Economic Impact Associated with Patients with Overactive Bladder on Drug Treatment with Mirabegron or Antimuscarinics in Spain.

OBJECTIVE: To assess the economic impact associated with overactive bladder (OAB) patients, treated with mirabegron or antimuscarinics (AM) in Spain, over a 12-month period. METHODS: A probabilistic model (second-order Monte Carlo simulation) was used in a hypothetical cohort of 1000 patients with OAB and a time horizon of 12 months. The use of resources was obtained from the retrospective observational study MIRACAT that included 3330 patients with OAB. The analysis was carried out from the perspective of the National Health System (NHS) including that of society with the indirect cost of abseenteism in a sensitivity analysis. Unit costs were obtained from Spanish public healthcare prices (€ 2021) and from previously published Spanish studies. RESULTS: The annual average savings for the NHS for each patient with OAB treated with mirabegron would be € 1135 (95%confidence interval (CI) € 390; 2421) compared with a patient treated with AM. Annual average savings were maintained in all the sensitivity analyses carried out, ranging from a minimum of € 299 to a maximum of € 3381 per patient. The substitution of 25% of the AM treatments (for 81534 patients) to mirabegron would generate, within 1 year, savings for the NHS of € 92 million (95% CI € 31; 197 million). CONCLUSIONS: According to the present model, the treatment of OAB with mirabegron would generate savings compared with treatment with AM in all scenarios and sensitivity analysis performed, and for the NHS and for society perspectives.

Economic Impact Associated with Patients with Overactive Bladder on Drug Treatment with Mirabegron or Antimuscarinics in Spain

Objective: To assess the economic impact associated with overactive bladder (OAB) patients, treated with mirabegron or antimuscarinics (AM) in Spain, over a 12-month period. Methods: A probabilistic model (second-order Monte Carlo simulation) was used in a hypothetical cohort of 1000 patients with OAB and a time horizon of 12 months. The use of resources was obtained from the retrospective observational study MIRACAT that included 3330 patients with OAB. The analysis was carried out from the perspective of the National Health System (NHS) including that of society with the indirect cost of abseenteism in a sensitivity analysis. Unit costs were obtained from Spanish public healthcare prices (€ 2021) and from previously published Spanish studies. Results: The annual average savings for the NHS for each patient with OAB treated with mirabegron would be € 1135 (95%confidence interval (CI) € 390; 2421) compared with a patient treated with AM. Annual average savings were maintained in all the sensitivity analyses carried out, ranging from a minimum of € 299 to a maximum of € 3381 per patient. The substitution of 25% of the AM treatments (for 81534 patients) to mirabegron would generate, within 1 year, savings for the NHS of € 92 million (95% CI € 31; 197 million). Conclusions: According to the present model, the treatment of OAB with mirabegron would generate savings compared with treatment with AM in all scenarios and sensitivity analysis performed, and for the NHS and for society perspectives (AU)

[IPSS storage score as a predictive tool of quality of life improvement to apply in therapeutic interventions.] / El IPSS de llenado como herramienta predictiva de la mejoría en la calidad de vida aplicable en intervenciones terapéuticas.

OBJECTIVES: The questionnaire International Prostate Symptom Score (IPSS) is well known and used in clinical practice as diagnostic tool and allows for obtaining a total score regarding the severity of the urinary symptoms. The objective of this analysis is to determine if the IPSS storage score (sum of the punctuation of the questions 2, 4 and 7) could be a predictive variable of the impact on quality of life. MATERIALS AND METHODS: Post-hoc analysis of an epidemiological, multicenter, cross-sectional study inmale patients, ≥18 years old with ≥6 micturitions and≥1 urgency and/or ≥2 nocturia and/or ≥1 daily incontinence episodes recruited by 291 urologists across Spain. Socio demographic variables, symptoms reported by patients (IPSS) and clinical variables were collected. The impact of voiding symptoms (IPSS-V) and storage symptoms (IPSS-S) on the quality of life, measured using the Overactive Bladder questionnaire Short Form(OABq-SF HRQoL), was evaluated using multivariate regression models (linear and logistic). RESULTS: 958 patients, whose mean score (standard deviation) of the OABq-SF HRQoL was 57.9 (18.3),were included in the study. 55.6% received drug treatment for urinary symptoms. 616 patients (64.4%) reported a puntuation >3 in the item 8 of the IPSS. The adjusted analysis showed a significant reduction in the qualityof life of -1.1 (p<0.001) and -3.3 (p<0.001) points associated with the worsening of the symptoms of voiding and storage respectively. This worsening was also associated with a minor risk of satisfaction (OR=1.14;p<0.001 and 1.36; p<0.001) for the voiding and storage symptoms respectively. CONCLUSION: In patients with mixed LUTS both components show a negative effect on the quality of life, with a greater impact of the storage symptoms.

OBJETIVOS:  El cuestionario Escala Internacionalde Síntomas Prostáticos (IPSS) es ampliamente utilizado en clínica como herramienta diagnóstica y permite obtener una puntuación total aportando información sobre la severidad de los síntomas urinarios. El objetivo de este análisis es determinar si la puntuación del IPSS de llenado (suma de la puntuación de las preguntas 2, 4 y 7) puede ser una variable predictora del impacto en la calidad de vida.MATERIALES Y MÉTODOS: Análisis post-hoc de un estudio epidemiológico, multicéntrico, transversal en pacientes varones, ≥18 años, ≥6 micciones, ≥1 episodios de urgencia y/o ≥2 nicturias y/o ≥1 episodio de incontinencia diarios, reclutados por 291 urólogosen España. Se recogieron variables sociodemográficas, síntomas reportados por pacientes (IPSS) y variables clínicas.Se ha evaluado el impacto de la sintomatología de vaciado (IPSS-V) y llenado (IPSS-S) en la calidad de vida, medida con la Versión Corta del Cuestionario de Vejiga Hiperactiva (OABq-SF HRQoL), y a través del ítem 8 del cuestionario IPSS (IPSS-8), mediante modelos de regresión multivariante lineal y logística. RESULTADOS: Se incluyeron 958 pacientes con una puntuación media (desviación estandar) de la escala OABq-SF HRQoL de 57,9 (18,3). 55,6% recibieron tratamiento médico para síntomas urinarios. 616 pacientes (64,4%) tuvieron una puntuación >3 en IPSS-8. El análisis ajustado mostró una reducción significativa en calidad de vida de -1,1 (p<0,01) y -3,3 (p<0,001) puntos asociada al empeoramiento de síntomas de vaciado y llenado, respectivamente. Este empeoramiento se asoció a menor satisfacción (OR=1,14; p<0,001 y 1,36; p<0,001) para síntomas de vaciado y llenado, prespectivamente. CONCLUSIONES: En pacientes con STUI mixtos, ambos componentes muestran un efecto negativo sobre la calidad de vida, siendo superior el impacto de los síntomas de llenado.

El IPSS de llenado como herramienta predictiva de la mejoría en la calidad de vida aplicable en intervenciones terapéuticas / IPSS storage score as a predictive tool of quality of life improvement to apply in therapeutic interventions

OBJETIVOS: El cuestionario Escala Internacionalde Síntomas Prostáticos (IPSS) es ampliamente utilizado en clínica como herramienta diagnóstica y permite obtener una puntuación total aportando información sobre la severidad de los síntomas urinarios. El objetivo de este análisis es determinar si la puntuación del IPSS de llenado (suma de la puntuación de las preguntas 2, 4 y 7) puede ser una variable predictora del impacto en la calidad de vida. MATERIALES Y MÉTODOS: Análisis post-hoc de un estudio epidemiológico, multicéntrico, transversal en pacientes varones, ≥ 18 años, ≥ 6 micciones, ≥ 1 episodios de urgencia y/o ≥ 2 nicturias y/o ≥ 1 episodio de incontinencia diarios, reclutados por 291 urólogosen España. Se recogieron variables sociodemográficas, síntomas reportados por pacientes (IPSS) y variables clínicas. Se ha evaluado el impacto de la sintomatología de vaciado (IPSS-V) y llenado (IPSS-S) en la calidad de vida, medida con la Versión Corta del Cuestionario de Vejiga Hiperactiva (OABq-SF HRQoL), y a través del ítem 8 del cuestionario IPSS (IPSS-8), mediante modelos de regresión multivariante lineal y logística. RESULTADOS: Se incluyeron 958 pacientes con una puntuación media (desviación estandar) de la escala OABq-SF HRQoL de 57,9 (18,3). 55,6% recibieron tratamiento médico para síntomas urinarios. 616 pacientes (64,4%) tuvieron una puntuación > 3 en IPSS-8. El análisis ajustado mostró una reducción significativa en calidad de vida de -1,1 (p < 0,01) y -3,3 (p < 0,001) puntos asociada al empeoramiento de síntomas de vaciado y llenado, respectivamente. Este empeoramiento se asoció a menor satisfacción (OR = 1,14; p < 0,001 y 1,36; p < 0,001) para síntomas de vaciado y llenado, prespectivamente. CONCLUSIONES: En pacientes con STUI mixtos, ambos componentes muestran un efecto negativo sobre la calidad de vida, siendo superior el impacto de los síntomas de llenado

OBJECTIVES: The questionnaire International Prostate Symptom Score (IPSS) is well known and used in clinical practice as diagnostic tool and allows for obtaining a total score regarding the severity of the urinary symptoms. The objective of this analysis is to determine if the IPSS storage score (sum of the punctuation of the questions 2, 4 and 7) could be a predictive variable of the impact on quality of life. MATERIALS AND METHODS: Post-hoc analysis of an epidemiological, multicenter, cross-sectional study inmale patients, ≥ 18 years old with ≥ 6 micturitions and ≥ 1 urgency and/or ≥ 2 nocturia and/or ≥ 1 daily incontinence episodes recruited by 291 urologists across Spain. Socio demographic variables, symptoms reported by patients (IPSS) and clinical variables were collected. The impact of voiding symptoms (IPSS-V) and storage symptoms (IPSS-S) on the quality of life, measured using the Overactive Bladder questionnaire Short Form(OABq-SF HRQoL), was evaluated using multivariate regression models (linear and logistic). RESULTS: 958 patients, whose mean score (standard deviation) of the OABq-SF HRQoL was 57.9 (18.3),were included in the study. 55.6% received drug treatment for urinary symptoms. 616 patients (64.4%) reported a puntuation > 3 in the item 8 of the IPSS. The adjusted analysis showed a significant reduction in the qualityof life of -1.1 (p < 0.001) and -3.3 (p < 0.001) points associated with the worsening of the symptoms of voiding and storage respectively. This worsening was also associated with a minor risk of satisfaction (OR = 1.14; p < 0.001 and 1.36; p < 0.001) for the voiding and storage symptoms respectively. CONCLUSION: In patients with mixed LUTS both components show a negative effect on the quality of life, with a greater impact of the storage symptoms

A retrospective study of treatment persistence and adherence to mirabegron versus antimuscarinics, for the treatment of overactive bladder in Spain.

BACKGROUND: Persistence on-treatment with antimuscarinics in patients with overactive bladder (OAB) is reported to be sub-optimal. This retrospective, longitudinal, observational cohort study assessed treatment persistence with ß3-adrenoceptor agonists (i.e. mirabegron) and antimuscarinics, both classes of OAB pharmacotherapy, in patients with OAB in Spain. METHODS: Adults who received mirabegron or an antimuscarinic in routine clinical practice (1 June-31 October 2014), were identified from anonymised prescription data within the Spanish Cegedim Electronic Medical Records database. The primary endpoint, treatment persistence (time to treatment discontinuation [TTD] and the proportion of patients remaining on-treatment after 12 months), was unadjusted for potential confounders. Multivariate Cox regression models of persistence, adjusted for baseline characteristics, were used to compare differences in treatment groups. Adjusted subgroup analyses (target OAB drug, age, treatment status and sex) and sensitivity analyses (extending the time used to define treatment discontinuation from 30 days [base-case] to 45, 60 or 90 days without prescription renewal) were also performed. RESULTS: Overall, 1798 patients received mirabegron (N = 1169) or an antimuscarinic (N = 629); the mean age was 66.42 years. Median TTD was longer for mirabegron versus antimuscarinics (90 vs 56 days) and a higher proportion of patients who received mirabegron were persistent after 12 months (20.2% vs 10.2%); multivariate analyses indicated significantly greater persistence with mirabegron versus antimuscarinics (hazard ratio [HR]: 1.52; 95% confidence interval [CI]: 1.37-1.70; p < 0.001). Significant differences were also observed in subgroup analyses of mirabegron versus individual antimuscarinics (median TTD: 90 vs [range] 28-60 days; HR range: 1.21-2.17; p ≤ 0.013) and in all other subgroups assessed (p < 0.001). Sensitivity analysis showed that the median TTD for mirabegron increased by up to 31 days, and was significantly longer versus antimuscarinics across all adjusted periods (HR range: 1.43-1.53; all p < 0.001). CONCLUSIONS: Patients with OAB in Spain who received mirabegron experienced longer persistence on-treatment than those who received antimuscarinics and the proportion of patients persistent on-treatment at 12 months with mirabegron was two-times higher versus antimuscarinics. These data may provide strategic insights for clinicians and policy makers involved in the management of OAB.

Epidemiología de la Enfermedad Asociada a Clostridium difficile (EACD) en Salamanca / Epidemiology of Clostridium difficile-associated disease (CDAD) in Salamanca

Introducción. La infección por Clostridium difficile se considera la principal causa de diarrea nosocomial en países desarrollados y cada vez cobra más relevancia como agente etiológico de diarreas comunitarias, y en pacientes sin factores considerados de riesgo. Método. En este estudio que comienza en Mayo de 2011 planteamos conocer las características de los pacientes afectados de Enfermedad Asociada a C. difficile en el Complejo Asistencial Universitario de Salamanca, recogiendo sus datos en una encuesta elaborada a tal efecto. Se consideró como caso el paciente con clínica compatible y diagnóstico microbiológico positivo. Resultados. A los 18 meses del comienzo se habían documentado 41 casos lo que supone una incidencia de 1.15 casos por 10.000 pacientes-día. Fueron pacientes hospitalizados (37) o relacionados con asistencia sanitaria (4), mujeres (54%), añosas (56%) con tratamiento antibiótico previo (80%), la mayoría presentaron diarrea tras el tercer día de ingreso, de menos de tres semanas y sin sangre. La mayoría fueron tratados solo con metronidazol (78%), un 19% con metronidazol y vancomicina asociados y el restante se resolvió sin tratamiento. Recayeron cerca de un 20% y 7 (17%) fallecieron. Conclusiones. Las características de nuestros pacientes con Enfermedad Asociada a C. difficile son las mismas que reportan otros autores. Es importante la vigilancia local para conocer la endemia y vigilar las modificaciones no esperables de la incidencia. Teniendo en cuenta los cambios epidemiológicos que reporta la bibliografía, desde Microbiología debemos trabajar en estrategias que optimicen el diagnóstico de esta enfermedad (AU)

Introduction. Clostridium difficile infection is considered a major cause of nosocomial diarrhoea in developed countries and is increasingly becoming more important as an etiologic agent of community diarrhoea, also in patients without risk factors. Method. Beginning in May 2011, the aim of our study is to know the characteristics of patients suffering from C. difficile Associated Disease in Salamanca University Hospital, collecting their data in a survey conducted for this purpose. A case was defined as a patient with compatible clinical and positive microbiological diagnosis. Results. After 18 months of study, 41 cases had been documented representing an incidence of 1.15 cases per 10,000 patient-days. Patients were hospitalized (37) or health care associated (4), females (54%), age ≥65 years (56%) with prior antibiotic treatment (80%), most had diarrhea after the third day of admission, less than three weeks and without blood. Most were treated with metronidazole alone (78%), 19% with metronidazole and vancomycin, and the remaining percentage was resolved without treatment. Recurrences were about 20% and 7 (17%) died. Conclusions. The characteristics of our patients with C. difficile - associated disease are the same as those reported by other authors. Local surveillance is important in order to study the endemic and epidemic C. difficile infection. According to published epidemiological changes, we sould be able to develop strategies from the Microbiology laboratories that will improve diagnosis of the disease (AU)