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

Investigators of the MICENAS II study; Investigators of the MICENAS II study.; Martínez-Castelao, Alberto; Cases, Aleix; Coll, Elisabeth; Bonal, Jordi; Galceran, Josep M.; Galceran, Josep M; Fort, Joan; Moreso, Francesc; Torregrosa, Vicente; Guirado, Lluís; Ruiz, Pilar

doi:10.3265/Nefrologia.pre2014.Sep.12588

Article information

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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