SureClick® (darbepoetina alfa) puede mejorar la satisfacción percibida y la competencia para el tratamiento de la anemia y aumentar la tasa de autoadministración en pacientes con enfermedad renal crónica no dializados

Grupo del Estudio PREFERENCE; Bonafont, Xavier; Romero, Ramón; Romero, R.; Martínez, Isabel; Martínez, I.; del Pino, María D.; del Pino, M.D.; Gil, José M.; Gil, J.M.; Aranda, Pedro; Aranda, P.; Roca, Ramón; Claverol, J.; Claverol, Joana; Cucala, M.; Cucala, Mercedes

doi:10.3265/Nefrologia.pre2012.Oct.11535

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Antecedentes y objetivos: SureClick® es una pluma precargada para la administración de darbepoetina alfa (DA), que está lista para usar. Se exploró la satisfacción del paciente con SureClick® en comparación con las jeringas precargadas. Métodos: Estudio observacional multicéntrico, prospectivo, de 6 meses, en el que se incluyeron pacientes no dializados con enfermedad renal crónica (ERC) tratados con DA en jeringas precargadas que cambiaron a SureClick® al inicio del estudio. Las principales variables fueron: cambios en el Cuestionario de Satisfacción con el Tratamiento de la Anemia (ATSQ-S), Escala de Competencia Percibida en el Manejo de la Anemia (PCAS) y el porcentaje de autoadministración. Resultados: Se incluyeron 132 pacientes con una media (± desviación estándar [DE]) de 71,3 (14,6) años y un 57,6 % de mujeres. Las puntuaciones basales y finales medias (DE) en la ATSQ-S fueron, respectivamente, 25,5 (7,9) y 31,6 (4,9) (en una escala de 0 a 36-máxima satisfacción, cambio medio: 6,2, intervalo de confianza [IC] 95%: 4,6-7,8, p < 0,0001). La puntuación de la PCAS también aumentó significativamente (4,3 [2,0] vs. 5,6 [1,6], en una escala de 1 a 7-máxima competencia, p < 0,0001). Al inicio del estudio, el 47,7 % de los pacientes se autoadministraba DA con jeringas precargadas, frente al 74,2 % con SureClick® (p < 0,001). No hubo cambios significativos en el nivel medio de hemoglobina (11,4 [0,5] vs. 11,6 [1,3] g/dl, p = 0,193). Dos pacientes (1,5 %) presentaron reacciones adversas a SureClick® (dolor en el lugar de aplicación). Conclusiones: Los resultados sugieren que el cambio de jeringas precargadas a SureClick® podría aumentar la satisfacción del paciente y la percepción de la competencia en el manejo de la anemia en pacientes con ERC no dializados, y podría aumentar la tasa de autoadministración, lo que reduciría el uso de recursos sanitarios.

Palabras clave:

Anemia

Palabras clave:

Competencia

Palabras clave:

Enfermedad renal crónica

Palabras clave:

Satisfacción

Palabras clave:

Darbepoetina alfa

Background and aims: SureClick® is a prefilled pen for administration of darbepoetin alfa (DA) that is ready-to-use. We explored patient satisfaction with SureClick® compared with prefilled syringes (PFS). Methods: Multicenter, prospective, 6-months, observational study in non-dialyzed patients with chronic kidney disease (CKD) treated with DA in PFS who switched to SureClick® at baseline. Main outcomes were: change in Anemia Treatment Satisfaction Questionnaire (ATSQ-S), Perceived Competence for Anemia Scale (PCAS) and self-administration rate. Results: We enrolled 132 patients with a mean(SD) age of 71.3 (14.6) years, 57.6% women. Mean(SD) ATSQ-S scores at baseline and final records were 25.5 (7.9) and 31.6 (4.9) (on a scale from 0 to 36 –maximum satisfaction-, mean change: 6.2, 95%CI: 4.6-7.8, p<0.0001). The PCAS also increased significantly (4.3 (2.0) vs 5.6 (1.6), on a scale from 1 to 7 –maximum competence, p<0.0001). At baseline 47.7% of patients self-administered DA with PFS, vs 74.2% with SureClick® (p<0.001). No significant changes in hemoglobin were observed (11.4 (0.5) vs 11.6 (1.3) g/dl, p=0.193). Two patients (1.5%) had adverse reactions to SureClick® (pain on application). Conclusions: Our results suggest that the change from PFS to SureClick® could increase patient satisfaction and perceived competence in anemia management in non-dialyzed CKD patients, and could increase the self-administration rate, thereby reducing use of health resources.

Keywords:

Anemia

Keywords:

Competence

Keywords:

Chronic kidney disease

Keywords:

Satisfaction

Keywords:

Darbepoetin alfa

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Bibliografía

[1]

Williams G, Frankel R, Campbell T, Deci E. Research on relationship-centered care and healthcare outcomes from the Rochester Biopsychosocial Program: a self-determination theory integration. Families Systems & Health 2000;18:79-90.

[2]

Williams GC, McGregor HA, Zeldman A, Freedman ZR, Deci EL. Testing a self-determination theory process model for promoting glycemic control through diabetes self-management. Health Psychol 2004;23(1):58-66. [Pubmed]

[3]

Williams GC, Freedman ZR, Deci EL. Supporting autonomy to motivate patients with diabetes for glucose control. Diabetes Care 1998;21(10):1644-51. [Pubmed]

[4]

Balshaw-Greer A, Casey J. Encouraging self-administration of erythropoietin. EDTNA ERCA J 2003;29(2):96-9. [Pubmed]

[5]

Kleophas W, Kult J, Kreusser W, Piper C, Plache H, Wunderle P, et al. Tolerability and efficacy of multidose epoetin beta (Reco-Pen) for subcutaneous administration in patients with anemia due to renal failure. Kidney Blood Press Res 2003;26(3):192-8. [Pubmed]

[6]

Centers of Disease Control and Prevention. Workbook for Designing, Implementing, and Evaluating a Sharps Injury Prevention Program. Available at: http://www.cdc.gov/sharpssafety/ [Accessed: April 18, 2012].

[7]

Weiss L. A rationale for an individualized administration frequency of epoetin beta: a clinical perspective. Nephrol Dial Transplant 2002;17 Suppl 6:8-12. [Pubmed]

[8]

U.S. Department of Labor. Occupational Safety & Health Administration. Bloodborne Pathogens and Needlestick Prevention. Possible Solutions. Available at: http://www.osha.gov/SLTC/bloodbornepathogens/ [Accessed: April 18, 2012].

[9]

Emery C, Fagnani F, Pérez Niddam K, Issad B. Le stylo injecteur d'EPO beta chez les patients dialysés: acceptabilité, satisfaction et bilan économique. Presse Med 2003;32(40):1907-12. [Pubmed]

[10]

Ruiz P, Balcke P, Martinez J, Harris K. Tolerability of the Epoetin-Beta multidose formulation (Reco-Pen) in patients with renal anaemia. Clin Drug Investig 2000;20(3):151-8.

[11]

Bradley C. Handbook of psychology and diabetes: a guide to psychological measurement in diabetes research and management. Chur, Switzerland: Harwood Academic Publishers; 1994.

[12]

Woodcock A, Bradley C. Validation of the HIV treatment satisfaction questionnaire (HIVTSQ). Qual Life Res 2001;10(6):517-31. [Pubmed]

[13]

Barendse S, Bradley C. The RTSQ (Renal Treatment Satisfaction Questionnaire): A condition-specific measure of satisfaction with treatment for end-stage renal failure. Peritoneal Dialysis Int 2000;20(1):S82.

[14]

Woodcock A, Bradley C, Plowright R, Kennedy-Martin T, Hirsch A. Patient experiences of treatment for diabetic retinopathy: development of a retinopathy-specific treatment satisfaction questionnaire. Diabet Med 2003;19 Suppl 2:10.

[15]

Gomis R, Herrera-Pombo J, Caderón A, Rubio-Terrès C, Sarasa P. Validación del cuestionario Diabetes treatment satisfaction questionnaire (DTSQ) en la población española. Pharmacoeconomics Sp Res Art 2006;3:7-18.

[16]

Bradley C, Plowright R, Stewart J, Valentine J, Witthaus E. The Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) evaluated in insulin glargine trials shows greater responsiveness to improvements than the original DTSQ. Health Qual Life Outcomes 2007;5:57. [Pubmed]

[17]

Williams GC, McGregor H, Sharp D, Kouides RW, Lévesque CS, Ryan RM, et al. A self-determination multiple risk intervention trial to improve smokers' health. J Gen Intern Med 2006;21(12):1288-94. [Pubmed]

[18]

Bonafont X, Pérez A, Ardèvol M, Pérez C, Bonal J, Romero R. Acceptance and self-administration rate of a new administration from of darbepoetin alfa (SureClick) in predialysis chronic kidney disease patients. 7th Spring Conference on Clinical Pharmacy. Oral Communication. PC-65. 2007.

[19]

McCoy EK, Wright BM. A review of insulin pen devices. Postgrad Med 2010;122(3):81-8. [Pubmed]

[20]

Borras-Blasco J, Gracia-Perez A, Rosique-Robles JD, Castera MD, Abad FJ. Acceptability of switching adalimumab from a prefilled syringe to an autoinjection pen. Expert Opin Biol Ther 2010;10(3):301-7. [Pubmed]

[21]

Pfützner A, Hartmann K, Winter F, Fuchs GS, Kappelgaard AM, Rohrer TR. Intuitiveness, ease of use, and preference of a prefilled growth hormone injection pen: a noninterventional, randomized, open-label, crossover, comparative usability study of three delivery devices in growth hormone-treated pediatric patients. Clin Ther 2010;32(11):1918-34. [Pubmed]

[22]

Welcker JT, Nawroth F, Bilger W. Patient evaluation of the use of follitropin alfa in a prefilled ready-to-use injection pen in assisted reproductive technology: an observational study. Reprod Biol Endocrinol 2010;8:111. [Pubmed]

[23]

Gallup E. Coverage inequalities of new therapies for rheumatoid arthritis in a managed care setting. Manag Care Interface 2001;14(7):52-4, 57-8, 69. [Pubmed]

[24]

Somkuti SG, Schertz JC, Moore M, Ferrande L, Kelly E. Patient experience with follitropin alfa prefilled pen versus previously used injectable gonadotropins for ovulation induction in oligoanovulatory women. Curr Med Res Opin 2006;22(10):1981-96. [Pubmed]

[25]

Korytkowski M, Bell D, Jacobsen C, Suwannasari R. A multicenter, randomized, open-label, comparative, two-period crossover trial of preference, efficacy, and safety profiles of a prefilled, disposable pen and conventional vial/syringe for insulin injection in patients with type 1 or 2 diabetes mellitus. Clin Ther 2003;25(11):2836-48. [Pubmed]

[26]

Kivitz A, Cohen S, Dowd JE, Edwards W, Thakker S, Wellborne FR, et al. Clinical assessment of pain, tolerability, and preference of an autoinjection pen versus a prefilled syringe for patient self-administration of the fully human, monoclonal antibody adalimumab: the TOUCH trial. Clin Ther 2006;28(10):1619-29. [Pubmed]

[27]

Reimer T, Hohberg C, Pfützner AH, Jørgensen C, Jensen KH, Pfützner A. Intuitiveness, instruction time, and patient acceptance of a prefilled insulin delivery device and a reusable insulin delivery device in a randomized, open-label, crossover handling study in patients with type 2 diabetes. Clin Ther 2008;30(12):2252-62. [Pubmed]

[28]

Weiss N. Gonadotrophin products: empowering patients to choose the product that meets their needs. Reprod Biomed Online 2007;15(1):31-7. [Pubmed]

[29]

Emery C, Fagnani F, Niddam KP, Issad B. [The EPO beta injection pen in patients in maintenance dialysis or predialysis: acceptability, satisfaction and cost assessment]. Presse Med 2003;32(40):1907-12. [Pubmed]

[30]

Aranesp (darbepoetin alfa) prescribing information. Amgen Inc. February 2010. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103951s5170lbl.pdf [Accessed: April 18, 2012].

[31]

Sousa A, Pimenta S, editors. Efficacy Of Darbepoetin Alfa (Aranesp®) Once Monthly (Qm) In Patients With Chronic Kidney Disease - Clinical Experience With Aranesp® Sureclick¿ [SP422]. XLIII ERA-EDTA CONGRESS, JULY 15-18, 2006 - GLASGOW, UNITED KINGDOM. http://wwwabstracts2viewcom/era_archive/viewphp?nu=ERA06L_1604; 2006.

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