Impacts of a multipurpose outpatient hospital pharmacy in the framework of 3P medicine.

Challenge in the framework of Predictive Preventive and Personalised Medicine: In recent years, we have been witnessing a change in the performance of hospital pharmacists, aimed at increasing their participation in the pharmacotherapeutic process of patients. The drug cycle, characterised as multidisciplinary, is very complex. It is essential for the multidisciplinary team to have a broad vision of the medication system in order to guarantee safety and quality.Considering the challenges of current healthcare systems and paradigm shift from reactive to predictive medicine, a new professional environment should be created to promote the implementation of Predictive, Preventive and Personalised Medicine in healthcare. Objectives and study design: To optimise care times in multipurpose outpatient hospital both in the preparation of ready-to-use medications and in the dispensing of medications for home treatment.To increase the confidence and value of hospital pharmacists in the process of patient and family care.The design of the study was carried out by the following:-Coordinating the schedules of the multi-pathology day hospital with the software and records of Medication Preparation in the pharmacy service.-Opening a Pharmacy Outpatient Clinic associated with the multi-pathology day hospital.-Planning and scheduling patient treatments. Achievements: With the implementation of this programme, the visibility of hospital pharmacists in the multidisciplinary team was increased.This Pharmacy Outpatient Clinic allowed the coordination of the pharmaceutical care process in the day hospital.This project increased the credibility of the Pharmacy Service in the improvement of the integral process of the medicine. Predictive approach: The presence of pharmacists in the multi-pathology day hospital has a predictive approach. A change is made in the workflow that allows to generate a speed of intervention by acting before prescribing, dispensing and administering the treatment to the patient. Targeted prevention: The presence of pharmacists in the multipurpose day hospital unit and their collaboration with other professionals and the patient bring about a selective prevention that decreases the possibility of medication errors occurring. Personalisation of medical services: With the individualised dispensing of treatments, a step forward is taken in the personalisation of medical services, which avoids medication errors in labelling and administration and improves safety in the overall medication circuit in the hospital.

Patient-reported outcome measures in severe asthma: an expert consensus.

OBJECTIVE: The study aimed to reach a consensus on the most relevant patient-reported outcomes (PROs), the corresponding measures (PROMs), and measurement frequency during severe asthma patient follow-up. METHODS: Two Delphi rounds were conducted. The questionnaire was developed based on a systematic literature review, a focus group with patients, and a nominal group with experts. It assessed PROs' relevance and the appropriateness (A) and feasibility (F) of PROMs using a Likert scale (1=totally agree; 9=totally disagree). The consensus was established when ≥75% of participants agreed (1-3) or disagreed (7-9). RESULTS: Sixty-three professionals (25 hospital pharmacists, 14 allergists, 13 pulmonologists, and 11 nurses) and 5 patients answered the Delphi questionnaire. A consensus was reached on all PROs regarding their relevance. Experts agreed on the use of ACT (A:95.24%; F:95.24%), mini AQLQ (A:93.65; F:79.37%), mMRC dyspnea scale (A:85.71%; F:85.71%), TAI (A:92.06%; F:85.71%), MMAS (A:75.40%; F:82%), and the dispensing register (A:96.83%; F:92.06%). Also considered suitable were: SNOT-22 (A:90.48%; F:73.80%), PSQI (A:82.54; F:63.90%), HADS (A:82.54; F:64%), WPAI (A:77.78%; F:49.20%), TSQM-9 (A:79.37; F:70.50%) and knowledge of asthma questionnaire (A:77%; F:68.80%); however, their use in clinical practice was considered unfeasible. Panelists also agreed on the appropriateness of EQ-5D, which was finally included despite being considered unfeasible (A: 84.13%; F:67.20%) in clinical practice. Agreement was reached on using ACT, TAI, mMRC, and a dispensing register every three months; mini-AQLQ and MMAS every six months; and EQ-5D every twelve months. CONCLUSION: This consensus paves the way toward patient-centered care, promoting the development of strategies supporting routine assessment of PROs in severe asthma management.

Efficacy and Safety of Inhaled Ethanol in Early-Stage SARS-CoV-2 Infection in Older Adults: A Phase II Randomized Clinical Trial.

BACKGROUND: Inhaled ethanol in the early stages of SARS-CoV-2 infection may reduce the viral load, decreasing progression and improving prognosis. The ALCOVID-19 trial was designed to study the efficacy and safety of inhaled ethanol in older adults at initial phases of infection. METHODS: Randomized, triple-blind, placebo-controlled phase II clinical trial. Experimental group (n = 38) inhaled 65° ethanol through an oxygen flow, while in the control group (n = 37), water for injection was used. General endpoint was to evaluate disease progression according to the modified World Health Organization (WHO) Clinical Progression Scale. Specific effectiveness endpoints were body temperature, oxygen saturation, viral load assessed by cycle threshold (Ct) on real-time polymerase chain reaction (RT-PCR), analytical biomarkers and use of antibiotics or corticosteroids. Specific safety outcomes were the absence of ethanol in plasma, electrographic, analytical, or respiratory alterations. RESULTS: In the intention-to-treat population, no differences were found regarding disease progression. Mean Ct values increased over time in both groups, being numerically higher in the ethanol group, reaching a value above 33 only in the ethanol group on day 14, a value above which patients are considered non-infective. No differences were found in the other specific effectiveness endpoints. Inhaled ethanol was proven to be safe as no plasma ethanol was detected, and there were no electrocardiographic, analytical, or respiratory alterations. CONCLUSIONS: The efficacy of inhaled ethanol in terms of the progression of SARS-CoV-2 infection was not demonstrated in the present trial. However, it is positioned as a safe treatment for elderly patients with early-stage COVID-19.

Development of a carbocysteine 10% + urea 5% cream for the topical treatment of congenital ichthyosis.

OBJECTIVE: Optimization of a topical formula of N-acetylcysteine and urea for  the topical treatment of ichthyosis. METHOD: We reviewed the chemical structure of the N-acetylcysteine molecule  and its metabolic processes. A search was conducted of possible alternative  molecules with a chemical structure similar to that of N-acetylcysteine that  could have improved organoleptic properties. The following databases were  used: PubChem®, Botplus®, the Drug Information Centre of the Spanish  Agency of Medicines and Medical Devices. The molecule selection criteria were  as follows: structural similarity, same therapeutic group, same mechanism of  action, same authorized indication, absence of unpleasant smell, and being  marketed as raw material in Spain. To complete the pharmaceutical  development and validation of the compound, several tests and controls were  conducted following the emulsion production procedure of the National  Formulary. In order to establish the validity period, we followed the  recommendations of the "Guide to Good Drug Preparation Practices in Hospital  Pharmacy Services". RESULTS: N-acetylcysteine has a free sulfhydryl group, which is responsible for  its smell, and undergoes deacetylation. Its main metabolites are cystine and  cysteamine. The following molecules were assessed: cystine, cysteamine,  carbocisteine, cysteine and methionine. Carbocisteine was selected because it met all the selection criteria. Carbocisteine is  ractically insoluble in water and soluble in mineral acids and alkaline hydroxides solutions. Unlike N-acetylcysteine, it does not have a fetid smell. It reaches its  maximum stability at pH 5.5 to 7.5. The composition of the compound (100 g)  was as follows: carbocisteine (10 g), urea (5 g), glycerine (15 g), water (44  mL), sodium hydroxide (1 g), and Neo PCL® Oil/Water (O/W) (25 g). It has an expiration period of 30 days. The organoleptic characteristics, emulsion type,  and pH remained stable within the established expiration period. The  arbocisteine compound has been incorporated into the group of topical  treatments available for the treatment of patients with ichthyosis in our  hospital. CONCLUSIONS: The carbocisteine molecule is a good therapeutic alternative that  lacks the unpleasant smell of N-acetylcysteine. The  arbocisteine compound developed has been included as topical treatment for  ichthyosis due to its tolerability, acceptability, and effectiveness in the  treatment of patients affected by this genodermatosis.

OBJETIVO: Optimización de una fórmula magistral tópica de N-acetilcisteína y urea para el tratamiento tópico de la ictiosis.Método: Se revisó la estructura química de la molécula de N-acetilcisteína y  sus procesos metabólicos. Se realizó una búsqueda de posibles moléculas  alternativas con una estructura química similar a la N-acetilcisteína que  pudiesen mejorar sus propiedades organolépticas. Bases de datos: PubChem®, Botplus®, Centro de Información de Medicamentos de la  Agencia Española de Medicamentos y Productos Sanitarios. Criterios de  selección de la molécula: similitud estructural, mismo grupo terapéutico,  mismo mecanismo de acción, misma indicación autorizada, ausencia de olor desagradable y estar comercializada como materia prima en España. Para el desarrollo galénico y validación de la fórmula se realizaron varios  ensayos y controles siguiendo el procedimiento de elaboración de emulsiones del Formulario Nacional. Para establecer el periodo de validez se  siguieron las recomendaciones de la "Guía de buenas prácticas de preparación  de medicamentos en los servicios de farmacia hospitalaria". RESULTADOS: La N-acetilcisteína presenta grupo sulfhidrilo libre, responsable del olor, sufre desacetilación y sus principales metabolitos son cistina y cisteamina. Las moléculas evaluadas fueron: cistina, cisteamina, carbocisteína, cisteína y metionina. Se seleccionó la carbocisteína  por  cumplir todos los criterios de selección. La carbocisteína es prácticamente insoluble en agua y soluble en disoluciones de ácidos minerales e hidróxidos  alcalinos. A diferencia de la N-acetilcisteína, carece de olor fétido.Presenta su  máxima estabilidad a pH 5,5-7,5. La composición de la fórmula magistral (100  g): carbocisteína (10 g), urea (5 g), glicerina (15 g), agua (44 ml), hidróxido  sódico (1 g) y Neo PCL® Oil/Water (O/W) (25 g). Periodo de caducidad: 30  días. Los caracteres organolépticos, signo de la emulsión y pH permanecieron  estables durante el periodo de caducidad establecido. La fórmula magistral de  carbocisteína elaborada se ha incorporado al arsenal de tratamientos tópicos  disponibles para los pacientes con ictiosis de nuestro centro. CONCLUSIONES: La molécula de carbocisteína resultó ser una buena alternativa  terapéutica que subsana el olor desagradable de la N-acetilcisteína. La fórmula  magistral de carbocisteína desarrollada fue incluida como tratamiento tópico de  la ictiosis gracias a su tolerabilidad, aceptabilidad y efectividad en el  tratamiento de pacientes afectos de esta genodermatosis.

The economic burden of pulmonary arterial hypertension in Spain.

BACKGROUND: Pulmonary Arterial Hypertension (PAH) is a rare, debilitating, and potentially fatal disease. This study aims to quantify the economic burden of PAH in Spain. METHODS: The study was conducted from a societal perspective, including direct and indirect costs associated with incident and prevalent patients. Average annual costs per patient were estimated by multiplying the number of resources consumed by their unit cost, differentiating the functional class (FC) of the patient. Total annual costs per FC were also calculated, taking the 2020 prevalence and incidence ranges into account. An expert committee validated the information on resource consumption and provided primary information on pharmacological consumption. Unit costs were estimated using official tariffs and salaries in Spain. A deterministic sensitivity analysis was conducted to test the uncertainty of the model. RESULTS: The average annual total cost was estimated at €98,839 per prevalent patient (FC I-II: €65,233; FC III: €103,736; FC IV: €208,821), being €42,110 for incident patients (FC I-II: €25,666; FC III: €44,667; FC IV: €95,188). The total annual cost of PAH in Spain, taking into account a prevalence between 16.0 and 25.9 cases per million adult inhabitants (FC I-II 31.8%; FC III 61.3%; FC IV 6.9%) and an incidence of 3.7, was estimated at €67,891,405 to €106,131,626, depending on the prevalence considered. Direct healthcare costs accounted for 64% of the total cost, followed by indirect costs (24%), and direct non-healthcare costs (12%). The total costs associated with patients in FC I-II ranged between €14,161,651 and €22,193,954, while for patients in FC III costs ranged between €43,763,019 and €68,391,651, and for patients in FC IV between €9,966,735 and €15,546,021. In global terms, patients with the worst functional status (FC IV) account for only 6.9% of the adults suffering from PAH in Spain, but are responsible for 14.7% of the total costs. CONCLUSIONS: PAH places a considerable economic burden on patients and their families, the healthcare system, and society as a whole. Efforts must be made to improve the health and management of these patients since the early stages of the disease.

Desarrollo de una crema de carbocisteína10% + urea 5% para el tratamiento tópico de las ictiosis congénitas / Development of a carbocysteine 10% + urea 5% cream for the topical treatment of congenital ichthyosis

Objetivo: Optimización de una fórmula magistral tópica de N-acetilcisteínay urea para el tratamiento tópico de la ictiosis.Método: Se revisó la estructura química de la molécula de N-acetilcisteínay sus procesos metabólicos. Se realizó una búsqueda de posiblesmoléculas alternativas con una estructura química similar a la N-acetilcisteínaque pudiesen mejorar sus propiedades organolépticas. Bases de datos:PubChem®, Botplus®, Centro de Información de Medicamentos de la Agencia Española de Medicamentos y Productos Sanitarios. Criterios de selecciónde la molécula: similitud estructural, mismo grupo terapéutico, mismomecanismo de acción, misma indicación autorizada, ausencia de olordesagradable y estar comercializada como materia prima en España. Parael desarrollo galénico y validación de la fórmula se realizaron varios ensayosy controles siguiendo el procedimiento de elaboración de emulsionesdel Formulario Nacional. Para establecer el periodo de validez se siguieronlas recomendaciones de la “Guía de buenas prácticas de preparación demedicamentos en los servicios de farmacia hospitalaria”.Resultados: La N-acetilcisteína presenta grupo sulfhidrilo libre, responsabledel olor, sufre desacetilación y sus principales metabolitos soncistina y cisteamina. Las moléculas evaluadas fueron: cistina, cisteamina,carbocisteína, cisteína y metionina. Se seleccionó la carbocisteína por cumplir todos los criterios de selección. La carbocisteína es prácticamenteinsoluble en agua y soluble en disoluciones de ácidos minerales e hidróxidosalcalinos. A diferencia de la N-acetilcisteína, carece de olor fétido.Presenta su máxima estabilidad a pH 5,5-7,5. La composición de la fórmulamagistral (100 g): carbocisteína (10 g), urea (5 g), glicerina (15 g),agua (44 ml), hidróxido sódico (1 g) y Neo PCL® Oil/Water (O/W)(25 g). Periodo de caducidad: 30 días.

Objective: Optimization of a topical formula of N-acetylcysteine andurea for the topical treatment of ichthyosis.Method: We reviewed the chemical structure of the N-acetylcysteinemolecule and its metabolic processes. A search was conducted of possiblealternative molecules with a chemical structure similar to that of N-acetylcysteinethat could have improved organoleptic properties. The followingdatabases were used: PubChem®, Botplus®, the Drug Information Centreof the Spanish Agency of Medicines and Medical Devices. The moleculeselection criteria were as follows: structural similarity, same therapeuticgroup, same mechanism of action, same authorized indication, absenceof unpleasant smell, and being marketed as raw material in Spain. To completethe pharmaceutical development and validation of the compound,several tests and controls were conducted following the emulsion productionprocedure of the National Formulary. In order to establish the validityperiod, we followed the recommendations of the “Guide to Good DrugPreparation Practices in Hospital Pharmacy Services”.Results: N-acetylcysteine has a free sulfhydryl group, which is responsiblefor its smell, and undergoes deacetylation. Its main metabolites arecystine and cysteamine. The following molecules were assessed: cystine,cysteamine,carbocisteine, cysteine and methionine. Carbocisteine practicallyinsoluble in water and soluble in mineral acids and alkaline hydroxidessolutions. Unlike N-acetylcysteine, it does not have a fetid smell. It reachesits maximum stability at pH 5.5 to 7.5. The composition of the compound(100 g) was as follows: carbocisteine (10 g), urea (5 g), glycerine (15 g),water (44 mL), sodium hydroxide (1 g), and Neo PCL® Oil/Water (O/W)(25 g). It has an expiration period of 30 days. The organoleptic characteristics,emulsion type, and pH remained stable within the established expirationperiod.

Efficacy of mepolizumab in usual clinical practice and characteristics of responders.

BACKGROUND: Severe eosinophilic asthma is a high-burden disease. Mepolizumab has been effective in several randomized clinical trials. However, such success might not be applicable to patients treated in usual clinical practice. The objectives of this article are to evaluate the efficacy of mepolizumab in severe uncontrolled eosinophilic asthma under usual clinical practice, and to determine characteristics associated with the response to this treatment. METHODS: We have conducted a retrospective, multicentre study, including all adult patients with severe uncontrolled eosinophilic asthma in Galicia, Spain, on whom mepolizumab treatment was started before June 2020, at least 6 months before the time of inclusion, and had received at least one dose of the drug. Patient characteristics, clinical data, respiratory function and comorbidities were collected at baseline and at the 6-month-follow-up. Responders and super-responders were defined according to clinical response and requirement of systemic corticosteroids. RESULTS: 122 patients (mean age 58 years old) were included. In the follow-up treatment 6 months later, 75.4% of the patients were well-controlled, displaying a significant reduction in blood eosinophil counts (p < 0.001), hospital admissions and disease exacerbations (p < 0.001), and had their systemic glucocorticosteroid dose significantly reduced (p < 0.001). The inhaled corticosteroid dose was also lowered (p < 0.01) after 6 months of treatment. Around two-thirds had a clinically significant increase in FEV1, 95% of the patients were considered responders and 43% super-responders. CONCLUSION: In routine clinical practice, mepolizumab is effective in patients with severe eosinophilic asthma and it has a good safety profile.

Baricitinib y tofacitinib en pacientes con artritis reumatoide: resultados de práctica clínica habitual / Baricitinib and tofacitinib in patients with rheumatoid arthritis: results of regular clinical practice

Objetivo: Objetivo principal: describir la efectividad y seguridad debaricitinib y tofacitinib en pacientes diagnosticados de artritis reumatoideen nuestro centro. Objetivo secundario: analizar si existen diferenciasentre ambos fármacos en práctica clínica real.Método: Estudio observacional retrospectivo de 2 años de duraciónque incluyó pacientes diagnosticados de artritis reumatoide en tratamientocon baricitinib o tofacitinib en nuestro centro durante al menos 6 meses.Bases de datos: historia clínica electrónica, aplicativo informático dedispensación a pacientes externos. Variables recogidas: demográficas,factores de mal pronóstico, tratamiento previo, duración de tratamiento,tratamiento concomitante, escala DAS28, número de articulaciones inflamadas y dolorosas, escala visual analógica del dolor, suspensión deltratamiento y reacciones adversas. Evaluación de la efectividad: disminución en la escala DAS28, articulaciones inflamadas y dolorosas y escalavisual analógica del dolor a los 6 y 12 meses de iniciado el tratamiento.Evaluación de la seguridad: detección de reacciones adversas. Análisisestadístico: prueba t-student.Resultados: Se evaluaron 44 pacientes, 20 (70% mujeres) recibierontratamiento con baricitinib, 24 (95,8% mujeres) con tofacitinib. Baricitinibredujo la puntuación en la escala DAS28 en 2,3 y 1,7 a los 6 y 12 meses.Tofacitinib en 2 y 1,9 respectivamente. Baricitinib redujo el número de articulaciones inflamadas y dolorosas en 7 a los 6 y 12 meses, tofacitinib en 4 las inflamadas y 6 las dolorosas. Baricitinib redujo la puntuación en la escala visual analógica del dolor en 7,8 y 6,8; tofacitinib en5 y 6 a los 6 y 12 meses. El 40% de los pacientes con baricitinib y el62,5% con tofacitinib precisaron tratamiento con corticoides. El 10% delos pacientes con baricitinib y el 25% de los pacientes con tofacitinibsuspendieron el tratamiento por ineficacia. (AU)

Objective: Main objective: Describe the effectiveness and safety ofbaricitinib and tofacitinib in patients diagnosed with rheumatoid arthritis inour hospital. Secondary objective: Analyse whether there are differencesbetween the two drugs in routine clinical practice.Method: Two-year retrospective study of patients diagnosed with rheumatoid arthritis treated in our hospital with baricitinib and tofacitinib forat least 6 months. Databases: Electronic medical record and outpatientmedication dispensing software. Variables collected: Demographic variables, poor prognosis factors, previous treatment, duration of treatment,concomitant treatment, DAS28, number of swollen and painful joints, painvisual analogy scale, treatment discontinuation, and adverse reactions.Effectiveness evaluation: Decreases in the DAS28 scale, the number ofswollen and painful joints, and the pain Visual Analogy Scale at 6 monthsand 12 months after starting treatment. Safety evaluation: Detection ofadverse reactions. Statistical analysis: Student t-test.Results: A total of 44 patients were evaluated. Of these, 20 (70% women)received treatment with baricitinib and 24 (95.8% women) received tofacitinib. Baricitinib reduced the DAS28 by 2.3 and 1.7 at 6 months and12 months, respectively, and tofacitinib reduced the scale by 2 and 1.9 at6 months and 12 months, respectively. Baricitinib reduced the numberof swollen and painful joints by 7 at both 6 months and 12 months, and tofacitinib reduced the number of swollen and painful joints by 4 and 6at 6 months and 12 months, respectively. Baricitinib reduced the VisualAnalogy Scale score by 7.8 and 6.8 at 6 months and 12 months, respectively, and tofacitinib reduced the score by 5 and 6 at 6 months and12 months, respectively. (AU)

Baricitinib and tofacitinib in patients with rheumatoid arthritis: results of regular clinical practice.

OBJECTIVE: Main objective: Describe the effectiveness and safety of baricitinib and tofacitinib in patients diagnosed with rheumatoid arthritis in our hospital. SECONDARY OBJECTIVE: Analyse whether there are  differences between the two drugs in routine clinical practice. METHOD: Two-year retrospective study of patients diagnosed with  rheumatoid arthritis treated in our hospital with baricitinib and tofacitinib  for at least 6 months. Databases: Electronic medical record and outpatient medication dispensing software. Variables collected:  Demographic variables, poor prognosis factors, previous treatment,  duration of treatment, concomitant treatment, DAS28, number of swollen  and painful joints, pain visual analogy scale, treatment discontinuation,  and adverse reactions. Effectiveness evaluation: Decreases in the DAS28  scale, the number of swollen and painful joints, and the pain Visual  Analogy Scale at 6 months and 12 months after starting treatment. Safety evaluation: Detection of adverse reactions. STATISTICAL ANALYSIS: Student t- test. RESULTS: A total of 44 patients were evaluated. Of these, 20 (70%  women) received treatment with baricitinib and 24 (95.8% women)  received tofacitinib. Baricitinib reduced the DAS28 by 2.3 and 1.7 at 6  months and 12 months, respectively, and tofacitinib reduced the scale by 2 and 1.9 at 6 months and 12 months, respectively. Baricitinib reduced the  number of swollen and painful joints by 7 at both 6 months and 12  months, and tofacitinib reduced the number of swollen and painful joints  by 4 and 6 at 6 months and 12 months, respectively. Baricitinib reduced  the Visual Analogy Scale score by 7.8 and 6.8 at 6 months and 12 months, respectively, and tofacitinib reduced the score by 5 and 6 at 6 months and 12 months, respectively. Corticosteroid treatment was needed in 40% of patients treated with baricitinib and 62.5% of patients treated with  rofacitinib. Treatment was discontinued due to loss of effectiveness in 10% of patients receiving baricitinib and 25% of patients treated with  tofacitinib. Adverse reactions were experienced by 10% of patients treated with baricitinib and 12.5% of patients treated with tofacitinib. Adverse  reactions led to treatment discontinuation in only 1 patient in each group.  No statistically significant differences were observed between the two  drugs. CONCLUSIONS: The results show that baricitinib and tofacitinib were  effective and safe in relation to all the variables analysed. Moreover, both drugs were similar in terms of effectiveness and safety for the  treatment of rheumatoid arthritis in real-world clinical practice.

Objetivo: Objetivo principal: describir la efectividad y seguridad de baricitinib y tofacitinib en pacientes diagnosticados de artritis  reumatoide en nuestro centro. Objetivo secundario: analizar si existen  diferencias entre ambos fármacos en práctica clínica real.Método: Estudio observacional retrospectivo de 2 años de duración que  incluyó pacientes diagnosticados de artritis reumatoide en tratamiento con  baricitinib o tofacitinib en nuestro centro durante al menos 6 meses. Bases de datos: historia clínica electrónica, aplicativo informático de dispensación a pacientes externos. Variables recogidas: demográficas, factores de mal  pronóstico, tratamiento previo, duración de tratamiento, tratamiento  concomitante, escala DAS28, número de articulaciones inflamadas y  dolorosas, escala visual analógica del dolor, suspensión del tratamiento y  reacciones adversas. Evaluación de la efectividad: disminución en la escala DAS28, articulaciones inflamadas y dolorosas y escala visual analógica del  dolor a los 6 y 12 meses de iniciado el tratamiento. Evaluación de la  seguridad: detección de reacciones adversas.Análisis estadístico: prueba t-student.Resultados: Se evaluaron 44 pacientes, 20 (70% mujeres) recibieron tratamiento con baricitinib, 24 (95,8% mujeres) con tofacitinib.  Baricitinib redujo la puntuación en la escala DAS28 en 2,3 y 1,7 a los 6 y  12 meses. Tofacitinib en 2 y 1,9 respectivamente. Baricitinib redujo el  número de articulaciones inflamadas y dolorosas en 7 a los 6 y 12 meses,  tofacitinib en 4 las inflamadas y 6 las dolorosas. Baricitinib redujo la  puntuación en la escala visual analógica del dolor en 7,8 y 6,8; tofacitinib  en 5 y 6 a los 6 y 12 meses. El 40% de los pacientes con baricitinib y el 62,5% con tofacitinib precisaron tratamiento con corticoides. El 10% de los pacientes con baricitinib y el 25% de los pacientes con tofacitinib suspendieron el tratamiento por ineficacia. El 10% de los pacientes de baricitinib y el 12,5% de tofacitinib experimentaron reacciones adversas. Sólo un paciente de cada grupo suspendió el tratamiento por reacciones adversas. No se observaron diferencias estadísticamente significativas entre ambos fármacos.Conclusiones: Según nuestros resultados, baricitinib y tofacitinib han demostrado ser efectivos y seguros en todas las variables analizadas. Además, ambos fármacos resultaron similares en efectividad y  seguridad en la práctica clínica habitual del tratamiento de la artritis  reumatoide.

Development and Characterization of Inhaled Ethanol as a Novel Pharmacological Strategy Currently Evaluated in a Phase II Clinical Trial for Early-Stage SARS-CoV-2 Infection.

Inhaled administration of ethanol in the early stages of COVID-19 would favor its location on the initial replication sites, being able to reduce the progression of the disease and improving its prognosis. Before evaluating the efficacy and safety of this novel therapeutic strategy in humans, its characterization is required. The developed 65° ethanol formulation is stable at room temperature and protected from light for 15 days, maintaining its physicochemical and microbiological properties. Two oxygen flows have been tested for its administration (2 and 3 L/min) using an automated headspace gas chromatographic analysis technique (HS-GC-MS), with that of 2 L/min being the most appropriate one, ensuring the inhalation of an ethanol daily dose of 33.6 ± 3.6 mg/min and achieving more stable concentrations during the entire treatment (45 min). Under these conditions of administration, the formulation has proven to be safe, based on histological studies of the respiratory tracts and lungs of rats. On the other hand, these results are accompanied by the first preclinical molecular imaging study with radiolabeled ethanol administered by this route. The current ethanol formulation has received approval from the Spanish Agency of Medicines and Medical Devices for a phase II clinical trial for early-stage COVID-19 patients, which is currently in the recruitment phase (ALCOVID-19; EudraCT number: 2020-001760-29).

Seguridad y persistencia del dimetilfumarato como tratamiento para la esclerosis múltiple remitente-recurrente / Safety and persistence of dimethyl fumarate as a treatment for relapsing-remitting multiple-sclerosis

Objetivo: Dimetilfumarato es un fármaco autorizado en el tratamientode la esclerosis múltiple recurrente-remitente. El objetivo es evaluar laseguridad y persistencia del dimetilfumarato en la práctica clínica, y analizar la evolución de las linfopenias en pacientes en tratamiento con dimetilfumarato un mínimo de 6 meses.Método: Estudio observacional, longitudinal, retrospectivo entre agostode 2015 y marzo de 2019. Se incluyeron todos los pacientes en tratamiento durante un periodo mínimo de 6 meses. Se recogieron los datosde recuento linfocitario a diferentes tiempos: pretratamiento, a los 3, 6,12 meses y al final del periodo de estudio. Como modelo estadístico seutilizó la regresión logística para analizar la evolución de las linfopenias.Se estudió la relación entre el descenso del recuento linfocitario los primeros 6 meses de tratamiento y el desarrollo a tiempo final del estudio delinfopenias grado II/III que podrían ser motivo de suspensión. Además, seevaluaron otros indicadores de seguridad: reacciones adversas, suspensiones y abandonos de tratamiento. Para el análisis de la persistencia secontabilizaron los meses transcurridos desde el inicio hasta la suspensióndel tratamiento.Resultados: Se incluyeron 55 pacientes. El 80% fueron mujeres. Lasreacciones adversas más frecuentes fueron: linfopenia (27), rubefacción(16), molestias digestivas (11), fatiga (9), cefalea (3) y alteraciones delsueño (2). Durante el periodo considerado hubo 11 abandonos/suspensiones de tratamiento, las razones fueron: embarazo (2), decisión propia(2), infección por virus John Cunningham (1), alergia al fármaco (2) ylinfopenia (4). La mediana de duración de tratamiento fue de 23 meses(4-43 meses). (AU)

Objective: Dimethyl fumarate is a medication approved for the treatmentof relapsing-remitting multiple sclerosis. The purpose of the study was toevaluate the safety and persistence of dimethyl fumarate in clinical practice and analyze the occurrence of lymphopenia is patients treated withdimethyl fumarate over a period of at least 6 months.Method: This is a retrospective longitudinal observational study carriedout between August 2015 and March 2019. The study cohort was madeup of patients who had been treated with dimethyl fumarate for at least6 months. Lymphocyte counts were recorded at different points of time(pre-treatment, at 3, 6, 12 months, and at the end of the study period). Theevolution of lymphopenia was evaluated by means of a logistic regressionstatistical model. An analysis was performed of the relationship betweena decreased lymphocyte count over the first 6 months of treatment andthe development, by the end of the study, of grade II-III lymphopenianecessitating discontinuation of dimethyl fumarate. Other safety indicatorswere also evaluated including adverse events and interruptions or discontinuations of treatment. Persistence was determined by measuring the timeto discontinuation of treatment.Results: The study included a total of 55 patients, of whom 80% werefemale. The most common adverse events were lymphopenia (27), rubefaction (16), digestive symptoms (11), fatigue (9), headache (3) and sleepdisturbances (2). Eleven subjects interrupted/discontinued their treatment during the study period; reasons were as follows: pregnancy (2), personal decision (2), John Cunningham virus infection (1), allergy to the drug(2), and lymphopenia (4). Median duration of treatment was 23 months(4-43 months). A statistically significant association was found betweena lower lymphocyte count over the first 6 months of treatment and thedevelopment of severe lymphopenia by the end of the study [OR = 1.34(1.27-11.41); 95% CI (p = 0.001)]. )(AU)

Effectiveness, Safety, and Adherence to Treatment of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors in Real Practice.

PURPOSE: To evaluate the effectiveness, adverse reactions, and adherence to treatment of hypolipidemic inhibitors of proprotein convertase subtilisin/kexin type 9 (PCSK9is) in a context of real clinical practice. METHODS: We present an observational, retrospective, descriptive, multicenter study of patients with hypercholesterolemia who began treatment with PCSK9is between January 2017 and December 2019, with a minimum treatment period of 3 months. The main variable we recorded was the frequency of cardiovascular events (cardiovascular death, myocardial infarction, stroke, coronary revascularization, and hospitalization for unstable angina) in patients treated with PCSK9is. We recorded patient demographic characteristics and cardiovascular risk factors at onset of treatment as well as LDL-C levels and their reductions at 3, 6, 12, and 24 months. We calculated adherence to treatment and recorded the adverse reactions during treatment. FINDINGS: A total of 154 patients were studied, 64 (41.6%) of whom were treated with alirocumab and 90 (58.4%) with evolocumab. The initial dose of alirocumab was 75 mg every 14 days in 48 patients (75%) and 150 mg eery 14 days in 16 (25%). All patients who in the evolocumab group received a dose of 140 mg every 14 days. The mean (SD) basal LDL-C level was 159.6 (50.1) mg/dL, the level at 3 months was 87.9 (49.9) mg/dL (mean [SD] decrease, 44.5% [28.2%]), the level at 6 months was 86.7 (49.2) mg/dL (mean [SD] decrease, 46.3% [25.6%]), and the level at 12 months was 80.5 (41.4) (mean [SD] decrease, 48.9% [23.0%]). These values were maintained at 24 months (mean [SD], 80.3 [41.8] mg/dL; mean [SD] decrease, 47.9% [27.8%]). The percentage decrease of LDL-C for both drugs was approximately 50%, which was maintained until 24 months after treatment. Six patients (3.9%) presented with some cardiovascular event: acute myocardial infarction (2 [1.3%]), stroke (1 [0.65%]), coronary revascularization (1 [0.65%]), and hospitalization for unstable angina (2 [1.3%]). We did not see any adverse reactions related to PCSK9i treatment in 76.5% of patients. In the first 6 months, adherence to treatment with PCSK9is, measured as the possession ratio, was a mean (SD) of 99.4% (3.9%). In the rest of the study period (6-24 months), the mean (SD) adherence to treatment was 99.2% (4.7%). IMPLICATIONS: The frequency of cardiovascular events in patients treated with PCSK9is was low and occurred despite adequate adherence to treatment (100% possession ratio) with PCSK9is and concomitant treatment with other hypolipidemics. The effectiveness of PCSK9is is similar to that referred to in other published studies with PCSK9is, and this was maintained in the long term (24 months) with few adverse events, all of which were mild.

Safety and persistence of dimethyl fumarate as a treatment for relapsing-remitting multiple-sclerosis.

OBJECTIVE: Dimethyl fumarate is a medication approved for the treatment of relapsing-remitting multiple sclerosis. The purpose of the  study was to evaluate the safety and persistence of dimethyl fumarate in  clinical practice and analyze the occurrence of lymphopenia is patients  treated with dimethyl fumarate over a period of at least 6 months. METHOD: This is a retrospective longitudinal observational study carried out between August 2015 and March 2019. The study cohort was  made up of patients who had been treated with dimethyl fumarate for at  least 6 months. Lymphocyte counts were recorded at different points of  time (pre-treatment, at 3, 6, 12 months, and at the end of the study  period). The evolution of lymphopenia was evaluated by means of a  logistic regression statistical model. An analysis was performed of the  relationship between a decreased lymphocyte count over the first 6  months of treatment and the development, by the end of the study, of  grade II-III lymphopenia necessitating discontinuation of dimethyl  fumarate. Other safety indicators were also evaluated including adverse  events and interruptions or discontinuations of treatment. Persistence was  determined by measuring the time to discontinuation of treatment. RESULTS: The study included a total of 55 patients, of whom 80% were female. The most common adverse events were lymphopenia (27),  rubefaction (16), digestive symptoms (11), fatigue (9), headache (3) and  sleep disturbances (2). Eleven subjects interrupted/discontinued their  treatment during the study period; reasons were as follows: pregnancy  (2), personal decision (2), John Cunningham virus infection (1), allergy to  the drug (2), and lymphopenia (4). Median duration of treatment was 23  months (4-43 months). A statistically significant association was found  between a lower lymphocyte count over the first 6 months of treatment  and the development of severe lymphopenia by the end of the study [OR  = 1.34 (0.35-2.60); 95% CI (p = 0.001)]. CONCLUSIONS: The adverse events observed in the present study are in line with those reported in previous analyses. Lymphopenia was the  most common adverse event. The persistence of the medication was  similar to that found in pivotal trials. The significant association found  between a decreased lymphocyte count over the first 6 months of  treatment and the development of severe lymphopenia by the end of the  study suggests a connection between both variables, which could be  instrumental in being able to predict and even prevent the occurrence of  such lymphopenias.

Objetivo: Dimetilfumarato es un fármaco autorizado en el tratamiento de  la esclerosis múltiple recurrente-remitente. El objetivo es evaluar la seguridad y persistencia del dimetilfumarato en la práctica clínica, y  analizar la evolución de las linfopenias en pacientes en tratamiento con  dimetilfumarato un mínimo de 6 meses.Método: Estudio observacional, longitudinal, retrospectivo entre agosto de 2015 y marzo de 2019. Se incluyeron todos los pacientes en tratamiento durante un periodo mínimo de 6 meses. Se recogieron los  datos de recuento linfocitario a diferentes tiempos: pretratamiento, a los  3, 6, 12 meses y al final del periodo de estudio. Como modelo estadístico  se utilizó la regresión logística para analizar la evolución de las linfopenias. Se estudió la relación entre el descenso del recuento  linfocitario los primeros 6 meses de tratamiento y el desarrollo a tiempo  final del estudio de linfopenias grado II/III que podrían ser motivo de  suspensión. Además, se evaluaron otros indicadores de seguridad:  reacciones adversas, suspensiones y abandonos de tratamiento. Para el  análisis de la persistencia se contabilizaron los meses transcurridos desde  el inicio hasta la suspensión del tratamiento.Resultados: Se incluyeron 55 pacientes. El 80% fueron mujeres. Las reacciones adversas más frecuentes fueron: linfopenia (27),  rubefacción (16), molestias digestivas (11), fatiga (9), cefalea (3) y  alteraciones del sueño (2). Durante el periodo considerado hubo 11  abandonos/suspensiones de tratamiento, las razones fueron: embarazo  (2), decisión propia (2), infección por virus John Cunningham (1), alergia  al fármaco (2) y linfopenia (4). La mediana de duración de tratamiento fue de 23 meses (4-43 meses). Se encontraron diferencias estadísticamente significativas en el análisis de la relación entre el descenso de linfocitos los primeros 6 meses de tratamiento y el desarrollo de linfopenias graves a  tiempo final del estudio, con una odds ratio de 1,34, un intervalo de  confianza del 95% de 0,35-2,60 y un valor de p de 0,001.Conclusiones: Las reacciones adversas observadas siguen la línea de ensayos y estudios previos. La linfopenia fue la reacción adversa más frecuente. Los resultados muestran una persistencia del tratamiento  similar a la de los ensayos pivotales. Las diferencias significativas  observadas entre la reducción de linfocitos los primeros 6 meses de  tratamiento y el desarrollo de linfopenias graves al final del estudio,  sugieren una relación entre ambas variables y la posibilidad de predecir y  evitar la aparición de dichas linfopenias.

Determinación del pH como criterio de calidad en la elaboración de fórmulas magistrales orales líquidas / pH determination as a quality standard for the elaboration of oral liquid compounding formula

Objetivo: El pH es un factor crítico para todos aquellos medicamentos que se encuentran en formas líquidas acuosas, ya que puede ejercer un efecto sobre la solubilidad del principio activo condicionando la estabilidad de los medicamentos, la tolerancia biológica de la forma farmacéutica y la actividad del principio activo. El objetivo de este trabajo es establecer el rango óptimo de pH de las fórmulas orales líquidas más frecuentemente elaboradas en el Servicio de Farmacia para estandarizar e incorporar dicho valor en los protocolos normalizados de trabajo como criterio de control de calidad. Método: El estudio se desarrolló en tres fases. En una primera fase se realizó un estudio retrospectivo de los registros de elaboración de las fórmulas orales líquidas elaboradas, al menos 5 veces, desde enero de 2015 a diciembre de 2016 en nuestro Servicio de Farmacia, y se calculó el valor medio y la desviación estándar de los valores de pH registrados para cada fórmula. En una segunda fase se realizó una búsqueda bibliográfica para conocer el pH de máxima estabilidad del principio activo y comprobar si esta característica se registra como requisito de control de calidad en los procedimientos descritos en los formularios de referencia. En una tercera fase se comprobó si los pH determinados se correspondían con el de máxima estabilidad descrito en la literatura y se establecieron rangos de aceptación. Resultados: Se revisaron un total de 31 fórmulas (14 soluciones/17 suspensiones). Se conocía el valor del pH de máxima estabilidad de 19 (61,3%) de los principios activos y/o fórmulas orales líquidas evaluadas, de las cuales 15 (78,9%) se encontraban dentro del mismo y las 4 restantes (21,1%) presentaron una desviación estándar de ± 0,5 con respecto al valor de pH referenciado en la bibliografía. El rango de pH para un mismo procedimiento normalizado de trabajo oscilaba entre 0,32 y 1,51. Se estableció como control de calidad un rango de aceptación de pH de ± 0,75

Objective: pH is a critical factor for all those medications prepared as aqueous liquid forms, because it has an impact on the solubility of the molecule, determining the stability of medications, the biological tolerability of the formulation, and the activity of the molecule. The objective of this study is to determine the optimum pH range for the oral liquid formulations more frequently prepared at the Pharmacy Unit, in order to standardize and incorporate said value into the standard protocols of action as a quality control criterion. Method: The study was conducted in three stages. The first stage consisted in a retrospective study of the records of preparation of those oral liquid formulations prepared at least 5 times since January, 2015 to December, 2016, in our Pharmacy Unit; the main value and standard deviation of the pH values recorded for each formulation were calculated. In a second stage, there was a bibliographic search in order to understand the pH for the maximum stability of the molecule, and to confirm if this characteristic was recorded as a requirement for quality control in the procedures described in the formulation guidelines. In the third stage, it was confirmed if the pH values determined coincided with the maximum stability pH described in literature, and acceptance ranges were established. Results: In total, 31 formulations were reviewed (14 solutions / 17 suspensions). The maximum stability pH value was known for 19 (61.3%) of the molecules and/or oral liquid formulations evaluated; 15 (78.9%) of these were within this range, and the remaining 4 (21.1%) presented a standard deviation of ± 0.5 regarding the pH value referenced in the bibliography. The pH range for the same standard work procedure ranged between 0.32 and 1.51. An acceptance pH range of ± 0.75 was determined as quality control

pH determination as a quality standard for the elaboration of oral liquid compounding formula.

OBJECTIVE: pH is a critical factor for all those medications prepared as aqueous  liquid forms, because it has an impact on the solubility of the molecule, determining the stability of medications, the biological tolerability of  the formulation, and the activity of the molecule. The objective of this study is to determine the optimum pH range for the oral liquid formulations more frequently prepared at the Pharmacy Unit, in order to standardize and incorporate said  value into the standard protocols of action as a quality control criterion. METHOD: The study was conducted in three stages. The first stage consisted in a retrospective study of the records of preparation of those oral liquid formulations prepared at least 5 times since January, 2015 to December, 2016, in our  Pharmacy Unit; the main value and standard deviation of the pH values recorded for each formulation were calculated. In a second stage, there was a  bibliographic search in order to understand the pH for the maximum stability of  the molecule, and to confirm if this characteristic was recorded as a requirement for quality control in the procedures described in the formulation guidelines. In  the third stage, it was confirmed if the pH values determined coincided with the  maximum stability pH described in literature, and acceptance ranges were  established. RESULTS: In total, 31 formulations were reviewed (14 solutions / 17  suspensions). The maximum stability pH value was known for 19 (61.3%) of the molecules and/or oral liquid formulations evaluated; 15 (78.9%) of these were  within this range, and the remaining 4 (21.1%) presented a standard deviation  of ± 0.5 regarding the pH value referenced in the bibliography. The pH range for the same standard work procedure ranged between 0.32 and 1.51. An  acceptance pH range of ± 0.75 was determined as quality control. CONCLUSIONS: An optimal pH range has been determined for the 31 oral liquid  formulations more widely prescribed in our hospital. This characteristic should be part of the galenic validation for these preparations, as well as of its routine  quality control, in order to ensure their quality and efficacy.

Objetivo: El pH es un factor crítico para todos aquellos medicamentos que se  encuentran en formas líquidas acuosas, ya que puede ejercer un efecto sobre la  solubilidad del principio activo condicionando la estabilidad de los medicamentos, la tolerancia biológica de la forma farmacéutica y la actividad del principio  activo. El objetivo de este trabajo es establecer el rango óptimo de pH de las  fórmulas orales líquidas más frecuentemente elaboradas en el Servicio de  Farmacia para estandarizar e incorporar dicho valor en los protocolos  normalizados de trabajo como criterio de control de calidad.Método: El estudio se desarrolló en tres fases. En una primera fase se realizó  un estudio retrospectivo de los registros de elaboración de las fórmulas orales  líquidas elaboradas, al menos 5 veces, desde enero de 2015 a diciembre de  2016 en nuestro Servicio de Farmacia, y se calculó el valor medio y la desviación estándar de los valores de pH registrados para cada fórmula. En una segunda  fase se realizó una búsqueda bibliográfica para conocer el pH de máxima  estabilidad del principio activo y comprobar si esta característica se registra  como requisito de control de calidad en los procedimientos descritos en los  formularios de referencia. En una tercera fase se comprobó si los pH  determinados se correspondían con el de máxima estabilidad descrito en la  literatura y se establecieron rangos de aceptación.Resultados: Se revisaron un total de 31 fórmulas (14 soluciones/17  suspensiones). Se conocía el valor del pH de máxima estabilidad de 19 (61,3%) de los principios activos y/o fórmulas orales líquidas evaluadas, de las  cuales 15 (78,9%) se encontraban dentro del mismo y las 4 restantes 21,1%) presentaron una desviación estándar de ± 0,5 con respecto al valor de  pH referenciado en la bibliografía. El rango de pH para un mismo procedimiento normalizado de trabajo oscilaba entre 0,32 y 1,51. Se estableció  como control de calidad un rango de aceptación de pH de ± 0,75.Conclusiones: Se ha establecido un rango óptimo de pH para las 31 fórmulas  orales líquidas de mayor prescripción en nuestro hospital. Esta característica  debería formar parte de la validación galénica de estas preparaciones, así como  de su control de calidad rutinario, para asegurar la calidad y eficacia de las  mismas.

Utilización del recambio plasmático como herramienta terapéutica en la práctica clínica / Use of plasma exchange as therapeutic tool in clinical practice

Objetivo: Describir la utilización del recambio plasmático terapéutico (RPT) en distintas patologías y su ajuste a las guías internacionales de referencia. Método: Estudio observacional, descriptivo y retrospectivo en pacientes que recibieron plasmaféresis entre enero de 2014 y diciembre de 2015. Se analizó la adecuación de su indicación según la bibliografía consultada, así como la respuesta obtenida. El Servicio de Hematología estableció la indicación, el volumen plasmático a recambiar, el número de sesiones y la periodicidad según la enfermedad de base y su evolución clínica. Resultados: Diez pacientes (8 mujeres) entre 28 y 72 años de edad, recibieron RPT. Las patologías eran de origen neurológico (9 pacientes), enfermedad de Waldenström (1 paciente). La técnica utilizada fue centrifugación continua con albúmina 5% como líquido de reposición. Conclusiones: El RPT en los pacientes revisados se ajustó a las guías de referencia. No se observó correlación directa entre el grado de recomendación establecido por dichas guías y la respuesta obtenida. El número reducido de pacientes supone una limitación a la hora de extraer resultados concluyentes (AU)

Objective: To descrive the use of therapeutic plasma exchange in several pathologies and its adjustment to international reference guides. Method: Observational, descriptive, retrospective study, of all the patients that received plasmapheresis between January 2014-December 2015. We analized the appropriate indication according to the bibliography consulted, and the therapeutic outcome. Indication, replaced volume of plasma, number of sessions and periodicity were established by the Hematology Service depending on the disease and its clinical course. Results: 10 patients (8 women), between 28-72 years old, received therapeutic plasma exchange. The pathologies treated were neurological (9 patients), Waldenström disease (1 patient). The technique used was continuous centrifugation with albumin 5% as replacement fluid. Conclusions: The therapeutic plasma exchange in reviewed patients agreed to reference guides. There was not a direct relation between the recommendation grade and the response obtained. The reduced number of patients is a limitation to obtain conclusive results (AU)

Use of plasma exchange as therapeutic tool in clinical practice.

OBJECTIVE: To descrive the use of therapeutic plasma exchange in several pathologies and its adjustment to international reference guides. METHOD: Observational, descriptive, retrospective study, of all the patients that  received plasmapheresis between January 2014-December 2015. We analized  the appropriate indication according to the bibliography consulted, and the  therapeutic outcome. Indication, replaced volume of plasma, number of sessions  and periodicity were established by the Hematology Service depending  on the disease and its clinical course. RESULTS: 10 patients (8 women), between 28-72 years old, received therapeutic  plasma exchange. The pathologies treated were  eurological (9 patients), Waldenström disease (1 patient). The technique used  was continuous centrifugation with albumin 5% as replacement fluid. CONCLUSIONS: The therapeutic plasma exchange in reviewed patients agreed to  reference guides. There was not a direct relation between the recommendation  grade and the response obtained. The reduced number of patients is a limitation  to obtain conclusive results.

Objetivo: Describir la utilización del recambio plasmático terapéutico (RPT) en  distintas patologías y su ajuste a las guías internacionales de referencia.Método: Estudio observacional, descriptivo y retrospectivo en pacientes que  recibieron plasmaféresis entre enero de 2014 y diciembre de 2015. Se analizó la  adecuación de su indicación según la bibliografía consultada, así como la  respuesta obtenida. El Servicio de Hematología estableció la indicación, el  volumen plasmático a recambiar, el número de sesiones y la periodicidad según  la enfermedad de base y su evolución clínica.Resultados: Diez pacientes (8 mujeres) entre 28 y 72 años de edad, recibieron  RPT. Las patologías eran de origen neurológico (9 pacientes), enfermedad de  Waldenström (1 paciente). La técnica utilizada fue centrifugación continua con  albúmina 5% como líquido de reposición.Conclusiones: El RPT en los pacientes revisados se ajustó a las guías de  referencia. No se observó correlación directa entre el grado de recomendación establecido por dichas guías y la respuesta obtenida. El número  reducido de pacientes supone una limitación a la hora de extraer resultados  concluyentes.

Adherence and safety study in patients on treatment with capecitabine / Estudio de adherencia y seguridad en pacientes a tratamiento con capecitabina

Background: The introduction of oral antineoplastic agents in therapeutics has caused a change in the treatment strategy against cancer. The objective of this study was to analyze the adherence in patients to treatment with capecitabine, their adverse events, and the overall health status of patients, as well as the relationship of these factors with adherence. Method: An observational, prospective study at 7 months, in a cohort of patients on capecitabine treatment, including treatment initiations and continuations, regardless of diagnosis or indication. The data collected were: demographic variables (age, gender), diagnostic (breast cancer, colorectal cancer, gastric cancer, off-label), adherence (tablet count, Morisky test, Sackett test), safety (assessment of adverse events, clinical evaluation by the oncologist) and quality of life (performance status, SF-12 test). Data sources: electronic clinical records (IANUS®), dispensing program for outpatients (SILICON®) and interviews with patients. Results: There were 111 evaluable patients, with a mean age of 66.7 years (range 32-86), ECOG PS 1 in 76.6%. Adherence level: 78.4% (81.7% in the initiation sub-group vs. 72.5% in the continuation sub-group). Adverse events: skin toxicity (33.33%), asthenia (25.22%), gastrointestinal toxicity (24.32%) and neurological toxicity (24.32%), mostly G1. Health status, SF-12 test: subjective evaluation as ‘good’ in 33.30% of cases. Conclusions: The low level of adherence in the continuation sub-group can be associated with the duration of treatment, toxicities, clinical evolution, and perception of their health status. It is necessary to conduct individualized monitoring in this group of patients in order to obtain a favorable clinical response (AU)

Introducción: La introducción en la terapéutica de antineoplásicos orales ha provocado un cambio en la estrategia de tratamiento frente al cáncer. El objetivo de este trabajo fue analizar la adherencia en pacientes en tratamiento con capecitabina, los acontecimientos adversos y el estado general de salud de los pacientes, así como la relación de estos factores con la adherencia. Método: Estudio observacional prospectivo, de siete meses de duración, en una cohorte de pacientes en tratamiento con capecitabina, incluyendo los inicios y las continuaciones de tratamiento, independientemente del diagnóstico o la indicación. Se registraron variables demográficas (edad, sexo), de diagnóstico (cáncer de mama, colon-recto, gástrico, off-label), de adherencia (recuento de comprimidos, test de Morisky, de Sackett), de seguridad (valoración de acontecimientos adversos, evaluación clínica del oncólogo) y calidad de vida (performance status, test SF-12). Fuentes de datos: historia clínica electrónica (IANUS®), programa de dispensación a pacientes externos (Silicon®) y entrevistas al paciente. Resultados: 111 pacientes evaluables, media de edad de 66,7 años (rango 32-86), ECOG PS 1 en el 76,6%. Nivel de adherencia: 78,4% (subgrupo inicio 81,7% vs. continuación 72,5%). Acontecimientos adversos: toxicidad cutánea (33,33%), astenia (25,22%), toxicidad gastrointestinal (24,32%) y neurológica (24,32%), en su mayoría G1. Estado de salud, test SF-12: valoración subjetiva ‘buena’ en el 33,30%. Conclusiones: El bajo nivel de adherencia en el subgrupo de continuación puede relacionarse con la duración del tratamiento, las toxicidades, la evolución clínica y la percepción de su estado de salud. Es necesario un seguimiento individualizado en este grupo de pacientes para obtener una respuesta clínica favorable (AU)

Adherence and safety study in patients on treatment with capecitabine.

BACKGROUND: The introduction of oral antineoplastic agents in therapeutics has caused a change in the treatment strategy against cancer. The objective of this study was to analyze the adherence in patients to treatment with capecitabine, their adverse events, and the overall health status of patients, as well as the relationship of these factors with adherence. METHOD: An observational, prospective study at 7 months, in a cohort of patients on capecitabine treatment, including treatment initiations and continuations, regardless of diagnosis or indication. The data collected were: demographic variables (age, gender), diagnostic (breast cancer, colorectal cancer, gastric cancer, off-label), adherence (tablet count, Morisky test,Sackett test), safety (assessment of adverse events, clinical evaluation by the oncologist) and quality of life (performance status, SF-12 test). DATA SOURCES: electronic clinical records (IANUS®), dispensing program for outpatients (SILICON®) and interviews with patients. RESULTS: There were 111 evaluable patients, with a mean age of 66.7 years (range 32-86), ECOG PS 1 in 76.6%. Adherence level: 78.4% (81.7% in the initiation sub-group vs. 72.5% in the continuation sub-group). Adverse events: skin toxicity (33.33%), asthenia (25.22%), gastrointestinal toxicity (24.32%) and neurological toxicity (24.32%), mostly G1.Health status, SF-12 test: subjective evaluation as "good" in 33.30% of cases. Conclusions: The low level of adherence in the continuation sub-group can be associated with the duration of treatment, toxicities, clinical evolution, and perception of their health status. It is necessary to conduct individualized monitoring in this group of patients in order to obtain a favorable clinical response.

Introducción: La introducción en la terapéutica de antineoplásicos orales ha provocado un cambio en la estrategia de tratamiento frente al cáncer. El objetivo de este trabajo fue analizar la adherencia en pacientes en tratamiento con capecitabina, los acontecimientos adversos y el estado general de salud de los pacientes, así como la relación de estos factores con la adherencia.Método: Estudio observacional prospectivo, de siete meses de duración, en una cohorte de pacientes en tratamiento con capecitabina, incluyendo los inicios y las continuaciones de tratamiento, independientemente del diagnóstico o la indicación. Se registraron variables demográficas (edad, sexo), de diagnóstico (cáncer de mama, colon-recto, gástrico, off-label), deadherencia (recuento de comprimidos, test de Morisky, de Sackett), de seguridad (valoración de acontecimientos adversos, evaluación clínica del oncólogo) y calidad de vida (performance status, test SF-12). Fuentes de datos: historia clínica electrónica (IANUS®), programa de dispensación a pacientes externos (Silicon ®) y entrevistas al paciente. Resultados: 111 pacientes evaluables, media de edad de 66,7 años (rango 32-86), ECOG PS 1 en el 76,6%. Nivel de adherencia: 78,4% (subgrupo inicio 81,7% vs. continuación 72,5%). Acontecimientos adversos: toxicidad cutánea (33,33%), astenia (25,22%), toxicidad gastrointestinal (24,32%) y neurológica (24,32%), en su mayoría G1. Estado de salud, test SF-12: valoración subjetiva "buena" en el 33,30%. Conclusiones: El bajo nivel de adherencia en el subgrupo de continuación puede relacionarse con la duración del tratamiento, las toxicidades, la evolución clínica y la percepción de su estado de salud. Es necesario un seguimiento individualizado en este grupo de pacientes para obtener una respuesta clínica favorable.

[Algorithm for diagnosis and treatment of hereditary angioedema as a tool for management]. / Algoritmo de diagnóstico y tratamiento del angioedema hereditario como herramienta para su manejo.

INTRODUCTION: Hereditary angioedema is a disease with low prevalence and high heterogeneity with regards to the severity of the clinical picture, which makes the diagnosis difficult and requires the need for early start of specific treatment in order to prevent complications. OBJECTIVE: To propose a decision algorithm for hereditary angioedema (HAE), based on the evidence available on the diagnosis, clinical assessment, and treatment. The aim is to present the available therapeutic options as well as a decision algorithm to select the most efficient therapy at each time. MATERIAL AND METHODS: Literature search by means of PubMed and other relevant sources. RESULTS: four decision algorithms have been developed for HAE; diagnosis of bradikinin-mediated angioedema, treatment of acute attacks and short and long-term prophylaxis for HAE due to C1 inhibitor deficiency. CONCLUSIONS: The application of a decision algorithm based on the clinical variables helps to select the most efficient therapeutic option at each time and may be a useful tool for the therapeutic approach.

Introducción: El angioedema hereditario es una enfermedad rara de baja prevalencia y gran heterogeneidad en la gravedad del cuadro clínico, lo que dificulta su diagnóstico, y establece la necesidad de iniciar un tratamiento precoz y específico con el fin de evitar complicaciones. Objetivo: Proponer un algoritmo de decisión en el angioedema hereditario (AEH), basado en la evidencia disponible, sobre el diagnóstico, valoración clínica y tratamiento. Se trata de presentar opciones terapéuticas disponibles, así como un algoritmo de decisión para seleccionar el tratamiento más eficiente en cada momento. Material y Métodos: Revisión bibliográfica mediante una búsqueda a través de PubMed y otras fuentes de interés. Resultados: Se han desarrollado cuatro algoritmos de decisión para el AEH; diagnóstico de angioedema mediado por bradicinina, tratamiento del ataque agudo y profilaxis a corto y largo plazo del AEH por déficit del inhibidor C1. Conclusiones: La aplicación de un algoritmo de decisión, en función de unas variables clínicas, ayuda a la selección de la opción terapéutica más eficiente en cada momento y puede ser un instrumento de utilidad en el abordaje terapéutico.