Patrones y resultados del cambio de anticoagulantes orales directos en la fibrilación auricular no valvular: experiencia en la práctica clínica en España / Patterns and outcomes of switching direct oral anticoagulants in non-valvular atrial fibrillation: A real-world experience from Spain

Objetivos El objetivo consistía en evaluar un programa de gestión de anticoagulantes orales directos (ACOD) en pacientes con fibrilación auricular no valvular (FANV) según sus perfiles, idoneidad de la dosis, patrones de cambio de tratamiento, efectividad y seguridad Se trató de un estudio observacional, prospectivo y longitudinal en una cohorte de pacientes atendidos en la práctica clínica cotidiana en un hospital regional español con un plan de seguimiento de 3 años para pacientes que iniciaron el tratamiento con dabigatrán, rivaroxabán o apixabán entre enero de 2012 y diciembre de 2016. Métodos Se analizaron 490 episodios de tratamiento (apixabán 2,5mg, 9,4%; apixabán 5mg, 21,4%; dabigatrán 75mg, 0,6%; dabigatrán 110mg, 12,4%; dabigatrán 150mg, 19,8%; rivaroxabán 15mg, 17,8%; rivaroxabán 20mg, 18,6%) en 445 pacientes. En el 13,6% de los pacientes tratados con dabigatrán, el 9,7% de los tratados con rivaroxabán y el 3,9% de los tratados con apixabán se cambió a otros ACOD o se modificó la dosis. Resultados El ACOD al que se cambió con mayor frecuencia fue el apixabán. Los motivos más frecuentes para cambiar de tratamiento fueron toxicidad (23,8%), hemorragia (21,4%) y deterioro renal (16,7%). En el 23,8% de los episodios se constató una inadecuación de la dosis. Las tasas de ictus y accidentes isquémicos transitorios (AIT) fueron de 1,64 y 0,54 eventos/100 años/paciente, respectivamente, mientras que las de hemorragias importantes, no importantes, pero clínicamente relevantes (NICR) e intracraneales fueron de 2,4, 5 y 0,5 eventos/100 años/paciente, respectivamente. Las hemorragias digestivas y genitourinarias fueron el tipo más frecuente de eventos hemorrágicos. En el análisis multifactorial, el ictus previo y la edad fueron factores predictivos independientes de ictus/AIT. El uso concomitante de antiagregantes plaquetarios, el sexo masculino y la edad fueron factores predictivos independientes de eventos hemorrágicos (AU)

Aims The aim is to evaluate a management program for direct oral anticoagulants (DOACs) in non-valvular atrial fibrillation (NVAF) patients according to their profiles, appropriateness of dosing, patterns of crossover, effectiveness and safety. This is an observational and longitudinal prospective study in a cohort of patients attended in daily clinical practice in a regional hospital in Spain with 3-year a follow-up plan for patients initiating dabigatran, rivaroxaban or apixaban between Jan/2012 and Dec/2016. Methods We analyzed 490 episodes of treatment (apixaban 2.5, 9.4%; apixaban 5, 21.4%; dabigatran 75, 0.6%; dabigatran 110, 12.4%; dabigatran 150, 19.8%; rivaroxaban 15, 17.8% and rivaroxaban 20, 18.6%) in 445 patients. 13.6% of patients on dabigatran, 9.7% on rivaroxaban, and 3.9% on apixaban switched to other DOACs or changed dosing. Results Apixaban was the most frequent DOAC switched to. The most frequent reasons for switching were toxicity (23.8%), bleeding (21.4%) and renal deterioration (16.7%). Inappropriateness of dose was found in 23.8% of episodes. Rates of stroke/transient ischemic attack (TIA) were 1.64/0.54 events/100 patients-years, while rates of major, clinically relevant non-major (CRNM) bleeding and intracranial bleeding were 2.4, 5, and 0.5 events/100 patients-years. Gastrointestinal and genitourinary bleeding were the most common type of bleeding events (BE). On multivariable analysis, prior stroke and age were independent predictors of stroke/TIA. Concurrent platelet inhibitors, male gender and age were independent predictors of BE. Conclusion This study complements the scant data available on the use of DOACs in NVAF patients in Spain, confirming a good safety and effectiveness profil (AU)

Patterns and outcomes of switching direct oral anticoagulants in non-valvular atrial fibrillation: A real-world experience from Spain.

AIMS: The aim is to evaluate a management program for direct oral anticoagulants (DOACs) in non-valvular atrial fibrillation (NVAF) patients according to their profiles, appropriateness of dosing, patterns of crossover, effectiveness and safety. This is an observational and longitudinal prospective study in a cohort of patients attended in daily clinical practice in a regional hospital in Spain with 3-year a follow-up plan for patients initiating dabigatran, rivaroxaban or apixaban between JAN/2012-DEC/2016. METHODS: We analyzed 490 episodes of treatment (apixaban 2.5 9.4%, apixaban 5 21.4%, dabigatran 75 0.6%, dabigatran 110 12,4%, dabigatran 150 19.8%, rivaroxaban 15 17.8% and rivaroxaban 20 18.6%) in 445 patients. 13.6% of patients on dabigatran, 9.7% on rivaroxaban, and 3.9% on apixaban switched to other DOACs or changed dosing. RESULTS: Apixaban was the most frequent DOAC switched to. The most frequent reasons for switching were toxicity (23.8%), bleeding (21.4%) and renal deterioration (16.7%). Inappropriateness of dose was found in 23.8% of episodes. Rates of stroke/transient ischemic attack (TIA) were 1.64/0.54 events/100 patients-years, while rates of major, clinically relevant non-major (CRNM) bleeding and intracranial bleeding were 2.4, 5, and 0.5 events/100 patients-years. Gastrointestinal and genitourinary bleeding were the most common type of bleeding events (BE). On multivariable analysis, prior stroke and age were independent predictors of stroke/TIA. Concurrent platelet inhibitors, male gender and age were independent predictors of BE. CONCLUSION: This study complements the scant data available on the use of DOACs in NVAF patients in Spain, confirming a good safety and effectiveness profile.

Evaluación de lenalidomida en el tratamiento del mieloma múltiple, la mielofibrosis y el síndrome mielodisplásico / Assessing lenalidomide for treating multiple myeloma, myelofibrosis and myelodysplastic syndrome

Objetivo La lenalidomida (LDM) es un agente inmunomodulador y antiangiogénico que ha demostrado su eficacia en varios trastornos hematológicos (mieloma múltiple [MM], metaplasma mieloide con mielofibrosis [MF] y síndrome mielodisplásico [SMD]). El objetivo de este estudio fue evaluar la efectividad y la tolerabilidad de la LDM en nuestros pacientes. Método Estudio retrospectivo observacional que incluyó a los pacientes de nuestro hospital en seguimiento por la consulta de Hematología que fueron diagnosticados de MM, MF y SMD, y que eran candidatos a recibir tratamiento con LDM. La evaluación de la eficacia se realizó transcurridos aproximadamente 4 ciclos desde el inicio del tratamiento. Resultados Desde febrero de 2007 hasta marzo de 2008 fueron 16 los pacientes candidatos a recibir tratamiento con LDM (50% mujeres, 50% varones, con una edad media de 69,6 años), aunque 3 de ellos no llegaron a iniciarlo. De los 6 pacientes con MM tratados en nuestro hospital, 5 de ellos obtuvieron algún tipo de respuesta (83,3%). De los 4 pacientes con MF, 2 (66,6%) experimentaron algún tipo de respuesta al tratamiento. De los 6 pacientes diagnosticados de SMD, únicamente se inició el tratamiento en 3, y en 2 de ellos se tuvo que suspender por distintas causas. Destacamos que únicamente hubo que suspender el tratamiento en dos de los 13 pacientes que lo iniciaron (15,4%) por los efectos adversos. Conclusión La LDM consigue, con buena tolerancia, beneficio clínico mantenido sobre todo en el MM y la MF. Son necesarios más estudios que profundicen en la duración del tratamiento, en nuevas indicaciones y en el uso de tratamientos combinados con otros agentes (AU)

Objective Lenalidomide (LDM) is an immunomodulatory and anti-angiogenic drug which has been shown to be effective in several haematological disorders (multiple myeloma [MM], myeloid metaplasia with myelofibrosis [MF] and myelodysplastic syndrome [MDS]). The objective of this study is to evaluate the effectiveness and tolerability of LDM in our patients. Method Retrospective observational study which included patients at our hospital who were monitored by the haematology unit, diagnosed with MM, MF and MDS and candidates for LDM treatment. Treatment effectiveness was assessed after approximately 4 cycles of treatment. Results Between February 2007 and March 2008, 16 patients were listed as candidates for receiving treatment with LDM (50% female/50% male, with a mean age of 69.6 years); of these candidates, 3 never initiated treatment. Five of the six patients with MM treated at our hospital obtained some sort of response (83.3%). Of the 4 patients with MF, 2 (66.6%) experienced some sort of response to treatment. Of the 6 patients diagnosed with MDS, treatment was initiated in 3, and it had to be suspended in 2 cases due to different reasons. Treatment only had to be suspended in two of the 13 patients who began it (15.4%) due to adverse effects (AE).Conclusion LDM is well-tolerated and produces sustained clinical benefits, especially in MM and MF. More studies are needed for in-depth examination of treatment duration, new indications and the use of treatments combined with other drugs (AU)

[Assessing lenalidomide for treating multiple myeloma, myelofibrosis and myelodysplastic syndrome]. / Evaluación de lenalidomida en el tratamiento del mieloma múltiple, la mielofibrosis y el síndrome mielodisplásico.

OBJECTIVE: Lenalidomide (LDM) is an immunomodulatory and anti-angiogenic drug which has been shown to be effective in several haematological disorders (multiple myeloma [MM], myeloid metaplasia with myelofibrosis [MF] and myelodysplastic syndrome [MDS]). The objective of this study is to evaluate the effectiveness and tolerability of LDM in our patients. METHOD: Retrospective observational study which included patients at our hospital who were monitored by the haematology unit, diagnosed with MM, MF and MDS and candidates for LDM treatment. Treatment effectiveness was assessed after approximately 4 cycles of treatment. RESULTS: Between February 2007 and March 2008, 16 patients were listed as candidates for receiving treatment with LDM (50% female/50% male, with a mean age of 69.6 years); of these candidates, 3 never initiated treatment. Five of the six patients with MM treated at our hospital obtained some sort of response (83.3%). Of the 4 patients with MF, 2 (66.6%) experienced some sort of response to treatment. Of the 6 patients diagnosed with MDS, treatment was initiated in 3, and it had to be suspended in 2 cases due to different reasons. Treatment only had to be suspended in two of the 13 patients who began it (15.4%) due to adverse effects (AE). CONCLUSION: LDM is well-tolerated and produces sustained clinical benefits, especially in MM and MF. More studies are needed for in-depth examination of treatment duration, new indications and the use of treatments combined with other drugs.