Effectiveness and safety of pembrolizumab monotherapy in patients with locally advanced or metastatic non-small-cell lung cancer.

INTRODUCTION: Immunotherapy has become a standard treatment for lung cancer; the objective of this study was to evaluate the effectiveness, safety of pembrolizumab monotherapy in patients with advanced or metastatic non-small-cell lung cancer used in real-world clinical practice. MATERIAL AND METHODS: Retrospective observational study of every patient treated with pembrolizumab in our centre from January 2017 to June 2019. Outcomes collected: sex, age, Eastern Cooperative Oncology Group, programmed death receptor 1 level, previous metastatic line therapies, adverse events and smoking status. RESULTS: A total of 62 patients were reviewed. The median age was 62.34 ± 10.62 years, 48 (77.41%) were men and 91.93% of patients had Eastern Cooperative Oncology Group 0. The median dose administered was 170.5 mg (108 - 240 mg) and the median follow-up was 3 months (range: 1 - 38). A median of four cycles of pembrolizumab (range: 1 - 56) were administered as monotherapy. The reason for treatment discontinuation was mainly due to disease progression in 38.70% of patients or death in 30.64%. As first-line pembrolizumab monotherapy, median progression-free survival was 7.7 months (95% CI: 3.66 - 11.73) (N = 33). With respect to patients who were treated in second-third-line treatment, median progression-free survival was 3.5 months (95% CI: 2.40 - 4.59) (N=29). As to overall survival, pembrolizumab-treated patients as first-line treatment reached 19 months median OG (95% CI: 13.36 - 24.63) (N = 33) and those treated in second-third-line treatment got 11 months (95% CI: 3.4 - 18.5). A total of 64.51% of patients presented some adverse events to pembrolizumab however, only, 9.38% of them were grade 3. CONCLUSION: Pembrolizumab represents an effective and feasible alternative in terms of progression-free survival. It is a well-tolerated treatment option.

Conciliación de la medicación al ingreso en el servicio de cirugía ortopédica y traumatológica / Medication reconciliation at admission to The Orthopaedic Surgery and Traumatology Department

INTRODUCCIÓN: Identificar las discrepancias existentes entre la medicación prescrita al ingreso en el servicio de traumatología y la medicación habitual de los pacientes, determinar la prevalencia de errores de conciliación y analizar el grado de aceptación de las intervenciones farmacéuticas realizadas para su resolución. MÉTODO: Estudio prospectivo de dos años de duración en un hospital comarcal público de España donde se seleccionaron los pacientes ingresados en traumatología con algún medicación domiciliario prescrito. Tras 24-48 horas del ingreso, el farmacéutico realizó la conciliación de la medicación, comparando la orden médica prescrita al ingreso con el tratamiento domiciliario. Se identificaron las discrepancias comunicándose al médico y se analizó el grado de aceptación de las recomendaciones. RESULTADOS: Se incluyeron 756 pacientes, con un total de 834 episodios de hospitalización; 66,1% mujeres, edad media: 72 ± 12,3 años, media de medicamentos domiciliarios por paciente: 8,1 ± 4,3. Se analizaron 8422 prescripciones, identificándose un 57,5% de discrepancias. La mayoría de las discrepancias no justificadas se debieron a omisión de medicamento (75%) seguido de la modificación de la posología o vía de un medicamento (19,1%). En el 87,4% de los episodios se encontró al menos una discrepancia. Las recomendaciones propuestas por el farmacéutico fueron aceptadas en el 69,9% de los casos. CONCLUSIONES: Existe un alta prevalencia de errores de conciliación al ingreso en el servicio de traumatología. Esta metodología ha permitido la coordinación del farmacéutico con el resto de profesionales implicados en la conciliación de la medicación, con el fin de detectar y resolver las discrepancias de medicación y reducir así los errores

INTRODUCTION: We aim to describe a method that would ensure continuity of patient care as regards drug therapy at admission to the orthopaedic surgery and traumatology department, identify the reconciliation discrepancies, determine the prevalence of reconciliation errors and analyse the acceptance of the pharmacist interventions. METHODS: Prospective observational study was conducted for two years in a regional public hospital in Spain. The study included patients hospitalized in the Orthopaedic Surgery and Traumatology Department with chronic medi¬cation prescribed. At 24-48 hours after hospital admission, the pharmacist compared the pre-admission pharmaco¬logical treatment of patients with the medication received in hospital to identify and reconciliation discrepancies. They were communicated and we analysed the acceptance of the pharmacist interventions. RESULTS: The study included 756 patients, with a total of 834 hospitalization episodes, 66,1% of whom were women, mean age: 72±12,3 years and a mean of 8,1±4,3 drugs. We analysed 8422 prescriptions, 57,5% reconciliation discrep¬ancies. The most frequent unjustified discrepancies were drug omission (75,2%), following by modification of the dose or route of administration (19,1%). There was at least one medication reconciliation discrepancy in 87,4% of hospitalization episodes. Pharmacist recommendations were accepted in 69,9% of cases. CONCLUSIONS: There was a high prevalence of reconciliation errors among patients admitted to the Orthopaedic Surgery and Traumatology Department. This methodology has allowed a workflow to be established that facilitates coordination between the pharmacist and others healthcare providers, to identify and resolve medication discrepancies to reduce medication errors

Effectiveness of 12 week ledipasvir/sofosbuvir and predictors of treatment failure in patients with hepatitis C / Efectividad de ledipasvir/sofosbuvir durante 12 semanas de tratamiento y factores predictivos de fracaso del tratamiento en pacientes con hepatitis C

INTRODUCTION: The efficacy of ledipasvir/sofosbuvir (LDV/SOF) have been demonstrated in randomized controlled trials, however,there is an unmet need for real-world effectiveness data. It is important to gather data regarding potential predictors of treatment failure with (LDV/SOF). Predictors of sustained virologic response (SVR) to all-oral HCV regimens can inform nuanced treatment decisions. The objectives of this study were to evaluate the effectiveness of LDV/SOF, SVR12 as main endpoint and SVR24 as second endpoint, and identify predictors of treatment failure. MATERIAL AND METHODS: Retrospective and observational study carried out from April 2015 to January 2016. Inclusion criteria: patients with HCV infection treated with LDV/SOF for 12 weeks during study period. The patients that were treated during 24 weeks were excluded as well as those treated with peg-interferon. Binary logistic regression was used to predict what variable was associated with treatment failure. RESULTS: A total of 122 patients were analyzed achieving SVR12 91.80% (112/122) of them. The patients with HCV genotype (GT) 1a or GT1b or GT4 achieved SVR12. Only one pre-treated non-cirrhotic HCV GT1 patients relapsed to treatment. The lowest SVR12 were obtained for GT3, 43.75%, (7/16). Everybody that got SVR12 achieved SVR24. None of the variables analyzed significantly influenced the SVR12, except GT (p = 0.001). Almost all the relapses occurred in GT3. CONCLUSION: LDV/SOF combination has been very effective to treat GT1 and GT4 infected patients, however, has constituted a suboptimal therapeutic option for those patients infected with GT3, regardless of the rest of the variables analyzed

INTRODUCCIÓN: La eficacia de ledipasvir/sofosbuvir (LDV/SOF) se ha demostrado en ensayos clínicos, sin embargo, son necesarios más estudios sobre su eficacia en la práctica clínica. Además es importante estudiar los posibles factores predictivos de fracaso de tratamiento con LDV/SOF. Los factores predictivos de respuesta viral sostenida (RVS) a antivirales de acción directa pueden informar sobre decisiones de tratamiento. Los objetivos de este estudio fueron evaluar la efectividad de LDV/SOF, RVS12 como variable principal y RVS24 como secundaria, e identificar los factores predictivos de fracaso del tratamiento. MATERIAL Y MÉTODOS: Estudio retrospectivo y observacional realizado desde abril de 2015 a enero de 2016. Criterios de inclusión: pacientes con infección por VHC tratados con LDV/SOF durante 12 semanas. Se excluyeron los pacientes tratados durante 24 semanas y los tratados con peg-interferón. Aplicamos el método estadístico denominado regresión logística binaria para predecir qué variable estaba relacionada con el fracaso del tratamiento. RESULTADOS: Se analizaron 122 pacientes logrando el 91,80% (112/122) RVS12. Los pacientes infectados con genotipo (GT) 1a o GT1b o GT4 lograron RVS12. Solo un paciente, no cirrótico y previamente tratado, infectado con GT1 no alcanzó RVS12. Las tasas más bajas de RVS12 se obtuvieron para GT3, 43.75%, (7/16). Todos los pacientes que obtuvieron RVS12 lograron RVS24. Ninguna de las variables analizadas influyó significativamente en la RVS12, excepto GT (p = 0.001). Casi todas las recaídas ocurrieron en GT3. CONCLUSIONES: La combinación LDV/SOF ha sido muy efectiva para tratar a los pacientes infectados con GT1 y GT4, sin embargo, ha constituido una opción terapéutica subóptima para los infectados con GT3, independientemente del resto de las variables analizadas

Vedolizumab en Enfermedad de Crohn; Informe de evaluación GENESIS-SEFH / Vedolizumab in Crohn Disease genesis-sefh drug evaluation report

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Adult severe haemophilia A patients under long-term prophylaxis with factor VIII in routine clinical practice.

There is no clear consensus on the best practice for long-term prophylaxis in adults with severe haemophilia A. This is a single-centre prospective case series study. We describe here the demographic data, type and reason of prophylaxis in adult patients (>18 years old) with severe (<1%) haemophilia A, treated in our centre from 2006 to 2013. Prophylaxis was tailored according to pharmacokinetic studies and posterior factor VIII (FVIII) trough level adjustment. We analysed FVIII consumption, bleeding rate, adherence and adverse events in this group of patients. In adult patients who initiated long-term prophylaxis during this period, we compared FVIII consumption and bleeding rate with the previous on-demand period. We analysed data from 18 patients. Median annual FVIII consumption was 2374.2 IU/kg/year. Among the patients receiving tertiary prophylaxis, initiated from 2006 onwards, the annual FVIII consumption was 2557.8 vs. 1696.8 IU/kg per year during the on-demand period (P = 0.312). In this group of patients, there was a decrease in annual bleeding events of 88.3% during prophylaxis compared with the on-demand therapy (P < 0.0001). A high adherence to prophylaxis was observed (84%). No cases of anaphylaxis or symptomatic thromboembolic events were recorded. In adult severe haemophilia A patients, the type of and reason to indicate long-term prophylaxis are diverse nowadays. FVIII consumption varies depending on the justification of prophylaxis. The observations reported provide further support for the efficacy of long-term prophylaxis in adult haemophilia A patients.