Adverse reactions to Janus kinase inhibitors: Study of their incidence and predictive factors in patients with rheumatoid arthritis. / Reacciones adversas a inhibidores de quinasa Janus: estudio de su incidencia y de factores predictivos en los pacientes con artritis reumatoide.

BACKGROUND AND OBJECTIVE: The safety profile of Janus Kinase (JAK) inhibitors has acquired attention due to post-marketing observed adverse drug reactions. The study focuses on the analysis of adverse reactions related to tofacitinib, baricitinib, upadacitinib, and filgotinib in rheumatoid arthritis patients, including identifying predictive factors linked to their occurrence. PATIENTS AND METHODS: Observational retrospective study. Adult patients with rheumatoid arthritis from a university hospital receiving JAK inhibitor treatment between September 2017 and January 2024 were included. The cumulative incidence of each adverse reaction was calculated using the Naranjo scale. Risk factors for developing adverse reactions were identified through logistic regression analyses. RESULTS: Two hundred twenty-three patients were included, with 28.7% presenting adverse reaction related to JAK inhibitor treatment. The adverse drug reactions with the highest cumulative incidence were infections and gastrointestinal disorders. Infections included: upper respiratory tract (4.5%), cellulitis (3.1%), urinary tract (2.7%), herpes zoster (1.8%). Gastrointestinal disorders comprised: abdominal pain (4.0%), diarrhea (3.6%), nausea and vomiting (3.6%), gastrointestinal perforation (1.3%), diverticulitis (0.9%). Classified at 0.5% were: headache, paresthesias, skin rash, severe neutropenia, insomnia, dyspnea, hypertensive crisis. As risk factors, were identified: the treatment with a non-selective JAK inhibitor (OR adjusted: 4.03; 95% CI: 1.15-14.10; P=.029) and older age (OR adjusted: 1.03; 95% CI: 1.00-1.05; P=.036). CONCLUSIONS: Infections and gastrointestinal disorders represented the adverse reactions related to JAK inhibitor treatment with the highest cumulative incidence, with risk factors for their occurrence being non-selective JAK inhibitor treatment and older age of the patient.

Safe administration of noradrenaline by the peripheral route: A systematic review. / Administración segura de noradrenalina por vía periférica: una revisión sistemática.

PURPOSE: To review and analyze the available literature on peripheral administration of noradrenaline (NA) with the aim of providing recommendations to ensure correct use and patient safety. METHODS: Systematic review on the databases PubMed, ISI Web of Science, SCOPUS and Science Direct, using the following search terms: ("Noradrenaline" [Mesh]) AND ("Norepinephrine" [Mesh]) AND ("Vasopressors" [Mesh]) AND ("Peripheral infusions" [Mesh]) OR ("Extravasations" [Mesh]). A total of 1,040 articles were identified. Animal studies and studies written in languages other than English were excluded. Finally, 83 articles were included. RESULTS: NA can be administered peripherally. The risk of extravasation should be taken into account, with phentolamine being the first pharmacological line of treatment. It has also been related to the appearance of thrombophlebitis, cellulitis, tissue necrosis, limb ischemia and gangrene, although its incidence seems to be low. The use of peripheral NA in children seems to be carried out without obvious complications. The use of standard concentrations is suggested to reduce the risk of errors. It is recommended to use 0.9% saline as the default diluent for peripheral NA. CONCLUSIONS: Peripheral infusions of NA could be a safe and beneficial option in early resuscitation provided that a number of guidelines are followed that reduce the likelihood of complications associated with this route.

Access in all areas? a round up of developments in market access and health technology assessment: part 4.

In this latest update, we look at recent developments in market access including the pricing agreement of Libmeldy® by the Beneluxa Initiative, the financial impact of managed entry agreements in Italy and the restructuring of Agenzia Italiana del Farmaco (AIFA). We also highlight the collaboration between FINOSE and the New Expensive Drug (NED) section of the Nordic Pharmaceutical Forum.

Estudio tecnofarmacéutico de los Anticuerpos Conjugados a Fármacos comercializados en España / Technopharmaceutical study of antibodies drug conjugated marketed in Spain

Introducción: el tratamiento del cáncer supone uno de los grandes desafíos a los que se enfrenta la sociedad cien-tífica actual. En esta lucha sanitaria, se desarrollan los anticuerpos conjugados a fármacos, capaces de lograr la muerte celular mediante el transporte y liberación de compuestos citotóxicos selectivamente sobre células tumorales. Se componen de un anticuerpo monoclonal (de naturaleza proteica) unido a un fármaco citotóxico (de carácter lipófilo) mediante un enlazador. Las formulaciones se han de diseñar para mantener dicha unión durante su almacenamiento y administración. Objetivo: identificar los medicamentos comercializados en España cuyo principio activo es un anticuerpo conjugado a fármaco, estudiando diferentes aspectos tecnofarmacéuticos, en especial los componentes de sus formulaciones. Método: dado que este tipo de medicamento pertenece al grupo ATC L01F, han sido identificados a través del bus-cador de la Agencia Española de Medicamentos y Productos Sanitarios. La consulta de sus fichas técnicas, artículos de revisión e investigación relacionados con el tema así como el Handbook of Pharmaceuticals Excipients, ha permitido realizar el estudio tecnofarmacéutico. Resultados: se han analizado distintos aspectos tecnofarmacéuticos: forma farmacéutica, vía de administración, conservación y, en especial, sus formulaciones. Se ha estudiado en profundidad la naturaleza del principio activo y los requisitos de las formulaciones en base a sus características. Conclusiones: los ocho anticuerpos conjugados a fármacos aprobados en España se presentan en forma de polvo liofilizado en vial que se deben almacenar entre 2-8 ºC. Para su administración, se reconstituyen obteniéndose inicialmente un concentrado, que posteriormente se diluye y administra en forma de perfusión intravenosa o goteo. Su formulación tipo incluye un lioprotector, un antiagregante, un regulador del pH y eventualmente antioxidantes o reductores de la viscosidad. (AU)

Introduction: cancer treatment is one of the great challenges facing today’s scientific society. In this health fight, drug-conjugated antibodies (ADCs) are being developed, drugs capable of causing cell death by transporting and releasing cytotoxic compounds into tumor cells. They are composed of a monoclonal antibody (of protein nature) linked to a cytotoxic drug (of lipophilic character) through a linker. Formulations must be designed to maintain this binding during storage and administration.Objective: identify the medicines marketed in Spain whose active ingredient is an antibody-drug conjugate, studying techno pharmaceutical aspects, especially the components of their formulations. Method: since this type of drugs belongs to the ATC group L01F, they have been identified through the search engine of the Spanish Agency of Medicines and Health Products. The search for their technical sheets, along with articles of review and research related to the topic, as well as the Handbook of Pharmaceuticals Excipients, has enabled the execution of the techno pharmaceutical study.the formulation of the tested conjugates to drugs marketed in Spain belonging to the ATC L01F group corresponding to “monoclonal antibodies and tested conjugated to drugs” identified through the search engine of the Spanish Agency of Medicines and Health Products has been studied. Results: different aspects of this group of drugs have been analyzed, such as the pharmaceutical form, the route of administration, conservation and especially the techno pharmaceutical formulation. The nature of the active ingredient and the requirements of the formulations based on their characteristics have been studied in depth. Conclusions: the eight antibody-drug conjugates approved in Spain are presented in the form of lyophilized powder in a vial and should be stored between 2-8 ºC... (AU)

Interacciones potenciales entre productos herbolarios con fármacos hipoglucemiantes en adultos mayores con diabetes mellitus, en una zona rural mexicana / Potenciais interacções entre produtos à base de plantas e medicamentos hipoglicemiantes em adultos mais velhos com diabetes mellitus no Mexico rural / Potential interactions between herbal products with hypoglycemic drugs in older adults with diabetes mellitus in rural Mexico

Introducción: El 50% de la población mundial usa tratamientos alternativos como productos herbarios. El 20% los consume de manera simultánea con algún tratamiento farmacológico para el control la Diabetes Mellitus tipo 2; enfermedad prevalente en adultos mayores. Es escasa la información acerca de las interacciones medicamentosas que pudieran producirse, siendo responsables de más de 7,000 muertes al año. Objetivo: Identificar los productos herbarios de mayor consumo del Adulto Mayor con Diabetes Mellitus Tipo 2, en Chapulco, Puebla, México y describir las posibles interacciones medicamentosas entre fármaco hipoglucemiante ­ producto herbario reportados en la literatura científica. Metodología: Estudio observacional, prolectivo, transversal, descriptivo, en una población de 35 adultos mayores diabéticos, con edad promedio de 70±7 años. Para la identificación de los productos herbarios de uso común y sus aplicaciones terapéuticas se aplicó el cuestionario U-PLANMED. Resultados: Se identificaron 50 productos herbarios y 18 combinaciones entre estos a la vez. El 40% de los participantes consumen simultáneamente más de dos productos herbarios con uno o dos fármacos hipoglucemiantes. Entre los productos de mayor consumo se encuentran el nopal (Opuntia ficus-indica L.), la manzanilla (Matricaria chamomilla L.) y el zacate de limón (Cymbopogon citratus DC. Stapf.). Las interacciones medicamentosas potenciales identificadas, principalmente en estudios experimentales en animales, sugieren que, existe una acción hipoglucemiante del producto herbario al aumentar la capacidad orgánica sobre la secreción/liberación de insulina endógena. Conclusiones: Se ha evidenciado la presencia de interacciones medicamentosas ante el consumo simultaneo de fármacos prescritos para el control de la diabetes mellitus tipo 2 con productos herbarios. Es necesario que, los profesionales en atención a la salud identifiquen el uso de dichos productos y orienten a los adultos mayores sobre las posibles repercusiones en los niveles de glucosa ante el consumo.

Introduction: 50% of the world's population uses alternative treatments such as herbal products. Twenty percent use them in conjunction with some form of pharmacological treatment to control type 2 diabetes mellitus, a disease prevalent in older adults. There is little information on the drug interactions that may occur, which are responsible for more than 7,000 deaths per year. Objective: To identify the most consumed herbal products among older adults with type 2 diabetes mellitus in Chapulco, Puebla, Mexico, and to describe the possible drug-drug interactions between hypoglycemic drugs and herbal products reported in the scientific literature. Methodology: Observational, prospective, cross-sectional, descriptive study in a population of 35 diabetic older adults with a mean age of 70±7 years. The U-PLANMED questionnaire was used to identify commonly used herbal products and their therapeutic applications. Results: Fifty herbal products and 18 combinations of them were identified. Forty percent of the participants used more than two herbal products simultaneously with one or two hypoglycemic drugs. The most used products included prickly pear cactus (Opuntia ficus-indica L.), chamomile (Matricaria chamomilla L.), and lemon grass (Cymbopogon citratus DC. Stapf.). Potential drug-drug interactions identified mainly in experimental animal studies suggest that there is a hypoglycemic effect of the herbal product by increasing the organic capacity on endogenous insulin secretion/release. Conclusions: The presence of drug-drug interactions has been demonstrated with the simultaneous consumption of drugs prescribed for the control of type 2 diabetes mellitus with herbal products. It is necessary for health care professionals to recognize the use of such products and to inform older adults about the possible repercussions on glucose levels when consuming them.

Introdução: 50% da população mundial utiliza tratamentos alternativos como os produtos à base de plantas. Vinte por cento utilizam-nos em conjunto com algum tipo de tratamento farmacológico para controlar a diabetes mellitus tipo 2, uma doença prevalente em adultos mais velhos. Há pouca informação sobre as interacções medicamentosas que podem ocorrer e que são responsáveis por mais de 7.000 mortes por ano. Objetivos: Identificar os produtos fitoterápicos mais consumidos entre os idosos com diabetes mellitus tipo 2 em Chapulco, Puebla, México, e descrever as possíveis interações medicamentosas entre medicamentos hipoglicemiantes e produtos fitoterápicos relatados na literatura científica. Metodologia: Estudo observacional, prospetivo, transversal e descritivo numa população de 35 idosos diabéticos com uma idade média de 70±7 anos. O questionário U-PLANMED foi utilizado para identificar os produtos fitoterápicos mais utilizados e suas aplicações terapêuticas. Resultados: Foram identificados 50 produtos à base de plantas e 18 combinações dos mesmos. Quarenta por cento dos participantes utilizaram mais de dois produtos à base de plantas em simultâneo com um ou dois medicamentos hipoglicemiantes. Os produtos mais utilizados foram o cato de figo da Índia (Opuntia ficus-indica L.), a camomila (Matricaria chamomilla L.) e o capim-limão (Cymbopogon citratus DC. Stapf.). As potenciais interacções medicamentosas identificadas principalmente em estudos experimentais em animais sugerem que existe um efeito hipoglicémico do produto à base de plantas através do aumento da capacidade orgânica na secreção/libertação de insulina endógena. Conclusões: A presença de interacções medicamentosas foi demonstrada com o consumo simultâneo de medicamentos prescritos para o controlo da diabetes mellitus tipo 2 com produtos à base de plantas. É necessário que os profissionais de saúde reconheçam o uso de tais produtos e informem os idosos sobre as possíveis repercussões nos níveis de glicose ao consumi-los.

Sirolimus-coated balloon in acute and chronic coronary syndromes: subanalysis of the EASTBOURNE registry.

INTRODUCTION AND OBJECTIVES: The PEACE study (Performance of a sirolimus-eluting balloon strategy in acute and chronic coronary syndromes) investigated for the first time whether a sirolimus-coated balloon (SCB) (Magic Touch, Concept Medical, India) is associated with different outcomes depending on whether it is used in acute coronary syndromes (ACS) or chronic coronary syndromes (CCS). METHODS: This was a post-hoc analysis from the all-comers EASTBOURNE Registry (NCT03085823). Out of 2083 patients enrolled, an SCB was used to treat 968 (46.5%) ACS and 1115 (53.5%) CCS patients. The primary endpoint was target lesion revascularization at 12 months, while secondary endpoints were angiographic success and major adverse cardiovascular events. RESULTS: Baseline demographics, mean reference vessel diameter and mean lesion length were comparable between ACS and CCS. Predilatation was more commonly performed in ACS (P=.007). SCB was inflated at a standard pressure in both groups with a slight trend toward longer inflation time in ACS. Angiographic success was high in both groups (ACS 97.4% vs CCS 97.7%, P=.820) with limited bailout stenting. Similarly, at 12 months the cumulative incidence of target lesion revascularization (ACS 6.6% vs CCS 5.2%, P=.258) was comparable between ACS and CCS. Conversely, a higher rate of major adverse cardiovascular events in acute presenters was mainly driven by myocardial infarction recurrencies (ACS 10.4% vs CCS 8.3%, P=.009). In-stent restenosis showed a higher proportion of target lesion revascularization and major adverse cardiovascular events than de novo lesions, independently of the type of presentation at the index procedure. CONCLUSIONS: This SCB shows good performance in terms of acute and 1-year outcomes independently of the clinical presentation.

Hydrogels in the Treatment of Degenerative Tendinopathy / Hidrogeles en el Tratamiento de la Tendinopatía Degenerativa

Abstract: Degenerative tendinopathy is a significant health problem, and its incidence increases yearly. This condition causes functional deficits in young and adult patients and sedentary or active individuals, resulting in health, social, and economic consequences. Due to limited blood supply, drug administration is complex for tendon diseases, such as degenerative tendinopathy. Biomaterials, such as hydrogels, have gained significant attention in designing drug delivery systems to treat musculoskeletal pathologies due to their attractive characteristics and the challenges posed by conventional drug delivery routes. This paper provides an overview of tendon pathology and discusses the use of hydrogels as drug carriers and release agents in emerging treatments.

Resumen: La tendinopatía degenerativa es un importante problema de salud, y su incidencia aumenta cada año en todo el mundo. Esta condición genera déficits funcionales en pacientes jóvenes o adultos, así como en personas sedentarias o activas, trayendo consigo repercusiones sanitarias, sociales y económicas. Debido al suministro de sangre limitado, la administración de medicamentos es compleja para las enfermedades de los tendones, como la tendinopatía degenerativa. El uso de biomateriales, como los hidrogeles, ha ganado una atención significativa en el diseño de sistemas de administración de fármacos para tratar patologías musculoesqueléticas debido a sus atractivas características y los desafíos que plantean las rutas convencionales de administración de fármacos. Este documento proporciona una descripción general de la patología del tendón y analiza el uso de hidrogeles como transportadores de fármacos y agentes de liberación en tratamientos emergentes.

Safety and effectiveness of bDMARDs during pregnancy in patients with rheumatic diseases: Real-world data from the BIOBADASER registry.

INTRODUCTION: Inflammatory rheumatic diseases usually affect women of childbearing age treated with biologic drugs. However, there is a lack of literature on the efficacy and toxicity of biologic disease-modifying drugs during pregnancy. The aim of this study was to determine the presence of pregnant patients treated with bDMARDs in a real-world dataset and to examine the impact of pregnancy and lactation on the evolution of rheumatic disease in a registry of Spanish patients. METHOD: This was a multicentre prospective study with a real-world setting. Information was obtained from BIOBADASER registry. Patients included are women who got pregnant until November 2020 from 19 rheumatology units. We conducted proportions, means, and standard deviations (SD) to describe the study population and the use of treatments. T-test and Chi-square test were applied to assess differences between groups. RESULT: Ninety cases of pregnancy were registered (n=68 full-term pregnancies; n=22 spontaneous miscarriages). Most of the cases discontinued bDMARDs during pregnancy (78.9%) but 13 cases continued treatment during pregnancy, mainly using certolizumab pegol. These cases were obtaining better management of rheumatic disease, although the differences were not statistically significant [DAS28-CRP, 2.9 (SD: 1.6) vs. 2.0 (1.2), p=.255; DAS28-ESR, 2.2 (1.0) vs. 1.7 (.5), p=.266]. No serious adverse events were reported during pregnancy and lactation. CONCLUSION: Being pregnant is still an uncommon condition in patients with rheumatic diseases and using bDMARDs. Our results show that rheumatic disease tended to progress better during pregnancy in patients who continued to take bDMARDs.

Safety and effectiveness of bDMARDs during pregnancy in patients with rheumatic diseases: Real-world data from the BIOBADASER registry / Seguridad y efectividad de los FAME biológicos durante el embarazo en pacientes con enfermedades reumáticas: datos del mundo real procedentes del registro BIOBADASER

Introduction: Inflammatory rheumatic diseases usually affect women of childbearing age treated with biologic drugs. However, there is a lack of literature on the efficacy and toxicity of biologic disease-modifying drugs during pregnancy. The aim of this study was to determine the presence of pregnant patients treated with bDMARDs in a real-world dataset and to examine the impact of pregnancy and lactation on the evolution of rheumatic disease in a registry of Spanish patients.Method: This was a multicentre prospective study with a real-world setting. Information was obtained from BIOBADASER registry. Patients included are women who got pregnant until November 2020 from 19 rheumatology units. We conducted proportions, means, and standard deviations (SD) to describe the study population and the use of treatments. T-test and Chi-square test were applied to assess differences between groups.Result: Ninety cases of pregnancy were registered (n=68 full-term pregnancies; n=22 spontaneous miscarriages). Most of the cases discontinued bDMARDs during pregnancy (78.9%) but 13 cases continued treatment during pregnancy, mainly using certolizumab pegol. These cases were obtaining better management of rheumatic disease, although the differences were not statistically significant [DAS28-CRP, 2.9 (SD: 1.6) vs. 2.0 (1.2), p=.255; DAS28-ESR, 2.2 (1.0) vs. 1.7 (.5), p=.266]. No serious adverse events were reported during pregnancy and lactation.Conclusion: Being pregnant is still an uncommon condition in patients with rheumatic diseases and using bDMARDs. Our results show that rheumatic disease tended to progress better during pregnancy in patients who continued to take bDMARDs.(AU)

Introducción: Las enfermedades reumáticas inflamatorias afectan normalmente a mujeres en edad fértil tratadas con fármacos biológicos. Sin embargo, escasea la literatura sobre la eficacia y la toxicidad de los fármacos modificadores de la enfermedad (FAME) biológicos durante el embarazo. El objetivo de este estudio fue determinar la presencia de pacientes embarazadas tratadas con FAME biológicos en un conjunto de datos del mundo real y examinar el impacto del embarazo y la lactancia en la evolución de la enfermedad reumática en un registro de pacientes españoles.Método: Estudio prospectivo multicéntrico en un entorno del mundo real. La información se obtuvo del registro BIOBADASER. Los pacientes fueron mujeres embarazadas hasta el mes de noviembre del 2020, de 19 unidades de Rreumatología. Obtuvimos proporciones, medias y desviaciones estándar (DE) para describir la población de estudio y el uso de tratamientos. Se realizaron las pruebas t y χ2 para evaluar las diferencias entre grupos.Resultado:Se registraron 90 casos de embarazo (n=68 embarazos a término; n=22 abortos espontáneos). La mayoría de los casos suspendieron el tratamiento con FAME biológicos durante el embarazo (78,9%), pero 13 casos prosiguieron el tratamiento durante el embarazo, utilizando principalmente certolizumab pegol. Dichos casos obtuvieron un mejor manejo de la enfermedad reumática, aunque las diferencias no fueron estadísticamente significativas (DAS28-CRP, 2,9 [DE 1,6] vs. 2 [1,2], p=0,255; DAS28-ESR, 2,2 [1] vs. 1,7 [0,5], p=0,266). No se reportaron episodios adversos graves durante el embarazo y la lactancia.Conclusión: La situación de embarazo sigue siendo infrecuente en las pacientes con enfermedades reumáticas que utilizan FAME biológicos. Nuestros resultados reflejan que la enfermedad reumática tendió a progresar mejor durante el embarazo en las mujeres tratadas con FAME biológicos.(AU)

Influencia del consumo crónico de estatinas en el estado de hidratación de personas mayores / Influence of chronic statin use on the hydration status of older people

Introducción: Las personas de edad avanzada en tratamiento crónico con fármacos son uno de los grupos de población con mayor riesgo de desarrollar alteraciones en el estado de hidratación. Uno de los fármacos más consumidos por este grupo de población y que pueden desencadenar la aparición de deshidratación son las estatinas. Sin embargo, hasta la fecha, estas interacciones no se han estudiado en profundidad. Objetivo: El objetivo del presente estudio fue evaluar la influencia del consumo crónico de estatinas sobre el estado de hidratación en personas de edad avanzada que acuden a la farmacia comunitaria. Métodos: Se llevó a cabo un estudio de casos y controles en voluntarios de edades comprendidas entre los 60 y 79 años residentes en Madrid, consumidores crónicos de estatinas (casos) y pacientes del mismo rango de edad, no consumidores de fármacos de forma crónica (controles). Resultados: El análisis de los datos generales de la población revelaron una elevada prevalencia de sobrepeso y obesidad, así como un elevado porcentaje de grasa corporal. Por su parte, el análisis de orina evidenció un mejor estado de hidratación de las mujeres frente a los hombres. Respecto al efecto de las estatinas en el estado de hidratación, se observó que los distintos parámetros analizados de los pacientes en tratamiento crónico con estatinas eran indicativos de deshidratación, frente al adecuado estado de hidratación de los pacientes sin tratamiento. Estos resultados se confirmaron con el análisis de la prevalencia de deshidratación en los distintos grupos. Conclusiones: Se concluye del presente estudio la importancia de monitorizar el consumo crónico de fármacos, como las estatinas, en las personas de edad avanzada, para evitar el desarrollo de patologías, incluyendo la aparición de deshidratación y sus complicaciones asociadas. Los farmacéuticos comunitarios como profesionales expertos en el medicamento son los profesionales más idóneos para llevar a cabo este seguimiento. (AU)

Introduction: Elderly people on chronic drug treatment are one of the population groups with the highest risk of developing alterations in hydration status. One of the drugs most consumed by this population group and that can trigger the onset of dehydration are statins. However, up to date, these interactions have not been studied in depth. Objective: The objective of this study was to evaluate the influence of chronic statin consumption on hydration status in elderly people attending the community pharmacy.Methods: A case-control study was conducted in volunteers aged between 60 and 79 years living in Madrid, chronic statin users (cases) and patients of the same age range, non-users of statin drugs. chronic form (controls). Results: Analysis of general population data revealed a high prevalence of overweight and obesity, as well as a high percentage of body fat. On the other hand, the urinalysis showed a better hydration status of women compared to men. Regarding the effect of statins on hydration status, it was observed that the different parameters analyzed in patients on chronic statin treatment were indicative of dehydration, compared to the adequate hydration status of patients without treatment. These results were confirmed by analyzing the prevalence of dehydration in the different groups. Conclusions: The importance of monitoring the chronic consumption of drugs, such as statins, in the elderly, to avoid the development of pathologies, including the appearance of dehydration and its associated complications, is concluded from the present study. Community pharmacists as expert professionals in the medication are the most suitable professionals to carry out this follow-up. (AU)

Problemas relacionados con los medicamentos en pacientes de Santiago de Cuba hospitalizados / Drug related problems in inpatients of Santiago de Cuba

Introducción: Los problemas relacionados con los medicamentos constituyen una gran preocupación sanitaria por su elevado impacto en la morbilidad de pacientes hospitalizados.Método: Estudio observacional, descriptivo y transversal en los servicios clínicos de cinco instituciones de salud de Santiago de Cuba, durante el primer trimestre de 2020. Se revisaron los perfiles de 329 pacientes que recibieron seguimiento farmacoterapéutico. La muestra fue caracterizada según variables biosociales, clínicas y farmacoterapéuticas, la identificación de los problemas relacionados a la medicación fue realizada utilizando los criterios de Cipolle, Stramd y Morley, determinándose además los medicamentos implicados en los problemas relacionados a la medicación. Los datos fueron procesados a través de frecuencias absolutas y relativas representadas por medio de tablas y figuras.Resultados: Predominaron los pacientes mayores o iguales de 60 años representando un 38,6 %; respecto al género un 61,4 % perteneció al femenino. La mayoría de los pacientes presentaron hasta dos enfermedades (76,3 %), las infecciones respiratorias complicadas (35,6 %) fueron el motivo de ingreso más frecuente. El 36,5 % consumió entre cuatro y seis medicamentos, siendo los antibacterianos de usos sistémicos los más prescritos. Se identificaron 598 Problemas Relacionados con los Medicamentos para una proporción de 1,8 PRM/paciente, de estos un 42,8 % corresponde a los problemas de Seguridad, un 31,1 % de Indicación, seguido de 24,9 % de Efectividad y finalmente el 1,2 % de Adherencia.Conclusiones: Los antimicrobianos resultaron los más implicados en la aparición de los problemas relacionados a la medicación. La atención farmacéutica ofrece servicios que garantizan el uso adecuado de los medicamentos. (AU)

Introduction: Drug-related problems are a major health concern because of their high impact on inpatient morbidity. Method: Descriptive and cross-sectional observational, study in the clinical services of five health institutions of Santiago de Cuba, during the first quarter of 2020. The profiles of 329 patients who received pharmacotherapeutic follow-up were reviewed. The sample was characterized according to biosocials, clinical and pharmacotherapeutic variables, the identification of medication-related problems was performed using the criteria of Cipolle, Stramd and Morley, also determining the drugs involved in medication-related problems. The data were processed through absolute and relative frequencies represented by means of tables and figures. Results: Patients over or equal to 60 years of age predominated, representing 38.6 %; 61.4 % of the patients were female. Most of the patients had up to two diseases (76.3 %); complicated respiratory infections (35.6 %) were the most frequent reason for admission. Between four and six medications were consumed by 36.5 %, with antibacterials for systemic use being the most prescribed. A total of 598 drug-related problems were identified for a ratio of 1.8 DRP/patient, of which 42.8 % corresponded to safety problems, 31.1 % to indication, followed by 24.9 % to effectiveness and finally 1.2 % to adherence. Conclusions: Antimicrobials were the most implicated in the occurrence of medication-related problems. Pharmaceutical care offers services that ensure the appropriate use of medications. (AU)

Relevancia clínica de los angiomas en cereza / Clinical Relevance of Cherry Angiomas

Los angiomas en cereza son los tumores vasculares cutáneos más frecuentes. Son muy prevalentes en la población general y esta prevalencia aumenta con la edad. Aunque, en sus primeras descripciones en la literatura, a finales del siglo XIX, se relacionaron con el cáncer, dicha asociación no pudo demostrarse posteriormente por lo que, durante muchas décadas, se han considerado unas lesiones asociadas al proceso del envejecimiento sin otro significado clínico particular. Sin embargo, en los últimos años, han sido objeto de un mayor interés al ser publicados algunos estudios que muestran una asociación con la exposición a diversos tóxicos y fármacos, enfermedades malignas y no malignas y la inmunosupresión que pueden ayudar a conocer mejor su etiopatogenia y su relevancia clínica (AU)

Cherry angiomas are the most common vascular tumors of the skin. They are particularly prevalent in the general population and become more common with age. Although an association with cancer was suggested at the end of the 19th century, when these tumors were first described, it could not be demonstrated. For many decades, therefore, cherry angiomas were considered to have no clinical relevance other than their association with age. A number of studies in recent years, however, have shown a link between cherry angiomas and exposure to various toxic substances and medications, benign and malignant diseases, and immunosuppression, rekindling interest in these lesions and providing clues for a better understanding of their etiology, pathophysiology, and clinical relevance (AU)

[Translated article] Clinical Relevance of Cherry Angiomas / Relevancia clínica de los angiomas en cereza

Cherry angiomas are the most common vascular tumors of the skin. They are particularly prevalent in the general population and become more common with age. Although an association with cancer was suggested at the end of the 19th century, when these tumors were first described, it could not be demonstrated. For many decades, therefore, cherry angiomas were considered to have no clinical relevance other than their association with age. A number of studies in recent years, however, have shown a link between cherry angiomas and exposure to various toxic substances and medications, benign and malignant diseases, and immunosuppression, rekindling interest in these lesions and providing clues for a better understanding of their etiology, pathophysiology, and clinical relevance (AU)

Los angiomas en cereza son los tumores vasculares cutáneos más frecuentes. Son muy prevalentes en la población general y esta prevalencia aumenta con la edad. Aunque, en sus primeras descripciones en la literatura, a finales del siglo XIX, se relacionaron con el cáncer, dicha asociación no pudo demostrarse posteriormente por lo que, durante muchas décadas, se han considerado unas lesiones asociadas al proceso del envejecimiento sin otro significado clínico particular. Sin embargo, en los últimos años, han sido objeto de un mayor interés al ser publicados algunos estudios que muestran una asociación con la exposición a diversos tóxicos y fármacos, enfermedades malignas y no malignas y la inmunosupresión que pueden ayudar a conocer mejor su etiopatogenia y su relevancia clínica (AU)

Clinical Relevance of Cherry Angiomas. / Relevancia clínica de los angiomas en cereza.

Cherry angiomas are the most common vascular tumors of the skin. They are particularly prevalent in the general population and become more common with age. Although an association with cancer was suggested at the end of the 19th century, when these tumors were first described, it could not be demonstrated. For many decades, therefore, cherry angiomas were considered to have no clinical relevance other than their association with age. A number of studies in recent years, however, have shown a link between cherry angiomas and exposure to various toxic substances and medications, benign and malignant diseases, and immunosuppression, rekindling interest in these lesions and providing clues for a better understanding of their etiology, pathophysiology, and clinical relevance.

Estrategias terapéuticas actuales en el tratamiento del cáncer de ovario

Introducción: El cáncer de ovario es uno de los tumores más frecuentes y letales entre las mujeres. Esto se debe a su detección en estados tardíos y al desarrollo de quimiorresistencia a la terapia estándar. El desarrollo de terapias dirigidas contra las propiedades distintivas de las células cancerosas y sus características habilitadoras ha surgido como una alternativa promisoria para el tratamiento de estos tumores. Objetivo: Describir las actuales estrategias terapéuticas dirigidas contra las distintas capacidades de las células tumorales en el tratamiento del cáncer de ovario. Método: Se realizó una búsqueda en las bases de datos ScienceDirect, Redalyc, Latindex, ResearchGate, PubMed, Elsevier, ClinicalTrials.gov, SpringerLink, LARVOL´s CLIN, Registro Público Cubano de Ensayos Clínicos, entre enero y abril de 2023. Se seleccionaron 50 artículos referentes al cáncer de ovario y las alternativas para su tratamiento. Desarrollo: Se mencionaron los diversos factores que influyen en la elección de terapias contra el cáncer de ovario. Se describieron las actuales dianas terapéuticas utilizadas en el tratamiento de esta neoplasia, así como el empleo de múltiples fármacos aprobados y en fases de estudio, y las combinaciones sinérgicas de los mismos. Consideraciones finales: Actualmente existen disímiles opciones de tratamiento del cáncer de ovario. A pesar de que la eficacia clínica de los agentes dirigidos todavía está restringida a subtipos moleculares específicos y ningún ensayo ilustra un beneficio en la supervivencia general, son notorios los resultados alcanzados en el desarrollo de fármacos específicamente dirigidos contra la inestabilidad del genoma y angiogénesis sostenida.

Introduction: Ovarian cancer is one of the most common and lethal tumor in women. This happens as a result of late-stage cancer detention and an increased chemoresistance to standard therapy. The current development in therapies to kill the cancer cells and its spread tendencies has emerged as a key alternative to treat tumors. Objective: To describe the current therapeutic strategies lead to confront different capabilities of tumor cells found in the ovarian cancer treatment. Method: A search of literuture was carried out in the following databases ScienceDirect, Redalyc, Latindex, ResearchGate, PubMed, Elsevier, ClinicalTrials.gov, SpringerLink, LARVOL's CLIN, Cuban Public Registry of Clinical Trials, from January to April 2023. A total of 50 text concerning ovarian cancer subject and alternative for treatment were selected. Development: The driving factors that promoted the use of ovarian cancer therapies were pointed out. The current therapeutic targets used in the treatment of this neoplasia were described, as well as the use of multiple approved drugs or in process of approval, including the synergistic drug combinations. Final considerations: There are a lot of options currently being implemented in ovarian cancer treatment. Despite clinical efficacy of targeted therapy, it´s presented still restricted to specific molecular subtypes and none of the assays illustrated survival benefit in general; the results obtained in the process of drugs development specifically targeting genome instability and sustained angiogenesis have been remarkable.

Introdução: O câncer de ovário é um dos tumores mais frequentes e letais entre as mulheres. Isso se deve à sua detecção em estágios tardios e ao desenvolvimento de quimiorresistência à terapia padrão. O desenvolvimento de terapias direcionadas contra as propriedades distintas das células cancerígenas e suas características facilitadoras surgiu como uma alternativa promissora para o tratamento desses tumores. Objetivo: Descrever as atuais estratégias terapêuticas dirigidas contra as diferentes capacidades das células tumorais no tratamento do câncer de ovário. Método: Foi realizada uma busca nas bases de dados ScienceDirect, Redalyc, Latindex, ResearchGate, PubMed, Elsevier, ClinicalTrials.gov, SpringerLink, LARVOL's CLIN, Registro Público Cubano de Ensaios Clínicos, entre janeiro e abril de 2023. 50 artigos referentes ao câncer de ovário e as alternativas para o seu tratamento. Desenvolvimento: Foram mencionados os vários fatores que influenciam a escolha das terapias contra o câncer de ovário. Foram descritos os atuais alvos terapêuticos utilizados no tratamento desta neoplasia, bem como o uso de múltiplas drogas aprovadas e em fase de estudo, e suas combinações sinérgicas. Considerações finais: Atualmente existem opções de tratamento dissimilares para o câncer de ovário. Apesar de a eficácia clínica dos agentes direcionados ainda estar restrita a subtipos moleculares específicos e nenhum ensaio mostrar benefício na sobrevida global, são notáveis os resultados alcançados no desenvolvimento de fármacos direcionados especificamente contra a instabilidade do genoma e a angiogênese sustentada.

Evaluación de la persistencia, tasa de retención y pauta de prescripción de infliximab original e infliximab CT-P13 en pacientes naive biológicos con colitis ulcerosa / Evaluation of persistence, retention “rate” and prescription pattern of original infliximab and infliximab CT-P13 in biologic-naïve patients with ulcerative colitis

Objetivo: Comparar la persistencia, tasa de retención y pauta de prescripción de infliximab original e infliximab CT-P13 en pacientes naive abiológicos con colitis ulcerosa.Método: Estudio ambispectivo de pacientes naive a biológicos en colitis ulcerosa que recibieron tratamiento en primera línea con Remicade®(infliximab) y Remsima® (infliximab CT-P13) de forma no simultánea duranteun periodo de estudio de 10 años (2012-2021). Se tomaron datos de suedad, peso, persistencia, tasa de retención y si precisó de intensificacióno desintensificación a lo largo del periodo de estudio. Se determinó elcoste paciente/año real de Remicade® y Remsima® de forma individualizada en función de las administraciones durante el periodo del estudio.Resultados: Un total de 27 pacientes naive a biológicos fueron tratadoscon Remicade® y 53 con Remsima®. Ambos grupos de pacientes no presentaron diferencias en cuanto al peso y edad. La persistencia (mediana ± rangointercuartílico) con Remicade® fue de 42,49 ± 57,48 meses frente a27,50 ± 58,50 meses para Remsima®, sin demostrar diferencias significati vas (p = 0,455). La tasa de retención a los 6, 12 y 24 meses fue del 81%,63% y 33%, respectivamente, para el grupo de Remicade®, y del 71%,47% y 37%, respectivamente, para el grupo de Remsima®. En el grupo depacientes tratados con Remicade®, 9 pacientes fueron intensificados frentea 11 pacientes en el grupo de Remsima®. En cuanto a las desintensificaciones, 5 pacientes que recibieron tratamiento con Remicade® fueron desintensificados frente a 7 pacientes en tratamiento con Remsima®. El ahorroobtenido con el uso de Remsima® fue de 203.649 €, que equivaldría atratar a 118 pacientes adicionales con infliximab biosimilar durante un año. (AU)

Objective: To compare the persistence, retention rate and prescription pattern of original infliximab and infliximab CT-P13 in biologic-naïvepatients with ulcerative colitis.Method: This was an ambispective study of biologic-naive patients withulcerative colitis who received non-simultaneous first-line treatment with Remicade® (infliximab) and Remsima® (infliximab CT-P13) over a 10-year studyperiod (2012-2021). Data on their age, weight, persistence, retention rateand on whether they required intensification or deintensification throughoutthe study period was collected. The real patient/year cost of Remicade®and Remsima® was determined individually based on the amounts administered during the study period.Results: 27 biologic-naive patients were treated with Remicade® and53 with Remsima®. Neither patient group presented with differences in termsof weight and age. Persistence (median ± interquartile range) with Remicade® was 42.49 ± 57.48 months, as compared to 27.50 ± 58.50 monthsfor Remsima®, without significant differences (p = 0.455). The retention rate at 6, 12, and 24 months was 81%, 63%, and 33%, respectively, for theRemicade® group and 71%, 47%, and 37%, respectively, for the Remsima®group. Nine subjects in the Remicade® group vs 11 patients in the Remsima® group were intensified. Regarding deintensification, five patientstreated with Remicade® were deintensified, as compared with 7 patientson Remsima®. Savings obtained with the use of Remsima® amounted to203,649 €, which would allow treating an additional 118 patients withbiosimilar infliximab for one year. (AU)

Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral / Handling of drugs for administration by percutaneous endoscopic gastrostomy in patients with amyotrophic lateral sclerosis and enteral nutrition

Introducción: la esclerosis lateral amiotrófica (ELA) es una enfermedad neurodegenerativa. Entre sus síntomas destaca la disfagia, que hace necesaria la colocación de una gastrostomía endoscópica percutánea (PEG) para alimentarse. La administración de fármacos por la PEG puede obstruirla, disminuir la eficacia del tratamiento y aumentar el riesgo de toxicidad, al alterar la forma farmacéutica original. Objetivo: describir y analizar el grado de adecuación de la prescripción de fármacos administrados por PEG en pacientes con ELA y con nutrición enteral (NE). Material y métodos: se revisó la prescripción del tratamiento farmacológico de los pacientes con ELA que ingresaban para la colocación de una PEG. Se analizó el grado de adecuación de los fármacos prescritos según los criterios de pérdida de eficacia, toxicidad, riesgo para el manipulador y compatibilidad con la NE, consultando la evidencia científica disponible. Resultados: se revisaron las prescripciones médicas de los tratamientos de 34 pacientes, con un total de 307 medicamentos (mediana de 9 fármacos por paciente; rango, 2-17). Se pautaron por la PEG 267 medicamentos de administración oral (mediana de 8 por paciente; rango, 2-15). El 81,65 % fueron formas sólidas y se modificó la forma farmacéutica en el 43 % por riesgo de oclusión de la sonda, toxicidad o pérdida de eficacia, afectando al 97 % de los pacientes. Conclusiones: los pacientes con ELA y con PEG tienen riesgo de presentar problemas de seguridad y de pérdida de eficacia del tratamiento relacionados con la alteración de la forma farmacéutica original y de la interacción con la NE. Palabras clave: Esclerosis lateral amiotrófica; Gastrostomía endoscópica percutánea; Interacción fármaco-nutriente; Medicamentos peligrosos; Nutrición enteral; Sondas digestivas (AU)

Introduction: amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease. Its symptoms include dysphagia that may make it necessary to place a percutaneous endoscopic gastrostomy (PEG) for feeding. The administration of drugs by PEG can obstruct it, decrease the effectiveness of treatment, and increase the risk of toxicity by altering the original pharmaceutical form. Objective: to describe and analyze the degree of adequacy of the prescription of drugs administered by PEG in patients with ALS and with enteral nutrition (EN). Material and methods: the prescription of pharmacological treatment for patients with ALS who were admitted for placement of a PEG was reviewed. The degree of adequacy of the prescribed drugs was analyzed according to criteria of loss of efficacy, toxicity, risk for handler, and compatibility with EN by consulting the available scientific evidence. Results: the medical prescriptions of the treatments of 34 patients were reviewed, with a total of 307 medications (median of 9 drugs per patient, range 2-17). Via PEG 267 oral medications (median 8 per patient, range 2-15) were prescribed; 81.65 % were solid forms, and the pharmaceutical form was modified in 43 %, due to the risk of catheter occlusion, toxicity or loss of efficacy, affecting 97 % of the patients. Conclusions: patients with ALS and PEG are at risk of presenting safety problems and loss of treatment efficacy related to alteration of the original pharmaceutical form and the interaction with EN (AU)

Diferencias de género en la titulación de fármacos de pacientes con insuficiencia cardiaca y fracción de eyección reducida del ensayo ETIFIC / Gender differences in drug titration among heart failure patients with reduced ejection fraction in the ETIFIC trial

Introducción y objetivos El tratamiento óptimo disminuye la mortalidad y hospitalizaciones por insuficiencia cardiaca (IC) en pacientes con IC y fracción de eyección reducida. En los ensayos clínicos las mujeres estuvieron infrarrepresentadas y no fueron evaluadas específicamente. Este estudio buscó comparar la seguridad y efectividad de titulación (ajuste de dosis) de fármacos en mujeres y varones. Métodos Estudio post hoc de género del ensayo aleatorizado multicéntrico ETIFIC. Se incluyeron pacientes hospitalizados con IC de novo y fracción de eyección reducida. Proceso estructurado de titulación en unidades de IC. Objetivo principal: la dosis relativa media de bloqueadores beta (% de la dosis objetivo) alcanzada por mujeres frente a varones. Objetivos secundarios: dosis relativas medias de otros fármacos de IC, eventos adversos y resultados clínicos a 6 meses. Resultados Se incluyeron 320 pacientes, 83 (25,93%) mujeres y 237 (74,06%) varones. (76 frente a 213 analizados). Media±desviación estándar de dosis relativa de bloqueadores beta mujeres frente a varones: 62,08±30,72% frente a 64,4±32,77%; diferencia −2,32%; IC95%, −10,58-5,94; p=0,580, antagonistas del receptor de mineralocorticoides 79,85±27,72% comparado con 67,29±31,43%; p=0,003, sin diferencias significativas en dosificación de otros fármacos. El análisis multivariante no encontró diferencias significativas. Mortalidad cardiovascular 1 (1,20%) frente a 3 (1,26%), p=1 y 0 hospitalizaciones por IC (0,00%) frente a 10 (4,22%), p=0,125. Conclusiones En un análisis post hoc del ensayo ETIFIC de titulación en IC no encontramos diferencias de género significativas en dosificación, mortalidad cardiovascular y hospitalizaciones por IC (AU)

Introduction and objectives Optimal medical therapy decreases mortality and heart failure (HF) hospitalizations in HF patients with reduced left ventricular ejection fraction. Women have been underrepresented in clinical trials and not specifically evaluated. This study aimed to compare the safety and effectiveness of drug titration in women vs men. Methods This post hoc gender study of the ETIFIC multicenter randomized trial included hospitalized patients with new-onset HF with reduced ejection fraction and New York Heart Association II-III and no contraindications to beta-blockers. A structured 4-month titration process was implemented in HF clinics. The primary endpoint was the mean relative dose (% of target dose) of beta-blockers achieved by women vs men. Secondary endpoints included the mean relative doses of angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, and mineralocorticoid receptor antagonists, adverse events, and other clinical outcomes at 6 months. Results A total of 320 patients were included, 83 (25.93%) women and 237 (74.06%) men (76 vs 213 analyzed). The mean±standard deviation of the relative doses achieved by women vs men were as follows: beta-blockers 62.08%±30.72% vs 64.4%±32.77%, with a difference of−2.32% (95%CI,−10.58-5.94), P = .580; and mineralocorticoid receptor antagonists 79.85%±27.72% vs 67.29%±31.43%, P =.003. No other differences in drug dosage were found. Multivariate analysis showed nonsignificant differences. CV mortality was 1 (1.20%) vs 3 (1.26%), P=1, and HF hospitalizations 0 (0.00%) vs 10 (4.22%), P=.125. Conclusions In a post hoc analysis from the HF-titration ETIFIC trial, we found nonsignificant gender differences in drug dosage, cardiovascular mortality, and HF hospitalizations (AU)