Enzalutamida y apalutamida en el tratamiento del cáncer de próstata no metastásico resistente a la castración: comparación indirecta de la eficacia / Efficacy of enzalutamide and apalutamide in the treatment of non-metastasic castration-resistant prostate cancer: Indirect comparison

Objetivos: Realizar una comparación indirecta ajustada de la eficacia relativa de enzalutamida y apalutamida en pacientes con cáncer de próstata no metastásico resistente a la castración (CPRCnm) con alto riesgo de progresión a enfermedad metastásica. Material y métodos: Tras realizar una búsqueda bibliográfica se llevó a cabo una comparación indirecta ajustada de la eficacia relativa de enzalutamida y apalutamida en pacientes con CPRCnm con alto riesgo de progresión a enfermedad metastásica siguiendo el método de Bucher et al. Como variables se seleccionaron la supervivencia libre de metástasis (SLM) y la tasa de respuesta al PSA (TRPSA). Resultados: No se observaron diferencias estadísticamente significativas para las variables evaluadas entre enzalutamida y apalutamida. Para la comparación enzalutamida + TDA vs. Apalutamida + TDA: SLM obtuvo un HR (IC95%) = 1,036 (0,781-1,373) y TRPSA obtuvo un RR (IC95%) = 0,81 (0,339-1,938). Conclusiones: La comparación indirecta ajustada realizada en este estudio muestra que no existen diferencias estadísticamente significativas en términos de eficacia, a nivel de SLM y TRPSA, entre enzalutamida + TDA y apalutamida + TDA en pacientes con CPRCnm con alto riesgo de progresión a enfermedad metastásica. Sin embargo, se debería diseñar un ensayo independiente en el que se comparasen directamente ambos fármacos para confirmar estos resultados

Objectives: To perform an adjusted indirect comparison of the efficacy of enzalutamide and apalutamide in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) with a high risk of progression to metastatic disease. Material and methods: After carrying out a literature search, we performed an adjusted indirect comparison (Bucher et al.) of the relative efficacy of enzalutamide and apalutamide in patients with nmCRPC with a high risk of progression to metastatic disease. The outcomes included were metastasis-free survival (MFS) and PSA response rate (PSARR). Results: There were no statistically significant differences between enzalutamide and apalutamide regarding the analysed outcomes. For the comparison enzalutamide + ADT vs. apalutamide + ADT: MFS a HR (95% CI) = 1,036 (0.781-1.373) was obtained. For PSARR, a RR (95% CI) = 0.81 (0.339-1.938) was obtained. Conclusions: The adjusted indirect comparison performed in this study shows that there are no statistically significant differences in terms of efficacy regarding MFS and PSARR between enzalutamide + ADT and apalutamide + ADT in patients with nmCRPC with a high risk of progression to metastatic disease. However, in order to confirm these results, an independent trial with direct comparison between both drugs would be required

Efficacy of enzalutamide and apalutamide in the treatment of non-metastasic castration-resistant prostate cancer: Indirect comparison. / Enzalutamida y apalutamida en el tratamiento del cáncer de próstata no metastásico resistente a la castración: comparación indirecta de la eficacia.

OBJECTIVES: To perform an adjusted indirect comparison of the efficacy of enzalutamide and apalutamide in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) with a high risk of progression to metastatic disease. MATERIAL AND METHODS: After carrying out a literature search, we performed an adjusted indirect comparison (Bucher et al.) of the relative efficacy of enzalutamide and apalutamide in patients with nmCRPC with a high risk of progression to metastatic disease. The outcomes included were metastasis-free survival (MFS) and PSA response rate (PSARR). RESULTS: There were no statistically significant differences between enzalutamide and apalutamide regarding the analysed outcomes. For the comparison enzalutamide+ADT vs. apalutamide+ADT: MFS a HR (95% CI)=1,036 (0.781-1.373) was obtained. For PSARR, a RR (95% CI)=0.81 (0.339-1.938) was obtained. CONCLUSIONS: The adjusted indirect comparison performed in this study shows that there are no statistically significant differences in terms of efficacy regarding MFS and PSARR between enzalutamide+ADT and apalutamide+ADT in patients with nmCRPC with a high risk of progression to metastatic disease. However, in order to confirm these results, an independent trial with direct comparison between both drugs would be required.

Medication reconciliation at admission and discharge: an analysis of prevalence and associated risk factors.

INTRODUCTION: Medication errors are frequent at care transition points and can have serious repercussions. Study objectives were to examine the frequency/type of reconciliation errors at hospital admission and discharge and to report on the drugs involved, associated risk factors and potential to cause harm in a healthcare setting with comprehensive digital health records. MATERIAL AND METHODS: A prospective observational 2-year study was conducted in the Internal Medicine Department of a regional hospital. The best possible medication history was obtained from different sources by clinical pharmacists and compared with prescriptions at admission and discharge. The frequency and type of reconciliation errors were studied at admission and discharge, evaluating risk factors for their occurrence and their potential to cause harm. RESULTS: The study included 814 patients (mean age: 80.2 years). At least one reconciliation error was detected in 525 (64.5%) patients at admission, with a mean of 2.2 ± 1.3 errors per patient and in 235 (32.4%) patients at discharge. Drug omission was the most frequent reconciliation error (73.6% at admission and 71.4% at discharge); 39% of errors at admission and 51% at discharge had potential to cause moderate or severe harm. The risk of error at admission was higher with more pre-admission drugs (p < 0.001) and, among patients with reconciliation errors, the number of errors was significantly higher in those receiving more drugs pre-admission or with more comorbidities. The risk at discharge was higher in patients with more drugs prescribed at discharge (p = 0.04) and in those with a longer hospital stay (p = 0.03). CONCLUSIONS: Medication reconciliation procedures are required to minimise medication discrepancies and enhance patient safety. Integration of patient health records across care levels is necessary but not sufficient to prevent errors.

Mitomicina C tópica endotraqueal como terapia complementaria al tratamiento endoscópico de la estenosis laringotraqueal fibrótico-cicatricial recurrente / Topical endotracheal mitomycin C as a complementary treatment for endoscopic treatment of recurrent laryngotracheal stenosis

Objetivo Describir la preparación de mitomicina C tópica endotraqueal y los resultados clínicos de 4 pacientes tratados de forma coadyuvante con mitomicina C tópica para estenosis laringotraqueales (ELT) graves y recurrentes. Método Revisión bibliográfica para determinar la concentración y forma de elaboración de mitomicina C para uso tópico endotraqueal. Revisión de las historias clínicas. Resultados Se determina una concentración de 0,4mg/ml mitomicina C tópica en el tratamiento de las estenosis laringotraqueales. En los casos tratados se aplicó la solución de 0,4mg/ml en la zona estenosada tras fotorresección con láser y dilatación con broncoscopio. Tres pacientes se encuentran asintomáticos desde el punto de vista respiratorio y en uno, ha fracasado el tratamiento. Conclusiones El tratamiento ELT es complejo debido al continuo desarrollo de tejido de granulación y fibrosis como consecuencia de lesiones de la vía aérea. La mitomicina C tópica, por sus potentes efectos antifibróticos, parece ser el agente coadyuvante idóneo (AU)

Objective To describe the preparation of topical endotracheal mitomycin C and the clinical outcomes of four patients with recurrent and severe laryngotracheal stenosis (LTS) treated with adjuvant topical mitomycin C. Method Literature review to determine the concentration and method of preparation of topical mitomycin C for endotracheal use. Review of clinical histories. Results We established a concentration of 0.4mg/ml topical mitomycin C for the treatment of laryngotracheal stenosis. In the treated cases, we applied a 0.4mg/ml solution to the wound site following laser surgery and dilatation with bronchoscope. Three patients remain asymptomatic from a respiratory perspective, and treatment failed in one case. Conclusions LTS treatment is complex due to the continuous development of granulation tissue and fibrosis following injury to the airways. Topical mitomycin C seems to be the ideal adjuvant agent thanks to its powerful antifibrotic effects (AU)

Topical endotracheal mitomycin C as a complementary treatment for endoscopic treatment of recurrent laryngotracheal stenosis.

OBJECTIVE: To describe the preparation of topical endotracheal mitomycin C and the clinical outcomes of four patients with recurrent and severe laryngotracheal stenosis (LTS) treated with adjuvant topical mitomycin C. METHOD: Literature review to determine the concentration and method of preparation of topical mitomycin C for endotracheal use. Review of clinical histories. RESULTS: We established a concentration of 0.4 mg/ml topical mitomycin C for the treatment of laryngotracheal stenosis. In the treated cases, we applied a 0.4 mg/ml solution to the wound site following laser surgery and dilatation with bronchoscope. Three patients remain asymptomatic from a respiratory perspective, and treatment failed in one case. CONCLUSIONS: LTS treatment is complex due to the continuous development of granulation tissue and fibrosis following injury to the airways. Topical mitomycin C seems to be the ideal adjuvant agent thanks to its powerful antifibrotic effects.

Metoxi-polietilenglicol epoetina beta en el tratamiento de una paciente con enfermedad renal crónica y que presenta hipersensibilidad retardada a otras epoetinas / No disponible

No disponible

Preparación ante una posible pandemia de gripe aviaria. Aportación del servicio de farmacia hospitalaria / Getting ready for a potential avian influenza pandemics. The contribution of hospital pharmacy

No disponible

Inadecuada presentación comercial de determinados medicamentos y sobrecoste económico asociado / No disponible

No disponible

Calidad de los ensayos clínicos aportados en la guía GINF / Quality of clinical trials provided in GINF

No disponible

[Adoption of new medications by prescribing physicians. The innovator physician]. / Adopción de los nuevos medicamentos por los médicos prescriptores. El médico innovador.

OBJECTIVES: To determine how new medicines are adopted by primary care doctors, identifying innovators or first adopters. Also, to define the variables determining the characteristics of innovative doctors. DESIGN: Retrospective, longitudinal, observational and descriptive study. SETTING: Primary care doctors from the Bahía-Vejer Area in Cádiz (78 general practitioners and 22 paediatricians). MEASUREMENTS AND MAIN RESULTS: All the prescriptions dispensed in pharmacy offices between 1/1/94 and 31/12/96 and prescribed by doctors with over three years experience (74 doctors) were analysed. The active principles sold for the first time between 1/10/93 and 31/12/96 and mainly used in primary care were chosen. Medicines coming on prescription were grouped by three-month periods (28 medicines) and studied for a year. The number of containers of each group prescribed by each doctor was calculated. The doctors were classified in decreasing order according to the number of containers used and given scores through weighting more the initial periods of the prescription of each medicine. The characteristics of the innovative doctor were found with the following variables: age, gender, training, type of care network, type of contract, drugs expenditure and prescription quality through logistic regression. The OR of prevalence for each variable analysed was calculated, and 90% confidence intervals were also determined. 33% of the total (25 doctors) were identified as innovative doctors or first adopters. The statistically significant variables correlating with this group of doctors were: doctors aged > 45, male, non-MIR training, temporary contract, not their sole job, with drug expenditure over the area's 50 percentile, from non-reformed centres. CONCLUSIONS: The identification of this group of doctors will enable specific programmes to be set up in an attempt to alter their attitude to the marketing of new medicines (objective information, evaluation comparing new medicines with existing ones, and increasing doctors' awareness of perceived risk of the use of medicines).

Rentabilidad de una unidad de mezclas intravenosas de nueva creación. aspectos prácticos y relación coste-beneficio / Performance of a newly created intravenous mixtures unit. practical aspects and cost-benefit analysis

Objetivo: Evaluar la rentabilidad tanto en costebeneficio como en calidad asistencial de una unidad de mezclas intravenosas (UMIV) de nueva creación. Método: Se seleccionaron las mezclas intravenosas (MIV) más utilizadas durante el año 1998, estudiándose su compatibilidad y estabilidad. Se estudia también la utilización de jeringas precargadas de furosemida, metilprednisolona, metoclopramida y heparina. Desde febrero a mayo de 1999 se elaboraron 44 MIV distintas. Se calcula el coste total en pesetas y el tiempo utilizado en la elaboración por el servicio de farmacia y se compara con el que ocasionaría su preparación por las unidades de enfermería. Resultados: Se obtiene un ahorro de 1.561.617 pesetas, lo que supone casi cinco millones en un año (2,5 por ciento del gasto total de medicamentos en pacientes ingresados) debido sólo a la utilización de envases de altas dosis y aprovechamiento total de las dosis. En cuanto al ahorro de tiempo, enfermería emplearía novecientas sesenta y seis horas (138 jornadas de siete horas), que ahora puede dedicar a mejorar la atención al paciente, pero además se disminuye el riesgo de contaminación microbiológica, la presencia de partículas y el número de accidentes en enfermería (AU)

Adopción de los nuevos medicamentos por los médicos prescriptores. El médico innovador / Adoption of new medicines by prescribing doctors. The innovative doctor

Objetivos. Determinar cómo son adoptados los nuevos medicamentos por los médicos de atención primaria, identificando a los innovadores o primeros adoptantes. Otro objetivo es definir las variables que determinan las características del médico innovador. Diseño. Estudio retrospectivo, longitudinal, observacional y descriptivo. Emplazamiento. Médicos de atención primaria del Distrito Bahía-Vejer de Cádiz (78 médicos generales y 22 pediatras). Mediciones y resultados principales. Se analizan todas las prescripciones realizadas por los médicos con más de 3 años de ejercicio (74 médicos) y dispensadas en oficinas de farmacia entre el 1-I-1994 y el 31-XII-1996. Se seleccionan los principios activos comercializados por primera vez desde el 1-X-1993 hasta el 31-XII-1996 y que sean de uso principal en atención primaria. Se agrupan los medicamentos que inician su prescripción por trimestres (28 medicamentos) y se estudian durante un año. Se calcula el número de envases de cada grupo prescrito por cada médico. Se ordenan los médicos en orden decreciente según el número de envases y se puntúan ponderando más los períodos iniciales de la prescripción de cada medicamento. Las características del médico innovador se obtienen con las siguientes variables: edad, sexo, formación, tipo de red asistencial, régimen de contratación, gasto farmacéutico y calidad de la prescripción mediante regresión logística. Se calcula la OR de prevalencia para cada variable analizada determinando también sus correspondientes intervalos de confianza del 90 por ciento. Se han identificado como médicos innovadores o primeros adoptantes al 33 por ciento del total (25 médicos). Las variables que se correlacionan con este grupo de médicos y que son estadísticamente significativas son: médicos con edad superior a 45 años, varones, con formación no MIR, no fijos, sin dedicación exclusiva, con desviación del gasto farmacéutico superior al percentil 50 del distrito, de centros no reconvertidos. Conclusiones. La identificación de este grupo de médicos permitirá establecer programas específicos para intentar modificar su actitud ante la comercialización de nuevos medicamentos (información objetiva, evaluación comparativa con los ya existentes y aumentar su nivel de riesgo percibido sobre el uso de los medicamentos) (AU)