Evaluación de la eficiencia de los tratamientos biológicos en la psoriasis moderada a grave en España: análisis de coste por número necesario a tratar (NNT) / A Cost-per-Number Needed to Treat Analysis Assessing the Efficiency of Biologic Drugs in Moderate to Severe Plaque Psoriasis

Antecedentes y objetivos: La psoriasis es una enfermedad inflamatoria crónica de la piel cuya prevalencia en España se estima en el 2,3% de la población y en la que alrededor del 30% de los pacientes tienen formas moderadas a graves. El tratamiento con agentes biológicos está suponiendo un avance en el manejo de la enfermedad, aunque también representa un reto económico. El objetivo de este estudio es determinar la eficiencia, en términos de coste por número necesario a tratar (NNT), de las terapias biológicas disponibles en España para el tratamiento de la psoriasis en placas moderada a grave. Métodos: Los datos de NNT se obtuvieron de un metaanálisis en red que incluía todos los ensayos clínicos aleatorizados con medicamentos biológicos comercializados en España. Los costes de cada terapia se calcularon según las posologías aprobadas en las fichas técnicas para el primer año de tratamiento. A partir de estos datos se calculó el coste por NNT de los fármacos para los distintos niveles de PASI (75, 90 y 100). Se realizó un análisis de sensibilidad considerando solamente el periodo de medición de la respuesta PASI (de 10 a 16 semanas) según el tratamiento. Resultados: Para la respuesta PASI 75, el orden de terapias de mayor a menor eficiencia es ixekizumab > ustekinumab 45 mg > ustekinumab 90 mg > secukinumab > infliximab > etanercept > adalimumab. Para la respuesta PASI 90, el orden es ixekizumab > secukinumab > ustekinumab 45 mg > ustekinumab 90 mg > infliximab > adalimumab > etanercept. Para la respuesta PASI 100 el orden es ixekizumab > secukinumab > infliximab > ustekinumab 90 mg > ustekinumab 45 mg > adalimumab > etanercept. El análisis de sensibilidad mostró algún cambio en el orden de las secuencias para el periodo de evaluación de la respuesta. Conclusiones: Este análisis muestra una relación entre la eficacia de los tratamientos biológicos disponibles en España para el tratamiento de la psoriasis en placas moderada a grave y su eficiencia, siendo ixekizumab el que mostró un menor coste por NNT en todos los niveles de respuesta PASI alcanzados (75, 90 y 100) para el primer año de tratamiento

Background and objectives: Psoriasis is a chronic inflammatory skin disease with an estimated prevalence in Spain of 2.3% of the population. Approximately 30% of patients have moderate-to-severe forms. Treatment with biologic agents is proving to be a step forward in the management of the disease, although these treatments are very expensive. The objective of this study was to determine the efficiency, in terms of cost per number needed to treat (NNT), of the biologic drugs available in Spain for the treatment of moderate to severe plaque psoriasis. Methods: NNT data were obtained from a network meta-analysis that included all randomized clinical trials of biologic drugs sold in Spain. The cost of each treatment was calculated based on the approved dosage for the first year of treatment, as indicated in the Summary of Product Characteristics. These data were used to calculate the cost per NNT of the drugs for various PASI scores (75, 90, and 100). A sensitivity analysis was performed taking into consideration only the PASI-response measurement time (after 10, 12, or 16 weeks, depending on the drug). Results: The order of efficiency, from most to least efficient, in the case of a PASI 75 response was ixekizumab > ustekinumab 45 mg > ustekinumab 90 mg > secukinumab > infliximab > etanercept > adalimumab. The order for PASI 90 was ixekizumab >secukinumab >ustekinumab 45 mg > ustekinumab 90 mg > infliximab > adalimumab > etanercept. The order for PASI 100 was ixekizumab > secukinumab > infliximab > ustekinumab 90 mg > ustekinumab 45 mg > adalimumab > etanercept. The sensitivity analysis showed some changes in the order, depending on the response-assessment period. Conclusions: The findings show a link between the efficacy of the biologic therapies available in Spain for the treatment of moderate-to-severe plaque psoriasis and their efficiency. Ixekizumab had the lowest cost per NNT for all PASI-response scores (75, 90, and 100) during the first year of treatment

Instrumentos para la valoración de los resultados percibidos por el paciente con psoriasis en España: revisión sistemática de la literatura / Patient-reported outcomes assessment tools for use in psoriasis in Spain: A systematic review

Objetivo: Revisar la bibliografía sobre instrumentos específicos de medida de los resultados percibidos por los pacientes (patient reported outcomes, PRO) validados y utilizados en población española con psoriasis, valorar sus propiedades psicométricas y describir los resultados de su aplicación práctica. Materiales y métodos: Revisión sistemática de la literatura científica en bases de datos internacionales (PubMed/Medline) y nacionales (Medes, Ibecs) referente a estudios que validen o implementen instrumentos específicos de valoración de PRO en población española con psoriasis. Se completó la búsqueda en bases de datos específicas de instrumentos para medir PRO (BiblioPRO, PROQOLID). Se incluyeron los estudios publicados en inglés o español hasta el 01/09/2017. Adicionalmente, se revisaron las listas de referencias bibliográficas de las publicaciones clave identificadas. La valoración de la calidad metodológica de los cuestionarios se efectuó con base en sus propiedades psicométricas (constructo, adaptación transcultural, fiabilidad, validez, factibilidad y sensibilidad al cambio). Resultados: Se seleccionaron 18 publicaciones. Seis artículos describieron la validación al español de 5 instrumentos de PRO: 4 cuestionarios de calidad de vida relacionada con la salud (CVRS) específicos de psoriasis/enfermedades dermatológicas y un cuestionario específico de satisfacción con el tratamiento. La valoración psicométrica muestra variabilidad en los criterios alcanzados por cada instrumento; el cuestionario de CVRS PSO-LIFE resultó el más completo. Los 12 artículos restantes correspondían a estudios observacionales que empleaban los instrumentos validados. Su utilización muestra un elevado impacto de la psoriasis en la CVRS, especialmente en pacientes jóvenes, de género femenino y con enfermedad grave. Conclusiones: Se han identificado 5 instrumentos específicos validados en España para valorar los PRO en pacientes con psoriasis. Dada la variedad de sus propiedades psicométricas, resulta esencial conocer las fortalezas y debilidades de cada uno para seleccionar el instrumento apropiado para cada situación. El empleo de estos cuestionarios pone de manifiesto el elevado impacto de la enfermedad en la CVRS de los pacientes. La evaluación de los PRO en el paciente con psoriasis complementa los resultados clínicos tradicionales y puede contribuir a un manejo más óptimo de la enfermedad

Objectives: To review the literature on validated tools for measuring patient-reported outcomes (PROs) in psoriasis in Spain. To evaluate the psychometric properties of the tools and describe the results of their practical application. Material and methods: Systematic review of studies validating or using instruments for assessing PROs in Spanish patients with psoriasis. Literature searches were performed in international (PubMed/Medline) and Spanish (Medes, Ibecs) databases. We also searched databases of instruments for measuring PROs (BiblioPRO, PROQOLID). The review included studies published in English or Spanish up to January 9, 2017. We also checked the reference lists of the key publications identified. The quality of the questionnaires was evaluated based on their psychometric properties (construct, transcultural adaptation, reliability, validity, feasibility, and sensitivity to change). Results: Eighteen publications were included. Six articles described the validation of Spanish versions of 5 PROs tools: 4 health-related quality of life (HRQoL) questionnaires specific to psoriasis and dermatologic diseases and 1 questionnaire specific to satisfaction with treatment. Our assessment of the HRQoL tools’ psychometric properties showed that the PSO-LIFE questionnaire received the highest scores, although specific properties varied from instrument to instrument. The 12 remaining articles were observational studies that used the validated instruments. In use, these tools detected the high impact of psoriasis on HRQoL, especially in young female patients with severe disease. Conclusions: We identified 5 specific instruments validated in Spain for scoring PROs in patients with psoriasis. The tools' psychometric properties vary, and it is essential to understand their strengths and weaknesses when selecting the right one for each situation. In use, these questionnaires are able to detect the high impact of psoriasis on patients' HRQoL. PROs provide useful information to complement routine clinical findings in psoriasis and may contribute to improving disease management

Patient-reported outcomes assessment tools for use in psoriasis in Spain: A systematic review. / Instrumentos para la valoración de los resultados percibidos por el paciente con psoriasis en España: revisión sistemática de la literatura.

OBJECTIVES: To review the literature on validated tools for measuring patient-reported outcomes (PROs) in psoriasis in Spain. To evaluate the psychometric properties of the tools and describe the results of their practical application. MATERIAL AND METHODS: Systematic review of studies validating or using instruments for assessing PROs in Spanish patients with psoriasis. Literature searches were performed in international (PubMed/Medline) and Spanish (Medes, Ibecs) databases. We also searched databases of instruments for measuring PROs (BiblioPRO, PROQOLID). The review included studies published in English or Spanish up to January 9, 2017. We also checked the reference lists of the key publications identified. The quality of the questionnaires was evaluated based on their psychometric properties (construct, transcultural adaptation, reliability, validity, feasibility, and sensitivity to change). RESULTS: Eighteen publications were included. Six articles described the validation of Spanish versions of 5 PROs tools: 4 health-related quality of life (HRQoL) questionnaires specific to psoriasis and dermatologic diseases and 1 questionnaire specific to satisfaction with treatment. Our assessment of the HRQoL tools' psychometric properties showed that the PSO-LIFE questionnaire received the highest scores, although specific properties varied from instrument to instrument. The 12 remaining articles were observational studies that used the validated instruments. In use, these tools detected the high impact of psoriasis on HRQoL, especially in young female patients with severe disease. CONCLUSIONS: We identified 5 specific instruments validated in Spain for scoring PROs in patients with psoriasis. The tools' psychometric properties vary, and it is essential to understand their strengths and weaknesses when selecting the right one for each situation. In use, these questionnaires are able to detect the high impact of psoriasis on patients' HRQoL. PROs provide useful information to complement routine clinical findings in psoriasis and may contribute to improving disease management.

A Cost-per-Number Needed to Treat Analysis Assessing the Efficiency of Biologic Drugs in Moderate to Severe Plaque Psoriasis. / Evaluación de la eficiencia de los tratamientos biológicos en la psoriasis moderada a grave en España: análisis de coste por número necesario a tratar (NNT).

BACKGROUND AND OBJECTIVES: Psoriasis is a chronic inflammatory skin disease with an estimated prevalence in Spain of 2.3% of the population. Approximately 30% of patients have moderate-to-severe forms. Treatment with biologic agents is proving to be a step forward in the management of the disease, although these treatments are very expensive. The objective of this study was to determine the efficiency, in terms of cost per number needed to treat (NNT), of the biologic drugs available in Spain for the treatment of moderate to severe plaque psoriasis. METHODS: NNT data were obtained from a network meta-analysis that included all randomized clinical trials of biologic drugs sold in Spain. The cost of each treatment was calculated based on the approved dosage for the first year of treatment, as indicated in the Summary of Product Characteristics. These data were used to calculate the cost per NNT of the drugs for various PASI scores (75, 90, and 100). A sensitivity analysis was performed taking into consideration only the PASI-response measurement time (after 10, 12, or 16 weeks, depending on the drug). RESULTS: The order of efficiency, from most to least efficient, in the case of a PASI 75 response was ixekizumab > ustekinumab 45mg > ustekinumab 90mg > secukinumab > infliximab > etanercept > adalimumab. The order for PASI 90 was ixekizumab >secukinumab >ustekinumab 45mg > ustekinumab 90mg > infliximab > adalimumab > etanercept. The order for PASI 100 was ixekizumab > secukinumab > infliximab > ustekinumab 90mg > ustekinumab 45mg > adalimumab > etanercept. The sensitivity analysis showed some changes in the order, depending on the response-assessment period. CONCLUSIONS: The findings show a link between the efficacy of the biologic therapies available in Spain for the treatment of moderate-to-severe plaque psoriasis and their efficiency. Ixekizumab had the lowest cost per NNT for all PASI-response scores (75, 90, and 100) during the first year of treatment.

Prasugrel compared to clopidogrel in patients with acute coronary syndrome undergoing percutenaous coronary intervention: a Spanish model-based cost effectiveness analysis.

OBJECTIVE: To assess the long-term cost-effectiveness of 12 months treatment of prasugrel compared to clopidogrel in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) in the Spanish health care system. METHODS: A Markov state transition model was developed to estimate health outcomes, quality adjusted life years (QALYs), life years (LY), and costs over patients' lifetimes. Clinical inputs were based on an analysis of the TRITON-TIMI 38 clinical trial. Hospital readmissions captured during the trial in a sub-study of patients from eight countries (and subsequent re-hospitalisations modelled to accrue beyond the time horizon of the trial), were assigned to Spanish diagnosis-related group payment schedules to estimate hospitalisation costs. RESULTS: Mean total treatment costs were ?11,427 and ?10,910 for prasugrel and clopidogrel respectively. The mean cost of the study drug was ?538 higher for prasugrel vs. clopidogrel, but rehospitalisation costs at 12 months were ?79 lower for prasugrel due to reduced rates of revascularisation. Hospitalisation costs beyond 12 months were higher with prasugrel by ?55, due to longer life expectancy (+0.071 LY and +0.054 QALYs) associated with the decreased nonfatal myocardial infarction rate in the prasugrel group. The incremental cost per life year and QALY gained with prasugrel was ?7,198, and ?9,489, respectively. CONCLUSION: Considering a willingness-to-pay threshold of ?30,000/QALY gained in the Spanish setting, prasugrel represents a cost-effective option in comparison with clopidogrel among patients with ACS undergoing PCI.

Objetivo: Evaluar a largo plazo el coste-efectividad de 12 meses de tratamiento con prasugrel frente a clopidogrel en pacientes con síndrome coronario agudo (SCA) sometidos a intervención coronaria percutánea (ICP) desde la perspectiva del sistema nacional de salud español. Métodos: Se desarrolló un modelo de Markov de transición entre estados para estimar los resultados en salud, los años de vida ajustados por calidad (AVACs), los años de vida (AV) y los costes a lo largo de la vida de los pacientes. Los datos clínicos fueron obtenidos de un análisis del ensayo clínico TRITON-TIMI 38. Los reingresos hospitalarios registrados durante el ensayo en un subestudio de pacientes provenientes de ocho países, (y las subsiguientes rehospitalizaciones fueron modeladas para acumularse más alla del horizonte temporal del ensayo) fueron asignados a grupos relacionados con el diagnóstico españoles para estimar los costes de hospitalización. Resultados: Los costes medios totales del tratamiento con prasugrel y clopidogrel fueron 11.427 ??y 10.910 ?, respectivamente. El coste medio del fármaco fue 538 ??superior para prasugrel frente a clopidogrel, pero los costes de rehospitalización a los 12 meses fueron 79 ??menores para prasugrel debido a la reducción en las tasas de revascularización. Los costes de hospitalización más allá de los 12 meses fueron 55 ??superiores con prasugrel, debido a la mayor esperanza de vida (+0,071 AV y +0,054 AVACs) asociada a la reducción de la tasa de infartos de miocardio no mortales en el grupo de prasugrel. El coste-efectividad incremental por año de vida y AVAC ganado con prasugrel fue 7.198 ??y 9.489 ?, respectivamente. Conclusión: Considerando el umbral de disponibilidad a pagar de 30.000 ?/ AVAC para España, prasugrel representa una opción coste-efectiva en comparación con clopidogrel en pacientes con SCA sometidos a ICP.

Prasugrel compared to clopidogrel in patients with acute coronary syndrome undergoing percutenous coronary intervention: a Spanish model-based cost-effectiveness analysis

OBJECTIVE: To assess the long-term cost-effectiveness of 12 months treatment of prasugrel compared to clopidogrel in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) in the Spanish health care system. METHODS: A Markov state transition model was developed to estimate health outcomes, quality adjusted life years (QALYs), life years (LY), and costs over patients' lifetimes. Clinical inputs were based on an analysis of the TRITON-TIMI 38 clinical trial. Hospital readmissions captured during the trial in a sub-study of patients from eight countries (and subsequent re-hospitalisations modelled to accrue beyond the time horizon of the trial), were assigned to Spanish diagnosis-related group payment schedules to estimate hospitalisation costs. RESULTS: Mean total treatment costs were €11,427 and €10,910 for prasugrel and clopidogrel respectively. The mean cost of the study drug was €538 higher for prasugrel vs. clopidogrel, but rehospitalisation costs at 12 months were €79 lower for prasugrel due to reduced rates of revascularisation. Hospitalisation costs beyond 12 months were higher with prasugrel by €55, due to longer life expectancy (+0.071 LY and +0.054 QALYs) associated with the decreased nonfatal myocardial infarction rate in the prasugrel group. The incremental cost per life year and QALY gained with prasugrel was €7,198, and €9,489, respectively. CONCLUSION: Considering a willingness-to-pay threshold of €30,000/QALY gained in the Spanish setting, prasugrel represents a cost-effective option in comparison with clopidogrel among patients with ACS undergoing PCI

OBJETIVO: Evaluar a largo plazo el coste-efectividad de 12 meses de tratamiento con prasugrel frente a clopidogrel en pacientes con síndrome coronario agudo (SCA) sometidos a intervención coronaria percutánea (ICP) desde la perspectiva del sistema nacional de salud español. MÉTODOS: Se desarrolló un modelo de Markov de transición entre estados para estimar los resultados en salud, los años de vida ajustados por calidad (AVACs), los años de vida (AV) y los costes a lo largo de la vida de los pacientes. Los datos clínicos fueron obtenidos de un análisis del ensayo clínico TRITON-TIMI 38. Los reingresos hospitalarios registrados durante el ensayo en un subestudio de pacientes provenientes de ocho países, (y las subsiguientes rehospitalizaciones fueron modeladas para acumularse más alla del horizonte temporal del ensayo) fueron asignados a grupos relacionados con el diagnóstico españoles para estimar los costes de hospitalización. RESULTADOS: Los costes medios totales del tratamiento con prasugrel y clopidogrel fueron 11.427 € y 10.910 €, respectivamente. El coste medio del fármaco fue 538 € superior para prasugrel frente a clopidogrel, pero los costes de rehospitalización a los 12 meses fueron 79 € menores para prasugrel debido a la reducción en las tasas de revascularización. Los costes de hospitalización más allá de los 12 meses fueron 55 € superiores con prasugrel, debido a la mayor esperanza de vida (+0,071 AV y +0,054 AVACs) asociada a la reducción de la tasa de infartos de miocardio no mortales en el grupo de prasugrel. El coste-efectividad incremental por año de vida y AVAC ganado con prasugrel fue 7.198 € y 9.489 €, respectivamente. CONCLUSIÓN: Considerando el umbral de disponibilidad a pagar de 30.000 €/ AVAC para España, prasugrel representa una opción coste-efectiva en comparación con clopidogrel en pacientes con SCA sometidos a ICP

La depresión: una hipoteca social. Últimos avances en el conocimiento del coste de la enfermedad / Depression: a social mortgage. Latest advances in knowledge of the cost of the diasease

Introducción. Tras la realización del último examen sobre la situación mundial de la salud mental, la Organización Mundial de la Salud ha estimado que la depresión produce la mayor disminución en salud en comparación con otras enfermedades crónicas y ha instado a todos los países a aumentar las inversiones y la cobertura de servicios en esta materia. Metodología. A la hora de invertir recursos en el cuidado de los pacientes con depresión, los estudios de costes de la enfermedad son complementarios a los de morbimortalidad y de gran relevancia a la hora de establecer políticas sanitarias. La finalidad de este trabajo es describir el impacto económico de la depresión en nuestro entorno a la luz de las últimas publicaciones a este respecto. Resultados. El coste total de la depresión en Europa se ha estimado en 118 billones de euros, y la mayor parte de esta cifra (61%) se debe a los costes indirectos referidos a bajas por enfermedad y pérdidas de productividad. La carga económica de la depresión en España ascendería a 5.005 millones de euros anuales, con una distribución por categoría de recursos muy parecida a la europea. Conclusiones. Los sistemas sanitarios y la sociedad tienen que hacer frente al alto coste de la depresión dado que conlleva una elevada utilización de recursos, principalmente fuera del sector sanitario. Existen diversas áreas de mejora con el objetivo de reducir la carga social de la depresión, pero la incorporación de la economía de la salud mental a las políticas sanitarias debe convertirse en una prioridad (AU)

Introduction. Following the latest examination of the worldwide mental health situation, the World Health Organization has estimated that depression produces the greatest decrement in health compared with other chronic diseases, and has encouraged to all countries to increase investment and resources in this field. Methodology. On investing resources for the care of patients with depression, cost of illness studies are a complement to morbidity-mortality studies, and are of great relevance in defining health care policies. The present study describes the economic impact of depression in our setting, in the light of the most recent publications on this subject. Results. The total cost of depression in Europe has been estimated to reach 118 billion euros, and most of this amount (61 %) is due to indirect costs associated with sick leave and productivity losses. The economic burden of depression in Spain could add up to 5.005 million euros a year, with a resource category distribution very similar to that found in Europe as a whole. Conclusions. Health care systems and society must cope with the important costs of depression, which implies intense resource utilization, fundamentally outside the health care sector as such. There are a number of areas in which improvements can be made in order to reduce this important burden associated with depression, though the incorporation of health economics to public health care policies must become a priority (AU)

[Depression: a social mortgage. Latest advances in knowledge of the cost of the disease]. / La depresión: una hipoteca social. Ultimos avances en el conocimiento del coste de la enfermedad.

INTRODUCTION: Following the latest examination of the worldwide mental health situation, the World Health Organization has estimated that depression produces the greatest decrement in health compared with other chronic diseases, and has encouraged to all countries to increase investment and resources in this field. METHODOLOGY: On investing resources for the care of patients with depression, cost of illness studies are a complement to morbidity-mortality studies, and are of great relevance in defining health care policies. The present study describes the economic impact of depression in our setting, in the light of the most recent publications on this subject. RESULTS: The total cost of depression in Europe has been estimated to reach 118 billion euros, and most of this amount (61 %) is due to indirect costs associated with sick leave and productivity losses. The economic burden of depression in Spain could add up to 5.005 million euros a year, with a resource category distribution very similar to that found in Europe as a whole. CONCLUSIONS: Health care systems and society must cope with the important costs of depression, which implies intense resource utilization, fundamentally outside the health care sector as such. There are a number of areas in which improvements can be made in order to reduce this important burden associated with depression, though the incorporation of health economics to public health care policies must become a priority.

[The impact of obesity in the management and evolution of diabetes mellitus]. / El impacto de la obesidad en el manejo y evolución de la diabetes mellitus.

OBJECTIVES: To assess both management and evolution of diabetes mellitus type 2 (DM2) in Primary Care centers in Spain and the related factors, especially obesity. METHODOLOGY: Epidemiological, cross-sectional, multicenter, retrospective study. PATIENTS: Patients suffering from DM2, over 20 years of age, were consecutively enrolled from 30 Primary Care centers in 16 autonomous communities. Métodos. Data was collected on age, gender, educational level, DM2 duration, HbA1c, treatment and body measurement index (BMI). RESULTS: A total of 294 patients, 50% male, with a mean age (SD) of 67.5 years (10.2) and BMI 28.9 (4.5) kg/m(2) were included. Of them, 58.16% had HbA1c levels >6.5%, 38% being obese or severely obese. A total of 93.9% were under drug treatment for DM2. Significant differences in the mean value of HbA1c were shown between the over-weight and severely obese groups (Tukey-Kramer test). Differences were observed in the presence of macrovascular complications between patients with normal weight and patients with obesity (p=0.006). Patients with low educational level had 3.39 more probability of being obese or severely obese than patients with secondary school or university studies (p=0.0041; 95% CI 1.47-7.80), and patients with primary school 2.22 more probability (p= 0.038; 95% CI 1.04-4.73). A total of 47.8% reported high compliance. Obese and severely obese patients showed 2.2 more probability of having low or mild compliance than non-obese patients (p=0.002; 95% CI 1.31-3.74). CONCLUSIONS: Results obtained in this population suggest that obesity is related with more macro-vascular complications, worst metabolic control and worst compliance.

El impacto de la obesidad en el manejo y evolución de la diabetes mellitus / The impact of obesity in the management and evolution of diabetes mellitus

Objetivo. Estudiar el manejo y evolución de ladiabetes mellitus tipo 2 (DM2) en Atención Primaria(AP) en España y los factores implicados,especialmente la obesidad.Diseño. Estudio epidemiológico, transversal,multicéntrico, retrospectivo.Participantes. Se incluyeron pacientes con DM2mayores de 20 años seleccionadosconsecutivamente en 30 centros de AP, en16 comunidades autónomas (CCAA).Métodos. Se recogió información sobre edad, sexo,nivel educativo, duración de DM2, HbA1c,tratamiento e índice de masa corporal (IMC).Resultados. De un total de 294 pacientes, 50%hombres, con edad media (DE) 67,5 años (10,2) eIMC 28,9 (4,5) kg/m2, el 58,16% presentabanniveles de HbA1c >6,5%, el 38% era obeso oseveramente obeso. El 93,9% seguía tratamientofarmacológico para su diabetes. Se mostrarondiferencias significativas en el valor medio deHbA1c entre el grupo con sobrepeso y el grupocon obesidad severa (test de Tukey-Kramer).Se observaron diferencias en la presencia decomplicaciones macrovasculares entrepacientes con peso normal y pacientes obesos(p=0,006). Pacientes con menor grado dealfabetización mostraron 3,39 más probabilidad deser obesos o severamente obesos que pacientescon estudios secundarios o universitarios(p=0,0041; 95% intervalo de confianza [IC] 1,47-7,80), y los pacientes con estudios primarios 2,22veces más (p=0,038; 95% IC 1,04-4,73). Un47,8% refirieron un cumplimiento elevado. Losobesos y severamente obesos presentaron 2,2veces más probabilidad de presentar cumplimientobajo o moderado que los no obesos (p=0,002;95% IC 1,31-3,74 ).Conclusiones. Los resultados obtenidos en estapoblación sugieren que la variable obesidad serelaciona con más complicaciones macrovasculares,peor control metabólico y peor cumplimiento

Objectives. To assess both management andevolution of diabetes mellitus type 2 (DM2) inPrimary Care centers in Spain and the relatedfactors, especially obesity.Methodology. Epidemiological, cross-sectional,multicenter, retrospective study.Patients. Patients suffering from DM2, over 20years of age, were consecutively enrolled from 30Primary Care centers in 16 autonomouscommunities.Métodos. Data was collected on age, gender,educational level, DM2 duration, HbA1c, treatmentand body measurement index (BMI).Results. A total of 294 patients, 50% male, with amean age (SD) of 67.5 years (10.2) and BMI 28.9(4.5) kg/m2 were included. Of them, 58.16% hadHbA1c levels >6.5%, 38% being obese or severelyobese. A total of 93.9% were under drug treatmentfor DM2. Significant differences in the mean valueof HbA1c were shown between the over-weight andseverely obese groups (Tukey-Kramer test).Differences were observed in the presence ofmacrovascular complications between patients withnormal weight and patients with obesity (p=0.006).Patients with low educational level had 3.39 moreprobability of being obese or severely obese thanpatients with secondary school or university studies(p=0.0041; 95% CI 1.47-7.80), and patients withprimary school 2.22 more probability (p= 0.038;95% CI 1.04-4.73). A total of 47.8% reported highcompliance. Obese and severely obese patientsshowed 2.2 more probability of having low or mildcompliance than non-obese patients (p=0.002; 95%CI 1.31-3.74).Conclusions. Results obtained in this populationsuggest that obesity is related with more macrovascularcomplications, worst metabolic control andworst compliance

[Comparison between the "ICIQ-UI Short Form" Questionnaire and the "King's Health Questionnaire" as assessment tools of urinary incontinence among women]. / Comparación entre el cuestionario "ICIQ-UI Short Form" y el "King's Health Questionnaire" como instrumentos de evaluación de la incontinencia urinaria en mujeres.

INTRODUCTION: In our country there are a few available instruments to diagnose urinary incontinence (UI) from the patient's perspective. The King's Health Questionnaire (KHQ) and the "International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form" (ICIQ-UI SF) are the most widespread among that. The present study aimed to compare the clinical utility between KHQ and ICIQ-UI SF with regard to the urodynamic test. MATERIAL AND METHODS: Cross-sectional study performed in 116 women who completed the ICIQ-UI SF, the KHQ and the urodynamic test and were diagnosed according to each test. Sensibility and specificity values of symptom dimension of the ICIQ-UI SF and the KHQ were analyzed with regard to the urodynamic test. In addition, correlation scores between the both compared measures were calculated. RESULTS: Mean age (SD) of women was 54 years (SD = 13.99). KHQ and ICIQ-UI SF mean scores were 39.93 (22.11) and 13.76 (4.11), respectively. Correlation between both measures was moderated (r = 0.6; p < 0.001). Percentages of pts with symptoms suggesting Stress UI (SUI), Urge UI (UUI) and Mixed UI (MUI) according to each instrument were: 33.7, 17.3 & 49 (KHQ); 40.4, 15.4 & 44.2 (ICIQ-UI SF). Patients' distribution according to urodynamic test was: SUI 41.3%, UUI 20.2%, MUI 26.9% and 11.5% with other diagnosis. Sensibility and specificity values of both questionnaires were very similar, but feasibility was worse for the KHQ (7.76% of pts did not complete the questionnaire) than for the ICIQ-UI SF (2.59% did not complete the questionnaire). CONCLUSIONS: Because of its better feasibility, clinical use of ICIQ-UI SF is recommended against KHQ for UI evaluation.

Comparación entre el cuestionario “ICIQ-UI Short Form” y el “King’s Health Questionnaire” como instrumentos de evaluación de la incontinencia urinaria en mujeres / Comparison between the "ICIQ-UI short form" questionnaire and the "King´s health questionnaire" as assessment tools of urinary incontinence among women

Introducción: En nuestro país existen diferentes cuestionarios para la evaluación de la Incontinencia Urinaria (IU) en la práctica clínica, desde el punto de vista de la paciente. El “King’s Health Questionnaire” (KHQ) y el “International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form” (ICIQ-UI SF) son los más utilizados. El presente estudio tuvo por objetivo comparar la utilidad clínica de KHQ y el ICIQ-UI SF respecto a la prueba urodinámica. Material y Métodos: Estudio transversal de 116 mujeres que completaron el ICIQ-UI SF, el KHQ y la prueba urodinámica, recibiendo un diagnóstico de tipo de IU según cada una de estas 3 pruebas. Se estudiaron la sensibilidad y especificidad de la dimensión de síntomas para el diagnóstico del tipo de IU del ICIQ-UI SF y del KHQ respecto a la prueba urodinámica. Además, se analizó la correlación existente entre ambas medidas, ICIQ-UI SF y KHQ. Resultados: La edad media fue de 54 años (DE= 13,99). La puntuación media del KHQ fue 39,93 (22,11) y la del ICIQ-UI SF 13,76 (4,11), presentando ambos cuestionarios una correlación moderada (r=0,6; p<0,001). Los porcentajes de pacientes con síntomas sugestivos de IU de Esfuerzo (IUE), IU de Urgencia (IUU) e IU Mixta (IUM) fueron respectivamente 33,7, 17,3 y 49 para el KHQ; 40,4, 15,4 y 44,2 para el ICIQ-UI SF. La distribución de las pacientes según las observaciones en el estudio urodinámico fue: IUE 41,3%, IUU 20,2%, IUM 26,9% y un 11,5% otros diagnósticos. La sensibilidad y especificidad de ambos cuestionarios fueron muy similares, pero la factibilidad fue peor para el KHQ (7,76% no lo completaron) que para el ICIQ-UI SF (2,59% no lo completaron). Conclusiones: Por su mejor factibilidad parece aconsejable el uso preferencial del ICIQ-UI SF frente al KHQ a la hora de evaluar la IU en la práctica clínica

Introduction: In our country there are a few available instruments to diagnose urinary incontinence (UI) from the patient’s perspective. The King’s Health Questionnaire (KHQ) and the “International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form” (ICIQ-UI SF) are the most widespread among that. The present study aimed to compare the clinical utility between KHQ and ICIQ-UI SF with regard to the urodynamic test. Material and Methods: Cross-sectional study performed in 116 women who completed the ICIQ-UI SF, the KHQ and the urodynamic test and were diagnosed according to each test. Sensibility and specificity values of symptom dimension of the ICIQUI SF and the KHQ were analyzed with regard to the urodynamic test. In addition, correlation scores between the both compared measures were calculated. Results: Mean age (SD) of women was 54 years (SD= 13.99). KHQ and ICIQ-UI SF mean scores were 39.93 (22.11) and 13.76 (4.11), respectively. Correlation between both measures was moderated (r= 0.6; p< 0.001). Percentages of pts with symptoms suggesting Stress UI (SUI), Urge UI (UUI) and Mixed UI (MUI) according to each instrument were: 33.7, 17.3 & 49 (KHQ); 40.4, 15.4 & 44.2 (ICIQ-UI SF). Patients’ distribution according to urodynamic test was: SUI 41.3%, UUI 20.2%, MUI 26.9% and 11.5% with other diagnosis. Sensibility and specificity values of both questionnaires were very similar, but feasibility was worse for the KHQ (7.76% of pts did not complete the questionnaire) than for the ICIQ-UI SF (2.59% did not complete the questionnaire). Conclusions: Because of its better feasibility, clinical use of ICIQ-UI SF is recommended against KHQ for UI evaluation

[Economic analyses of olanzapine in the treatment of schizophrenia and bipolar disorder]. / Análisis económico de la olanzapina en el tratamiento de la esquizofrenia y el trastorno bipolar.

Schizophrenia generates important costs for society both direct, as a consequence of hospitalization and outpatient treatment, and indirect; related to loss of productivity. The atypical antipsychotics, such as olanzapine, have supposed an important advance in the treatment of schizophrenia. The greater cost of atypical antipsychotics with respect to conventional drugs has led to the conduction of pharmacoeconomic studies to determine its efficiency. This article reviews the complete pharmacoeconomic studies that compare olanzapine with haloperidol and risperidone in the treatment of schizophrenia. Cost analyses comparing olanzapine and haloperidol show that the former drug does not add increased cost to therapy, and even contributes to lessen expenses fundamentally as a result of a decrease in hospitalizations. In the economic evaluations comparing olanzapine and risperidone, the results are not conclusive, and in general, the total costs associated with both treatments were similar. In the treatment of bipolar disorder, although few studies have estimated the economic impact of olanzapine, it has been observed a reduction of hospitalization costs associated to the treatment with olanzapine.

Análisis económico de la olanzapine en el tratamiento de la esquizofrenia y el trastorno bipolar / Economic analyses of olanzapine in the treatment of shizophrenia and bipolar disorder

La esquizofrenia es una enfermedad que genera importantes costes para la sociedad, tanto directos, derivados principalmente de la hospitalización y el tratamiento ambulatorio, como indirectos, debidos a la pérdida de productividad de los pacientes. Los antipsicóticos atípicos como la olanzapina han supuesto un avance muy importante en el tratamiento de la esquizofrenia. Su mayor coste respecto a los antipsicóticos convencionales como el baloperidol ha impulsado la realización de estudios farmacoeconómicos encaminados a evaluar su rentabilidad. En el presente trabajo se revisan las evaluaciones farmacoeconómicas completas que comparan la olanzapina con el haloperidol y la risperidona comparando olazanzapina con el haloperidol y la risperidona en el tratamiento de la esquizofrenia. Los análisis de costes comparando olanzapina y haloperidol ponen de manifiesto que la olanzapina no añade costes al tratamiento de la esquizofrenia, produciendo incluso disminución en los mismos debido fundamentalmente a una menor hospitalización. En las evaluaciones económicas que comparaban olanzapina y risperidona los resultados no son concluyentes y en general los costes totales asociados a ambos tratamientos fueron similares. En el tratamiento del trastorno bipolar; aunque las evaluaciones económicas realizadas hasta la fecha son escasas, se observó una reducción en los costes de hospitalización asociada al tratamiento con olanzapina (AU)

Schizophrenia generates important cost for society-both direct. As a consequence of hospitalization and outpatient treatment, and indirect; related to loss of productivity. The atypical antipsychotics, such as olanzapine, have supposed an important advance in the treatment of schizophrenia. The greater cost of atypical antipsychotics with respect to conventional drugs had led to the conduction of pharmacoeconomic studies to determine its efficiency. This article reviews the complete pharmacoeconomic studies that compare olanzapine with haloperidol and risperidone in the treatment of schizophrenia. Cost analyses comparing olanzapine and haloperidol show that the former drug does not add increased cost to therapy, and even contributes to lessen expenses fundamentally as a result of a decrease in hospitalizations. In the economic evaluations comparing olanzapine and risperidone, the results are not conclusive, and in general, the total cost associated with both treatment were similar. In the treatments were similar: In the treatment of bipolar disorder, although few studies have estimated the economic impact of olanzapine, it has been observed a reduction of hospitalization costs associated to the treatment with olanzapine (AU)

The MDM2 oncoprotein promotes apoptosis in p53-deficient human medullary thyroid carcinoma cells.

The MDM2 oncoprotein has been shown to inhibit p53-mediated growth arrest and apoptosis. It also confers growth advantage to different cell lines in the absence of p53. Recently, the ability of MDM2 to arrest the cell cycle of normal human fibroblasts has also been described. We report a novel function for this protein, showing that overexpression of MDM2 promotes apoptosis in p53-deficient, human medullary thyroid carcinoma cells. These cells, devoid of endogenous MDM2 protein, exhibited a significant growth retardation after stable transfection with mdm2. Cell cycle distribution of MDM2 transfectants [medullary thyroid tumor (MTT)-mdm2] revealed a fraction of the cell population in a hypodiploid status, suggesting that MDM2 is sufficient to promote apoptosis. This circumstance is further demonstrated by annexin V labeling. MDM2-induced apoptosis is partially reverted by transient transfection with p53 and p19ARF. Both MTT and MTT-mdm2 cells were tumorigenic when injected into nude mice. However, the percentage ofapoptotic nuclei in tumor sections derived from MDM2-expressing cells was significantly higher relative to that in the parental cell line. MDM2-mediated programmed cell death is at least mediated by a down-regulation of the antiapoptotic protein Bcl-2. Protein levels of caspase-2, which are undetectable in the parental cell line, appear clearly elevated in MTT-mdm2 cells. Caspase-3 activation does not participate in MDM2-induced apoptosis, as determined by protein levels or poly(ADP-ribose) polymerase fragmentation. The results observed in this medullary carcinoma cell line show for the first time that the product of the mdm2 oncogene mediates cell death by apoptosis in p53-deficient tumor cells.