Tratamientos modificadores de la enfermedad en pacientes con esclerosis múltiple en España / Disease-modifying treatments for patients with multiple sclerosis in Spain

La esclerosis múltiple es una enfermedad desmielinizante crónica del sistema nervioso central y discapacitante a largo plazo. Existen diferentes tratamientos modificadores de la enfermedad. Estos pacientes, a pesar de ser generalmente jóvenes, tienen una elevada comorbilidad y riesgo de polimedicación por su compleja sintomatología y discapacidad. Objetivo principal determinar el tipo de tratamiento modificador de la enfermedad en los pacientes atendidos en servicios de farmacia de hospitales españoles. Objetivos secundarios Conocer los tratamientos concomitantes, determinar la prevalencia de la polifarmacia, identificar la prevalencia de interacciones y analizar la complejidad farmacoterapéutica. Método estudio observacional, transversal y multicéntrico. Se incluyeron todos los pacientes con diagnóstico de esclerosis múltiple y tratamiento modificador de la enfermedad activo a los que se atendió en las consultas de pacientes externos o en los hospitales de día durante la segunda semana de febrero 2021. Se recogieron: el tratamiento modificador, las comorbilidades y los tratamientos concomitantes para determinar el patrón de multimorbilidad, polifarmacia, complejidad farmacoterapéutica (Medication Regimen Complexity Index) e interacciones medicamentosas. Resultados se incluyeron 1.407 pacientes de 57 centros de 15 Comunidades Autónomas. La forma de presentación de la enfermedad más frecuente fue la forma remitente recurrente (89,3%). El tratamiento modificador de la enfermedad más prescrito fue dimetilfumarato (19,1%), seguido de teriflunomida (14,0%). De los tratamientos modificadores parenterales, los 2 más prescritos fueron el acetato de glatiramero y el natalizumab con un 11,1 y 10,8% respectivamente. El 24,7% de los pacientes tenían una comorbilidad y el 39,8% al menos 2 comorbilidades. El 13,3% pertenecía al menos a uno de los patrones definidos de multimorbilidad y el 16,5% pertenecían a 2 o más patrones. ... (AU)

Multiple sclerosis is a chronic demyelinating disease of the central nervous system and long-term disabling. Different disease-modifying treatments are available. These patients, despite being generally young, have high comorbidity and risk of polymedication due to their complex symptomatology and disability.Objective primaryTo determine the type of disease-modifying treatment in patients seen in Spanish hospital pharmacy departments.Secondary objectivesTo determine concomitant treatments, determine the prevalence of polypharmacy, identify the prevalence of interactions and analyse pharmacotherapeutic complexity.MethodObservational, cross-sectional, multicentre study. All patients with a diagnosis of multiple sclerosis and active disease-modifying treatment who were seen in outpatient clinics or day hospitals during the second week of February 2021 were included. Modifying treatment, comorbidities and concomitant treatments were collected to determine multimorbidity pattern, polypharmacy, pharmacotherapeutic complexity (Medication Regimen Complexity Index) and drug-drug interactions.Results1,407 patients from 57 centres in 15 autonomous communities were included. The most frequent form of disease presentation was the relapsing remitting form (89.3%). The most prescribed disease-modifying treatment was dimethyl fumarate (19.1%), followed by teriflunomide (14.0%). Of the parenteral disease-modifying treatments, the two most prescribed were glatiramer acetate and natalizumab with 11.1% and 10.8%. 24.7% of the patients had one comorbidity and 39.8% had at least 2 comorbidities. 13.3% belonged to at least one of the defined patterns of multimorbidity and 16.5% belonged to 2 or more patterns. The concomitant treatments prescribed were psychotropic drugs (35.5%); antiepileptic drugs (13.9%) and antihypertensive drugs and drugs for cardiovascular pathologies (12.4%). ... (AU)

Disease-modifying treatments for patients with multiple sclerosis in Spain. / Tratamientos modificadores de la enfermedad en pacientes con esclerosis múltiple en España.

Multiple sclerosis is a chronic demyelinating disease of the central nervous system and long-term disabling. Different disease-modifying treatments are available. These patients, despite being generally young, have high comorbidity and risk of polymedication due to their complex symptomatology and disability. OBJECTIVE PRIMARY: To determine the type of disease-modifying treatment in patients seen in Spanish hospital pharmacy departments. SECONDARY OBJECTIVES: To determine concomitant treatments, determine the prevalence of polypharmacy, identify the prevalence of interactions and analyse pharmacotherapeutic complexity. METHOD: Observational, cross-sectional, multicentre study. All patients with a diagnosis of multiple sclerosis and active disease-modifying treatment who were seen in outpatient clinics or day hospitals during the second week of February 2021 were included. Modifying treatment, comorbidities and concomitant treatments were collected to determine multimorbidity pattern, polypharmacy, pharmacotherapeutic complexity (Medication Regimen Complexity Index) and drug-drug interactions. RESULTS: 1,407 patients from 57 centres in 15 autonomous communities were included. The most frequent form of disease presentation was the relapsing remitting form (89.3%). The most prescribed disease-modifying treatment was dimethyl fumarate (19.1%), followed by teriflunomide (14.0%). Of the parenteral disease-modifying treatments, the two most prescribed were glatiramer acetate and natalizumab with 11.1% and 10.8%. 24.7% of the patients had one comorbidity and 39.8% had at least 2 comorbidities. 13.3% belonged to at least one of the defined patterns of multimorbidity and 16.5% belonged to 2 or more patterns. The concomitant treatments prescribed were psychotropic drugs (35.5%); antiepileptic drugs (13.9%) and antihypertensive drugs and drugs for cardiovascular pathologies (12.4%). The presence of polypharmacy was 32.7% and extreme polypharmacy 8.1%. The prevalence of interactions was 14.8%. Median pharmacotherapeutic complexity was 8.0 (IQR: 3.3 -- 15.0). CONCLUSIONS: We have described the disease-modifying treatment of patients with multiple sclerosis seen in Spanish pharmacy services and characterised concomitant treatments, the prevalence of polypharmacy, interactions, and their complexity.

Assessment of the effectiveness of tocilizumab on mortality and progression to mechanical ventilation or intensive care in patients with COVID-19 admitted to a tertiary hospital.

OBJECTIVES: The evidence for tocilizumab in the treatment of COVID-19 is contradictory, with some clinical trials showing benefits in regard to progression to mechanical ventilation (MV) and/or mortality. The aim of this study is to evaluate in real clinical practice the effectiveness of tocilizumab in treating COVID-19 and to identify prognostic factors for patient outcomes. METHODS: This was an observational, retrospective study of COVID-19 patients treated with tocilizumab between March 2020 and February 2021 in a tertiary hospital. Variables were demographics, comorbidities, vital signs, analytical parameters, COVID-19 treatment, progression to MV, intensive care unit (ICU) admission, hospital stay, and mortality. RESULTS: A total of 685 patients (64.7% men, median 68 years) were included. Overall mortality was 23.4% (14.2% in the first 14 days post-tocilizumab) and 93.3% in patients with MV and/or in the ICU at 14 days post-tocilizumab. In addition, 61.5% of discharges occurred during the same period. In patients who died, statistically significant differences were observed in the baseline analytical parameters of C-reactive protein (CRP), D-dimer and higher lactate dehydrogenase (LDH) (p<0.05). CONCLUSIONS: In most patients the clinical results of tocilizumab were observed at 14 days post-administration and could benefit from earlier administration of treatment. Baseline levels of CRP, D-dimer and LDH could be prognostic factors for the evolution of the COVID-19 patient.

Formulación magistral en la atención farmacéutica del paciente oncopediátrico / Drug Compounding in Pharmaceutical Care of Oncopediatric Patients

Introducción: El tratamiento farmacológico del paciente oncopediátrico supone una dificultad para el equipo asistencial ya que muchos medicamen-tos registrados por la administración sanitaria no están indicados en población pediátrica, creándo-se un vacío terapéutico en el tratamiento que es cubierto a través de la formulación magistral (FM). El objetivo del estudio es analizar la elaboración de medicamentos individualizados para oncopediatría en los últimos tres años en el Servicio de Farmacia de un hospital de tercer nivel.Métodos: Estudio descriptivo, observacional, retrospectivo de las FM que se elaboraron para el Servicio de Oncopediatría en el periodo 2019-2021. Para cada FM se detalló su indicación y aplicación clínica. En la descripción cuantitativa se especificó número de fórmulas elaboradas y porcentaje. En la descripción cualitativa se detalló principio activo y concentración, procedimiento para elaborar la for-mulación, dosis de principio activo y de excipientes; condiciones de conservación y fecha de caducidad.Resultados: En el periodo de estudio, se elaboraron 3730 FM para el Servicio de Oncopediatría. Las 4 fórmulas magistrales con mayor peso en la prepa-ración son las de los principios activos: etopósido, fenofibrato, ondansetrón y mercaptopurina. El 57,4% de las FM fueron soluciones orales y el 26,5% suspensiones. La aplicación clínica del 71% de las FM preparadas fue el tratamiento de las patologías onco-hematológicas.Conclusiones: En el paciente oncopediátrico, se acentúa la necesidad de una farmacoterapia más individualizada para asegurar una correcta dosifi-cación y adherencia al tratamiento, siendo la FM la herramienta que solventaría sus necesidades terapéuticas (AU)

Introduction: The pharmacological treatment of the oncopediatric patient represents a difficulty for the health care team, since many drugs registered by the health administration are not indicated in the pediatric population, creating a therapeutic gap in the treatment that is covered through the drug compounding (DC). The aim of this study is to analyze the preparation of individualized drugs for oncopediatrics in the last three years in the Phar-macy Service of a tertiary hospital.Methods: It was carried out a descriptive, observa-tional and retrospective study of the DCs that were prepared for the Oncopediatric Service in the period 2019-2021. For each DC, its indication and clinical application were detailed. In the quantitative de-scription, the number of DC elaborated and percent-age were specified. In the qualitative description, active ingredient and concentration, procedure to prepare the formulation, dose of active ingredient, excipients, storage conditions and expiration date were detailed.Results: During the study period, 3730 DC were prepared for the Oncopediatric Service. It is import-ant to note that the 4 formulations with the greatest weight in the preparation were those of the active ingredients: etoposide, fenofibrate, ondansetron and mercaptopurine. Oral solutions and suspen-sions accounted for 57.4% and 26.5% of the DC. The clinical application of 71% of the DC prepared was the treatment of onco-hematological patholo-gies.Conclusions: In the oncopediatric patient, the need for a more individualized pharmacotherapy is accentuated to ensure a correct dosage and adher-ence to treatment, being the DC the tool that would solve its therapeutic needs (AU)

Trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel in the neoadjuvant setting of HER-2 positive breast cancer.

BACKGROUD: Neoadjuvant treatment based on the combination of trastuzumab plus chemotherapy is the standard of care in patients with HER2-positive early or locally advanced breast cancer. The concurrent use of trastuzumab, anthracyclines and taxanes is frequently used in this setting despite the potential cardiotoxicity of both anthracyclines and trastuzumab. However, not much information is available about this chemotherapy scheme. OBJECTIVE: We wanted to evaluate the efficacy and safety profile of the combination of trastuzumab, liposome-encapsulated doxorubicin and paclitaxel as neoadjuvant scheme. We also tried to establish predictive factors of pathologic complete response. SETTING: The study was carried out in a tertiary University Hospital of Spain. METHOD: This is a descriptive study of the clinical practice performed in our hospital. MAIN OUTCOME MEASURE: Efficacy was measured in terms of pathologic complete response, which was defined as the absence of invasive cancer cells in the breast and the axilla after neoadjuvant treatment. RESULTS: Thirty patients were included, the median age was 48. Seventeen (56.7 %) were hormonal receptor (HR) positive, 14 (46.6 %) had IIIa-b clinical stage and one of them had inflammatory breast cancer. 12 patients (40 %) achieved pCR. Patients with HR-negative BC achieved a higher pCR rate than those ones with HR-positive BC (61.5 % and 23.5 %, respectively; p value = 0.035). 21 patients (70 %) underwent breast conservative surgery. The treatment was in general well tolerated, most frequent grade 3-4 adverse events were neutropenia (20 %), asthenia and liver enzyme alteration (10 %) and febrile neutropenia (6.7 %). No patient developed heart failure, but one (3.3 %) presented a 10 % asymptomatic absolute reduction in left ventricular fraction ejection. CONCLUSIONS: The studied treatment for the neoadjuvant setting of HER2 positive breast cancer seems to be an effective therapeutic option. Despite the expected high rate of cardiotoxicity of this regimen, the study results shows that this treatment regimen appears to be safe. The combination of trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel should be considered for the treatment of HER2-overexpressing breast cancer.