital, Ahmedabad, Gujarat, India
  • A. V. Ingale Department of Nephrology and Renal Transplantation, Fortis Group of Hospitals, Mumbai, Maharashtra, India
  • Salman Motlekar Department of Medical Affairs, Wockhardt Limited, Mumbai, Maharashtra, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20170808

Keywords:

Anemia, Chronic kidney disease, Darbepoetin, India

Abstract

Chronic kidney disease (CKD) is a significant clinical problem across the world including India. The SEEK (Screening and Early Evaluation of Kidney Disease) study from India reported the prevalence of CKD as 17.2%. Diabetic nephropathy, undetermined etiology, chronic glomerulonephritis and hypertensive nephrosclerosis are the common causes of CKD in India. Rising rates of diabetes and hypertension, late presentation of patients to nephrologists and limited number of nephrologists in India adds to the concerns related to management of CKD. Considering the pathophysiology of CKD, anemia is almost an inevitable complication in these patients. Untreated anemia significantly contributes to the morbidity and mortality associated with CKD. Early recognition, timely management with appropriate therapy helps to reduce the complications of anemia. Erythropoiesis-stimulating agents (ESAs) are one of the important measures for correction of anemia in CKD patients. Darbepoetin, an ESA is a valuable therapeutic option for the treatment of anemia in CKD patients and has played a vital role in enhancing anemia management. In this article we reviewed the efficacy and safety data along with key benefits and place of darbepoetin alfa in the management of anemia in CKD patients.

References

Varma PP. Prevalence of chronic kidney disease in India - Where are we heading. Indian J of Nephrology. 2005;25:133-5.

Anupama YJ, Uma G. Prevalence of chronic kidney disease among adults in a rural community in South India: Results from the kidney disease screening (KIDS) project Indian J Nephrol. 2014;24:214-21.

Singh AK, Farag YMK, Mittal BV, Subramanian KK, Reddy SRK, Acharya VN, et al. Epidemiology and risk factors of chronic kidney disease in India - results from the SEEK (Screening and Early Evaluation of Kidney Disease) study. BMC Nephrology. 2013;14:114.

Rajapurkar MM, John GT, Kirpalani AL, Abraham G, Agarwal SK, Almeida AF, et al. What do we know about chronic kidney disease in India: first report of the Indian CKD registry. BMC Nephrology 2012;13:10.

Hirakata H, Tsubakihara Y, Gejyo F, Nishi S, Iino Y, Watanake Y, et al. Maintaining high hemoglobin levels improved the left ventricular mass index and quality of life scores in pre-dialysis Japanese chronic kidney disease patients. Clin Exp Nephrol. 2010;14:28-35.

Shaheen FAM, Souqiyyeh MZ, Al-Attar BA, Karkar A, Al Jazairi AMH, Badawi LS. Prevalence of anemia in predialysis chronic kidney disease patients. Saudi J Kidney Dis Transpl. 2011;22:456-63.

Horl WH, Vanrenterghem Y, Aljama P, Brunet P, Brunkhorst R, Gesualdo L, et al. OPTA: Optimal treatment of anemia in patients with chronic kidney disease (CKD). Nephrol Dial Transplant. 2007;22(3):20-6.

Talwar VK, Gupta HL, Shashinarayan. Clinicohaematological profile in chronic renal failure. J Assoc Physicians India. 2002;50:228-33.

Mudiyammanavara RN, Dhanajaya PE, Agarwal R. Cross sectional study of anaemia in chronic kidney disease. Indian Journal of Basic and Applied Medical Research. 2015;4:414-9.

Arun S, Venkatraya PM, Chowta NK, Bengre ML. The haematological Pattern of the Patients with Chronic Kidney Disease in a Tertiary Care Setup in South India. Journal of Clinical and Diagnostic Research. 2012;6:1003-6.

Schmidt RJ, Dalton CL. Treating anemia of chronic kidney disease in the primary care setting: cardiovascular outcomes and management recommendations. Osteopathic Medicine and Primary Care. 2007;1:14.

Kuwahara M, Hasumi S, Mandai S, Tanaka T, Shikuma S, Akita W, et al. Effects of three kinds of erythropoiesis-stimulating agents on renal anemia in Japanese non-dialysis chronic kidney disease patients. Clin Exp Nephrol. 2014;18:755-62.

Suzuki M, Hada Y, Akaishi M, Hiroe M, Aonuma K, Tsybakihara Y, et al. Effects of anemia correction by erythropoiesis-stimulating agents on cardiovascular function in non-dialysis patients with chronic kidney disease. Int Heart J. 2012;53:238-43.

Neves PL, Morgado E, Faisca M, Carrasqueira H, Baptista A, Silva AP. Nutritional and inflammatory status influence darbepoetin dose in pre-dialysis elderly patients. International Urology and Nephrology. 2006;38:811-3.

Lenkhorst CE, Wish JB. Anemia in renal disease: Diagnosis and management. Blood Reviews. 2010;24:39-47.

Carrera F, Burnier M. Use of darbepoetin alfa in the treatment of anemia of chronic kidney disease: clinical and pharmacoeconomic considerations. NDT Plus. 2009;2(1):9-17.

Macdougall IC, Gray SJ, Elston O, Breen C, Jenkins B, Browne J, et al. Pharmacokinetics of novel erythropoiesis stimulating protein compared with epoetin alfa in dialysis patients. J Am Soc Nephrol. 1999;10:2392-5.

Macdougall IC. Darbepoetin alfa: A new therapeutic agent for renal anemia. Kidney Internationa. 2002;61(80):S55-61.

Aranesp (darbepoetinalfa) Prescribing information; 2011: Available from: www.accessdata.fda.gov/drugsatfda.../103951Orig1s5173_103951Orig1s5258lbl.pdf.

Molina M, Garcia-Hernandez MA, Navarro MJ, Perez Silva F, Cacho M,T De Gracia MC. Treatment of renal anemia with darbepoetin alfa administered once every other week in predialysis patients with chronic kidney disease and previously treated with epoetin alfa. Nefrologia. 2004;24:54-9.

Martinez PM, Garcia de VS, Ortega DM, Goicoechea M, Gomez CF, Luno J. Evaluation of efficacy of darbepoetin alfa administered once monthly as treatment of anemia in predialysis patients with chronic kidney disease. Nephrologia. 2005;25:663-7.

Koibuchi K, Miyagi M, Arai T, Aoki T, Aikawa A, Sakai K. Comparing the efficacy of continuous erythropoietin receptor activator and darbepoetin alfa treatments in Japanese patients with chronic kidney disease during the predialysis period: A propensity-matched analysis. Nephrology (Carlton). 2015;20(4):22-8.

Furukawa T, Okada K, Abe M, Tei R, Oikawa O, Maruyama N, et al. Randomized controlled trial of sarbepoetin α versus continuous erythropoietin receptor activator injected subcutaneously once every four weeks in patients with chronic kidney disease at the pre-dialysis stage. Int J Mol Sci. 2015;16:20181-9.

Hoggard J, Crouch T. McMurray S, Levine M, Prathikanti R, Scarlata D, et al. Preference for monthly darbepoetin alfa dosing in patients with chronic kidney disease not receiving dialysis. Current Medical Research and Opinion. 2006;22;10:2023-30.

de Lurdes ACA, Pinho A, Malho A, Morgado E, Faisca M, Carrasqueira H, et al. Risk factors for high erythropoiesis stimulating agent resistance index in pre-dialysis chronic kidney disease patients, stages 4 and 5. Int Urol Nephrol. 2011;43:835-40.

Bristoyiannis G, Germanos N, Grekas D, Hatzidimitriou C, latrou C, Memmos D, et al. Dosing of darbepoetin alfa for the treatment of anemia in patients with end-stage renal disease being switched from recombinant human erythropoietin: Results of a phase IIIb, 27-week, multicenter, open-label study in Greek patients. Current Therapeutic Research. 2005;66:195-211.

Agrawal V, Mukherkee S, Kosuri R, Dumler F. Anemia management with darbepoetin alfa in outpatient hemodialysis patients switched from epoetin-alfa: a community hospital experience. Am J Ther. 2010;17:469-75.

Alsaran K, Sabry A, Abdulghafour M, Hji M. The efficacy of monthly administration of darbepoetin alfa in Saudi hemodialysis patients. Journal of Nephrology and Renal Transplantation (JNRT). 2009;2:1-16.

Nguyen T, Wells D. Anemia management in adult chronic hemodialysis patients using darbepoetin alfa protocol. Dialysis and Transplantation. 2007;Oct:1-5.

Remon C, Quiros P, Marchena DF, Romero MH, del Castillo R, Ruiz EF. Darbepoetin alfa in the treatment of renal anemia in the patient undergoing peritoneal dialysis and previously treated with epoietin alfa. Nefrologia. 2005;225:170-7.

Feriani M, De Meester JMJ, McMahon LP, Rottembourg JB, Bridges I, Farouk M, et al. Extended dosing of darbepoetin alfa in peritoneal dialysis patients. BMC Nephrology. 2011;12:13.

Locatelli F, Canaud B, Giacardy F, Martin-Malo A, Baker N, Wilson J. Treatment of anemia in dialysis patients with unit dosing of darbepoetin alfa at a reduced dose frequency relative to recombinant human erythropoietin (rHuEpo). Nephrol Dial Transplant. 2003;18:362-9.

Sanz-Granda A. Probabilistic cost-minimisation analysis of darbepoetin alfa versus epoetin alfa in treating anemia secondary to chronic renal failure. Assessment in Spanish clinical practice. Farm Hosp. 2009;33:208-16.

Pankewycz O, Kulaylat M, Fagan L, Matthews B, Kohli R, Laftavi MR. A prospective protocol-based trial of darbepoetin alfa therapy to correct the early anemia following renal transplantation. Transplantation Proceedings. 2010;42:3537-41.

Jimenez C, Gonzalez E, Marques M, Galeano C, Andres A, Calvo N, et al. The impact of darbepoetin alfa in early post-transplant anemia management: retrospective exploratory study. Nefrologia. 2013;33:107-15.

Goshorn J, Youell TD. Darbepoetin alfa treatment for post-renal transplantation anemia during pregnancy. Am J Kidney Dis. 2005;46:e81-6.

Schriber J, Alvarnas J, Adoo SC, Forman S. Darbepoetin alfa is an effective therapy for anemia following allogeneic stem-cell transplantation. The Journal of Supportive Oncology. 2004;2(2):28-9.

Ribes D, Kamar N, Guitard J, Esposito L, Rostaing L. Darbepoetin-alfa in renal-transplant patients: an observational monocentric study. Clin Nephrol. 2008;69:102-6.

Hattori M, Matsunaga A, Akioka Y, Fujinaga S, Nagai T, Uemura O, et al. Darbepoetin alfa for the treatment of anemia in children undergoing peritoneal dialysis: a multicenter prospective study in Japan. Clin Exp Nephrol. 2013;17:582-8.

Hattori M, Uemura O, Hataya H, Ito S, Hisano M, Ohta T, et al. Efficacy and safety of darbepoetin alfa for anemia in children with chronic kidney disease: a multicenter prospective study in Japan. Clin Exp Naphrol. 2014;18:634-41.

Can C, Emre S, Bilge I, Yilmaz A, Sirin A. Comparison of recombinant human erythropoietin and darbepoet in alfa in children. Pediatr Int. 2013;55:296-9.

Schaefer F, Hoppe B, Jungrajthmayr T, Klaus G, Pape L, Farouk M, et al. Safety and usage of darbepoetin alfa in children with chronic kidney disease: prospective registry study. Pediatr Nephrol. 2016;31:443-53.

Krause MW, Raja R, Agarwal A, Silver MR, Scarlata D, Sciarra A, et al. Every-other-week darbepoetin alfa in the correction and maintenance of haemoglobin levels in elderly patients with chronic kidney disease. Post Hoc subanalysis of data from two clinical trials. Drugs Aging. 2009;26:665-75.

Jordon J, Breckles J, Leung V, Hopkins M, Battistella M. Conversion from epoetin alfa to darbepoetin alfa: Effects on patients’ hemoglobin and costs to Canadian dialysis centres. Can J Hosp Pharm. 2012;65:443-9.

Kidney Disease: Improving Global Outcomes (KDIGO) Anemia Work Group. KDIGO clinical practice guideline for anemia in chronic kidney disease. Kidney Inter. 2012;2:279-335.

Teehan G, Benz RL. An update on the controversies in anemia management in chronic kidney disease: Lessons learned and lost. Anemia; 2011. Article ID 623673.

Downloads

Published

2017-02-24

How to Cite

Barkate, H., Kothari, J., Patel, H., Ingale, A. V., & Motlekar, S. (2017). Darbepoetin alfa: review in the management of anemia in patients with chronic kidney disease. International Journal of Basic & Clinical Pharmacology, 6(3), 474–481. https://doi.org/10.18203/2319-2003.ijbcp20170808

Issue

Section

Review Articles