Utilización de recursos sanitarios y costes asociados al manejo de los pacientes con infarto cerebral cardioembólico agudo en la Comunidad de Madrid: Estudio CODICE / Use of healthcare resources and costs of acute cardioembolic stroke management in the Region of Madrid: The CODICE Study

Introducción: El ictus es la principal causa de ingreso en los servicios de Neurología, siendo el infarto cerebral cardioembólico (ICE) de los subtipos más frecuentes. Métodos: Estudio observacional, multicéntrico, prospectivo, realizado en 5 hospitales públicos de la Comunidad de Madrid, cuyo objetivo fue estimar la utilización de recursos sanitarios y costes en el manejo del ICE agudo. Se incluyeron pacientes con ICE agudo de evolución < 48 h. Se registraron datos sociodemográficos, clínicos y los recursos sanitarios utilizados durante el ingreso y al alta hasta 30 días desde el ingreso, incluyendo el tratamiento rehabilitador al alta. Resultados: Se seleccionaron 128 pacientes durante 8 meses, de 75,3 ± 11,25 años, siendo un 46,9% mujeres, con una mortalidad del 4,7%. El 100% cumplía los criterios diagnósticos del GEENCV-SEN por antecedentes o el estudio realizado. Como antecedentes clínicos, el 50% presentó fibrilación auricular, y el 18,8%, otras fuentes mayores embolígenas. La fibrilación auricular no valvular fue la causa más frecuente de ICE (33,6%). Consumo de recursos: estancia media, 10,3 ± 9,3 días; rehabilitación durante el ingreso, 46,9%, media 4,5 días, y al alta, 56,3%, media 26,8 días; complicaciones, 32%; intervenciones hospitalarias específicas, 19,5%; pruebas diagnósticas y analíticas sanguíneas, 100%, siendo la TAC craneal (98,4%), el dúplex TSA (87,5%) y el electrocardiograma (85,9%), las diagnósticas más frecuentes. El coste total medio por paciente en la fase aguda y rehabilitación por ICE fue de 13.139 Euros, siendo la estancia hospitalaria (45,0%) y la rehabilitación al alta (29,2%) los recursos más importantes. Conclusiones: El manejo agudo del ICE en la Comunidad de Madrid generó un importante consumo de recursos (13.139 Euros) debido a la asistencia hospitalaria y la rehabilitación

Introduction: Stroke is the main cause of admission to Neurology departments and cardioembolic stroke (CS) is one of the most common subtypes of stroke. Methods: A multicentre prospective observational study was performed in 5 Neurology departments in public hospitals in the Region of Madrid (Spain). The objective was to estimate the use of healthcare resources and costs of acute CS management. Patients with acute CS at < 48 h from onset were recruited. Patients’ socio-demographic, clinical, and healthcare resource use data were collected during hospitalisation and at discharge up to 30 days after admission, including data for rehabilitation treatment after discharge. Results: During an 8-month recruitment period, 128 patients were recruited: mean age, 75.3 ± 11.25; 46.9% women; mortality rate, 4.7%. All patients met the CS diagnostic criteria established by GEENCV-SEN, based on medical history or diagnostic tests. Fifty per cent of the patients had a history of atrial fibrillation and 18.8% presented other major cardioembolic sources. Non-valvular atrial fibrillation was the most frequent cause of CS (33.6%). Data for healthcare resource use, given a mean total hospital stay of 10.3 ± 9.3 days, are as follows: rehabilitation therapy during hospital stay (46.9%, mean 4.5 days) and after discharge (56.3%, mean 26.8 days), complications (32%), specific interventions (19.5%), and laboratory and diagnostic tests (100%). Head CT (98.4%), duplex ultrasound of supra-aortic trunks (87.5%), and electrocardiogram (85.9%) were the most frequently performed diagnostic procedures. Average total cost per patient during acute-phase management and rehabilitation was Euros 13,139. Hospital stay (45.0%) and rehabilitation at discharge (29.2%) accounted for the largest part of resources used. Conclusions: Acute CS management in the Region of Madrid resulted consumes large amounts of resources (Euros 13,139), mainly due to hospital stays and rehabilitation

Situación del tratamiento anticoagulante oral en pacientes con fibrilación auricular no valvular en España. Estudio REACT-AF / Status of oral anticoagulant treatment in patients with nonvalvular atrial fibrillation in Spain. REACT-AF Study

Antecedentes y objetivos: La terapia anticoagulante oral resulta compleja dadas las necesidades de control y el riesgo hemorrágico que conlleva. Este estudio pretende determinar la práctica clínica habitual del tratamiento para la prevención del ictus en pacientes con fibrilación auricular no valvular (FANV) en España. Pacientes y método: El Real Evidence of Anti Coagulation Treatment in AF es una cohorte multicéntrica, europea, multinacional, observacional, de seguimiento retrospectivo, de pacientes con FANV. En este estudio se incluye a los pacientes reclutados en España con al menos una visita en el periodo de inclusión (mayo 2010/abril 2012). Se evaluaron: a) la persistencia del tratamiento con anticoagulantes orales (tiempo hasta discontinuación); b) la tasa de persistencia (porcentaje de pacientes en tratamiento) a los 6, 12 y 24 meses, y 5 años; c) la adherencia terapéutica (tasa de posesión de medicación); d) la concordancia entre el tratamiento seguido y el recomendado según la Sociedad Europea de Cardiología; y e) la incidencia de ictus y eventos hemorrágicos. Resultados: Los pacientes tratados con anticoagulantes orales (n=7.526) presentaron un tiempo hasta discontinuación del tratamiento de 1,99 años (mediana) y una tasa de persistencia a 5 años del 26% (discontinuación ≥3 meses). La adherencia (tasa de posesión de medicación media) fue 0,54±0,36. La incidencia de ictus fue 0,3/100 personas-año y la de eventos hemorrágicos, 2,4/100 personas-año. El 58% de los pacientes con FANV (n=12.514) seguía las recomendaciones de la Sociedad Europea de Cardiología. Conclusión: El 42% de los pacientes con FANV no seguía las recomendaciones de la Sociedad Europea de Cardiología. Se detectó una baja persistencia y adherencia al tratamiento con anticoagulantes orales (AU)

Background and objectives: Oral anticoagulant therapy is complex due to the need for control and the hemorrhagic risk the therapy entails. This study aims to determine the standard clinical practice in the treatment for preventing stroke in patients with nonvalvular atrial fibrillation (NVAF) in Spain. Patients and method: The Real Evidence of Anti Coagulation Treatment in AF is a European, multicenter, multinational, observational, retrospectively monitored cohort of patients with NVAF. This study included patients recruited in Spain with at least one visit during the period of inclusion (May 2010/April 2012). The study evaluated the following: a) persistence of oral anticoagulant treatment (time to discontinuation); b) persistence rate (% of patients in treatment) at 6, 12 and 24 months and at 5 years; c) therapeutic compliance (medication possession ratio); d) the correlation between the treatment followed and that recommended by the European Society of Cardiology; and the incidence of stroke and hemorrhagic events. Results: The patients treated with oral anticoagulants (n=7,526) had a median time to discontinuation of treatment of 1.99 years and a persistence rate at 5 years of 26% (discontinuation ≥3 months). The compliance (mean MPR) was 0.54±0.36. The incidence of stroke was 0.3/100 person-years, and the incidence of hemorrhagic events was 2.4/100 person-years. Fifty-eight percent of the patients with NVAF (n=12,514) followed the recommendations of the European Society of Cardiology. Conclusion: Forty-two percent of the patients with NVAF did not follow the recommendations of the European Society of Cardiology. We detected low persistence and treatment compliance rates for oral anticoagulants (AU)

Use of healthcare resources and costs of acute cardioembolic stroke management in the Region of Madrid: The CODICE Study.

INTRODUCTION: Stroke is the main cause of admission to Neurology departments and cardioembolic stroke (CS) is one of the most common subtypes of stroke. METHODS: A multicentre prospective observational study was performed in 5 Neurology departments in public hospitals in the Region of Madrid (Spain). The objective was to estimate the use of healthcare resources and costs of acute CS management. Patients with acute CS at<48h from onset were recruited. Patients' socio-demographic, clinical, and healthcare resource use data were collected during hospitalisation and at discharge up to 30 days after admission, including data for rehabilitation treatment after discharge. RESULTS: During an 8-month recruitment period, 128 patients were recruited: mean age, 75.3±11.25; 46.9% women; mortality rate, 4.7%. All patients met the CS diagnostic criteria established by GEENCV-SEN, based on medical history or diagnostic tests. Fifty per cent of the patients had a history of atrial fibrillation and 18.8% presented other major cardioembolic sources. Non-valvular atrial fibrillation was the most frequent cause of CS (33.6%). Data for healthcare resource use, given a mean total hospital stay of 10.3±9.3 days, are as follows: rehabilitation therapy during hospital stay (46.9%, mean 4.5 days) and after discharge (56.3%, mean 26.8 days), complications (32%), specific interventions (19.5%), and laboratory and diagnostic tests (100%). Head CT (98.4%), duplex ultrasound of supra-aortic trunks (87.5%), and electrocardiogram (85.9%) were the most frequently performed diagnostic procedures. Average total cost per patient during acute-phase management and rehabilitation was €13,139. Hospital stay (45.0%) and rehabilitation at discharge (29.2%) accounted for the largest part of resources used. CONCLUSIONS: Acute CS management in the Region of Madrid resulted consumes large amounts of resources (€13,139), mainly due to hospital stays and rehabilitation.

Status of oral anticoagulant treatment in patients with nonvalvular atrial fibrillation in Spain. REACT-AF Study. / Situación del tratamiento anticoagulante oral en pacientes con fibrilación auricular no valvular en España. Estudio REACT-AF.

BACKGROUND AND OBJECTIVES: Oral anticoagulant therapy is complex due to the need for control and the hemorrhagic risk the therapy entails. This study aims to determine the standard clinical practice in the treatment for preventing stroke in patients with nonvalvular atrial fibrillation (NVAF) in Spain. PATIENTS AND METHOD: The Real Evidence of Anti Coagulation Treatment in AF is a European, multicenter, multinational, observational, retrospectively monitored cohort of patients with NVAF. This study included patients recruited in Spain with at least one visit during the period of inclusion (May 2010/April 2012). The study evaluated the following: a) persistence of oral anticoagulant treatment (time to discontinuation); b) persistence rate (% of patients in treatment) at 6, 12 and 24 months and at 5 years; c) therapeutic compliance (medication possession ratio); d) the correlation between the treatment followed and that recommended by the European Society of Cardiology; and the incidence of stroke and hemorrhagic events. RESULTS: The patients treated with oral anticoagulants (n=7,526) had a median time to discontinuation of treatment of 1.99 years and a persistence rate at 5 years of 26% (discontinuation ≥3 months). The compliance (mean MPR) was 0.54±0.36. The incidence of stroke was 0.3/100 person-years, and the incidence of hemorrhagic events was 2.4/100 person-years. Fifty-eight percent of the patients with NVAF (n=12,514) followed the recommendations of the European Society of Cardiology. CONCLUSION: Forty-two percent of the patients with NVAF did not follow the recommendations of the European Society of Cardiology. We detected low persistence and treatment compliance rates for oral anticoagulants.

[Development of conjunctival hyperemia with the use of a fixed combination of latanoprost/timolol: systematic review and meta-analysis of clinical trials]. / Desarrollo de hiperemia conjuntival tras el empleo de la combinación fija de latanoprost/timolol: revisión sistemática y metaanálisis de ensayos clínicos publicados.

PURPOSE: To asses the association of conjunctival hyperemia with the use of a fixed combination of latanoprost/timolol, through a systematic review and meta-analysis of clinical trials in patients with glaucoma. METHODS: A systematic review of published clinical trials of latanoprost/timolol and other competitors was conducted in Medline, Embasse and Cochrane Controlled Clinical Trials Register, between 2000 and 2007. Statistical analysis included calculation of the odds ratio (OR) with its 95% confidence interval (CI) using the fixed effects model of Mantel-Haenszel and the random effects model of Der Simonian and Laird. To assess the heterogeneity between trials the Cochrane Q test and the I(2) rate were calculated. The conjunctival hyperemia rates obtained were compared with the Chi-square test. RESULTS: A total of 8 clinical trials comparing latanoprost/timolol fixed combination with different therapeutic options were found. As trial heterogeneity was moderate (Q: 14.64; df=7; p=0.041; I(2)= 52.2%) a random effects model was used. The final OR was 0.47 (CI 95%: 0.24-0.90); p = 0.024. The total conjunctival hyperemia incidence was 2.9% in the latanoprost/timolol group and 7.0% for the competitors (p<0.0001). CONCLUSIONS: The use of a fixed combination of latanoprost/timolol is associated with a significant reduction (53%; CI 95%: 10%-76%) in the development of conjunctival hyperemia against the other compared options for the treatment of glaucoma.

Desarrollo de hiperemia conjuntival tras el empleo de la combinación fija de latanoprost/timolol: revisión sistemática y metaanálisis de ensayos clínicos publicados / Conjuntival hyperemia with the use of a fixed combination of latanoprost/timolol: systematic review and meta-analysis of clinical trials

Objetivo: Valorar la asociación de hiperemia conjuntival con el uso de la combinación fija de la tanoprost/timolol en el tratamiento del glaucoma, a través de una revisión sistemática y de un metaanálisis. Métodos: Se efectuó una búsqueda de los ensayos clínicos publicados de la tanoprost/timolol y distintos comparadores en las bases de datos Medline, Embasse y Cochrane Controlled Clinical Trials Register, entre 2000 y 2007. La medida para valorar el tamaño del efecto ha sido la odds ratio (OR) y su intervalo de confianza (IC) del 95 %, habiéndose calculado mediante el modelo de efectos fijos de Mantel-Haenszel y el de efectos aleatorios de DerSimonian and Laird. Para valorar la existencia de heterogeneidad entre los estudios, se llevó a cabo la prueba Q de Cochran así como el cálculo del índiceI2. Los porcentajes de hiperemia hallados se han comparado a través de la prueba de Chi-cuadrado. Resultados: Se encontraron 8 ensayos clínicos que comparaban la tanoprost/timolol con distintas opciones terapéuticas. La heterogeneidad de los estudios fue moderada (Q: 14,64; df = 7; p = 0,041;I2 = 52,2%) por lo que se utilizó el modelo de efectos aleatorios. La OR final fue de 0,47 (IC 95%:0,24-0,90); p = 0,024. La incidencia total de hiperemia fue de 2,9% en el grupo la tanoprost/timolol y de 7,0% para los comparadores (p < 0,0001). Conclusiones: El uso de la tanoprost/timolol se asocia con una disminución significativa de la aparición de hiperemia conjuntival del 53% (IC 95%:10%-76%) frente a otras opciones de tratamiento en el manejo del glaucoma (AU)

Purpose: To asses the association of conjuntival hiperemia with the use of a fixed combination of la tanoprost/timolol, through a systematic review and metaanalysis of clinical trials in patients with glaucoma. Methods: A systematic review of published clinical trials of la tanoprost/timolol and other competitors was conducted in Medline, Embasse and Cochrane Controlled Clinical Trials Register, between 2000 and 2007. Statistical analysis included calculation of the odds ratio (OR) with its 95% confidence interval (CI) using the fixed effects model of Mantel-Haenszel and the random effects model of Der Simonian and Laird. To assess the heterogeneity between trials the Cochran Q test and the I2 ratewere calculated. The conjuntival hyperemia rates obtained were compared with the Chi-square test. Results: A total of 8 clinical trials comparing la tanoprost/timolol fixed combination with different therapeutic options were found. As trial heterogeneity was moderate (Q: 14.64; df = 7; p = 0.041; I2 = 52.2%) a random effects model was used. The fina lOR was 0.47 (CI 95%: 0.24-0.90); p = 0.024. The total conjuntival hyperemia incidence was 2.9% inthe latanoprost/timolol group and 7.0% for the competitors (p< 0.0001). Conclusions: The use of a fixed combination of la tanoprost/timolol is associated with a significant reduction (53%; CI 95%: 10%-76%) in the development of conjuntival hyperemia against the other compared options for the treatment of glaucoma (AU)

[Estimation of the prevalence, incidence, comorbidities and direct costs associated to stroke patients requiring care in an area of the Spanish population]. / Estimación de la prevalencia, incidencia, comorbilidades y costes directos asociados en pacientes que demandan atención por ictus en un ámbito poblacional español.

AIM: To determinate the prevalence, incidence, co-morbidities and therapeutic objectives and costs of stroke among Spanish population. PATIENTS AND METHODS: A retrospective study was performed based on data from patients attended for stroke, aged > 30 years, from five Spanish primary care centres and two hospitals in 2006. Comparative group: patients without stroke. Main analysed variables were: age, sex, co-morbidity (cardiovascular/others), clinical parameters and direct costs (pharmacy, derivations, visits, emergencies, procurement, and hospitalisation). An ANCOVA analysis and logistic regression were used to fit the model. RESULTS: A 4.5% of 57.026 patients (n = 2.585; CI 95% = 4.3-4.7%) suffered stroke. The incidence of stroke was 220 new-cases/100.000 populations. Main differences between patients suffering stroke/control group were: age (72.5 vs. 53.5), men (58.2% vs. 44.6%), episodes/year (7,9 vs. 4,8), visits/year (15,8 vs. 8,1), p < 0,001. Stroke had an independent relation with age (OR = 1,4), male (OR = 2,3), diabetes (OR = 1,6), hypertension (OR = 1,5), smoking (OR = 1,5), alcohol (OR = 1,4), depression (OR = 1,4), dyslipidemia (OR = 1,3) and dementia (OR = 1,2). Some of the results were: systolic pressure (134.1 vs. 127.6 mmHg) and LDL-cholesterol (116.4 vs. 126.2 mg/dL), in presence/absence of stroke, p < 0,001. The average of annual costs of stroke was 2,590.36 vs. 985.26 euros, p < 0.001. After the correction of the logistic model results did not change: 1,774.33 (CI 95% = 1,720.10-1.828.55) vs. 1,021.98 euros (CI 95% = 1,010.92-1,033.03), p < 0,001. All components of costs were higher in the stroke group. CONCLUSIONS: Patients that demanded assistance for stroke had a higher number of co-morbidities and a higher total cost/patient/year. Therapeutic objectives could be improved, mainly in primary prevention of cardiovascular risk factors.

Estimación de la prevalencia, incidencia, comorbilidades y costes directos asociados en pacientes que demandan atención por ictus en un ámbito poblacional español / Estimation of the prevalence, incidence, comorbidities and direct costs associated to stroke patients requiring care in an area of the Spanish population

Estimar la prevalencia e incidencia, así como la comorbilidad, objetivos terapéuticos y costes del ictusen un ámbito poblacional español. Pacientes y métodos. Es un diseño retrospectivo-multicéntrico. Se incluyeron pacientes mayores de 30 años que demandaron asistencia por ictus, pertenecientes a cinco equipos de atención primaria y dos hospitales durante el año 2006. Grupo comparativo: pacientes sin ictus. Principales variables: edad, sexo, casuística/comorbilid (cardiovascular/otras), parámetros bioquímicos y modelo de costes directos (medicamentos, procedimientos, derivaciones, visitas, hospitalizaciones y urgencias). Análisis estadístico: regresión logística y de análisis de covarianza (ANCOVA) para la corrección de los modelos, p < 0,05. Resultados. De los 57.026 pacientes, el 4,5% (n = 2.585; IC 95% = 4,3-4,7%) presentóictus. Incidencia: 220 casos nuevos por cada 100.000 habitantes. Los pacientes con/sin ictus mostraron: edad, 72,5/53,5 años; varones, 58,2/44,6%; episodios al año, 7,9/4,8; visitas al año, 15,8/8,1; p < 0,001. El ictus tuvo relación independiente con: edad (OR = 1,4), varones (OR = 2,3), diabetes (OR = 1,6), hipertensión (OR = 1,5), fumadores (OR = 1,5), alcoholismo(OR = 1,4), depresión (OR = 1,4), dislipemia (OR = 1,3) y demencias (OR = 1,2). Algunos resultados metabólicos fueron: tensión sistólica (134,1 frente a 127,6 mmHg) y colesterol-LDL (116,4 frente a 126,2 mg/dL), en presencia/ausencia de ictus,p < 0,001. El promedio de coste anual fue de 2.590,36 frente a 985,26 euros, p < 0,001, y se mantuvo después de corregir por edad-sexo y comorbilidades: 1.774,33 (IC 95% = 1.720,10-1.828,55) frente a 1.021,98 euros (IC 95% = 1.010,92-1.033,03), p < 0,001. Todos los componentes del coste fueron mayores en el ictus. Conclusiones. Los pacientes que demandaron atenciónpor ictus presentaron un elevado número de comorbilidades y un mayor coste total/paciente/año. Los objetivos terapéuticos de control siguen siendo mejorables, sobre todo en la prevención primaria de los factores de riesgo cardiovascular

To determinate the prevalence, incidence, co-morbidities and therapeutic objectives and costs of strokeamong Spanish population. Patients and methods. A retrospective study was performed based on data from patients attended for stroke, aged > 30 years, from five Spanish primary care centres and two hospitals in 2006. Comparative group: patientswithout stroke. Main analysed variables were: age, sex, co-morbidity (cardiovascular/others), clinical parameters and direct costs (pharmacy, derivations, visits, emergencies, procurement, and hospitalisation). An ANCOVA analysis and logisticregression were used to fit the model. Results. A 4.5% of 57.026 patients (n = 2.585; CI 95% = 4.3-4.7%) suffered stroke. The incidence of stroke was 220 new-cases/100.000 populations. Main differences between patients suffering stroke/control groupwere: age (72.5 vs. 53.5), men (58.2% vs. 44.6%), episodes/year (7,9 vs. 4,8), visits/year (15,8 vs. 8,1), p < 0,001. Stroke had an independent relation with age (OR = 1,4), male (OR = 2,3), diabetes (OR = 1,6), hypertension (OR = 1,5), smoking (OR =1,5), alcohol (OR = 1,4), depression (OR = 1,4), dyslipidemia (OR = 1,3) and dementia (OR = 1,2). Some of the results were: systolic pressure (134.1 vs. 127.6 mmHg) and LDL-cholesterol (116.4 vs. 126.2 mg/dL), in presence/absence of stroke, p <0,001. The average of annual costs of stroke was 2,590.36 vs. 985.26 euros, p < 0.001. After the correction of the logisticmodel results did not change: 1,774.33 (CI 95% = 1,720.10-1.828.55) vs. 1,021.98 euros (CI 95% = 1,010.92-1,033.03), p <0,001. All components of costs were higher in the stroke group. Conclusions. Patients that demanded assistance for stroke had a higher number of co-morbidities and a higher total cost/patient/year. Therapeutic objectives could be improved, mainly inprimary prevention of cardiovascular risk factors

Implicación de la investigación de resultados en salud en la mejora continua de la calidad asistencial del Sistema Nacional de Salud / No disponible

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[Cost-effectiveness analysis of the use of atorvastatin in patients with type 2 diabetes mellitus: a pharmacoeconomic model of the CARDS study]. / Análisis coste-efectividad del uso de atorvastatina en pacientes diabéticos de tipo 2: modelo farmacoeconómico del estudio CARDS.

BACKGROUND AND OBJECTIVE: To perform a cost-effectiveness analysis of the use of Atorvastatin 10 mg in the primary prevention of cardiovascular disease in patients with type 2 diabetes (DM2). METHOD: A deterministic and retrospective model by a decision analysis based on CARDS study (Collaborative Atorvastatin Diabetes Study) was performed. In the CARDS study, a significant reduction in cardiovascular morbimortality by the use of Atorvastatin 10 mg versus placebo (5.8 vs. 9.0%, p=0.001) in DM2 patients with an additional condition, had previously been demonstrated. In the present cost-effectiveness analysis, effectiveness units were life years gained (LYG) and quality adjusted life years (QALY), obtained from differences in morbimortality and life expectancy in DM2 patients, with and without previous cardiovascular events. Costs of the evaluated alternatives were obtained from the CARDS results. RESULTS: Incremental cost-effectiveness ratio of using Atorvastin 10 mg versus placebo was 5,886 euro per LYG and 8,046 euro per QALY. Sensitivity analyses confirmed the model stability. CONCLUSIONS: In the primary prevention of the cardiovascular disease in type 2 diabetic patients, the use of Atorvastatin 10 mg is cost-effective, with a cost per LYG and per QALY below that of other alternatives widely used in the Spanish National Health System, and also below a value considered as a reasonable threshold for our country, which might unofficialy be around 30,000 euro/ QALY.

Análisis coste-efectividad del uso de atorvastatina en pacientes diabéticos de tipo 2: modelo farmacoeconómico del estudio CARDS / Cost-effectiveness analysis of the use of atorvastatin in patients with type 2 diabetes mellitus: a pharmacoeconomic model of the CARDS study

Fundamento y objetivo: Efectuar un análisis coste-efectividad del uso de Atorvastatina 10 mg en la prevención primaria de la enfermedad cardiovascular en el paciente con Diabetes Mellitus tipo 2 (DM2). Método: Se elaboró un modelo retrospectivo y determinístico basado en un análisis de decisión a partir del estudio CARDS (Collaborative Atorvastatin Diabetes Study). En el estudio CARDS se había demostrado que Atorvastatina 10 mg versus placebo en prevención primaria en pacientes con DM2 y alguna patología asociada, reduce la morbimortalidad cardiovascular (5,8 vs. 9,0%, p = 0,001). En el presente análisis coste-efectividad, las unidades de efectividad utilizadas fueron años de vida ganados (AVG) y años de vida ajustados por calidad (AVAC), obtenidos a partir de las diferencias de morbimortalidad y de la esperanza de vida de los diabéticos, con y sin eventos previos, obtenidos de la literatura. El consumo de recursos de las alternativas en evaluación se ha extraído del estudio CARDS aplicando costes españoles. Resultados: El cociente coste-efectividad incremental derivado de utilizar Atorvastatina 10 mg versus placebo fue 5.886 € por AVG y de 8.046 € por AVAC. Los análisis de sensibilidad confirmaron la estabilidad del modelo. Conclusiones: En la prevención primaria del riesgo cardiovascular en pacientes diabéticos tipo 2, el uso de Atorvastatina 10 mg es coste-efectivo, con un coste por AVG y por AVAC por debajo de otras alternativas empleadas ampliamente en el Sistema Nacional de Salud español, y también por debajo de un valor que podría considerarse como un umbral razonable para nuestro país, situado oficiosamente en torno a los 30.000 € por AVAC

Background and objective: To perform a cost-effectiveness analysis of the use of Atorvastatin 10 mg in the primary prevention of cardiovascular disease in patients with type 2 diabetes (DM2). Method: A deterministic and retrospective model by a decision analysis based on CARDS study (Collaborative Atorvastatin Diabetes Study) was performed. In the CARDS study, a significant reduction in cardiovascular morbimortality by the use of Atorvastatin 10 mg versus placebo (5.8 vs. 9.0%, p=0.001) in DM2 patients with an additional condition, had previously been demonstrated. In the present cost-effectiveness analysis, effectiveness units were life years gained (LYG) and quality adjusted life years (QALY), obtained from differences in morbimortality and life expectancy in DM2 patients, with and without previous cardiovascular events. Costs of the evaluated alternatives were obtained from the CARDS results. Results: Incremental cost-effectiveness ratio of using Atorvastin 10 mg versus placebo was 5,886 € per LYG and 8,046 € per QALY. Sensitivity analyses confirmed the model stability. Conclusions: In the primary prevention of the cardiovascular disease in type 2 diabetic patients, the use of Atorvastatin 10 mg is cost-effective, with a cost per LYG and per QALY below that of other alternatives widely used in the Spanish National Health System, and also below a value considered as a reasonable threshold for our country, which might unofficialy be around 30,000 €/ QALY

Valoración de los resultados en salud percibidos y comunicados por los pacientes: ¿necesidad o lujo? / Assessment of patient-reported outcomes: necesity or luxury?

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[Economic evaluation of voriconazole versus amphotericin B in the treatment of invasive aspergilosis]. / Evaluación económica del uso de voriconazol versus anfotericina B en el tratamiento de la aspergilosis invasiva.

OBJECTIVE: Invasive aspergillosis is an infection with high incidence and mortality. Voriconazole is a new antifungal agent that presents a high efficacy against Aspergillus. The aim of this evaluation was to carry out a pharmacoeconomic analysis of the use of voriconazole versus amphotericin B deoxycholate in the treatment of invasive aspergillosis in Spain. MATERIAL AND METHODS: A cost-effectiveness analysis has been performed by building a decision analytical model. Effectiveness data, probabilities of the different branches of the decision tree and consumption of healthcare resources were obtained from a clinical trial that compared voriconazole versus amphotericin B in the treatment of invasive aspergillosis and from a local expert panel in order to incorporate the model in the daily medical practice in our country. Only direct medical costs were included in the model (drug acquisition, length of hospital stay, analytical tests and treatment of therapeutic failures). The perspective chosen for this analysis was hospital assistance and the time horizon selected was 12 weeks, the maximum time that patients were followed up in the referenced clinical trial. RESULTS: Therapeutic success was reached in 52.8% of patients treated with voriconazole and in 31.6% of the group treated with amphotericin B. The cost of treating a patient with voriconazole or amphotericin B was of 56,296 and 56,382 Euros respectively, while the cost/effectiveness ratio was of 106,621 and 178,424 Euros. The incremental analysis performed shows how the use of voriconazole versus amphotericin B produces a healthcare resources saving of 406 Euros per patient. CONCLUSIONS: Voriconazole is more efficient than amphotericin B deoxycholate in the treatment of invasive aspergillosis, (thus) resulting in healthcare resources saving due to better clinical results with lower associated costs.

Estudios observacionales para evaluar la efectividad clínica de los medicamentos. Uso de listas-guía para su diseño, análisis e interpretación / Observational studies to evaluate the clinical effectiveness of drugs. Use of guide lists for their design, analysis, and interpretation

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Evaluación económica del uso de voriconazol versus anfotericina B en el tratamiento de la aspergilosis invasiva / Economic evaluation of voriconazole versus amphotericin B in the treatment of invasive aspergilosis

Introducción: La aspergilosis invasiva es una infección con una incidencia creciente y una elevada mortalidad asociada. Voriconazoles un antifúngico que ha demostrado una alta eficacia en el tratamiento de esta enfermedad. El objetivo de este estudio ha sido efectuar un análisis farmacoeconómico del uso de voriconazol versus anfotericina B deoxicolato, en el tratamiento de la aspergilosis invasiva en nuestro país. Material y métodos: Se ha elaborado un análisis coste-efectividad empleando un modelo farmacoeconómico elaborado a través de un análisis de decisión. Los datos de efectividad, las probabilidades del árbol de decisión y el consumo de recursos, fueron obtenidos de un ensayo clínico que comparó ambas alternativas terapéuticas y de un panel de expertos local, con el fin de incorporar el modelo a la práctica médica habitual de nuestro medio. Solamente se han incluido en este análisis los costes médicos directos (coste de la medicación, días de hospitalización, analíticas y tratamiento del fallo terapéutico).La perspectiva elegida para el análisis ha sido el hospital, y el horizonte temporal escogido ha sido de 12 semanas, tiempo máximo que los pacientes fueron seguidos en el ensayo clínico de referencia. Resultados: En el estudio de referencia, los pacientes tratados con voriconazol presentaron éxito terapéutico en el 52,8 frente al31,6% en el grupo tratado con anfotericina B deoxicolato. El coste de tratar un paciente con voriconazol o con anfotericina B deoxicolato, fue de 56.296 y 56.382 € respectivamente, mientras que el cociente coste/efectividad medio fue de 106.621 y 178.424 €, al emplear ambas opciones en evaluación. El análisis coste-efectividad incremental efectuado muestra queel uso de voriconazol versus el de anfotericina B deoxicolato,supone un ahorro de recursos sanitarios de 406 € por paciente. Conclusiones: Voriconazol es una opción más eficiente que la anfotericina B deoxicolato en el tratamiento de la aspergilosis invasiva, lo que se traduce en un ahorro de recursos, derivado de producir mejores resultados clínicos con costes asociados más bajos

Objective: Invasive aspergillosis is an infection with high incidence and mortality. Voriconazole is a new antifungal agent that presents a high efficacy against Aspergillus. The aim of this evaluation was to carry out a pharmacoeconomic analysis of the use of voriconazole versus amphotericin B deoxycholate in the treatment of invasive aspergillosis in Spain. Material and methods: A cost-effectiveness analysis has been performed by building a decision analytical model. Effectiveness data, probabilities of the different branches of the decision tree and consumption of healthcare resources were obtained from a clinical trial that compared voriconazole versus amphotericin B in the treatment of invasive aspergillosis and from a local expert panel in order to incorporate the model in the daily medical practice in our country. Only direct medical costs were included in the model (drug acquisition, length of hospital stay, analytical tests and treatmentof therapeutic failures).The perspective chosen for this analysis was hospital assistance and the time horizon selected was 12 weeks, the maximum time that patients were followed up in the referenced clinical trial. Results: Therapeutic success was reached in 52.8% of patients treated with voriconazole and in 31.6% of the group treated with amphotericin B. The cost of treating a patient with voriconazole or amphotericinB was of 56,296 and 56,382 € respectively, while the cost/effectiveness ratio was of 106,621 and 178,424 €.The incremental analysis performed shows how the use of voriconazole versus amphotericin B produces a healthcare resources saving of 406 € per patient. Conclusions: Voriconazole is more efficient than amphotericin B deoxycholate in the treatment of invasive aspergillosis, (thus)resulting in healthcare resources saving due to better clinical results with lower associated costs

Valor terapéutico añadido de los medicamentos: ¿qué es, cómo se evalúa y cuál debería ser su papel en política farmacéutica? / Drug added therapeutic value: what is, how is it assessed and what should be its role in pharmaceutical policy?

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