[Off-label use of gabapentinoid drugs: is it necessary a deprescription strategy?] / Gabapentinoides en indicaciones no autorizadas en la ficha técnica: ¿es necesaria una estrategia de desprescripción?

OBJECTIVE: To evaluate gabapentin and pregabalin treatment adequacy to label indications, to analyze off-label use and to identify patients at high risk of respiratory depression. METHOD: An observational, retrospective study was performed. It included patients treated with pregabalin and gabapentin during 2020 in Navarre. RESULTS: A total of 9778 patients were treated with gabapentin or pregabalin during the first two months of 2020. In 56% of the cases, gabapentinoids were prescribed for off-label uses. Sixty percent of patients were taking at least one central nervous system (CNS) depressant drug concomitantly, 33% of them opioids, 20% of them combined opioids with CNS depressants and 4% of them at least one systemic antihistamine. In addition, 11% of the patients had a diagnosis of asthma or COPD. Prevalences remained constant along the year. CONCLUSIONS: It is necessary to implement a gabapentinoid deprescription strategy to improve its use and reduce safety problems.

Gabapentinoides en indicaciones no autorizadas en la ficha técnica: ¿es necesaria una estrategia de desprescripción? / Off-label use of gabapentinoid drugs: is it necessary a deprescription strategy?

Objetivo: Evaluar la adecuación de los tratamientos con gabapentina y pregabalina a las indicaciones autorizadas, analizar su uso en las no autorizadas e identificar los pacientes con más riesgo de sufrir depresión respiratoria. Método: Estudio observacional retrospectivo que incluyó a los pacientes en tratamiento con gabapentina o pregabalina en 2020 en Navarra. Resultados: Se incluyeron 9778 pacientes en tratamiento con gabapentina o pregabalina durante el primer bimestre de 2020. En el 56% de los casos se prescribieron para indicaciones no autorizadas. El 60% tomaba concomitantemente al menos un depresor del sistema nervioso central (SNC), el 33% algún opiáceo, el 20% opiáceos combinados con depresores del SNC y el 4% algún antihistamínico. El 11% tenía diagnóstico de asma o enfermedad pulmonar obstructiva crónica. Estas prevalencias se mantuvieron constantes durante el resto del año. Conclusiones: Es necesario implementar una estrategia de desprescripción de gabapentinoides para adecuar su uso y disminuir los problemas de seguridad. (AU)

Objective: To evaluate gabapentin and pregabalin treatment adequacy to label indications, to analyze off-label use and to identify patients at high risk of respiratory depression. Method: An observational, retrospective study was performed. It included patients treated with pregabalin and gabapentin during 2020 in Navarre. Results: A total of 9778 patients were treated with gabapentin or pregabalin during the first two months of 2020. In 56% of the cases, gabapentinoids were prescribed for off-label uses. Sixty percent of patients were taking at least one central nervous system (CNS) depressant drug concomitantly, 33% of them opioids, 20% of them combined opioids with CNS depressants and 4% of them at least one systemic antihistamine. In addition, 11% of the patients had a diagnosis of asthma or COPD. Prevalences remained constant along the year. Conclusions: It is necessary to implement a gabapentinoid deprescription strategy to improve its use and reduce safety problems.

[Study protocol: A strategy for deprescribing statins and ezetimibe in primary prevention of cardiovascular disease in patients older than 75 years: health outcomes analysis.] / Protocolo del estudio Estrategia de deprescripción de estatinas y ezetimiba en prevención primaria en mayores de 75 años: análisis de los resultados en salud.

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.

Protocolo del estudioEstrategia de deprescripción deestatinas y ezetimiba en prevenciónprimaria en mayores de 75 años: análisis de los resultados en salud / Study protocol: A strategy for deprescribing statins and ezetimibe in primary prevention of cardiovascular disease in patients older than 75 years: health outcomes analysis

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)

Sars-Cov-2 Infection in Patients on Long-Term Treatment with Macrolides in Spain: A National Cross-Sectional Study.

The aim of this study was to know the prevalence and severity of COVID-19 in patients treated with long-term macrolides and to describe the factors associated with worse outcomes. A cross-sectional study was conducted in Primary Care setting. Patients with macrolides dispensed continuously from 1 October 2019 to 31 March 2020, were considered. Main outcome: diagnosis of coronavirus disease-19 (COVID-19). Secondary outcomes: symptoms, severity, characteristics of patients, comorbidities, concomitant treatments. A total of 3057 patients met the inclusion criteria. Median age: 73 (64-81) years; 55% were men; 62% smokers/ex-smokers; 56% obese/overweight. Overall, 95% of patients had chronic respiratory diseases and four comorbidities as a median. Prevalence of COVID-19: 4.8%. This was in accordance with official data during the first wave of the pandemic. The most common symptoms were respiratory: shortness of breath, cough, and pneumonia. Additionally, 53% percent of patients had mild/moderate symptoms, 28% required hospital admission, and 19% died with COVID-19. The percentage of patients hospitalized and deaths were 2.6 and 5.8 times higher, respectively, in the COVID-19 group (p < 0.001). There was no evidence of a beneficial effect of long-term courses of macrolides in preventing SARS-CoV-2 infection or the progression to worse outcomes in old patients with underlying chronic respiratory diseases and a high burden of comorbidity.

Patients receiving a high burden of antibiotics in the community in Spain: a cross-sectional study.

Some patients in the community receive a high burden of antibiotics. We aimed at describing the characteristics of these patients, antibiotics used, and conditions for which they received antibiotics. We carried out a cross-sectional study. Setting: Thirty Health Primary Care Areas from 12 regions in Spain, covering 5,960,191 inhabitants. Patients having at least 30 packages of antibacterials for systemic use dispensed in 2017 were considered. Main outcome measures: Prevalence of antibiotic use, conditions for which antibiotics were prescribed, clinical characteristics of patients, comorbidities, concomitant treatments, and microbiological isolates. Patient's average age was 70 years; 52% were men; 60% smokers/ex-smokers; 54% obese. Overall, 93% of patients had, at least, one chronic condition, and four comorbidities on average. Most common comorbidities were cardiovascular and/or hypertension (67%), respiratory diseases (62%), neurological/mental conditions (32%), diabetes (23%), and urological diseases (21%); 29% were immunosuppressed, 10% were dead at the time of data collection. Patients received three antibiotic treatments per year, mainly fluoroquinolones (28%), macrolides (21%), penicillins (19%), or cephalosporins (12%). Most frequently treated conditions were lower respiratory tract (infections or prophylaxis) (48%), urinary (27%), and skin/soft tissue infections (11%). Thirty-five percent have been guided by a microbiological diagnosis, being Pseudomonas aeruginosa (30%) and Escherichia coli (16%) the most frequent isolates. In conclusion, high antibiotic consumers in the community were basically elder, with multimorbidity and polymedication. They frequently received broad-spectrum antibiotics for long periods of time. The approach to infections in high consumers should be differentiated from healthy patients receiving antibiotics occasionally.

Resultados de la implementación de un programa piloto de optimización de antimicrobianos (PROA) en Atención Primaria / Results of implementation of a pilot antimicrobial stewardship program (ASP) in Primary Care

FUNDAMENTO: El objetivo de este estudio fue evaluar la implementación de un programa piloto de optimización de antimicrobianos (PROA) en equipos de Atención Primaria (EAP) en Navarra. MATERIAL Y MÉTODOS: Estudio experimental, no aleatorizado, realizado con datos del sistema de facturación de recetas. Se calculó la variación del uso de antibióticos antes (2018) y después (2019) de implementar el PROA en doce EAP, y se comparó con la variación en otros doce EAP sin PROA. Se consideró el consumo global y por grupo terapéutico: beta-lactámicos, fluoroquinolonas, macrólidos, cefalosporinas y fosfomicina-trometamol, expresado como número de pacientes tratados y DDD (dosis diarias definidas). RESULTADOS: El número de pacientes tratados con antibióticos disminuyó significativamente más en el grupo de EAP con PROA (-9,1 vs -1,7%), especialmente en el caso de fluoroquinolonas (-25 vs -20,4%), macrólidos (-20,4 vs -8,5%) y amoxicilina-clavulánico (-10,3 vs -2,5%). Las reducciones en DDD siguieron el mismo patrón. En ambos grupos de EAP se mantuvo constante el número de pacientes tratados con cefalosporinas de tercera generación, mientras que aumentaron de forma similar los tratados con cefalosporinas de primera generación y con penicilinas sensibles a betalactamasa. En los EAP con PROA aumentó significativamente menos el número de pacientes tratados con fosfomicina-trometamol (4,0 vs 11,5%), reduciendo su consumo en DDD mientras que aumentaron en los EAP sin PROA (-1 vs 10%, p < 0,001). CONCLUSIONES: Los EAP con PROA redujeron significativamente más el consumo global de antimicrobianos, fluoroquinolonas, macrólidos y amoxicilina-clavulánico que el grupo sin PROA. Estos resultados positivos han propiciado su extensión al resto de EAP de Navarra

BACKGROUND: The aim of this study was to evaluate the implementation of a pilot antimicrobial stewardship program (ASP) in Primary Health Care teams (PHCT) in Navarre (Spain). MATERIAL AND METHODS: Non-randomized experimental study performed with data obtained from the electronic pharmacy records. Differences in consumption of antibiotics before (2018) and after (2019) ASP implementation in twelve PHCT were calculated. Another twelve PHCT without ASP were used for comparison. We analysed data on global and beta-lactams, fluoroquinolones, macrolides, cephalosporines and fosfomycin-trometamol, expressed in number of treated patients and DDD (defined daily doses). RESULTS: The number of patients with prescribed antibiotics decreased significantly more in PHCT with ASP (-9.1 vs. -1.7%), particularly with fluoroquinolones (-25 vs. -20.4%), macrolids (-20.4 vs. -8.5%) and amoxicillin-clavulanic (-10.3 vs. -2.5%). Decreased DDD followed the same pattern. Both PHCT groups kept constant the number of patients with prescribed third generation cephalosporins, while those with prescribed first generation cephalosporins and betalactamase-sensible penicilins increased similarly. In PHCT with ASP, increased number of patients with prescribed phosphomycin-trometamol was smaller (4.0 vs. 11.5%) while its consumption expressed in DDDs was reduced while increasing in PHCT without ASP (-1 vs. 10%, p < 0.001). CONCLUSIONS: PHCT with ASP resulted in a significantly greater decrease in the global use of antimicrobials, fluoroquinolones, macrolides and amoxicillin-clavulanic than PHCT without ASP. These very positive results promoted their extension to the remaining PHCT