Reversion of chronic to episodic migraine in working age and botulinum toxin-resistant patients treated with fremanezumab: A real-life study.

OBJECTIVES: The objectives of this real-life study were to analyze the reversion of chronic migraine (CM) to episodic migraine (EM) with fremanezumab, evaluate its benefit on the symptomatology, and determine the influence of possible clinical features on the reversion. BACKGROUND: The clinical manifestations of CM have a high impact on the quality of life of patients, and monoclonal antibodies such as fremanezumab are used as prophylactic treatment. METHODS: Diagnosed CM patients treated for at least 3 months with monthly fremanezumab were interviewed. The data to assess efficacy were before treatment and at the time of the interview: monthly headache days (MHDs), daily headache hours (DHHs), monthly symptomatic medication days (MSMDs), percentage of patients with symptomatic medication overuse (SMO), and pain intensity with the numerical rating scale (NRS) score. Possible predictors of reversion were analyzed: percentage of patients treated for at least 12 months, hypertension, diabetes mellitus, depression, anxiety, symptomatic control with non-steroidal anti-inflammatory drugs (NSAIDs), triptans or both, and amitriptyline prophylaxis. RESULTS: A total of 54 patients were included, of whom 40 (74.1%) were converters to EM. There were significant improvements in converters compared to pre-treatment in MHDs (28.0 vs. 5.0 days), as well as on the variables DHHs, MSMDs, and SMO. The percentage of erenumab failures was significantly higher in non-converters than in converters, as was the percentage of patients with anxiety. CONCLUSIONS: High reversion from CM to EM was achieved with fremanezumab and notable symptomatological improvement, establishing previous failure to erenumab and anxiety as possible detrimental factors for reversion.

PAUSATE Study: Prevalence and appropriateness of the use of antimicrobials in Spanish hospitals.

OBJECTIVE: To determine the prevalence and appropriateness of antimicrobial use in Spanish hospitals through a pharmacist-led systematic cross-sectional review. METHOD: A nationwide multicenter cross-sectional study was conducted on  10% of the patients admitted to the participating hospitals on one day in April  2021. Hospital participation was voluntary, and the population was randomly  selected. The study sample was made up of patients who, on the day of the  study, received at least one antimicrobial belonging to groups J01, J02, J04,  J05AB, J05AD or J05AH in the Anatomical Therapeutic Chemical Classification  System. The pharmacist in charge made a record and carried out an evaluation  of the appropriateness of antimicrobial use following a method  proposed and validated by the Pharmaceutical Care of Patients with Infectious  Diseases Working Group of the Spanish Society of Hospital Pharmacy. The  evaluation method considered each of the items comprising antimicrobial  prescriptions. An algorithm was used to assess prescriptions as appropriate,  suboptimal, inappropriate and unevaluableResults: One-hundred three hospitals participated in the study and the treatment of 3,568 patients was reviewed. A total of 1,498 (42.0%) patients received antimicrobial therapy, 424 (28.3%) of them in  combination therapy. The most commonly prescribed antimicrobials were  moxicillin-clavulanic acid (7.2%), ceftriaxone (6.4%), piperacillin-tazobactam  (5.8%), and meropenem 4.0%. As regards appropriateness,  prescriptions were considered appropriate in 34% of cases, suboptimal in 45%,  inappropriate in 19% and unevaluable in 2%. The items that most  influenced the assessment of a prescription as suboptimal were completeness  f medical record entries, choice of agent, duration of treatment and monitoring of efficacy and safety. The item that most influences the  assessment of a prescription as inappropriate was the indication of  ntimicrobial agent. Conclusions: The method used provided information on the prevalence and  appropriateness of the use of antimicrobials, a preliminary step in the design  and implementation of actions aimed at measuring the impact of the use of  ntimicrobials within the antimicrobial stewardship programs.

OBJETIVO: Conocer la prevalencia y el grado de adecuación del uso de  antimicrobianos en los hospitales españoles mediante una revisión sistemática  transversal realizada por farmacéuticos.Método: Estudio multicéntrico, nacional, transversal sobre el 10% de los pacientes ingresados en los hospitales participantes un día del mes de abril  de 2021. La participación de los hospitales fue voluntaria y la selección de la  población aleatoria. De la población se disgregó la muestra de estudio,  constituida por los pacientes que recibían el día del corte al menos un  antimicrobiano perteneciente a los grupos J01, J02, J04, J05AB, J05AD y  J05AH del Sistema de Clasificación Anatómica, Terapéutica y Química. Sobre la  muestra de estudio, el farmacéutico realizó un registro y evaluación de la  adecuación del tratamiento antimicrobiano siguiendo una metódica propuesta y  validada por el Grupo de trabajo de Atención Farmacéutica al Paciente con  nfermedad Infecciosa de la Sociedad Española de Farmacia Hospitalaria. La  metódica de evaluación consideró cada una de las dimensiones que conforman  la prescripción del antimicrobiano e incluyó un algoritmo para calificar la  prescripción global como adecuada, mejorable, inadecuada y no valorable. RESULTADOS: Participaron 103 hospitales y se revisó el tratamiento de 3.568  pacientes, de los que 1.498 (42,0%) recibieron terapia antimicrobiana, 424  (28,3%) en combinación. La prevalencia de los antimicrobianos más frecuentes  fue: amoxicilina-clavulánico 7,2%, ceftriaxona 6,4%, piperacilina- tazobactam 5,8% y meropenem 4,0%. Respecto a la adecuación del  tratamiento la prescripción, fue considerada adecuada en el 34% de los casos,  mejorable en el 45%, inadecuada en el 19% y no valorable en el 2%. Las  dimensiones que más influyeron en la calificación de la prescripción como  mejorable fueron el registro en la historia clínica, la elección del agente, la  duración del tratamiento y la monitorización de la eficacia y seguridad, y como  inadecuada la indicación de antimicrobiano. CONCLUSIONES: La metódica utilizada permite conocer la prevalencia y  adecuación del uso de antimicrobianos, paso previo para diseñar y emprender  acciones de mejora y medir el impacto de su implantación en el marco de los  programas de optimización del uso de antimicrobianos.

Estudio PAUSATE: Prevalencia y adecuación del uso hospitalario de antimicrobianos en España / PAUSATE Study: Prevalence and appropriateness of the use of antimicrobials in Spanish hospitals

Objetivo: Conocer la prevalencia y el grado de adecuación del usode antimicrobianos en los hospitales españoles mediante una revisiónsistemática transversal realizada por farmacéuticos.Método: Estudio multicéntrico, nacional, transversal sobre el 10% de lospacientes ingresados en los hospitales participantes un día del mes deabril de 2021. La participación de los hospitales fue voluntaria y la selección de la población aleatoria. De la población se disgregó la muestrade estudio, constituida por los pacientes que recibían el día del corte almenos un antimicrobiano perteneciente a los grupos J01, J02, J04, J05AB,J05AD y J05AH del Sistema de Clasificación Anatómica, Terapéutica yQuímica. Sobre la muestra de estudio, el farmacéutico realizó un registroy evaluación de la adecuación del tratamiento antimicrobiano siguiendouna metódica propuesta y validada por el Grupo de trabajo de AtenciónFarmacéutica al Paciente con Enfermedad Infecciosa de la Sociedad Española de Farmacia Hospitalaria. La metódica de evaluación consideró cadauna de las dimensiones que conforman la prescripción del antimicrobiano eincluyó un algoritmo para calificar la prescripción global como adecuada,mejorable, inadecuada y no valorable. (AU)

Objective: To determine the prevalence and appropriateness of antimicrobial use in Spanish hospitals through a pharmacist-led systematiccross-sectional review.Method: A nationwide multicenter cross-sectional study was conductedon 10% of the patients admitted to the participating hospitals on one dayin April 2021. Hospital participation was voluntary, and the populationwas randomly selected. The study sample was made up of patients who,on the day of the study, received at least one antimicrobial belonging togroups J01, J02, J04, J05AB, J05AD or J05AH in the Anatomical Therapeutic Chemical Classification System. The pharmacist in charge madea record and carried out an evaluation of the appropriateness of antimicrobial use following a method proposed and validated by the Pharmaceutical Care of Patients with Infectious Diseases Working Group of theSpanish Society of Hospital Pharmacy. The evaluation method consideredeach of the items comprising antimicrobial prescriptions. An algorithm wasused to assess prescriptions as appropriate, suboptimal, inappropriateand unevaluable. (AU)

Off-label antineoplastic drugs. An effectiveness and safety study / Efectividad y seguridad de los medicamentos antineoplásicos en situaciones especiales de uso

Objective: The use of antineoplastic medicines in special situations is common in clinical practice; it is strongly regulated and there is little information on its outcomes. We have analysed such use and health outcomes. Methods: All off-label cases between 2005 and 2015, with any type of cancer and in any stage were included. Health histories of a single health centre were reviewed to gather information on treatment features, response, survival, and toxicity. Results: 85 men and 83 women, aged 56, had largely metastatic tumours treated with a median of 4 cycles (0-118) of chemotherapy, hormone therapy, or biotherapy, for palliative purposes between 1st and 4th lines (80% of cases). The subjective response rate was 32.5%, complete objective 1.9%, partial 8.8%, stabilisation 15.6%, progression 38.8%, and not assessable 35.1%. The median duration of response was 2.5 months (1-17), progression-free survival (PFS) 5 months (4 - 21.3), and overall survival (OS) 11 months (9.2-20.6). In the univariate analysis, performance status, treatment line, number of cycles, and type of response influenced on OS. In the multivariate model, the functional status (HR 0.36; CI 95% 0.17-0.77. P= 0.009) and number of cycles (HR 3.66; CI 95% 2.08-6.44. P= 0.0001) influenced independently on overall survival. The most frequent grade 3 and 4 toxicity were asthenia (19%), neutropenia (10.7%), and nausea and vomiting (8.9%). Conclusions: Off-label antineoplastic drugs were mostly used in metastatic tumours, with little effectiveness. The functional status must be considered to select the patients to be treated (AU)

Objetivos: El uso de medicamentos antineoplásicos en situaciones especiales es común en la práctica clínica, está fuertemente regulado y hay poca información sobre sus resultados. Hemos analizado su empleo y los resultados en salud. Método: Se analiza una cohorte de todos los casos off label entre 2005 y 2015, en cualquier cáncer y estadio. Se revisaron historias de salud de un centro para extraer información sobre tratamiento, respuesta, supervivencia y toxicidad. Resultados: 85 hombres y 83 mujeres, de 56 años de mediana de edad, tenían mayoritariamente tumores metastásicos tratados con una mediana de 4 ciclos (0-118) de quimioterapia, hormonoterapia o bioterapia, con finalidad paliativa entre 1.ª y 4.ª línea (80% de casos). La tasa de respuesta subjetiva fue 32,5%, objetiva completa 1,9%, parcial 8,8%, estabilización 15,6%, progresión 38,8% y no valorable 35,1%. La mediana de duración de la respuesta fue 2,5 meses (1-17), de supervivencia libre de progresión (SLE) 5 meses (4 - 21,3) y global (SG) 11 meses (9,2-20,6). En el análisis univariante, el estado funcional, la línea de tratamiento, el número de ciclos y el tipo de respuesta influyeron en la SG. En el modelo multivariante, el estado funcional (HR 0,36; IC 95% 0,17-0,77. P= 0,009) y el número de ciclos (HR 3,66; IC 95% 2,08-6,44. P= 0,0001) influían de forma independiente en la SG. La toxicidad grado 3 y 4 más frecuente fue la astenia (19%), la neutropenia (10,7%) y la emesis (8,9%). Conclusiones: Los medicamentes antineoplásicos en situaciones especiales de uso se emplearon mayoritariamente en tumores metastásicos, con poca efectividad. El estado funcional debe ser tenido en cuenta para seleccionar los pacientes a tratar (AU)

Off-label antineoplastic drugs. An effectiveness and safety study.

OBJECTIVE: The use of antineoplastic medicines in special situations is common in clinical practice; it is strongly regulated and there is little information on its outcomes. We have analysed such use and health outcomes. METHODS: All off-label cases between 2005 and 2015, with any type of cancer and in any stage were included. Health histories of a single health centre were reviewed to gather information on treatment features, response, survival, andtoxicity. RESULTS: 85 men and 83 women, aged 56, had largely metastatic tumours treated with a median of 4 cycles (0-118) of chemotherapy, hormone therapy, or biotherapy, for palliative purposes between 1st and 4th lines (80% of cases). The subjective response rate was 32.5%, complete objective 1.9%, partial 8.8%, stabilisation 15.6%, progression 38.8%, and not assessable 35.1%. The median duration of response was 2.5 months (1-17), progression-free survival (PFS) 5 months (4 - 21.3), and overall survival (OS) 11 months (9.2-20.6). In the univariate analysis, performance status, treatment line, number of cycles, and type of response influenced on OS. In the multivariate model, the functional status (HR 0.36; CI 95% 0.17-0.77. P= 0.009) and number of cycles (HR 3.66; CI 95% 2.08-6.44. P= 0.0001) influenced independently on overall survival. The most frequent grade 3 and 4 toxicity were asthenia (19%), neutropenia (10.7%), and nausea and vomiting (8.9%). CONCLUSIONS: Off-label antineoplastic drugs were mostly used in metastatic tumours, with little effectiveness. The functional status must be considered to select the patients to be treated.

Objetivos: El uso de medicamentos antineoplásicos en situaciones especiales es común en la práctica clínica, está fuertemente regulado y hay poca información sobre sus resultados. Hemos analizado su empleo y los resultados en salud.Método: Se analiza una cohorte de todos los casos off label entre 2005 y 2015, en cualquier cáncer y estadio. Se revisaron historias de salud de un centro para extraer información sobre tratamiento, respuesta, supervivencia y toxicidad.Resultados: 85 hombres y 83 mujeres, de 56 años de mediana de edad, tenían mayoritariamente tumores metastásicos tratados con una mediana de 4 ciclos (0-118) de quimioterapia, hormonoterapia o bioterapia, con finalidad paliativa entre 1.ª y 4.ª línea (80% de casos). La tasa de respuesta subjetiva fue 32,5%, objetiva completa 1,9%, parcial 8,8%, estabilización 15,6%, progresión 38,8% y no valorable 35,1%. La mediana de duración de la respuesta fue 2,5 meses (1-17), de supervivencia libre de progresión (SLE) 5 meses (4 ­ 21,3) y global (SG) 11 meses (9,2-20,6). En el análisis univariante, el estado funcional, la línea de tratamiento, el número de ciclos y el tipo de respuesta influyeron en la SG. En el modelo multivariante, el estado funcional (HR 0,36; IC 95% 0,17- 0,77. P= 0,009) y el número de ciclos (HR 3,66; IC 95% 2,08-6,44. P= 0,0001) influían de forma independiente en la SG. La toxicidad grado 3 y 4 más frecuente fue la astenia (19%), la neutropenia (10,7%) y la emesis (8,9%).Conclusiones: Los medicamentes antineoplásicos en situaciones especiales de uso se emplearon mayoritariamente en tumores metastásicos, con poca efectividad. El estado funcional debe ser tenido en cuenta para seleccionar los pacientes a tratar.

Treatment of prurigo nodularis with lenalidomide.

Prurigo nodularis (PN) is an intensely pruriginous dermatological disorder whose treatment is challenging for dermatologists. It is characterized by eruptions of papules and hyperkeratotic nodules, some of which are eroded, on the extensor surfaces of the limbs. The most commonly used treatments for this condition are oral antihistamines and topical or systemic steroids. Thalidomide is an effective treatment option in cases of recalcitrant PN; however, its most frequent adverse effect is neurotoxicity, which often results in its discontinuation. Lenalidomide is an analogue of thalidomide that is more powerful and associated with less neurotoxicity than thalidomide. We report the third case of PN treated with lenalidomide, which involved a patient who was refractory to thalidomide. Lenalidomide may be a more effective treatment for PN than thalidomide and has a more favorable side effects profile than its counterpart.

Treatment of thromboangiitis obliterans (Buerger's disease) with high-potency vasodilators.

Thromboangiitis obliterans (TAO) or Buerger's disease is a vascular inflammatory thrombotic occlusive and segmental disease affecting distal small and medium-sized arteries of the limbs. Tobacco is the main trigger factor and avoiding it is the main treatment. Frequently, it is necessary to use high-potency vasodilators, such as iloprost, bosentan, sildenafil, or alprostadil, to relieve symptoms and reduce the risk of amputation. Iloprost is the only one that has been shown to be effective in randomized clinical trials. We report the third case of TAO treated with sildenafil and a new case treated with bosentan. This condition can be diagnosed and treated by a dermatologist. We would like to highlight the excellent clinical response despite the fact that patients continued to smoke. This finding may have important therapeutic implications because early treatment may prevent amputation and can be effective even during the process of giving up smoking.

Treatment of pruritus in early-stage hypopigmented mycosis fungoides with aprepitant.

Pruritus is a symptom that significantly affects the patient's quality of life in cutaneous T cell lymphoma (CTCL). The most effective treatments are those that address the condition itself; however, it is often not possible to control this symptom. Lymphoma-related pruritus normally becomes more severe as CTCL progresses, constituting an important factor for quality of life in these patients. Substance P is a neuromodulator which appears to play a key role in pruritus. Aprepitant is a neurokinin-1 receptor antagonist affecting the substance P receptor. So far, several cases have been documented with an antipruritic response to the drug aprepitant in advanced-stage mycosis fungoides (MF). In this paper, we describe an excellent response to aprepitant in a female patient with severe pruritus secondary to hypopigmented stage I MF. We would also like to stress the absence of nausea and vomiting of this combined therapy of interferon and aprepitant. Aprepitant could improve tolerance to interferon.