ABSTRACT
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)
Subject(s)
Humans , Heart Failure , Valsartan , Hypertension , Drug TherapyABSTRACT
OBJECTIVE: Many studies have indicated that hospitalization and readmissions occur frequently, especially among people living with HIV. The aim of the study was to determine the effectiveness of a programmed and structured pharmaceutical intervention, based on "CMO PC model" to reduce the readmission rate in high-risk HIV patients. METHODS: This was a single-center, prospective study based on a structured health intervention conducted between March-2017 and March-2018 with 12 months of follow-up at outpatient pharmacy services. At discharge, HIV patients included were classified according to the risk of readmission as low or high risk patients, being the latter proposed to participate. The selected patients were randomly assigned to a control group (usual care) or intervention group (including stratification-motivational interview and new technologies: CMO pharmaceutical care). The primary endpoint was readmission rate at one year of follow-up in each group. RESULTS: A total of 39 patients were included. As regards the main variable, in the intervention group, 21,4% (n=3) of patients were readmitted in the first year after discharge vs. 66,7% (n=6) in the control group (p=0,042). CONCLUSIONS: Tailored pharmaceutical care based on risk stratification, motivational interviewing, and new technologies has a positive influence to reduce the percentage of readmission in high risk HIV patients.
