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Evaluación clínica y económica de la profilaxis con fondaparinux en comparación con enoxaparina en cirugía ortopédica mayor

  • Artículo De Investigación Original
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PharmacoEconomics Spanish Research Articles

Resumen

Objetivo: En ensayos clínicos, fondaparinux ha mostrado mayor eficacia que enoxaparina en la prevención de la enfermedad tromboembólica venosa después de cirugía ortopédica mayor. El objetivo de este estudio era comparar las consecuencias clínicas y económicas de la profilaxis con ambos fármacos a medio y largo plazo, es decir, más allá del horizonte temporal de los ensayos clínicos.

Métodos: Se utilizó un modelo de análisis de decisiones que representa la evolución natural y el tratamiento de los episodios tromboembólicos que pueden ocurrir después de una intervención de cirugía ortopédica mayor a pesar de tromboprofilaxis. Se estudian la incidencia de los episodios tromboembólicos y los costes de su profilaxis y tratamiento en dos cohortes tratadas durante siete días, respectivamente, con enoxaparina o fondaparinux, a lo largo de cinco años a partir de la intervención ortopédica. Para determinar los efectos en la salud, el modelo combina resultados de ensayos clínicos y estudios epidemiológicos. Para calcular las consecuencias económicas, se valora el consumo de recursos sanitarios, obtenido a partir de un grupo de expertos, en términos monetarios según una base de datos de costes sanitarios nacionales.

Resultados: Durante cinco años, la profilaxis con fondaparinux en comparación con enoxaparina reduce la incidencia de trombosis venosa profunda en un 34%, la de tromboembolia pulmonar en un 46%, la de muerte por tromboembolia pulmonar en un 46%, la de recurrencia de enfermedad tromboembólica venosa en un 42% y la de síndrome postrombótico en un 28%. El mayor coste farmacológico de fondaparinux, generado inicialmente durante la profilaxis, luego es compensado por los ahorros conseguidos al evitar episodios tromboembólicos

Conclusión: La profilaxis con fondaparinux se presenta como una opción más eficaz y coste-efectiva que enoxaparina.

Abstract

Objective: In clinical trials fondaparinux has shown higher efficacy than enoxaparin in the avoidance of deep venous thromboembolism (VTE) after major orthopedic surgery. The objective of this study is to compare the clinical and economic consequences of the prophylaxis with these two drugs in the mid and long-term, beyond the horizon of the clinical trials.

Methods: A decision-analytic model is analyzed which represents the natural course and management of VTE events that can occur after major orthopedic surgery in spite of prophylaxis. The incidence of VTE events over a period of five years after surgery took place and the costs of their prophylaxis and treatment are determined for two cohorts that received either enoxaparin or fondaparinux during seven days. The model combines findings from clinical trials and epidemiological studies, and values resource consumption obtained from an expert panel using a national healthcare cost data base.

Results: Over a five year period prophylaxis with fondaparinux vs enoxaparin reduces the incidence of deep vein thrombosis by 34% pulmonary embolism by 46%; death due to pulmonary embolism by 46%; recurrent venous thromboembo-lism by 42%; and post-thrombotic syndrome by 28%. Higher pharmacological costs of fondaparinux, incurred during the prophylactic phase, are subsequently compensated by savings due to the avoidance of VTE events.

Conclusion: Compared with enoxaparin, prophylaxis with fondaparinux shows higher efficacy and cost-effectiveness.

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Authors and Affiliations

  1. Universidad Autónoma de Barcelona, España

    John Slof

  2. Health Outcomes Research Europe, Avda. Diagonal, 618 C; 1o C-D, 08021, Barcelona, España

    Xavier Badia

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  1. John Slof
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Correspondence to Xavier Badia.

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Fuentes de financiación

El estudio en que se basa este artículo fue patrocinado por el laboratorio GlaxoSmithKline. John Slof agradece la ayuda concedida por el Ministerio de Ciencia y Tecnología a través del proyecto SEC2003-04770.

Clinical and economic evaluation of prophylaxis with fondaparinux vs. enoxaparin after major orthopedic surgery

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Slof, J., Badia, X. Evaluación clínica y económica de la profilaxis con fondaparinux en comparación con enoxaparina en cirugía ortopédica mayor. Pharmacoecon. Span. Res. Artic. 3, 75–88 (2006). https://doi.org/10.1007/BF03320912

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