Tipo de análisis Para llevar a cabo la evaluación correspondiente, se plantea la realización de una evaluación costo-efectividad: determinaremos, por un lado, los costos que implican la aplicación de cada una de las alternativas. Así mismo, estableceremos los resultados en salud que midan el efecto de los tratamientos a evaluar.
Comparadores El único tratamiento específico, hasta ahora aceptado desde 1996 por la FDA para el EVC, es la trombolisis intravenosa con activador tisular de plasminógeno obtenido por el proceso de recombinación (rTPA). Hasta ahora no se ha tenido éxito para obtener un medicamento que funcione como neuroprotector. En estudios previos se utilizaron se consideraron como grupo control, pacientes que recibieron como terapia antihipertensiva y antiagregataria estándar.
Horizonte temporal y perspectiva En estudios clínicos, la efectividad del tratamiento se observa al final de la última dosis (de 2 a 4 semanas) y posteriormente se realizan evaluaciones de seguimiento entre 60 y 90 días. La perspectiva del estudio es la de las instituciones públicas de salud.
Análisis de sensibilidad Se realizará un análisis de sensibilidad univariado en diferentes parámetros y otro de tipo escenarios extremos, para evaluar aquellos parámetros que puedan resultar influyentes en los resultados del modelo. Algunos de ellos son:
Precio de los tratamientos
Costo de las complicaciones
Duración de la estancia hospitalaria
Finalmente, se elaborará un análisis probabilístico que incorpore las distribuciones encontradas en los costos y en las efectividades reportadas en la literatura internacional sobre los diferentes tratamientos, con la finalidad de obtener datos de una forma más certera y de presentar resultados más robustos de la evaluación.
CRONOGRAMA (sERÁ ACTUALIZADO A LA NUEVA FECHA)

ENTREGABLES Al finalizar el estudio los documentos entregados serán:
Documento Final de la Evaluación Económica
Soporte en medio magnético de:
Documento Final, en formato pdf
Resumen Ejecutivo, en formato pdf
Presentación de Resultados, en formato ppt
Copia Full Text de estudios clínicos utilizados (de acuerdo con políticas de Derechos de Autor)
Soporte Base de Datos Modelo Matemático/Económico (si se aplica) formato según software utilizado.
Soporte Encuestas Instrumento, aplicación y base de datos (si se aplica).
A la espera de poder resolver cualquier inquietud o comentario adicional.
 León Zapata Sánchez
Director General
REFERENCIAS
Liu M, Counsell C, Zhao XL, Wardlaw J. . Agentes desfibrinogenantes para el accidente cerebrovascular isquémico agudo (Cochrane Review). In: La Biblioteca Cochrane Plus, Issue 3, CD000091.
Bath PMW, Bath-Hextall FJ . Pentoxifilina, propentofilina y pentifilina para el accidente cerebrovascular isquémico agudo (Cochrane Review). In: La Biblioteca Cochrane Plus, Issue 3, CD000162.
Fajardo G. Prevalencias, discapacidades, fallecimientos y costos de la enfermedad. Arch neurocien (Mex) 2000; 5(4): 205-210.
World Development Report: Investing in Health. London, England: Oxford University Press, 1993.
Villanueva J. Enfermedad vascular cerebral: factores de riesgo y prevención secundaria. An Med Interna (Madrid) 2004; 21:159-160.
Hinkle JL, McKenna M, Acute Ischemic Stroke Review: Initial Assessment J Neurosci Nurs. 2007;39(5):285-293
Cabrera A, Martínez O, Laguna G, Juárez R, Rosas V, et al. Epidemiología de la enfermedad vascular cerebral en hospitales de la ciudad de México. Estudio multicéntrico. Med Int Med 2008;24:98-103.
Europa Public Health. Alzheimer disease and other dementias [online].
Available from URL:
http://ec.europa.eu/health/ph_information/dissemination/diseases/alzheimer_ en.htm [Accessed 2009 May 27]
National Institute of Neurological Disorders and Stroke. National institutes of Health. Dementia: hope through research [online]. Available from URL:
http://www.ninds.nih.gov/disorders/dementias/detail_dementia.htm?css=print [Accessed 2009 May 27].
Ruiz-Sandoval JL, Ortega-Alvarez L, García-Navarro V, et al. Hemorragia intracerebral en un hospital de referencia de la región centro-occidente de México. Rev Neurol 2005;40:656-660.
Cantu-Brito C, Majersik JJ, Sánchez BN et al. Hospitalized stroke surveillance in the community of Durango, Mexico. Stroke 2010;41:878-884.
Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomized trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ 2002;324: 71-86.
Adams HP Jr, del Zoppo G, Alberts MJ y cols. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups. Stroke. 2007;38:1655–1711.
Furie KL , Kasner SE, Adams RJ y cols. Guidelines for the Prevention of Stroke in Patients With Stroke or Transient Ischemic Attack: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association Stroke 2011;42;227-276
Dion JE. Management of ischemic stroke in the next decade: stroke centers of excellence. J Vasc Interv Radiol. 2004;15:S133-41.
Cina CS, Clase CM, Haynes RB. Carotid endarterectomy for symptomatic carotid stenosis (Cochrane Review). In: The Cochrane Library, Issue 2, 2002. Oxford: Update Software.
Van Swieten JC. Doudstaal PJ, Visser MC, Schouten HJA, Van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke 1988; 19(5): 604-607.
Gubitz G, Sandercock P, Counsell C. Antiplatelet therapy for acute ischaemic stroke (Cochrane Review). In: The Cochrane Library, Issue 2, 2002. Oxford: Update Software.
Wardlaw JM, del Zoppo G, Yamaguchi T. Thrombolysis for acute ischaemic stroke. In: The Cochrane Library, Issue 2, 2002. Oxford: Update Software.
Skvortsova VI, Stakhoskaya LV, Gubsky LV, Shamalov IV, Randomized, Double-Blind, Placebo-Controlled Study of CerebrolysinSafety and Efficacy in Treatment of Acute Ischemic Stroke. Stroke 2004; 11.
Plosker G, Gauthier. Cerebrolysin. A review of its use in dementia. Drugs Aging 2009; 26(11): 893-915.
Masliah E, Armasolo F, Veinbergs I, Mallory M, Samuel W. Cerebrolysin ameliorates performance deficits, and neuronal damage in apolipoprotein E-deficient mice. Pharmacol Biochem Behav 1999; 62(2): 239-245.
Hutter-Paier B, Grigar E, Windisch M. Death of cultured telencephalon neurons induced by glutamate is reduced by the peptide derivative Cerebrolysin. J Neural Transm 1996;47: 267-73.
Windisch M, Gschanes A, Hutter-Paier B. Neurotrophic activities and therapeutic experience with a brain derived peptide preparation. J Neural Transm 1998; 53: 289-98.
Rütter R, Apecechea M, Freytag S, Gmeinbauer R, Windsch M. Sustained improvements in patients with dementia of the Alzheimer type (DAT) 6 months after termination of Cerebrolysin therapy.. J Neural Transm 2000;107: 815-29.
Boado R.J. Molecular regulation of the blood-brain barrier GLUT1 glucose transporter by brainderived factor, ageing and dementia. J Neural Transmis 1998: Suppl 53
Gonzalez ME, Francis-Turner L. et al. Antioxidant systemic effect of short-term Cerebrolysin administration, ageing and dementia. J Neural Transmis 1998; Suppl 53.
Alvarez X.A., Sampedro C., Perez P. et al. Positive effects of cerebrolysin on electroencephalogram slowing, cognition and clinical outcome in patients with postacute traumatic brain injury: an exploratory study. Int. Clin. Psychopharmacol. 2003; 18: 5: 271— 278.
Wong G.K., Zhu X.L., Poon W.S. Beneficial effect of cerebrolysin on moderate and severe head injury patients: result of a cohort study. Acta Neurochir Suppl 2005; 95: 59-60.
Ladurner G., Kalvach P., MoesslerH. Cerebrolysin Study Group. Neuroprotective treatment with cerebrolysin in patients with acute stroke: a randomized controlled trial. J Neural Transm 2005; 112: 3: 415— 428.
Gusev E.I., Skvortsova V.I. Modern concepts about the treatment of acute cerebral stroke. Neurology. Consilium medicum 2000; 2: 2: 60-66.
Gusev EI, Gekth AB, Belousov IB, Pavlov NA, Galanov DV, Popov GR, et al. Clinical and pharmacoeconomic peculiarities of the treatment with cerebrolysin in the period of rehabilitation of is ischemic stroke. Zh Nevrl Psikhiatr IM S S Korsakova 2007;107(10):26-33.
Hong Z., Li S.W., Chen Q.T. et al. Reevaluation of Cerebrolysin in treatment of early rehabilitation after ischemic stroke. Chinese J New Drugs and Clin Remedies. 2002; 21: 3: 133-136.
Jech M, Shamalov NA, Moessler H, Skortsova VI. Safety and efficacy of cerebrolysin as adjuvant therapy in patients suffering from acute ischemic stroke. [En línea: http://www.esc-archive.eu/stockholm09/sto_s12_poster.asp] [07.06.2010XVII]
Ziganshina Lilia E, Abakumova Tatyana, Kuchaeva Alexandra. Cerebrolysin for acute ischaemic stroke. Cochrane Database of Systematic Reviews. In: The Cochrane Library, Issue 4, Art. No. CD007026. DOI: 10.1002/14651858.CD007026.pub4
Conferencia europea sobre el EVC, Estocolmo Suecia, 26-29 Mayo 2009. [En línea: http://www.esc-archive.eu/stockholm09/PDF/ESC09_FP.pdf] [07.06.2010]
Damulin IV, Koberskaya NN, Mkhitaryan EA. Effects of cerebrolysin on moderate cognitive impairments in cerebral vascular insufficiency (a clinical-electrophysiological study). Neurosci Behav Physiol 2008 Jul; 38 (6): 639-45
Ladurner G, Kalvach P, Moessler H, Cerebrolysin Study Group. Neuroprotective treatment with cerebrolysin in patients with acute stroke: a randomised controlled trial. Journal of neural transmission 2005; 112 (3): 415-28.
Muresanu DF, Alvarez XA, Moessler H, et al. A pilot study to evaluate the effects of Cerebrolysin on cognition and qEEG in vascular dementia: cognitive improvement correlates with qEEG acceleration. J Neurol Sci 2008 Apr 15; 267 (1-2): 112-9
Muresanu DF. The influence of Cerebrolysin on cognitive performances in patients suffering from vascular dementia. Unterach, Austria: EBEWE Pharmaceuticals Ltd, 1999
Gusev EI. Integrated clinical study report (protocol EBERU- 051201). A randomized, double-blind, placebocontrolled clinical trial to evaluate the safety and efficacy of 20 ml Cerebrolysin in patients with vascular dementia. Unterach, Austria: EBEWE Neuro Pharma GmbH, 2008 Aug 18. (Data on file)
Guekht A, Moessler H, Doppler E, et al. Cerebrolysin in vascular dementia: improvement of clinical outcome in a randomized, double-blind, placebo-controlled multicenter trial [abstract plus poster]. 9th International Conference for Alzheimer’s and Parkinson’s Disease; 2009 Mar 11-15; Prague
Agency for Healthcare Research and Quality. Pharmacological treatment of dementia. [En línea: http://www.ahrq.gov/clinic/epcsums/demphsum.pdf] [02.06.2010]
Malouf R, Birks J. Donepezil para el deterioro cognitivo vascular (Cochrane Review). In: La Biblioteca Cochrane Plus, Issue 3, CD004395.
Craig D, Birks J. Galantamina para el deterioro cognitivo vascular (Cochrane Review). In: La Biblioteca Cochrane Plus, Issue 3, CD004746.
Plosker GL, Gauthier S. Spotlight on cerebrolysin in dementia. CNS Drugs 2010; 24(3): 263-6.
Kavanagh S., Knapp M., Patel A. Costs and disability among stroke patients. J Public Health Med 1999; 21: 4: 385-394.
American Heart Association. Heart disease and stroke. Statistics update 2004. http://www.americanheart.org. Accessed 7/1/04.
Andrade O, Salazar A. Factores de riesgo de la enfermedad cerebrovascular en el Hospital Central Militar. Revista de Neurología, Neurocirugía y Psiquiatría. 2002; 35 (2):84-88.
Gusev EI, Guekhl AB, Belousov YU, Pavlov NA, Galanov D, Popov G. Clinical and pharmacoeconomic peculiarities of the treatment with cerebrolysin in rehabilitative period of ischemic stroke. Zh Nevrol Psikhiatr Im SS Korsakova 2007;107:10.
Johnston SC. The economic case for new stroke thrombolytics Stroke. 2010;41:S59-62.
Law M, Letts L. A critical review of scales of activities of daily living. Am J Occup Ther 1989;43:522-528.
Granger CV, Greer DS, Liset E et al. Measurement of outcomes of care for stroke patients. Stroke 1975;6:34-41.
Wade DT, Legh-Smith, Langton Hewer R. Social activities after stroke:measurements and natural history using the Frenchay Activity Index. Int Rehabil Med 1985;7:176-181.
Vuadens P. Marcel Dekker Inc 9-24
Kwon S, Hartzema AG, Duncan PW,Lai S. Disability measures in stroke. Relationship among the Barthel Index, the Functional Independence measure and the modified Rankin Scale. Stroke 2004;35:918-923.
Stroke Unit Trialist Collaboration. Organised in-patient (stroke-unit) care after stroke (Cochrane Review). En: The Cochrane Library. Oxford: Update Software, Issue 1,2002.
Saka O, Serra V, Samyshkin Y, et al. Cost-Effectiveness of stroke unit care followed by early supported discharge. Stroke 2009;40:24-29.
Al Mahdy H. Management of acute ischaemic stroke. Br J Hosp Med 2009;70:572-577.
Christensen MC, Broderick J, Vincent C, et al. Global differences in patients characteristics, case management and outcomes in intracerebral hemorrhage : the factor seven for acute hemorrhagic stroke (FAST) trial. Cerebrovasc Dis 2009;28:55-64.
Crimmins DS, Levi CR, Gerraty RP; et al. Acute stroke and transient ischaemic attack management-time to act fast. Internal Medicine Journal 2009;39:325-331.
Arnold M, Halpern M, Meier N, et al. Age-dependent differences in demographics, risk factors, co-morbidity, etiology, management, and clinical outcome of acute ischemic stroke. J Neurol 2008;255:1503-1507.
International Stroke Trial Collaborative Group. The International Stroke Trial (IST):a randomized trial of aspirin, subcutaneous heparin, both or neither among 19435 patients with acute ischemic stroke. Lancet 1997;349:1569-1581.
CAST (Chinese Acute Stroke Trial) Collaborative Group CAST: a randomized placebo-controlled trial of early aspirin use in 20,000 patients with acute ischaemic stroke. Lancet 1997;349:1641-1649.
Wardlaw JM, del Zoppo G, Yamaguchi T. Thrombolysis for acute ischaemic stroke (Cochrane Review). En : The Cochrane Library. Oxford: Update Software, Issue 1, 2002.
Sandercock PAG, Gubitz G, Counsell C , et al. Immediate anticoagulant therapy for acute ischaemic stroke. Part 1. A systemic review of 21 randomised trials of anticoagulant vs control, including 23,374 patients. Stroke 1999;30:248.
Lees KR. Does neuroprotection improve stroke outcome? Lancet 1998;351:1447-1448.
Ginsberg MD. Neuroprotection for ischemic stroke: past, present and future. Neuropharmacology 2008;55:363-389.
Hankey GJ, Hon C. Surgery for primary intracerebral haemorrahage: is it safe and effective? A systematic review of case series and randomized trials. Stroke 1997;28:2126-2132.
ESCALAS UTILIZADAS PARA MEDIR EL IMPACTO O DESCENLACE POSTERIOR A UN EVENTO VASCULAR CEREBRAL
|