Información de la revista
Vol. 35. Núm. 1.enero 2015
Páginas 1-124
Vol. 35. Núm. 1.enero 2015
Páginas 1-124
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C.E.R.A. en administración mensual corrige y mantiene niveles estables de hemoglobina en pacientes con Enfermedad Renal Crónica no en diálisis: estudio observacional MICENAS II
C.E.R.A. administered once monthly corrects and maintains stable hemoglobin levels in chronic kidney disease patients not on dialysis: the observational study MICENAS II
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Investigators of the MICENAS II study, Investigators of the MICENAS II study., Alberto Martínez-Castelaob, Aleix Casesc, Elisabeth Colld, Jordi Bonale, Josep M. Galceranf, Josep M Galcerang, Joan Forth, Francesc Moresob, Vicente Torregrosac, Lluís Guiradod, Pilar Ruizi
b Servicio de Nefrología, Hospital Universitari de Bellvitge Barcelona, Barcelona, Spain,
c Servicio de Nefrología, Hospital Clínic, Barcelona, Barcelona, Spain,
d Servicio de Nefrología, Fundació Puigvert, Barcelona, Barcelona, Spain,
e Servicio de Nefrología, Hospital Germans Trías i Pujol, Barcelona, Barcelona, Spain,
f Servicio de Nefrología, Fundación Althaia, Manresa, Barcelona,
g Servicio de Nefrología, Fundación Althaia, Manresa, Barclelona, Spain,
h Servicio de Nefrología, Hospital Vall d'Hebron, Barcelona, Barcelona, Spain,
i Servicio de Nefrología, Hospital Dos de Maig, Barcelona, Barcelona, Spain,
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Introducción y objetivo: C.E.R.A. (activador continuo del receptor de la eritropoyetina) administrado una vez al mes corrige y mantiene estables los niveles de hemoglobina en pacientes con enfermedad renal crónica (ERC). Este estudio fue diseñado para evaluar el manejo de la anemia con C.E.R.A. en pacientes con ERC no en diálisis (ERC-ND) en la práctica clínica. Métodos: Estudio observacional, retrospectivo y multicéntrico, llevado a cabo en pacientes con anemia asociada a ERC-ND en tratamiento con C.E.R.A. durante 2010. Se recogieron datos demográficos, parámetros de laboratorio relacionados con la anemia, datos del tratamiento y estado del hierro. Resultados: El tratamiento con C.E.R.A. logró un buen control de la anemia tanto en los pacientes naïve (hemoglobina media 11,6 g/dl) como en aquellos en conversión desde otros agentes estimulantes de la eritropoyesis (hemoglobina media 11,7 g/dl). La mayoría de los pacientes naïve recibieron C.E.R.A. una vez al mes durante el período de corrección y requirieron una dosis mensual baja (dosis mediana 75 µg/mes). Las dosis de C.E.R.A. utilizadas en pacientes en conversión fueron inferiores a las dosis de conversión recomendadas en la ficha técnica. El estatus del hierro fue adecuado en el 75 % de los pacientes con anemia asociada a ERC-ND, y únicamente el 50 % de aquellos con deficiencia de hierro recibieron suplementos de hierro. Conclusiones: En pacientes con anemia asociada a ERC-ND, naïve o en conversión, la administración mensual de C.E.R.A. corrige y mantiene estables los niveles de hemoglobina, incluso en dosis inferiores a las recomendadas en la ficha técnica.

Palabras clave:
Activador continuo del receptor de la eritropoyetina
Palabras clave:
Agentes estimulantes de la eritropoyesis
Palabras clave:
Enfermedad renal crónica
Palabras clave:
Anemia

Background and objective: C.E.R.A. (continuous erythropoietin receptor activator, pegilated-rHuEPO ß) corrects and maintains stable hemoglobin levels in once-monthly administration in chronic kidney disease (CKD) patients. The aim of this study was to evaluate the management of anemia with C.E.R.A. in CKD patients not on dialysis in the clinical setting. Methods: Two hundred seventy two anemic CKD patients not on dialysis treated with C.E.R.A. were included in this retrospective, observational, multicentric study during 2010. Demographical characteristics, analytical parameters concerning anemia, treatment data and iron status were recorded. Results: C.E.R.A. achieved a good control of anemia in both naïve patients (mean Hemoglobin 11.6g/dL) and patients converted from a previous ESA (mean Hemoglobin 11.7g/dL). Most naïve patients received C.E.R.A. once monthly during the correction phase and required a low monthly dose (median dose 75µg/month). The same median dose was required in patients converted from a previous ESA, and it was lower than recommended in the Summary of Product Characteristics (SPC). Iron status was adequate in 75% of anemic CKD patients, but only 50% of anemic patients with iron deficiency received iron supplementation. Conclusions: C.E.R.A. corrects and maintains stable hemoglobin levels in anemic CKD patients not on dialysis, requiring conversion doses lower than those recommended by the SPC, and achieving target hemoglobin levels with once-monthly dosing frequency both in naïve and converted patients.

Keywords:
Continuous erythropoietin receptor activator
Keywords:
Erythropoiesis stimulating agents
Keywords:
Chronic kidney disease (CKD)
Keywords:
Anemia
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Bibliografía
[1]
Jones M, Ibels L, Schenkel B, Zagari M. Impact of epoetin alfa on clinical end points in patients with chronic renal failure: a meta-analysis. Kidney Int 2004;65(3):757-67. [Pubmed]
[2]
Levin A. Anemia and left ventricular hypertrophy in chronic kidney disease populations: a review of the current state of knowledge. Kidney Int Suppl 2002;(80):35-8.
[3]
Locatelli F, Covic A, Eckardt KU, Wiecek A, Vanholder R. Anaemia management in patients with chronic kidney disease: a position statement by the Anaemia Working Group of European Renal Best Practice (ERBP). Nephrol Dial Transplant 2009;24(2):348-54. [Pubmed]
[4]
Singh AK, Szczech L, Tang KL, Barnhart H, Sapp S, Wolfson M, et al. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med 2006;355(20):2085-98. [Pubmed]
[5]
Drueke TB, Locatelli F, Clyne N, Eckardt KU, Macdougall IC, Tsakiris D, et al. Normalization of hemoglobin level in patients with chronic kidney disease and anemia. N Engl J Med 2006;355(20):2071-84. [Pubmed]
[6]
Pfeffer MA, Burdmann EA, Chen CY, Cooper ME, de Zeeuw D, Eckardt KU, et al. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med 2009;361(21):2019-32. [Pubmed]
[7]
Palmer SC, Navaneethan SD, Craig JC, Johnson DW, Tonelli M, Garg AX, et al. Meta-analysis: erythropoiesis-stimulating agents in patients with chronic kidney disease. Ann Intern Med 2010;153(1):23-33. [Pubmed]
[8]
Clement FM, Klarenbach S, Tonelli M, Johnson JA, Manns BJ. The impact of selecting a high hemoglobin target level on health-related quality of life for patients with chronic kidney disease: a systematic review and meta-analysis. Arch Intern Med 2009;169(12):1104-12. [Pubmed]
[9]
Parfrey PS, Lauve M, Latremouille-Viau D, Lefebvre P. Erythropoietin therapy and left ventricular mass index in CKD and ESRD patients: a meta-analysis. Clin J Am Soc Nephrol 2009;4(4):755-62. [Pubmed]
[10]
KDOQI Clinical Practice Guideline and Clinical Practice Recommendations for anemia in chronic kidney disease: 2007 update of hemoglobin target. Am J Kidney Dis 2007;50(3):471-530. [Pubmed]
[11]
Locatelli F, Aljama P, Canaud B, Covic A, De FA, Macdougall IC, et al. Target haemoglobin to aim for with erythropoiesis-stimulating agents: a position statement by ERBP following publication of the trial to reduce cardiovascular events with Aranesp therapy (TREAT) study. Nephrol Dial Transplant 2010;25(9):2846-50. [Pubmed]
[12]
KDIGO Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int Suppl 2012;2:279-335.
[13]
Jarsch M, Brandt M, Lanzendorfer M, Haselbeck A. Comparative erythropoietin receptor binding kinetics of C.E.R.A. and epoetin-beta determined by surface plasmon resonance and competition binding assay. Pharmacology 2008;81(1):63-9. [Pubmed]
[14]
Macdougall IC, Robson R, Opatrna S, Liogier X, Pannier A, Jordan P, et al. Pharmacokinetics and pharmacodynamics of intravenous and subcutaneous continuous erythropoietin receptor activator (C.E.R.A.) in patients with chronic kidney disease. Clin J Am Soc Nephrol 2006;1(6):1211-5. [Pubmed]
[15]
MIRCERA® Summary of Product Characteristics. F. Hoffmann-La Roche Ltd. 2007.
[16]
Frimat L, Mariat C, Landais P, Kone S, Commenges B, Choukroun G. Anaemia management with C.E.R.A. in routine clinical practice: OCEANE (Cohorte Mircera patients non-dialyses), a national, multicenter, longitudinal, observational prospective study, in patients with chronic kidney disease not on dialysis. BMJ Open 2013;3(3). [Pubmed]
[17]
Heidenreich S, Leistikow F, Zinn S, Baumann J, Atzeni A, Bajeski V, et al. Monthly administration of a continuous erythropoietin receptor activator provides efficient haemoglobin control in non-dialysis patients during routine clinical practice: results from the non-interventional, single-cohort, multicentre, SUPRA study. Clin Drug Investig 2012;32(2):99-110. [Pubmed]
[18]
Minutolo R, Zamboli P, Chiodini P, Mascia S, Vitiello S, Stanzione G, et al. Conversion of darbepoetin to low doses of CERA maintains hemoglobin levels in non-dialysis chronic kidney disease patients. Blood Purif 2010;30(3):186-94. [Pubmed]
[19]
Sanchez-Fructuoso A, Guirado L, Ruiz JC, Torregrosa V, Gonzalez E, Suarez ML, et al. Anemia control in kidney transplant patients treated with methoxy polyethylene glycol-epoetin beta (mircera): the Anemiatrans Group. Transplant Proc 2010;42(8):2931-4. [Pubmed]
[20]
Macdougall IC, Walker R, Provenzano R, de Alvaro F, Locay HR, Nader PC, et al. C.E.R.A. corrects anemia in patients with chronic kidney disease not on dialysis: results of a randomized clinical trial. Clin J Am Soc Nephrol 2008;3(2):337-47. [Pubmed]
[21]
Roger SD, Locatelli F, Woitas RP, Laville M, Tobe SW, Provenzano R, et al. C.E.R.A. once every 4 weeks corrects anaemia and maintains haemoglobin in patients with chronic kidney disease not on dialysis. Nephrol Dial Transplant 2011;26(12):3980-6. [Pubmed]
[22]
Choi JY, Yang CW, Kim YH, Joo KW, Yoo TH, Lee KW, et al. Effect of conversion from ESA with shorter half-life to CERA once monthly for maintaining Hb concentration in pre-dialysis CKD patients. Kidney Blood Press Res 2013;37:259-68. [Pubmed]
[23]
Parfrey PS. Critical appraisal of randomized controlled trials of anemia correction in patients with renal failure. Curr Opin Nephrol Hypertens 2011;20(2):177-81. [Pubmed]
[24]
Horl WH. Non-erythropoietin-based anaemia management in chronic kidney disease. Nephrol Dial Transplant 2002;17 Suppl 11:35-8. [Pubmed]
[25]
Roger S. The CARI guidelines. Haematological targets. Iron. Nephrology (Carlton) 2006;11 Suppl 1:S217-29.
[26]
Besarab A, Coyne DW. Iron supplementation to treat anemia in patients with chronic kidney disease. Nat Rev Nephrol 2010;6(12):699-710. [Pubmed]
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