Abordaje de síntomas de diarrea y estreñimiento por el farmacéutico comunitario en periodo de pandemia por la COVID-19: estudio observacional, transversal y multicéntrico

Introducción: el papel del farmacéutico comunitario ha adquirido mayor relevancia en el contexto de las restricciones derivadas por la pandemia de COVID-19. Objetivo del estudio: identificar el resultado de la indicación farmacéutica ante la consulta por diarrea o estreñimiento durante este período. Material y métodos: estudio observacional, transversal, multicéntrico y nacional. Se invitó a participar a los farmacéuticos comunitarios registrados en la base de datos Medynet. Los seleccionados se estratificaron por comunidades autónomas y población rural o urbana. La población de estudio fueron los pacientes que acudieron a las farmacias comunitarias desde enero a junio de 2021 por estreñimiento o diarrea. Resultados: un total de 121 farmacéuticos de un máximo establecido de 120 reclutaron a 849 pacientes (49,7 % consultaron por diarrea y un 50,3 % por estreñimiento). Un 83,5 % de farmacéuticos consideraba haber atendido un mayor número de consultas por síntomas digestivos, pero sin llegar a ser el doble que antes de la pandemia. En los pacientes con diarrea, dieta (76,9 %) y suero oral (64,2 %) fueron las indicaciones más frecuentes, mientras que en los pacientes con estreñimiento destacaron el aumento de la ingesta de agua (86,9 %), la dieta (84,1 %) y la indicación de algún medicamento de prescripción libre (68,1 %). 4 de cada 5 consultas farmacéuticas por diarrea o estreñimiento fueron resueltas en la farmacia comunitaria sin precisar derivación al médico. Conclusión: el presente estudio refuerza el papel destacado del farmacéutico comunitario como profesional de primera línea, realizando indicaciones farmacéuticas personalizadas a pacientes con diarrea o estreñimiento, contribuyendo de forma sustancial a la eficiencia y sostenibilidad del sistema sanitario durante la pandemia de COVID-19

EoE CONNECT, the European Registry of Clinical, Environmental, and Genetic Determinants in Eosinophilic Esophagitis:rationale, design, and study protocol of a large-scale epidemiological study in Europe

BACKGROUND: The growing prevalence of eosinophilic esophagitis (EoE) represents a considerable burden to patients and health care systems. Optimizing cost-effective management and identifying mechanisms for disease onset and progression are required. However, the paucity of large patient cohorts and heterogeneity of practice hinder the defining of optimal management of EoE. METHODS: EoE CONNECT is an ongoing, prospective registry study initiated in 2016 and currently managed by EUREOS, the European Consortium for Eosinophilic Diseases of the Gastrointestinal Tract. Patients are managed and treated by their responsible specialists independently. Data recorded using a web-based system include demographic and clinical variables; patient allergies; environmental, intrapartum, and early life exposures; and family background. Symptoms are structurally assessed at every visit; endoscopic features and histological findings are recorded for each examination. Prospective treatment data are registered sequentially, with new sequences created each time a different treatment (active principle, formulation, or dose) is administered to a patient. EoE CONNECT database is actively monitored to ensure the highest data accuracy and the highest scientific and ethical standards. RESULTS: EoE CONNECT is currently being conducted at 39 centers in Europe and enrolls patients of all ages with EoE. In its aim to increase knowledge, to date EoE CONNECT has provided evidence on the effectiveness of first- and second-line therapies for EoE in clinical practice, the ability of proton pump inhibitors to induce disease remission, and factors associated with improved response. Drug effects to reverse fibrous remodeling and endoscopic features of fibrosis in EoE have also been assessed. CONCLUSION: This prospective registry study will provide important information on the epidemiological and clinical aspects of EoE and evidence as to the real-world and long-term effectiveness and safety of therapy. These data will potentially be a vital benchmark for planning future EoE health care services in Europe

Budesonide orodispersible tablets maintain remission in a randomized, placebo-controlled trial of patients with eosinophilic esophagitis

Background & Aims: Eosinophilic esophagitis (EoE) is a chronic inflammatory disorder. Swallowed topical-acting corticosteroids are effective in bringing active EoE into remission. However, it is not clear whether these drugs are effective for long-term maintenance of remission. Methods: We performed a double-blind trial to compare the efficacy and safety of 2 dosages of a budesonide orodispersible tablet (BOT) vs placebo in maintaining remission of EoE. Maintenance of remission was defined as absence of clinical and histologic relapse and no premature withdrawal for any reason. Two hundred and four adults with EoE in clinical and histologic remission, from 29 European study sites, were randomly assigned to groups given BOT 0.5 mg twice daily (n = 68), BOT 1.0 mg twice daily (n = 68), or placebo twice daily (n = 68) for up to 48 weeks. Results: At end of treatment, 73.5% of patients receiving BOT 0.5 mg twice daily and 75% receiving BOT 1.0 mg twice daily were in persistent remission compared with 4.4% of patients in the placebo group (P < .001 for both comparisons of BOT with placebo). Median time to relapse in the placebo group was 87 days. The frequency of adverse events was similar in the BOT and placebo groups. Morning serum levels of cortisol were in the normal range at baseline and did not significantly change during treatment. Four patients receiving BOT developed asymptomatic, low serum levels of cortisol. Clinically manifested candidiasis was suspected in 16.2% of patients in the BOT 0.5 mg group and in 11.8% of patients in the BOT 1.0 mg group; all infections resolved with treatment. Conclusions: In a phase 3 trial, up to 48 weeks of treatment with BOT (0.5 mg or 1.0 mg twice daily) was superior to placebo in maintaining remission of EoE. Both dosages were equally effective and well tolerated. EudraCT number; 2014-001485-99; ClinicalTrials.gov number, NCT02434029

Accurate and timely diagnosis of Eosinophilic Esophagitis improves over time in Europe. An analysis of the EoE CONNECT Registry

BACKGROUND: Poor adherence to clinical practice guidelines for eosinophilic esophagitis (EoE) has been described and the diagnostic delay of the disease continues to be unacceptable in many settings. OBJECTIVE: To analyze the impact of improved knowledge provided by the successive international clinical practice guidelines on reducing diagnostic delay and improving the diagnostic process for European patients with EoE. METHODS: Cross‐sectional analysis of the EoE CONNECT registry based on clinical practice. Time periods defined by the publication dates of four major sets of guidelines over 10 years were considered. Patients were grouped per time period according to date of symptom onset. RESULTS: Data from 1,132 patients was analyzed and median (IQR) diagnostic delay in the whole series was 2.1 (0.7‐6.2) years. This gradually decreased over time with subsequent release of new guidelines (p < 0.001), from 12.7 years up to 2007 to 0.7 years after 2017. The proportion of patients with stricturing of mixed phenotypes at the point of EoE diagnosis also decreased over time (41.3% vs. 16%; p < 0.001), as did EREFS scores. The fibrotic sub‐score decreased from a median (IQR) of 2 (1‐2) to 0 (0‐1) when patients whose symptoms started up to 2007 and after 2017 were compared (p < 0.001). In parallel, symptoms measured with the Dysphagia Symptoms Score reduced significantly when patients with symptoms starting before 2007 and after 2012 were compared. A reduction in the number of endoscopies patients underwent before the one that achieved an EoE diagnosis, and the use of allergy testing as part of the diagnostic workout of EoE, also reduced significantly over time (p = 0.010 and p < 0.001, respectively). CONCLUSION: The diagnostic work‐up of EoE patients improved substantially over time at the European sites contributing to EoE CONNECT, with a dramatic reduction in diagnostic delay

EoE CONNECT, the European Registry of Clinical, Environmental, and Genetic Determinants in Eosinophilic Esophagitis: rationale, design, and study protocol of a large-scale epidemiological study in Europe

Background: The growing prevalence of eosinophilic esophagitis (EoE) represents a considerable burden to patients and health care systems. Optimizing cost-effective management and identifying mechanisms for disease onset and progression are required. However, the paucity of large patient cohorts and heterogeneity of practice hinder the defining of optimal management of EoE. Methods: EoE CONNECT is an ongoing, prospective registry study initiated in 2016 and currently managed by EUREOS, the European Consortium for Eosinophilic Diseases of the Gastrointestinal Tract. Patients are managed and treated by their responsible specialists independently. Data recorded using a web-based system include demographic and clinical variables; patient allergies; environmental, intrapartum, and early life exposures; and family background. Symptoms are structurally assessed at every visit; endoscopic features and histological findings are recorded for each examination. Prospective treatment data are registered sequentially, with new sequences created each time a different treatment (active principle, formulation, or dose) is administered to a patient. EoE CONNECT database is actively monitored to ensure the highest data accuracy and the highest scientific and ethical standards. Results: EoE CONNECT is currently being conducted at 39 centers in Europe and enrolls patients of all ages with EoE. In its aim to increase knowledge, to date EoE CONNECT has provided evidence on the effectiveness of first- and second-line therapies for EoE in clinical practice, the ability of proton pump inhibitors to induce disease remission, and factors associated with improved response. Drug effects to reverse fibrous remodeling and endoscopic features of fibrosis in EoE have also been assessed. Conclusion: This prospective registry study will provide important information on the epidemiological and clinical aspects of EoE and evidence as to the real-world and long-term effectiveness and safety of therapy. These data will potentially be a vital benchmark for planning future EoE health care services in Europe

Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial.

BACKGROUND & AIMS: Swallowed topical-acting corticosteroids are recommended as first-line therapy for eosinophilic esophagitis (EoE). Asthma medications not optimized for esophageal delivery are sometimes effective, although given off-label. We performed a randomized, placebo-controlled trial to assess the effectiveness and tolerability of a budesonide orodispersible tablet (BOT), which allows the drug to be delivered to the esophagus in adults with active EoE. METHODS: We performed a double-blind, parallel study of 88 adults with active EoE in Europe. Patients were randomly assigned to groups that received BOT (1 mg twice daily; n = 59) or placebo (n = 29) for 6 weeks. The primary end point was complete remission, based on clinical and histologic factors, including dysphagia and odynophagia severity ≤2 on a scale of 0-10 on each of the 7 days before the end of the double-blind phase and a peak eosinophil count <5 eosinophils/high power field. Patients who did not achieve complete remission at the end of the 6-week double-blind phase were offered 6 weeks of open-label treatment with BOT (1 mg twice daily). RESULTS: At 6 weeks, 58% of patients given BOT were in complete remission compared with no patients given placebo (P < .0001). The secondary end point of histologic remission was achieved by 93% of patients given BOT vs no patients given placebo (P < .0001). After 12 weeks, 85% of patients had achieved remission. Six-week and 12-week BOT administration were safe and well tolerated; 5% of patients who received BOT developed symptomatic, mild candida, which was easily treated with an oral antifungal agent. CONCLUSIONS: In a randomized trial of adults with active EoE, we found that budesonide oral tablets were significantly more effective than placebo in inducing clinical and histologic remission. Eudra-CT number 2014-001485-99; ClinicalTrials.gov ID NCT02434029

Epiphrenic and middle esophageal diverticula: a rare cause of esophageal dysphagia. Esophageal high resolution manometry findings

Los divertículos esofágicos (DE) constituyen una patología poco frecuente siendo en su mayoría asintomáticos. Cuando ocasionan síntomas, la disfagia suele ser el más frecuente como consecuencia del tamaño del divertículo y de las alteraciones de la motilidad concomitantes. La manometría de alta resolución (MAR) permite diagnosticar con mayor precisión los trastornos motores subyacentes que se asocian con los DE y comprender su mecanismo fisiopatogénico. Se presentan seis pacientes con disfagia que fueron diagnosticados de DE asociado a un trastorno motor esofágico en la MAR

How useful is esophageal high resolution manometry in diagnosing gastroesophageal junction disruption: causes affecting this disruption and its relationship with manometric alterations and gastroesophageal reflux

Background: High-resolution manometry (HRM) is a breakthrough in the morphological study of the gastroesophageal junction (GEJ) and its degrees of disruption. Objectives: a) Assessment of risk factors involved in the disruption of the GEJ in patients with gastroesophageal reflux (GER) symptoms; b) the relationship between the type of GEJ and GER demonstrated by 24 hours pH-monitoring; and c) identification of the alterations in the manometric parameters related to the morphology of the GEJ. Methods: One hundred and fifteen patients with symptoms of GER studied with HRM and classified by the type of GEJ (type I: Normal; type II: Sliding; type III: Hiatal hernia). Twenty four hour pH-monitoring without proton pump inhibitors was performed in all of them. Epidemiological aspects, manometric parameters (Chicago 2012 classification) and the pH-monitoring results were evaluated. Results: Age (OR 1.033 [1.006-1.060]; p = 0.16), BMI (OR 1.097 [1.022-1.176]; p = 0. 01) and abdominal perimeter (OR 1.034 [1.005-1.063]; p = 0.0215) were independent risk factors for the GEJ type III (area under the curve 0.70). Disruption of the GEJ was associated with a lower resting pressure (p = 0.006), greater length (p < 0.001) and greater esophageal shortening (p < 0.001). Abnormal acidic reflux was found in the total period (p = 0.015), standing (p = 0.022) and supine (p = 0.001) in patients with GEJ type II and III with respect to type I. Conclusions: Increased age, overweight and central obesity pose a higher risk of GEJ type III (hiatal hernia). The greater disruption of the GEJ is associated with lower resting pressure, esophageal shortening, and higher acid exposure in the pH-monitoring

Esophageal motor disorders are frequent during pre and post lung transplantation. Can they influence lung rejection?

ABSTRACT Background: lung transplantation (LTx) is a viable option for most patients with end-stage lung diseases. Esophageal motor disorders (EMD) are frequent in candidates for LTx, but there is very little data about changes in esophageal motility post-LTx. Aim: the aim of our study was to assess esophageal motor disorders by high resolution manometry (HRM) both pre-LTx and six months post-LTx in patients with and without organ rejection. Study: HRM (Manoscan(r)) was performed in 57 patients both pre-LTx and six months post-LTx. HRM plots were analyzed according to the Chicago classification 3.0. Results: EMD were found in 33.3% and in 49.1% of patients pre-LTx and post-LTx, respectively, and abnormal peristalsis was more frequently found post-LTx (p = 0.018). Hypercontractile esophagus was frequently found post-LTx (1.8% and 19.3% pre-LTx and post-LTx, respectively). Esophagogastric junction (EGJ) morphology changed significantly pre-LTx and post-LTx; type I (normal) was more frequent post-LTx (63-2% and 82.5% respectively, p = 0.007). EMD were more frequent post-LTx in both the non-rejection and rejection group, although particularly in the rejection group (43.2% and 69.2% respectively, p = 0.09). EMD such as distal spasm, hypercontractile esophagus and EGJ outflow obstruction were also observed more frequently post-LTx in the rejection group. Conclusion: significant changes in esophageal motility were observed pre-LTx and particularly post-LTx; hypercontractile esophagus was a frequent EMD found post-LTx. EMD were more frequent in the group of patients that experienced organ rejection compared to the non-rejection group. EMD leading to an impaired esophageal clearance should be considered as an additional factor that contributes to LTx failure

Transcultural adaptation and validation of the "Adult Eosinophilic Esophagitis Quality of Life Questionnaire" into Spanish

Background: The "Adult Eosinophilic Esophagitis Quality of Life (EoE-QoL-A) Questionnaire" was developed in English as a valid, reliable, and disease-specific health-related QoL measure. This research aims to adapt and validate this questionnaire for Spanish-speaking patients. Patients and methods: A multicenter, observational, prospective study was conducted at 8 Spanish hospitals. The cultural adaptation of the original EoE-QoL-A questionnaire was undertaken through a standardized 3-phase procedure: 1. Translation; 2. Retrotranslation; and 3. Pilot study. Patients completed the Hospital Anxiety and Depression Scale (HADS), the Short Form (SF)-12, the Brief Illness Perception Questionnaire (BIPQ), and the adapted EoE-QoL-A, with a retest 3 months later. Statistical analysis included construct validity, internal consistency, criterion validity, and reproducibility. Results: One hundred and seventy adult EoE patients (73.5 % male; aged 33.5 ± 11.4-y) were included in the study. With regard to internal validity, all Cronbach alpha values were > 0.75. A significant correlation between items assessed in the SF-12, BIPQ and EoE-QoL-A questionnaires (p < 0.001) was observed. Correlations with the HADS were stronger for anxiety than for depression levels. Anxiety related to disease diagnosis and choking were the most affected dimensions; less affected were the dimensions related to eating, social, and emotional development. Intraclass correlation coefficients between the test and retest assessments were acceptable for all questionnaires, with the highest values (0.73-0.84) calculated for the EoE-QoL-A Spanish version. Conclusion: The Spanish version of the EoE-QoL-A is a reliable, valid, and responsive questionnaire. Diagnosis and choking anxiety were the most affected dimensions in the health-related QoL in adult EoE patients