Resumen
Objetivo:Eplerenona disminuye la mortalidad y reduce las hospitalizaciones en pacientes con insuficiencia cardiaca tras infarto agudo de miocardio (IAM). El objetivo del estudio fue determinar el coste-efectividad de incorporar eplerenona a la terapia médica estándar (TE) en el tratamiento de la insuficiencia cardiaca post-IAM, desde la perspectiva del Sistema Nacional de Salud español.
Métodos: Se analizó la relación coste-efectividad de eplerenona con TE frente a TE en términos de años de vida ganados (AVG) y años de vida ganados ajustados por calidad (AVAC). Los datos de eficacia se obtuvieron de los 16 meses de seguimiento medio del estudio EPHESUS. La supervivencia se estimó a partir de la base de datos epidemiológica Framingham. Los costes unitarios se obtuvieron de una base de datos sanitaria española (€ de 2008). Sólo se consideraron costes médicos directos. Se aplicó una tasa de descuento anual del 3% a costes y a resultados en salud. Se realizó un análisis de sensibilidad considerando los AVG a partir de las bases de datos epidemiológicas Saskatchewan y Worcester.
Resultados: El número de AVG con eplerenona fue de 0,1014 frente a TE. El coste total fue 660 € superior con eplerenona debido principalmente al coste de adquisición del fármaco (744 €). La relación coste-efectividad incremental de eplerenona frente a TE fue de 6.506 €/AVG y 9.759 €/AVAC. El análisis de sensibilidad confirmó la robustez de los resultados (10.374 €/AVG con Saskatchewan y 4.933€/AVG con Worcester).
Conclusiones: El empleo de eplerenona incorporada a la terapia estándar en pacientes con insuficiencia cardiaca secundaria a IAM es una terapia eficiente en España.
Abstract
Objective: Eplerenone reduces mortality and hospitalizations in patients with heart failure secondary to acute myocardial infarction (AMI). The aim of this study was to assess the cost-effectiveness of adding eplerenone to standard treatment (ST) for post-AMI heart failure from a Spanish Health National System perspective.
Methods: The incremental cost-effectiveness ratio of eplerenone versus ST was assessed by means of the life years gained (LYG) and quality-adjusted life years (QALY) gained. Efficacy data were obtained from the average follow-up period of 16 months in EPHESUS study. Survival estimates were based on the Framingham epidemiologic database. Unitary costs (€ 2008) were obtained from a Spanish cost database. Only direct medical costs were considered. A 3% annual discount rate was applied to cost and health benefits. Deterministic sensitivity analyses were performed based on LYG obtained from Saskatchewan and Worcester databases.
Results: Eplerenone versus ST yields 0.1014 LYG. Total cost with eplerenona was 660 € higher due to pharmacological cost (744 €). Incremental cost-effectiveness ratio of eplerenone versus ST was 6.506 €/LYG and 9.759 €/QALY. Robustness of results was confirmed by the sensitivity analyses (10.374 €/LYG with Saskatchewan and 4.933 €/LYG with Worcester).
Conclusions: The addition of eplerenone to ST in patients with heart failure secondary to AMI is an efficient therapy in Spain.
Bibliografía
McKee PA, Castelli WP, McNamara PM, et al. The natural history of congestive heart failure: the Framingham study. N Engl J Med. 1971;285:1441–6.
Levy D, Kenchaiah S, Larson MG, et al. Long-term trends in the incidence of and survival with heart failure. N Engl J Med. 2002;347:1397–402.
Mosterd A, Hoes AW. Clinical epidemiology of heart failure. Heart. 2007;93:1137–46.
Boix R, Almazán J, Medrano MJ. Mortalidad por insuficien-cia cardíaca en España, 1977–1998. Rev Esp Cardiol 2002;55:219–26.
Rodriguez-Artalejo F, Banegas Banegas JR, Cuallar-Castillon P. Epidemiología de la insuficiencia cardíaca. Rev Esp Cardiol 2004;57:163–70.
Muñiz García J, Crespo Leiro MG, Castro Beiras A. Insuficiencia cardíaca en España. Epidemiología e importancia del grado de adecuación a las guías de práctica clínica. Rev Esp Cardiol 2006;(supl 6):2F–8F.
Steg G, Dabbous OH, Feldman LJ, et al. Determinants and Prognostic Impact of Heart Failure Complicating Acute Coronary Syndromes: Observations from the Global Registry of Acute Coronary Events (GRACE). Circulation 2004;109:494–9.
Weir RA, McMurray JJ. Epidemiology of heart failure and left ventricular dysfunction after acute myocardial infarction. Curr Heart Fail Rep. 2006;3:175–80.
Weir RA, McMurray JJ, Velazquez EJ. Epidemiology of heart failure and left ventricular systolic dysfunction after acute myocardial infarction: prevalence, clinical characteristics, and prognostic importance. Am J Cardiol. 2006;97:13F–25F.
Worner F, Viles D, Díez-Aja S. Epidemiología y pronóstico de la insuficiencia cardíaca postinfarto. Rev Esp Cardio 2006;(supl 6):3B–14B.
Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Pérez A, et al. For the Randomized Aldactone Evolution Study Investigators. The effect of spironolactone on morbidity and mortality in patiients with severe heart failure. N Engl J Med 1999; 341; 709–717.
Pitt B, Remme W, Zannad F, et al. Epleronone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med. 2003;348:1309–21.
Jimenez Navarro MF, García Pinilla JM, Montiel Trujillo A, et al. Tratamiento médico de la insuficiencia cardíaca por disfunción sistólica. Rev Esp Cardiol 2006;6(supl):46F–52F.
López-Sendón J, López de Sa E. Problemas en la aplicación de las guías de práctica clínica en la insuficiencia cardíaca post-infarto. Rev Esp Cardiol 2006;(supl 6):59B–68B.
Dickstein K, Cohen-Solal A, Filippatos G, et al. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2008. The task force for the diagnosis and treatment of acute and chronic heart failure 2008 of the European society of Cardiology. Developed in collaboration with the Heart Failure Association of the ESC (HFA) and endorsed by the European Society of Intensive Care Medicine (ESICM). Eur J Heart Fail. 2008;10:933–89.
Spertus JA, Tooley J, Jones P, et al. Expanding the outcomes in clinical trials of heart failure: The quality of life and economic components of EPHESUS (EPlerenone’s neuroHormonal Efficacy and Survival Study). Am Heart J. 2002;143:636–42.
Weintraub WS, Zhang Z, Mahoney EM, et al. Cost-effectiveness of eplerenone compared with placebo in patients with myocardial infarction complicated by left ventricular dysfunction and heart failure. Circulation. 2005;111:1106–13.
Kvasz Z, Spertus JA, Pitt B, et al. Cost-effectiveness of eplerenone by age and sex subgroups in patients with heart failure after myocardial infarction: results from EPHESUS [abstract no 1753]. Circulation 2004; 110(suppl 17):367.
Szucs TD, Holm MV, Schwenkglenks M, et al. Cost-effec. tiveness of eplerenona in patients with left ventricular dysfunction after myocardial infarction-an analysis of the EPHESUS study from a Swiss perspective. Cardiovasc Drugs Ther. 2006;20:193–204.
Pouvourville G, Solesse A, Beillat M. Cost-effectiveness analysis of aldosterone blockade with eplerenone in patients with heart failure after acute myocardial infarction in the French context: The EPHESUS study. Arch Cardiovasc Dis 2008;101:515–21.
López Bastida J, Oliva J, Antoñanzas F, et al. Propuesta de guía para la evaluación económica aplicada a las tecnologías sanitarias. Gac Sanit. 2010;24:154–70.
Peeters A, Mamun AA, Willekens F, et al. A cardiovascular life history. A life course analysis of the original Framingham Heart Study cohort. Eur Heart J. 2002;23:45–66.
Downey W, Beck P, McNutt M, et al. Health databases in Saskatchewan. In: Strol BL, ed. Pharmacoepidemiology. 3rd ed. Chichester, UK: Wiley;2000:325–45.
Saskatchewan Health. Health Services Databases: Information document, 2004. Saskatchewan Health Services Databases: information document, June 2004. http://www.health.gov. sk.ca/mc_dp_phb_infodoc_0604.pdf.
Pickett W, Day L, Hagel L, et al. The Saskatchewan Farm Injury Cohort: rationale and methodology. Public Health Rep. 2008;123:567–75.
Goldberg RJ, Yarzebski J, Lessard D, et al. A two decades (1975 to 1995) long experience in the incidence, in-hospital and long-term case-fatality rates of acute myocardial infarction: a community-wide perspective. J Am Coll Cardiol. 1999;33:1533–39.
Spencer FA, Meyer TE, Goldberg RJ, et al. Twenty year trends (1975–1995) in the incidence, in-hospital and long-term death rates associated with heart failure complicating acute myocardial infarction: a community-wide perspective. J Am Coll Cardiol. 1999;34:1378–87.
Rabin R, De Charro F. EQ-5D: a measure of health status from the EuroQoL group. Ann Med. 2001;33:337–43.
Consejo General de Colegios de Farmacéuticos. Catálogo de Especialidades Farmacéuticas. Consejo Plus 2007. Madrid: Consejo General de Colegios de Farmacéuticos 2007. Disponible en: http://www.portalfarma.com.
Sacristán JA, Oliva J, Del Llano J, et al. ¿Qué es una tecnología sanitaria eficiente en España? Gac San 2002;16:334–43.
Barbieri M, Drummond M, Willke R, et al. Variability of cost-effectiveness estimates for pharmaceuticals in Western Europe: lessons for inferring generalizability. Value Health 2005;8:10–23.
De Cock E, Miratvilles M, González-Juanatey JR, et al. Valor umbral del coste por año de vida ganado para recomendar la adopción de tecnologías sanitarias en España: evidencias procedentes de una revisión de la literatura. Pharmacoeconomics Spanish Res Art 2007;4:97–107.
Croom KF, Plosker GL. Eplerenone: a pharmacoeconomic review of its use in patients with post-myocardial infarction heart failure. Pharmacoeconomics. 2005;23:1057–1072.
Weir R, McMurray JJ. Treatments that improve outcome in the patient with heart failure, left ventricular systolic dysfunction, or both after acute myocardial infarction. Heart. 2005;91(Suppl 2):17–20.
Struthers A, Krum H, Williams GH. A comparison of the aldosterone-blocking agents eplerenone and spironolactone. Clin Cardiol 2008;31:153–8.
Badia X, Bueno H, González Juanatey JR, et al. Análisis de la relación coste-efectividad a corto y largo plazo de clopidogrel añadido a terapia estándar en pacientes con síndrome coronario agudo en España. Rev Esp Cardiol. 2005;58:1385–95.
Latour-Pérez J, Navarro-Ruiz A, Ridao-López M, et al. Using clopidogrel in non-ST-segment elevation acute coronary syndrome patients: a cost-utility analysis in Spain. Value Health. 2004;7:52–60.
Díez Manglano J. Análisis coste-efectividad y coste-beneficio del tratamiento con bloqueadores beta de la insuficiencia cardíaca congestiva en España. Rev Clin Esp. 2005;205:149–56.
Hart WM, Rubio-Terrés C, Margalet Fernández I, et al. Análisis coste-efectividad del tratamiento con Ramipril de pacientes con alto riesgo de padecer eventos cardiovasculares en España. An Med Interna. 2002;19:515–20.
Soto Alvarez J, González Vilchez F. Análisis coste-efectividad del uso de espironolactona en el tratamiento de la insuficiencia cardíaca crónica. An Med Interna. 2001;18:421–5.
Goeree R, Burke N, O’Reilly D et al. Transferability of economic evaluations: approaches and factors to consider when using results form one geographic area for another. Curr Med Res Opin 2007;23:671–82.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
López-Sendón, J.L., Martí-Sánchez, D., Martí, B. et al. Análisis coste-efectividad de eplerenona en pacientes con insuficiencia cardiaca post-infarto agudo de miocardio. Pharmacoecon. Span. Res. Artic. 8, 39–50 (2011). https://doi.org/10.1007/BF03320887
Published:
Issue Date:
DOI: https://doi.org/10.1007/BF03320887