Indirect comparison for Anti-TNF drugs in moderate to severe ulcerative colitis.

OBJECTIVE: To compare the relative efficacy of infliximab, adalimumab and golimumab through adjusted indirect treatment comparisons (ITCs). METHODS: An exhaustive search was performed until October 2013. Databases consulted were MEDLINE, EMBASE, the Cochrane Library, the Centre for Reviews and Dissemination and the Web of Science. Randomized control trials (RCTs) comparing the efficacy of infliximab, adalimumab or golimumab versus placebo, in terms of clinical remission, clinical response and mucosal healing, were included. In the case that more than one RCT fulfilled the inclusion criteria for the same drug, a metanalysis was undertaken using a fixed effects model. ITCs were carried out using the method proposed by Bucher et al. RESULTS: 6 RCTs published in 5 papers were included: 2 for infliximab (ACT 1 and ACT 2), 2 for adalimumab (ULTRA 1 y ULTRA 2) and 2 for golimumab (PURSUIT-SC y PURSUIT-M).In these RTCs, each biological agent was superior in efficacy to placebo. The results of the adjusted ITC are the following. In relation to the clinical remission, in the induction and maintenance period, there are no statistically significant differences between the three anti-TNF drugs. In relation to the clinical response and mucosal healing, in the induction period, there are statistically significant differences between infliximab and adalimumab. CONCLUSION: In view of the results obtained, infliximab, adalimumab and golimumab appear to be similarly effective therapeutic alternatives. Therefore, other considerations such as safety, tolerance and cost-effectiveness should be taken into account in order to select the most appropriate treatment.

Objetivo: Comparar la eficacia relativa de infliximab, adalimumab y golimumab mediante comparaciones indirectas (CI) ajustadas. Métodos: Se realizó una búsqueda bibliográfica que abarcó hasta Octubre 2013. Las bases de datos consultadas fueron: MEDLINE, EMBASE, the Cochrane Library, the Centre for Reviews and Dissemination y the Web of Science. Se incluyeron ensayos clínicos aleatorizados (ECA) que compararan la eficacia de infliximab, adalimumab o golimumab frente a placebo en términos de remisión clínica, respuesta clínica y curación de la mucosa. En el caso de que se incluyera más de un ECA para un mismo fármaco se llevó a cabo un metanálisis utilizado el modelo de efectos fijos. Las CI se realizaron utilizando el método de Butcher et al. Resultados: Se incluyeron 6 ECA publicados en 5 artículos: 2 para infliximab (ACT 1 y ACT 2), 2 para adalimumab (ULTRA 1 y ULTRA 2) y 2 para golimumab (PURSUIT-SC y PURSUIT-M). Los tres agentes biológicos presentaron mayor eficacia que placebo. Los resultados de las CI fueron los siguientes: en relación a la remisión clínica, en el período de inducción y en el período de mantenimiento, no hubo diferencias estadísticamente significativas entre los tres fármacos anti-TNF. En relación a la respuesta clínica y a la curación de la mucosa, en el período de inducción hay diferencias estadísticamente significativas entre infliximab y adalimumab. Conclusiones: En base a los resultados obtenidos (eficacia similar), infliximab, adalimumab y golimumab parecen ser alternativas terapéuticas. Así, otras consideraciones como la seguridad, la tolerancia y el coste-efectividad deben considerarse a la hora de seleccionar el tratamiento más adecuado.

Factors related with the appropriateness of pharmacological treatment in polypathological patients.

OBJECTIVE: To evaluate the association between the number of pharmacological inappropriateness and possible factors related with it. METHODS: All polyphatological patients of the IMPACTO project in a tertiary hospital were included (July 2010-March 2012). The pharmacist performed the interventions based on a combined strategy that included the modified MAI and the STOPP-START criteria. A greater number of interventions indicated smaller treatment appropriateness. In the analysis of the strength of association between two continuous variables the Pearson correlation coefficient was used. Test of Student's t or Mann-Whitney comparisons of quantitative data between two groups were applied. Subsequently, a multivariate analysis was performed to study possible variables which explain the inappropriateness of the pharmacological treatment. RESULTS: 242 patients were included. 838 inappropriateness were detected (average per patient of 3±2). The appropriateness was associated with: number of diagnoses, medications, and categories of polypathology, Charlson Comorbidity Index, sex, and categories A1 and B2. When diagnosing collinearity in the multivariate model, we observed that there was collinearity between "Charlson Comorbidity Index" and "number of categories of polypathological patients", so it was decided to conduct two multivariate models variables, one each. The number of drugs, the number of diagnoses and the gender remained significant in both multivariate models. CONCLUSIONS: The appropriateness of pharmacological treatment decreases with increasing number of drugs and number of diagnoses, as well as female gender. However, both multi variate models explain a low percentage of variability in the number of inappropriateness.

Objetivo: evaluar la asociación entre el número de inadecuaciones farmacológicas y posibles factores relacionados con la misma. Métodos: : Se incluyeron todos los pacientes pluripatológicos del proyecto IMPACTO en un hospital de tercer nivel (Julio 2010-Marzo 2012). El farmacéutico realizó las intervenciones en base a una estrategia combinada que incluía el MAI modificado y los criterios STOPP-START. A mayor número de intervenciones menor adecuación del tratamiento. En los análisis de la fuerza de asociación entre dos variables continuas se utilizó el coeficiente de correlación de Pearson. Se aplicó el test de la t de Student o U de Mann-Whitney en comparaciones de datos cuantitativos entre dos grupos. Posteriormente, se realizó un análisis multivariante, para estudiar posibles variables que explicasen las inadecuaciones del tratamiento farmacológico. Resultados: Se incluyeron un total de 242 pacientes. Se detectaron un total de 838 inadecuaciones, siendo la media por paciente de 3±2. La adecuación del tratamiento farmacológico se asoció con el número de diagnósticos, el número de medicamentos, el número de categorías de paciente pluripatológico, el índice de comorbilidad de Charlson, el sexo y las categorías A1 y B2. Al realizar el diagnóstico de colinealidad, en el modelo multivariante, de las variables se observó que existía colinealidad entre las variables "índice de comorbilidad de Charlson" y "número de categorías de paciente pluripatológico", por lo que se decidió realizar dos modelos multivariantes, uno con cada una de ellas. Se mantuvieron significativos con el multivariante y para ambos modelos el número de medicamentos, el número de diagnósticos y el sexo. Conclusiones: La adecuación del tratamiento farmacológico disminuyó al aumentar el número de medicamentos y el número de diagnósticos, así como en mujeres. No obstante, ambos modelos multivariantes, explicaron un porcentaje de variabilidad del número de inadecuaciones leve.

Reliability of a questionnaire for pharmacological treatment appropriateness in patients with multiple chronic conditions.

BACKGROUND: The original Medication Appropriateness Index was validated for elderly and polymedicated patients, both in hospital and outpatient contexts. However, no studies have applied this questionnaire in patients with multiple chronic conditions. The objective of this study is to assess the reliability of a modified Medication Appropriateness Index questionnaire in a population of patients with multiple chronic conditions. METHODS: We selected patients with multiple chronic conditions who were included in an integrated care project conducted at the Hospital Universitario Virgen del Rocío. To determine inter-observer reliability, each professional (internist or hospital pharmacy specialist) applied the questionnaire under the same conditions and with the same resources. To determine intra-observer reliability, each physician applied the tool at baseline and two months later. We measured inter- and intra-observer reliability using the kappa coefficient. The proportion of overall agreement was also determined. RESULTS: We obtained a weak overall kappa (k=0.38) for inter-observer reliability and moderate (k=0.52) and very good (k=0.84) values for intra-observer reliability of the internist and specialist in hospital pharmacy, respectively. The proportion of overall agreement is very high in all three situations: 96%, 98%, and 99%, respectively. CONCLUSIONS: Despite its limitations, the Medication Appropriateness Index questionnaire modified by our group can be used, as a reliable method, to assess the appropriateness of pharmacotherapy in patients with multiple chronic conditions.

[Health care models for patients with multiple chronic conditions and the role of the hospital pharmacy/the hospital pharmacist]. / Modelos de atención al paciente pluripatológico y el papel de la farmacia hospitalaria.

INTRODUCTION: Managing care for patients with chronic conditions currently represents one of the greatest challenges to health care systems. As a subgroup of these patients, those with multiple chronic conditions are at greater risk for death or disability, and they consume more resources. They are characterized by the coexistence of two or more chronic illnesses lasting a year or longer which require ongoing medical attention and/or interfere with their daily activities. For these polypathological patients pharmaceutical care would be of special benefit, thus, their needs should be a priority objective for hospital pharmacy. OBJECTIVE: To increase awareness of this type of patients and the characteristics of the principal approaches and health care models proposed to improve chronic disease management, as well as to emphasize the urgency for hospital pharmacists to join these models, and to present various activities that pharmacists might carry out as an integral part of these approaches. RESULTS: Numerous models exist internationally, including the Chronic Care Model and the Kaiser Permanente pyramid of risks. In our country a growing number of initiatives has culminated in the recent Seville Declaration. For the hospital pharmacy, caring for the chronically ill patient following a model that is multi-professional, cooperative, integral, and patient centered, is an enormous task. Pharmacy departments and the Spanish Society of Hospital Pharmacy should reorient their strategies for pharmaceutical care, training, and research. Of special interest are those activities designed to improve adherence, adequacy, and continuity in treatments, all the while emphasizing active patient participation.