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        "resumen" => "<span class="elsevierStyleSectionTitle">Introducci&#243;n</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">El ensayo cl&#237;nico PROWESS ha demostrado que el tratamiento con drotrecogina alfa &#40;activada&#41; en pacientes con sepsis grave se asocia a una reducci&#243;n del riesgo absoluto de muerte en comparaci&#243;n con el tratamiento est&#225;ndar&#46; El objetivo del estudio fue evaluar el coste-efectividad de drotrecogina alfa &#40;activada&#41;&#44; frente a tratamiento est&#225;ndar&#44; en el tratamiento de la sepsis grave en Espa&#241;a&#46;</p> <span class="elsevierStyleSectionTitle">Pacientes y m&#233;todos</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Se elabor&#243; un modelo de an&#225;lisis de decisi&#243;n en el que se compararon los costes hasta el alta hospitalaria y la eficacia a largo plazo de drotrecogina alfa &#40;activada&#41; frente a tratamiento est&#225;ndar de pacientes con sepsis grave en Espa&#241;a&#44; desde la perspectiva del financiador de los servicios sanitarios&#46; La mayor&#237;a de la informaci&#243;n para realizar el modelo se obtuvo del ensayo cl&#237;nico PROWESS&#46; El an&#225;lisis basal fue doble&#58; a&#41; para todos los pacientes incluidos en el ensayo cl&#237;nico PROWESS&#44; y b&#41; para los pacientes con 2 o m&#225;s fallos org&#225;nicos&#46; Las variables principales de valoraci&#243;n cl&#237;nica fueron la reducci&#243;n de la mortalidad hospitalaria y los a&#241;os de vida ganados &#40;AVG&#41;&#46; El coste-efectividad se expres&#243; como coste por AVG&#46; Se realiz&#243; un an&#225;lisis de sensibilidad utilizando tasas de descuento del 3 y el 5&#37; para los AVG y modificando los patrones de atenci&#243;n sanitaria&#44; los costes de la unidad de cuidados intensivos&#44; la esperanza de vida seg&#250;n la comorbilidad inicial y la eficacia terap&#233;utica de drotrecogina alfa &#40;activada&#41;&#46;</p> <span class="elsevierStyleSectionTitle">Resultados</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">El tratamiento con drotrecogina alfa &#40;activada&#41; se asoci&#243; a un descenso del riesgo absoluto de mortalidad hospitalaria del 6&#44;0&#37; &#40;p &#61; 0&#44;005&#41; cuando se incluyeron todos los pacientes del estudio PROWESS&#44; y una reducci&#243;n del 7&#44;3&#37; &#40;p &#61; 0&#44;005&#41; cuando s&#243;lo se incluyeron los pacientes con 2 o m&#225;s fracasos org&#225;nicos&#46; El coste-efectividad de drotrecogina alfa &#40;activada&#41; fue de 13&#46;550 euros por AVG respecto a placebo cuando se analiz&#243; el total de pacientes&#44; y de 9&#46;800 euros por AVG en el grupo de pacientes con 2 o m&#225;s fallos org&#225;nicos&#46; En el an&#225;lisis de sensibilidad&#44; los resultados oscilaron desde 7&#46;322 a 16&#46;493 euros por AVG&#46; Los factores que m&#225;s influyeron en los resultados fueron la modificaci&#243;n de la eficacia de drotrecogina alfa &#40;activada&#41;&#44; el ajuste de la supervivencia seg&#250;n la comorbilidad inicial y la aplicaci&#243;n de descuento a los AVG&#46;</p> <span class="elsevierStyleSectionTitle">Conclusiones</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">El tratamiento con drotrecogina alfa &#40;activada&#41; presenta una relaci&#243;n coste-efectividad favorable en comparaci&#243;n con otras intervenciones sanitarias com&#250;nmente utilizadas en Espa&#241;a&#46;</p>"
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        "titulo" => "Abstract"
        "resumen" => "<span class="elsevierStyleSectionTitle">Introduction</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">The PROWESS clinical trial has shown that treatment with drotrecogin alpha &#40;activated&#41; in patients with severe sepsis is associated with a reduction in the absolute risk of death compared with standard treatment&#46; The aim of the present study was to assess the cost-effectiveness of drotrecogin alpha &#40;activated&#41; versus that of standard care in the treatment of severe sepsis in Spain&#46;</p> <span class="elsevierStyleSectionTitle">Patients and methods</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">A decision analysis model was drawn up to compare costs to hospital discharge and the long-term efficacy of drotrecogin alpha &#40;activated&#41; versus those of standard care in the treatment of severe sepsis in Spain from the perspective of the health care payer&#46; Most of the information for creating the model was obtained from the PROWESS clinical trial&#46; A two-fold baseline analysis was performed&#58; a&#41; for all patients included in the PROWESS clinical trial and b&#41; for the patients with two or more organ failures&#46; The major variables for clinical assessment were the reduction in mortality and years of life gained &#40;YLG&#41;&#46; Cost-effectiveness was expressed as cost per YLG&#46; A sensitivity analysis was applied using 3&#37; and 5&#37; discount rates for YLG and by modifying the patterns of health care&#44; intensive care unit costs&#44; and life expectancy by initial co-morbidity and therapeutic efficacy of drotrecogin alpha &#40;activated&#41;&#46;</p> <span class="elsevierStyleSectionTitle">Results</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Treatment with drotrecogin alfa &#40;activated&#41; was associated with a 6&#46;0&#37; drop in the absolute risk of death &#40;p &#61; 0&#46;005&#41; when all of the patients from the PROWESS trial were included and with a 7&#46;3&#37; reduction &#40;p &#61; 0&#46;005&#41; when the analysis was restricted to patients with two or more organ failures&#46; The cost-effectiveness of drotrecogin alfa &#40;activated&#41; was euros 13&#44;550 per YLG with respect to standard care after analysing all of the patients and euros 9&#44;800 per YLG in the group of patients with two or more organ failures&#46; In the sensitivity analysis&#44; the results ranged from 7&#44;322 to euros 16&#44;493 per YLG&#46; The factors with the greatest impact on the results were the change in the efficacy of drotrecogin alfa &#40;activated&#41;&#44; adjustment of survival by initial co-morbidity and the application of discount rates to YLG&#46;</p> <span class="elsevierStyleSectionTitle">Conclusions</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Treatment with drotrecogin alfa &#40;activated&#41; presents a favorable cost-effectiveness ratio compared with other health care interventions commonly used in Spain&#46;</p>"
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Vol. 18. Núm. 1.
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Vol. 18. Núm. 1.
Páginas 50-57 (enero - febrero 2004)
Open Access
Coste-efectividad de drotrecogina alfa (activada) en el tratamiento de la sepsis grave en España
Cost-effectiveness of drotrecogin alpha [activated] in the treatment of severe sepsis in Spain
Visitas
5652
José A. Sacristána,
Autor para correspondencia
Sacristan_jose@lilly.com

Correspondencia:ee Departamento de Investigación Clínica, Lilly S.A. Avda. de la Industria, 30. 28108 Alcobendas. Madrid. España.
, Luis Prietoa, Teresa Huetea, Antonio Artigasb, Xavier Badiac, Christopher Chinnd, Peter Hudsone
a Departamento de Investigación Clínica, Lilly España
b Hospital Parc Taulí. Sabadell (Barcelona)
c Health Outcomes Research Europe. Barcelona. España
d Health Outcomes Research. Lilly Europa
e Consultor independiente. Reino Unido
Este artículo ha recibido

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Información del artículo
Resumen
Bibliografía
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Estadísticas
Resumen
Introducción

El ensayo clínico PROWESS ha demostrado que el tratamiento con drotrecogina alfa (activada) en pacientes con sepsis grave se asocia a una reducción del riesgo absoluto de muerte en comparación con el tratamiento estándar. El objetivo del estudio fue evaluar el coste-efectividad de drotrecogina alfa (activada), frente a tratamiento estándar, en el tratamiento de la sepsis grave en España.

Pacientes y métodos

Se elaboró un modelo de análisis de decisión en el que se compararon los costes hasta el alta hospitalaria y la eficacia a largo plazo de drotrecogina alfa (activada) frente a tratamiento estándar de pacientes con sepsis grave en España, desde la perspectiva del financiador de los servicios sanitarios. La mayoría de la información para realizar el modelo se obtuvo del ensayo clínico PROWESS. El análisis basal fue doble: a) para todos los pacientes incluidos en el ensayo clínico PROWESS, y b) para los pacientes con 2 o más fallos orgánicos. Las variables principales de valoración clínica fueron la reducción de la mortalidad hospitalaria y los años de vida ganados (AVG). El coste-efectividad se expresó como coste por AVG. Se realizó un análisis de sensibilidad utilizando tasas de descuento del 3 y el 5% para los AVG y modificando los patrones de atención sanitaria, los costes de la unidad de cuidados intensivos, la esperanza de vida según la comorbilidad inicial y la eficacia terapéutica de drotrecogina alfa (activada).

Resultados

El tratamiento con drotrecogina alfa (activada) se asoció a un descenso del riesgo absoluto de mortalidad hospitalaria del 6,0% (p = 0,005) cuando se incluyeron todos los pacientes del estudio PROWESS, y una reducción del 7,3% (p = 0,005) cuando sólo se incluyeron los pacientes con 2 o más fracasos orgánicos. El coste-efectividad de drotrecogina alfa (activada) fue de 13.550 euros por AVG respecto a placebo cuando se analizó el total de pacientes, y de 9.800 euros por AVG en el grupo de pacientes con 2 o más fallos orgánicos. En el análisis de sensibilidad, los resultados oscilaron desde 7.322 a 16.493 euros por AVG. Los factores que más influyeron en los resultados fueron la modificación de la eficacia de drotrecogina alfa (activada), el ajuste de la supervivencia según la comorbilidad inicial y la aplicación de descuento a los AVG.

Conclusiones

El tratamiento con drotrecogina alfa (activada) presenta una relación coste-efectividad favorable en comparación con otras intervenciones sanitarias comúnmente utilizadas en España.

Palabras clave:
Sepsis grave
Drotrecogina alfa (activada)
Coste-efectividad
Abstract
Introduction

The PROWESS clinical trial has shown that treatment with drotrecogin alpha (activated) in patients with severe sepsis is associated with a reduction in the absolute risk of death compared with standard treatment. The aim of the present study was to assess the cost-effectiveness of drotrecogin alpha (activated) versus that of standard care in the treatment of severe sepsis in Spain.

Patients and methods

A decision analysis model was drawn up to compare costs to hospital discharge and the long-term efficacy of drotrecogin alpha (activated) versus those of standard care in the treatment of severe sepsis in Spain from the perspective of the health care payer. Most of the information for creating the model was obtained from the PROWESS clinical trial. A two-fold baseline analysis was performed: a) for all patients included in the PROWESS clinical trial and b) for the patients with two or more organ failures. The major variables for clinical assessment were the reduction in mortality and years of life gained (YLG). Cost-effectiveness was expressed as cost per YLG. A sensitivity analysis was applied using 3% and 5% discount rates for YLG and by modifying the patterns of health care, intensive care unit costs, and life expectancy by initial co-morbidity and therapeutic efficacy of drotrecogin alpha (activated).

Results

Treatment with drotrecogin alfa (activated) was associated with a 6.0% drop in the absolute risk of death (p = 0.005) when all of the patients from the PROWESS trial were included and with a 7.3% reduction (p = 0.005) when the analysis was restricted to patients with two or more organ failures. The cost-effectiveness of drotrecogin alfa (activated) was euros 13,550 per YLG with respect to standard care after analysing all of the patients and euros 9,800 per YLG in the group of patients with two or more organ failures. In the sensitivity analysis, the results ranged from 7,322 to euros 16,493 per YLG. The factors with the greatest impact on the results were the change in the efficacy of drotrecogin alfa (activated), adjustment of survival by initial co-morbidity and the application of discount rates to YLG.

Conclusions

Treatment with drotrecogin alfa (activated) presents a favorable cost-effectiveness ratio compared with other health care interventions commonly used in Spain.

Key words:
Severe sepsis
Drotrecogin alfa (activated)
Cost effectiveness
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