Real life study of sacubitril valsartan combined therapy in chronic heart failure / Estudio en vida real de la terapia combinada de sacubitril valsartán en insuficiencia cardíaca crónica

Objectives: Sacubitril/valsartan is a drug for chronic heart failure (CHF), approved by Drugs Regulatory Agencies based on the results of the PARADIGM-HF, which could have several limitations on internal validity and applicability. Furthermore, this drug has a high economic impact. The objectives of this study are to evaluate effectiveness and safety of sacubitril/valsartan in CHF, as well as to evaluate adequation to use criteria stablished in a Health Management Area (HMA). Methods: Retrospective, observational study including adult patients with CHF who were receiving sacubitril/valsartan during 2017 in an HMA. The treatment effectiveness was assesed by death and/or hospitalization rates related to CHF. Frequency of adverse events was used to safety evaluation. Furthermore, adequation rate was assessed. Findings: A total of 68 patients were included. Death or hospitalization rates due to CHF at 12 months were 32.3% globally (2.9% and 29.4% respectively). Among patients analyzed, 33.8% presented hypotension, during the first year after treatment initiation. Overall adequation rate was 67.6%. Conclusions: A high percentage of death and/or hospitalization due to CHF was observed. Hypotension is a frequent adverse event which leads to dose adjustment and/or drug withdrawal. Overall adequation rate of sacubitril/valsartan prescription is acceptable. (AU)

Objetivos: El sacubitril/valsartán es un medicamento para la insuficiencia cardíaca crónica (ICC), aprobado por las agencias reguladoras de medicamentos en base a los resultados del ensayo pivotal PARADIGM-HF, que podría tener varias limitaciones en la validez interna y la aplicabilidad. Además, este fármaco tiene un alto impacto económico. Los objetivos de este estudio son evaluar la efectividad y la seguridad de sacubitril/valsartán en la ICC, así como evaluar la adecuación a los criterios establecidos en un Área de Gestión de Salud (AGS). Métodos: Estudio observacional retrospectivo que incluye pacientes adultos con ICC que recibieron sacubitril/valsartán durante 2017 en una AGS. La efectividad del tratamiento fue evaluada mediante la tasa de mortalidad y/o hospitalización relacionadas con la ICC. La frecuencia de los eventos adversos se utilizó para la evaluación de seguridad. Además, se evaluó la tasa de adecuación. Resultados: Se incluyeron un total de 68 pacientes. Las tasas de mortalidad u hospitalización por ICC a los 12 meses fueron del 32,3% a nivel global (2,9% y 29,4%, respectivamente). Entre los pacientes analizados, el 33,8% presentó hipotensión durante el primer año después del inicio del tratamiento. La tasa de adaptación global fue del 67,6%. Conclusiones: Se observó un alto porcentaje de muerte y/o hospitalización por ICC. La hipotensión es un evento adverso frecuente que conduce al ajuste de la dosis y/o a la retirada del medicamento. La tasa general de adecuación de la prescripción de sacubitril/valsartán es aceptable. (AU)

[Adequacy of treatment with ertapenem according to the criterion approved for the infection´s commission of a specialty hospital]. / Adecuación del tratamiento con ertapenem según los criterios aprobados por la comisión de infecciones de un hospital de especialidades.

OBJECTIVE: The inappropriate use of antibiotics in our environment increases the risk of multi-resistant bacteria, therefore it is necessary to present studies to meet and promote the proper use of antimicrobial. METHODS: Retrospective observational study in which patients who are receiving ertapenem during the period of stady (5 ½ months), were included. The adequacy of the indication to the conditions of use agreed in the Hospital was evaluated and the evolution of the treatment was monitored until the end, determining the degree of therapeutic de-escalation. RESULTS: 84 ertapenem prescriptions were included. The vast mayority of the prescriptions were carried out by Internal Medicine (41.7%) and the main indication was urinary tract infection (47.2%). Microbiological cultures were requested in the 75% of the patients before the first dose of ertapenem. The prescription was adapted in 69 (82.14%) of ertapenem patients to the criteria approved by the Hospital. Regarding the evolution of antibiotic therapy, treatment with ertapenem continued until resolution of the infection in 58.33% of patients. In 15 of 23 (66.21%) patients with the possibility of therapeutic de-escalation it was performed after 2-3 days of empirical treatment. CONCLUSIONS: The vast majority of treatments ertapenem fit the criteria of prescription our Hospital. The high percentage of patients with microbiological results available, allowed in many patients the appropriate adjustment of the treatment in the first 72 hours.

Modificación del tratamiento antibiótico empírico en las primeras 72 horas de hospitalización / Modification of empirical antimicrobial regimen during the first 72 hours of hospitalisation

Objetivo: Los objetivos del presente estudio fueron describir la modificación que se realiza de la antibioterapia empírica indicada a los pacientes ingresados desde el área de urgencias en los primeros días de estancia en la planta de hospitalización y conocer las características de dicho tratamiento antibiótico. Método: Estudio prospectivo y observacional en el que se incluyó a pacientes mayores de 14 años que ingresaron desde el área de urgencias con al menos un antibiótico prescrito y tuvieron una hospitalización de al menos 72 h. Se realizó un seguimiento diario de cada caso durante los primeros 3 días de hospitalización, documentando el tipo de infección diagnosticada, los datos microbiológicos y la antibioterapia empírica prescrita y sus modificaciones. Resultados: Se incluyó a 225 pacientes. Los diagnósticos más frecuentes fueron infección respiratoria, neumonía e infección de la piel y los tejidos blandos, y los antibióticos más empleados fueron amoxicilina-ácido clavulánico, levofloxacino y cefalosporinas de tercera generación. Se solicitó al menos un tipo de muestra microbiológica a 80 enfermos (36%). De las 225 pautas antibióticas prescritas en urgencias, 94 (42%) fueron modificadas durante las primeras 72 h de hospitalización: 37 (16%) pautas se cambiaron por completo, 31 (14%) se suspendieron totalmente y en 26 (12%) se añadió o suspendió algún antimicrobiano, aunque sólo en 40 de ellas (42%) se dispuso de cultivos para dirigir el tratamiento. Conclusiones: La frecuencia con la que las pautas antimicrobianas prescritas en urgencias se modificaron durante los primeros días de estancia en la planta de hospitalización es elevada, y destaca la escasa utilización de los resultados microbiológicos para realizar estos cambios (AU)

Objective: The aims of this study were to determine the empirical antibiotic therapy used in patients admitted to the Emergency Department who were later hospitalised, and to describe the antibiotic changes during their first days of hospitalisation. Method: All 14-year-old patients admitted to the Emergency Department who were started on antibiotic therapy and subsequently were hospitalised for at least 72 hours in an in-patient hospital ward, were included in a prospective observational study. Patients underwent daily follow-up during the first three days of hospitalisation. The type of infection, microbiological data and empirical antibiotic therapy and its changes were registered. Results: 225 patients were included in this study. The most frequent types of infection diagnosed were infection of the respiratory airways, pneumonia and skin and soft-tissue infection. Amoxicillin-clavulanic acid was the most widely prescribed antibiotic followed bylevofloxacin and third generation cephalosporins. Microbiological samples were taken in 80 (36%) patients. Of the 225 antimicrobial regimens started in the Emergency Department, 94 (42%) were changed during the first 72 hours of hospitalisation: 37 (16%) were completely modified, 31 (14%) were discontinued and antibiotics were added or stopped from the existing regimen in 26 cases(12%). Among these 94 patients whose treatment was changed, only in 40 (42%) there was a microbiological result for aiding in the adjustment of the antibiotic therapy. Conclusion: The frequency of early changes during inpatient hospitalisation to antimicrobial regimens which were initially prescribed in the Emergency Department is high. Microbiological results were rarely used to guide these changes (AU)

[Modification of empirical antimicrobial regimen during the first 72 hours of hospitalisation]. / Modificación del tratamiento antibiótico empírico en las primeras 72 horas de hospitalización.

OBJECTIVE: The aims of this study were to determine the empirical antibiotic therapy used in patients admitted to the Emergency Department who were later hospitalised, and to describe the antibiotic changes during their first days of hospitalisation. METHOD: All 14-year-old patients admitted to the Emergency Department who were started on antibiotic therapy and subsequently were hospitalised for at least 72 hours in an in-patient hospital ward, were included in a prospective observational study. Patients underwent daily follow-up during the first three days of hospitalisation. The type of infection, microbiological data and empirical antibiotic therapy and its changes were registered. RESULTS: 225 patients were included in this study. The most frequent types of infection diagnosed were infection of the respiratory airways, pneumonia and skin and soft-tissue infection. Amoxicillin-clavulanic acid was the most widely prescribed antibiotic followed by levofloxacin and third generation cephalosporins. Microbiological samples were taken in 80 (36%) patients. Of the 225 antimicrobial regimens started in the Emergency Department, 94 (42%) were changed during the first 72 hours of hospitalisation: 37 (16%) were completely modified, 31 (14%) were discontinued and antibiotics were added or stopped from the existing regimen in 26 cases (12%). Among these 94 patients whose treatment was changed, only in 40 (42%) there was a microbiological result for aiding in the adjustment of the antibiotic therapy. CONCLUSION: The frequency of early changes during inpatient hospitalisation to antimicrobial regimens which were initially prescribed in the Emergency Department is high. Microbiological results were rarely used to guide these changes.

[An analisys fo causes for the discontinuation of a simplified antiretroviral regimen with abacavir, lamivudine and zidovudine]. / Análisis de las causas de suspensión del régimen antirretroviral simplificado abacavir, lamivudina y zidovudina.

OBJECTIVE: To identify and analyze the most common causes for the discontinuation of antiretroviral therapy, including the co-formulation of abacavir, lamivudine and zidovudine (ABC-3TC-AZT). METHOD: An observational, retrospective study was carried out on patients receiving antiretroviral therapy with ABC-3TC-AZT seen in the Pharmacy Department s outpatient unit from February 2002 through June 2004. The causes for discontinuation among patients withdrawing from this therapy were analyzed. Adherence was assessed using computerized dispensation records. A Kaplan-Meier survival analysis was designed in order to identify factors predictive of discontinuation. RESULTS: In all, 114 patients (85 males, 74.6%) received this therapy - 25.4% of them were naïve patients - and 34.2% (39/114) withdrew from this regimen, amongst them 44.8% (13/29) of naïve subjects. In 92.3% of cases this happened before treatment week 48. Discontinuation causes included: adverse reactions (46.1%), voluntary discontinuation (33.3%), clinical decision (15.4%), and other reasons (5.1%). A possible hypersensitivity reaction to ABC was reported for 9 patients. A greater likelihood of discontinuation was associated with detectable viral load at therapy onset, ex-parenteral drug abuser status, and naïve status (p < 0.05). CONCLUSIONS: A high percentage of discontinuations due to adverse events and voluntary withdrawal was found, particularly early during treatment. Patients who may therapeutically benefit from this regimen, particularly naïve subjects, should be identified, and interventions to improve adherence and optimize recovery parameters should be implemented.

Análisis de las causas de suspensión del régimen antirretroviral simplificado abacavir, lamivudina y zidovudina / An analysis of causes for the discontinuation of a simplified antiretroviral regimen with abacavir, lamivudine and zidovudine

Objetivo: Identificar y analizar las causas más frecuentes de discontinuación de la terapia antirretroviral que incluye la co-formulación: abacavir, lamivudina y zidovudina (ABC-3TC-AZT). Método: Estudio retrospectivo observacional de los pacientesen tratamiento antirretroviral con ABC-3TC-AZT, atendidos en la unidad de pacientes externos del servicio de farmacia durante el periodo comprendido entre febrero de 2002 y junio de 2004. Se analizó la causa de discontinuación en aquellos pacientes que no siguieron con esta terapia. Se evaluó la adherencia mediante los registros informáticos de dispensación. Se diseñó un análisis de supervivencia de Kaplan-Meier para identificar factores predictivos de discontinuación. Resultados: Un total de 114 pacientes (85 hombres, 74,6%) fueron tratados con esta terapia. Un 25,4% era naïve. El 34,2% (39/114) de los pacientes discontinuó el tratamiento. Entre ellos, el 44,8% (13/29) de los sujetos naïve. En el 92,3% del total de casos esto ocurrió antes de alcanzar las 48 semanas en tratamiento. Las causas de discontinuación fueron: reacciones adversas (46,1%), abandono voluntario (33,3%), decisión clínica (15,4%) y otros motivos (5,1%). Posible reacción de hipersensibilidad a ABC fue descrita en 9 pacientes. Se relacionó tener carga viral detectable al inicio del tratamiento, ser ex-ADVP, y paciente naïve, con mayor probabilidad de discontinuación (p < 0,05). Conclusiones: Se encontró un alto porcentaje de discontinuación debido a efectos adversos y abandono voluntario, principalmente al inicio del tratamiento. Es necesario identificar a aquellos pacientes a los cuales este esquema les puede aportar un beneficio terapéutico, especialmente los sujetos naïve, y realizar intervenciones para mejorar la adherencia y optimizar así los parámetros de recuperación

Objective: To identify and analyze the most common causes for the discontinuation of antiretroviral therapy, including the coformulation of abacavir, lamivudine and zidovudine (ABC-3TCAZT). Method: An observational, retrospective study was carried out on patients receiving antiretroviral therapy with ABC-3TC-AZT seen in the Pharmacy Department’s outpatient unit from February 2002 through June 2004. The causes for discontinuation among patients with drawing from this therapy were analyzed. Adherence was assessed using computerized dispensation records. A Kaplan-Meier survival analysis was designed in order to identify factors predictive of discontinuation. Results: In all, 114 patients (85 males, 74.6%) received this therapy – 25.4% of them were naïve patients – and 34.2% (39/114) with drew from this regimen, amongst them 44.8%(13/29) of naïve subjects. In 92.3% of cases this happened before treatment week 48. Discontinuation causes included: adverse reactions (46.1%), voluntary discontinuation (33.3%), clinical decision (15.4%), and other reasons (5.1%). A possible hypersensitivity reaction to ABC was reported for 9 patients. A greater likelihood of discontinuation was associated with detectable viral load at therapy onset, ex-parenteral drug abuser status, and naïve status (p < 0.05). Conclusions: A high percentage of discontinuations due to adverse events and voluntary withdrawal was found, particularly early during treatment. Patients who may therapeutically benefit from this regimen, particularly naïve subjects, should be identified, and interventions to improve adherence and optimize recovery parameters should be implemented

Prescripción de medicamentos en receta y en informe de alta del servicio de medicina interna de un hospital general / Medicines given out on prescription and on discharge reports of the internal medicine service of a general hospital

No disponible

No disponible

[A study of erythropoietin use for myelodysplastic syndrome]. / Estudio de utilización de eritropoyetina en el síndrome mielodisplásico.

OBJECTIVES: To assess the effectiveness of erythropoietin (EPO) and to study the extent of application of published recommendations for use in treating anemia in patients with myelodysplastic syndrome (MDS). MATERIALS AND METHODS: An observational retrospective study of patients with MDS receiving at least one dose of EPO. Patients were selected from the outpatient database at the Pharmacy Department, and the medical history as well as both clinical and pharmacotherapeutic data were collected. The clinical effectiveness of EPO was assessed at 6, 12, 16 and 24 weeks after treatment using two distinct criteria for erythroid response. Three items were defined and assessed for each patient in order to establish the extent of application of published recommendations on the efficient use of EPO. RESULTS: Eleven patients were enrolled. Three of them responded to EPO at some point during follow-up, according to pre-defined criteria. All three items used in the assessment of the efficient use of EPO showed significantly high inadequacy rates. CONCLUSIONS: In our study, the effectiveness of EPO in the management of MDS-related anemia is similar to that described in the literature. However, upon the assessment of its use in our hospital, this drug was shown not to have been employed according to published recommendations, which promote its cost-effective use. We believe that the cooperation of the Pharmacy Department in the design of a protocol for EPO use in MDS is of interest, and would contribute to EPO's efficient use.