ABSTRACT
OBJECTIVE: The benefit-risk balance of statins and ezetimibe as primary prevention of cardiovascular disease is controversial in elderly patients due to the doubts about their effectiveness and certainty about adverse effects. The aim of this paper was to analyze health outcomes of a statin and ezetimibe deprescription strategy in patients aged 75 or older treated with these drugs for primary prevention of cardiovascular disease. METHODS: An observational ambispective cohort study was made to evaluate health outcomes after the implementation of a strategy for deprescribing statins and ezetimibe in patients aged 75 or older who take these drugs for primary prevention of cardiovascular disease. To avoid the risk of bias due to non-random assignment of patients to different groups, a propensity score will be calculated for each patient using logistic regression. The outcome of interest will be the deprescription or not of statins or ezetimibe. Time to hospital admission or death from any cause and other variables related to health outcomes will be analysed. Groups with and without statin or ezetimibe deprescription will be compared by survival analysis using Cox regression to estimate the hazard ratio. CONCLUSIONS: It is expected to obtain health outcomes of the strategy of deprescribing statins and ezetimibe in primary prevention in patients aged 75 or older. They will provide information on the advisability of continuing the strategy.
OBJETIVO: El balance beneficio-riesgo de estatinas y ezetimiba como prevención primaria de la enfermedad cardiovascular (ECV) resulta controvertido en pacientes de edad avanzada, debido a las dudas sobre su efectividad y las certezas sobre efectos adversos. El objetivo de este estudio fue analizar los resultados en salud de una estrategia de deprescripción de estatinas y ezetimiba en prevención primaria de ECV en pacientes mayores de 75 años. METODOS: Se realizó un estudio ambispectivo de cohortes para evaluar los resultados en salud obtenidos tras la implementación de una estrategia poblacional de deprescripción de estatinas y ezetimiba en pacientes con edad igual o mayor a 75 años que tomaban estos fármacos como prevención primaria de ECV. Para evitar posibles sesgos debidos a la asignación no aleatoria de los pacientes a los distintos grupos, se calculará un índice de propensión para cada paciente utilizando una regresión logística, en la que la variable de resultado será la deprescripción o no de estatinas o ezetimiba. Se analizará el tiempo hasta el ingreso hospitalario o la muerte por cualquier causa y otras variables relacionadas con resultados en salud. Se compararán los grupos con y sin deprescripción de estatina o ezetimiba mediante un análisis de supervivencia utilizando un modelo de riesgos proporcionales de Cox para estimar el hazard ratio. CONCLUSIONES: Se espera obtener información sobre los resultados en salud de la estrategia de deprescripción de estatinas y ezetimiba en prevención primaria en mayores de 75 años que informarán sobre la conveniencia de continuarla.
Subject(s)
Cardiovascular Diseases , Deprescriptions , Ezetimibe , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Aged , Cardiovascular Diseases/prevention & control , Cohort Studies , Humans , Observational Studies as Topic , Outcome Assessment, Health Care , Primary Prevention , SpainABSTRACT
FUNDAMENTOS: l balance beneficio-riesgo de estatinas y ezetimiba como prevención primaria de la enfermedad cardiovascular (ECV) resulta controvertido en pacientes de edad avanzada, debido a las dudas sobre su efectividad y las certezas sobre efectos adversos. El objetivo de este estudio fue analizar los resultados en salud de una estrategia de deprescripción de estatinas y ezetimiba en prevención primaria de ECV en pacientes mayores de 75 años. MÉTODOS: Se realizó un estudio ambispectivo de cohortes para evaluar los resultados en salud obtenidos tras la implementación de una estrategia poblacional de deprescripción de estatinas y ezetimiba en pacientes con edad igual o mayor a 75 años que tomaban estos fármacos como prevención primaria de ECV. Para evitar posibles sesgos debidos a la asignación no aleatoria de los pacientes a los distintos grupos, se calculará un índice de propensión para cada paciente utilizando una regresión logística, en la que la variable de resultado será la deprescripción o no de estatinas o ezetimiba. Se analizará el tiempo hasta el ingreso hospitalario o la muerte por cualquier causa y otras variables relacionadas con resultados en salud. Se compararán los grupos con y sin deprescripción de estatina o ezetimiba mediante un análisis de supervivencia utilizando un modelo de riesgos proporcionales de Cox para estimar el hazard ratio. CONCLUSIONES: Se espera obtener información sobre los resultados en salud de la estrategia de deprescripción de estatinas y ezetimiba en prevención primaria en mayores de 75 años que informarán sobre la conveniencia de continuarla.(AU)
BACKGROUND: The benefit-risk balance of statins and ezetimibe as primary prevention of cardiovascular disease is controversial in elderly patients due to the doubts about their effectiveness and certainty about adverse effects. The aim of this paper was to analyze health outcomes of a statin and ezetimibe deprescription strategy in patients aged 75 or older treated with these drugs for primary prevention of cardiovascular disease. METHODS: An observational ambispective cohort study was made to evaluate health outcomes after the implementation of a strategy for deprescribing statins and ezetimibe in patients aged 75 or older who take these drugs for primary prevention of cardiovascular disease. To avoid the risk of bias due to non-random assignment of patients to different groups, a propensity score will be calculated for each patient using logistic regression. The outcome of interest will be the deprescription or not of statins or ezetimibe. Time to hospital admission or death from any cause and other variables related to health outcomes will be analysed. Groups with and without statin or ezetimibe deprescription will be compared by survival analysis using Cox regression to estimate the hazard ratio. CONCLUSIONS: It is expected to obtain health outcomes of the strategy of deprescribing statins and ezetimibe in primary prevention in patients aged 75 or older. They will provide information on the advisability of continuing the strategy.(AU)
Subject(s)
Humans , Male , Female , Aged , Primary Prevention , Deprescriptions , Ezetimibe , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Cardiovascular Diseases , Public Health , Cohort StudiesABSTRACT
PURPOSE: In the last decades, different criteria have been developed for detecting inappropriate prescription in older patients. In Spain, translations and adaptations of international lists are available but it would be necessary a national list which could cope with the peculiarities of our health system, existing pharmaceutical market, and prescription habits. We propose in this project the creation of a Spanish potentially inappropriate drugs list which could be applicable in our clinical scenario. METHODS: We use a Delphi method involving 25 experts from different backgrounds (Clinical Pharmacology, Geriatrics, Rational Use of Drugs and Pharmacy, Primary Care and Pharmacoepidemiology, and Pharmacovigilance) that were asked to participate in two-round questionnaires. For analysis, current recommendations of Worth and Pigni were applied, and every statement was classified into one of three groups: strong, moderate, or low agreement. Statements with strong agreement were accepted to be part of the inadequate prescription list. Moderate agreement statements were selected to enter the second questionnaire, and statements with low agreement were further analyzed to determine if it was due to heterogeneity or due to dispersion in the answers. RESULTS: The first questionnaire consisted of 160 proposed sentences, of which 106 reached a high agreement, 32 a moderate agreement, and 22 a low agreement. All sentences proposed in the second questionnaire reached a strong agreement. The total accepted sentences were 138. CONCLUSIONS: We offer a list of inadequate prescription in older patients adapted to the Spanish pharmacopeia and according to the prescription habits in our environment.
