Good practice guidelines on the use of erythropoiesis-stimulating agents in 2011
Buenas prácticas clínicas para el empleo de los agentes estimulantes de la eritropoyesis en 2011
a Dirección de Atención al Programa de Enfermedad Renal, Diálisis y Trasplante Renal, Instituto Nacional de Nefrologia Dr. Abelardo Buch López, La Habana, Cuba,
b Direccion Atencion al Programa Enfermedad Renal, Dialisis y Trasplante Renal, Instituto nacional de Nefrologia "Dr. Abelardo Buch López", La Habana, La Habana, Cuba,
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Pérez-Oliva Díaz, Jorge F. Perez-Oliva Diaz" "autores" => array:2 [ 0 => array:4 [ "Iniciales" => "J.F." "apellidos" => "Pérez-Oliva Díaz" "email" => array:1 [ 0 => "jfpolivd@infomed.sld.cu" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "affa" ] ] ] 1 => array:4 [ "nombre" => "Jorge F." "apellidos" => "Perez-Oliva Diaz" "email" => array:1 [ 0 => "jfpolivd@infomed.sld.cu" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "affb" ] ] ] ] "afiliaciones" => array:2 [ 0 => array:3 [ "entidad" => "Dirección de Atención al Programa de Enfermedad Renal, Diálisis y Trasplante Renal, Instituto Nacional de Nefrologia Dr. Abelardo Buch López, La Habana, Cuba, " "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "affa" ] 1 => array:3 [ "entidad" => "Direccion Atencion al Programa Enfermedad Renal, Dialisis y Trasplante Renal, Instituto nacional de Nefrologia "Dr. Abelardo Buch López", La Habana, La Habana, Cuba, " "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "affb" ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Buenas prácticas clínicas para el empleo de los agentes estimulantes de la eritropoyesis en 2011" ] ] "textoCompleto" => "<p class="elsevierStylePara"><span class="elsevierStyleBold">To the Editor, </span></p><p class="elsevierStylePara">As coordinator of the Kidney, Dialysis and Transplant Programme in Cuba, I would be extremely grateful if you could publish this letter. I would like to highlight my opinions regarding the safe use of erythropoiesis-stimulating agents (ESA), and give my contributions on its optimal use, which is currently subject to debate.<span class="elsevierStyleSup">1</span></p><p class="elsevierStylePara">For me, introducing recombinant human erythropoietin (rhEPO) and ESA to clinical practice following replacement dialysis has been one of the most important advances in stage 5 chronic kidney disease (CKD) treatment. These techniques are the best example of how biotechnology has been successfully applied as a clinical treatment as it is used to correct severe anaemia linked with CKD, despite the adverse results highlighted by the most recent prospective and controlled studies.<span class="elsevierStyleSup">2</span> Furthermore, we must remember that to do so we have to use supraphysiological doses of erythropoietin, justified by its non-haematopoietic effects.<span class="elsevierStyleSup">3</span></p><p class="elsevierStylePara">The reason why these studies report a greater risk to negative events, mortality and cancer makes us reflect upon important questions that are yet to be completely resolved:</p><p class="elsevierStylePara">1.   Would the population with the greatest haemoglobin levels and worst results show other rhEPO effects and be likely to have to a homogeneous analysis?</p><p class="elsevierStylePara">2.   Is the maximum rhEPO dose to be employed for each haemoglobin level clear?</p><p class="elsevierStylePara">3.   Have we considered that rhEPO dose does not have to be increased to reach any haemoglobin level?</p><p class="elsevierStylePara">4.   Are patients with adverse effects and a higher ESA dosage those with an accepted ‘accelerated atherosclerosis’ and clinical or subclinical problems determining worse results in terms of mortality, previously hyporesponsive to the ESA (ferric state actually representing a deficit or decreased availability from the deposits, acute inflammation or chronic microinflammation, secondary hyperparathyroidism, among other factors)?</p><p class="elsevierStylePara">Recently, we are reaching a crucial moment and are currently analysing a prospective, phase IV, multicentre, open, non-controlled study, to assess the effectiveness of Cuban rhEPO. We are assessing haemoglobin levels and rhEPO doses employed over a period of 12 months, the type of response over time (variability), and adverse events. We included 617 patients from 15 nephrology departments throughout Cuba.<span class="elsevierStyleSup">4</span></p><p class="elsevierStylePara">This study highlights problems in controlling haemoglobin levels and rhEPO doses similar to those detected in other international studies.<span class="elsevierStyleSup">5</span></p><p class="elsevierStylePara">I have summarised my opinion based on the current evidence, as a strategy for guaranteeing efficient ESA use with minimum risks and in line with good clinical practice:</p><p class="elsevierStylePara">1.   Avoid blood transfusions.</p><p class="elsevierStylePara">2.   Start rhEPO treatment in renal anaemia patients with haemoglobin of 10g/dl.</p><p class="elsevierStylePara">3.   Keep haemoglobin levels between 11.5g/dl and 13g/dl.</p><p class="elsevierStylePara">4.   Never try and reach the latter by increasing rhEPO doses.</p><p class="elsevierStylePara">5.   Question rhEPO doses over 8000U/week.</p><p class="elsevierStylePara">6.   Use the best intravenous iron products available, depending on the elements of iron metabolism for each patient.</p><p class="elsevierStylePara">7.   Increase the clinical method, scientific and rigorous search of the factors concerning a lack of response that are associated with ESA, undertake energetic and effective actions on this, and on those well identified mortality factors for patients with stage 5 CKD.</p><p class="elsevierStylePara">In summary, we must be careful in our prescription and assess the risk-benefit for each haemoglobin level, in accordance with each patient’s characteristics and needs. We must consider that an inadequate EPO response or using it at a high dosage is a risk marker for mortality.</p><p class="elsevierStylePara">We must not forget that stage 5 CKD patients are becoming increasingly more heterogeneous with regards epidemiological and clinical aspects and related comorbidities.</p>" "pdfFichero" => "P1-E521-S2973-A10797-EN.pdf" "tienePdf" => true "bibliografia" => array:2 [ "titulo" => "Bibliography" "seccion" => array:1 [ 0 => array:1 [ "bibliografiaReferencia" => array:5 [ 0 => array:3 [ "identificador" => "bib1" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:3 [ "referenciaCompleta" => "De Bakris G, Singh A. Managing anemia in\u{A0}CKD-new insights on a challenging problem. Medscape Nephrology,\u{A0}December\u{A0}2010. http://www.medscape.com/viewarticle/733117" "contribucion" => array:1 [ 0 => null ] "host" => array:1 [ 0 => null ] ] ] ] 1 => array:3 [ "identificador" => "bib2" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:3 [ "referenciaCompleta" => "Solomon SD, Uno H, Lewis EF, Eckardt KU, Lin J, Burdmann EA, et al.,\u{A0}Trial to Reduce Cardiovascular Events with Arasnep Therapy (TREAT) Investigators. Erytrhopoietic response and outcomes in kidney disease and type 2 diabetes. N Engl J Med 2010;362(12):1146-55." "contribucion" => array:1 [ 0 => null ] "host" => array:1 [ 0 => null ] ] ] ] 2 => array:3 [ "identificador" => "bib3" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:3 [ "referenciaCompleta" => "Ortega LM, Contreras G. El impacto clínico de los efectos fisiológicos\u{A0}de la eritropoyetina (EPO) y de los agentes estimulantes de la eritropoyetina en la incidencia de malignidad, trombosis e hipertensión: más allá de la anemia. Nefrologia 2009;29(4):288-94. <a href="http://www.ncbi.nlm.nih.gov/pubmed/19668298" target="_blank">[Pubmed]</a>" "contribucion" => array:1 [ 0 => null ] "host" => array:1 [ 0 => null ] ] ] ] 3 => array:3 [ "identificador" => "bib4" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:3 [ "referenciaCompleta" => "Hasegawa T, Bragg-Gresham JL, Pisoni RL, Robinson BM, Fukuhara S, Akiba T, et al.\u{A0}Changes in anemia management and hemoglobin levels following revisión of a bundling policy to incorpórate recombinant human erythroppoietin. Kidney Int. Published online 20 October 2010." "contribucion" => array:1 [ 0 => null ] "host" => array:1 [ 0 => null ] ] ] ] 4 => array:3 [ "identificador" => "bib5" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:3 [ "referenciaCompleta" => "Pérez-Oliva DJF. Effectiveness and Safety of ior EPOCIM in patients with Chronic Renal Failure on dialysis methods. Registro Público Cubano de Ensayos Clínicos. Reference Number: 24-076-07-B. Secondary Identifying Numbers: IIC RD-091. http://registroclinico.sld.cu/ Centro Nacional Coordinador de Ensayos Clínicos." "contribucion" => array:1 [ 0 => null ] "host" => array:1 [ 0 => null ] ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/20132514/0000003100000003/v0_201502091638/X2013251411051907/v0_201502091639/en/main.assets" "Apartado" => array:4 [ "identificador" => "35438" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Letters to the Editor - Brief papers about basic research or clinical experiences" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/20132514/0000003100000003/v0_201502091638/X2013251411051907/v0_201502091639/en/P1-E521-S2973-A10797-EN.pdf?idApp=UINPBA000064&text.app=https://revistanefrologia.com/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/X2013251411051907?idApp=UINPBA000064" ]
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