Eosinophil Depletion with Benralizumab for Eosinophilic Esophagitis.

BACKGROUND: Benralizumab is an eosinophil-depleting anti-interleukin-5 receptor α monoclonal antibody. The efficacy and safety of benralizumab in patients with eosinophilic esophagitis are unclear. METHODS: In a phase 3, multicenter, double-blind, randomized, placebo-controlled trial, we assigned patients 12 to 65 years of age with symptomatic and histologically active eosinophilic esophagitis in a 1:1 ratio to receive subcutaneous benralizumab (30 mg) or placebo every 4 weeks. The two primary efficacy end points were histologic response (≤6 eosinophils per high-power field) and the change from baseline in the score on the Dysphagia Symptom Questionnaire (DSQ; range, 0 to 84, with higher scores indicating more frequent or severe dysphagia) at week 24. RESULTS: A total of 211 patients underwent randomization: 104 were assigned to receive benralizumab, and 107 were assigned to receive placebo. At week 24, more patients had a histologic response with benralizumab than with placebo (87.4% vs. 6.5%; difference, 80.8 percentage points; 95% confidence interval [CI], 72.9 to 88.8; P<0.001). However, the change from baseline in the DSQ score did not differ significantly between the two groups (difference in least-squares means, 3.0 points; 95% CI, -1.4 to 7.4; P = 0.18). There was no substantial between-group difference in the change from baseline in the Eosinophilic Esophagitis Endoscopic Reference Score, which reflects endoscopic abnormalities. Adverse events were reported in 64.1% of the patients in the benralizumab group and in 61.7% of those in the placebo group. No patients discontinued the trial because of adverse events. CONCLUSIONS: In this trial involving patients 12 to 65 years of age with eosinophilic esophagitis, a histologic response (≤6 eosinophils per high-power field) occurred in significantly more patients in the benralizumab group than in the placebo group. However, treatment with benralizumab did not result in fewer or less severe dysphagia symptoms than placebo. (Funded by AstraZeneca; MESSINA ClinicalTrials.gov number, NCT04543409.).

Rheological characterization of chia seed gum as a thickening agent used for dysphagia management.

Dysphagia has emerged as a serious health issue facing contemporary society. Consuming thickened liquids is an effective approach for improving the swallowing safety for dysphagia patients. The thickening effect of chia seed gum (CSG), a novel thickener, in different dispersing media (water, orange juice, and skim milk) was investigated. Moreover, the potential application of CSG for dysphagia management was evaluated by comparison with xanthan gum (XG) and guar gum (GG). The thickened liquids prepared with 0.4 %-1.2 % (w/v) CSG, XG, and GG could be classified into levels 1-4, 2-4, and 1-3, respectively, according to the International Dysphagia Diet Standardization Initiative (IDDSI) framework. All the thickened liquids displayed shear-thinning characteristics that facilitated safe swallowing. The viscosities (η50) of CSG dissolved in water (0.202-1.027 Pa·s) were significantly greater than those of CSG dissolved in orange juice (0.070-0.690 Pa·s) and skim milk (0.081-0.739 Pa·s), indicating that CSG had a greater thickening effect in water than in orange juice and skim milk. Compared with those prepared with GG, the thickened liquids prepared with CSG and XG exhibited greater viscoelasticity, better water-holding capacity, and more compact networks. The findings suggested that CSG can be used as a potential thickener for thickening liquid foods to manage dysphagia.

Central neuromodulators for patients with functional esophageal disorders: A systematic review and meta-analysis.

BACKGROUD: The use of neuromodulators is prevalent in various functional gastrointestinal disease. However, data concerning the outcomes of these treatments in functional esophageal disorders (FED) remains limited and inadequate. AIMS: The aim of the present study is to examine the efficacy of central neuromodulators in FED. METHODS: We searched PubMed, EMBASE, and the Cochrane library databases from inception to April 2023. Randomized controlled trials that compared the effects of neuromodulators and placebos on FED are included. Primary outcome is the symptom improvement, and Rome IV criteria is used to assess eligible studies. RESULTS: Eleven randomized controlled studies (three for functional chest pain, four for reflux hypersensitivity/functional heartburn, three for globus, and one for functional dysphagia) were included in the final analysis. Neuromodulators reduced chest pain by 52%-71% in patients with functional chest pain, and alleviated symptom by 46%-75% in patients with globus (n = 3, Odds ratio 6.30, 95% confidence interval 4.17-9.50). However, the results were inconsistent for reflux hypersensitivity and functional heartburn. There was a lack of convincing evidence to support the use of neuromodulators for functional dysphagia. The use of neuromodulators did not have a significant impact on the quality of life. CONCLUSIONS: Functional chest pain and globus may potentially benefit from the use of neuromodulators, but their effectiveness for functional dysphagia, functional heartburn and reflux hypersensitivity remains controversial. More controlled trials are needed to confirm the therapeutic effects on these conditions.

Botulinum Toxin Injection for Retrograde Cricopharyngeal Dysfunction: A Prospective Cohort Study.

OBJECTIVES: Retrograde Cricopharyngeal Dysfunction (RCPD) is treated by botulinum toxin (BTX) injection into the cricopharyngeus. This prospective study compares the effectiveness and side effects of operating room (OR) and in-office (IO) injections. METHODS: Patients over 18 years of age with inability to burp, abdominal, thoracic, or cervical gurgling sounds, bloating, and excessive flatulence were diagnosed with RCPD and included in the study. Injections were performed in the OR (80U) or IO (30U) by the senior author. An RCPD questionnaire quantifying major and minor symptoms on a Likert scale, Eating Assessment Tool-10 (EAT-10), and Generalized Anxiety Score-7 (GAD-7), were completed preinjection; at 1, 2, and 3 weeks; and 3 months postoperatively. Linear mixed models were used to analyze effects of BTX injection on RCPD symptoms, the EAT-10, and the GAD-7. RESULTS: 108 (55 M/53F) patients completed the pretreatment survey, 53 (31 OR vs. 22 IO) completed the 3-week follow-up, and 36 (22 OR vs. 14 IO) completed the 3-month questionnaire. Average posttreatment RCPD scores were significantly lower in both groups at 3 weeks and 3 months (p < 0.0001), There was no difference between IO or OR (p = 0.4924). GAD-7 scores were significantly lower in both groups at week 3 (p = 0.0018) and month 3 (p = 0.0012). Postinjection EAT-10 scores were significantly higher in OR compared with IO (p = 0.0379). CONCLUSION: OR and IO injections are equally effective in the treatment of RCPD. Postinjection dysphagia is more severe after the OR injections which may be related to higher doses of BTX used. General anxiety levels decrease with treatment. LEVEL OF EVIDENCE: 2 Laryngoscope, 134:4614-4619, 2024.

Retrograde cricopharyngeal dysfunction and treatment with botulinum toxin: a systematic review.

PURPOSE: Retrograde cricopharyngeal dysfunction (RCPD) is a disease first described systematically in 2019. The main symptom is inability to belch due to cricopharyngeal muscle dysfunction. Other symptoms include gurgling noises, chest pain, bloating, and excessive flatulence. This paper aims to describe RCPD, the aetiology and diagnosis, treatment options, follow-up, and treatment with botulinum toxin (BT). METHODS: A systematic review was done according to the PRISMA guidelines, using the databases PubMed, Embase, and Cochrane at 8/3/2024. The search combined BT with different descriptions of RCPD. All papers were screened by two authors. RESULTS: 120 papers were identified in the search. After screening 13 papers describing 472 patients in total were included. Mean age was 29.3 years with 51.1% men. Diagnosis was established in 82.4% of the cases by symptomatology, 2.1% by high-resolution manometry, and 15.3% by oesophagoscopy. The mean amount of BT was 66 units (U). Mean follow-up time was 13 months. After 1-4 weeks 93.7% had an effect post-treatment and 81.0% after 6 months. Common symptoms were inability to belch (99.8%), chest pain and/or bloating (95.4%), gurgling noises (84.9%), and excessive flatulence (75.9%). Common complications were mild and transient dysphagia (59.4%) and reflux (35.4%). CONCLUSION: The accumulated numbers of patients with RCPD indicates a growing attention to the plausible condition. Injection with BT is a good and safe treatment of RCPD. Most patients only experience mild and transient complications to the treatment. Much is still unknown about RCPD and conditions for setting the diagnosis needs to be evaluated and established internationally.

Risdiplam improves subjective swallowing quality in non-ambulatory adult patients with 5q-spinal muscular atrophy despite advanced motor impairment.

BACKGROUND: 5q-associated spinal muscular atrophy (SMA) is characterized by the progressive loss of motor neurons with consecutive weakness and atrophy of the limb, respiratory, and bulbar muscles. While trunk and limb motor function improve or stabilize in adults with SMA under nusinersen and risdiplam treatment, the efficacy on bulbar function in this age group of patients remains uncertain. However, it is important to assess bulbar dysfunction, which frequently occurs in the disease course and is associated with increased morbidity and mortality. METHODS: Bulbar function was evaluated prospectively in 25 non-ambulatory adults with type 2 and 3 SMA before and 4 and 12 months after risdiplam treatment initiation using the Sydney Swallow Questionnaire (SSQ) and the bulbar subscore of the Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (b-ALSFRS-R). Extremity function was assessed using the Hammersmith Functional Motor Scale Expanded (HFMSE) and Revised Upper Limb Module (RULM). RESULTS: Subjective swallowing quality, measured with the SSQ, improved after 12 months of therapy with risdiplam. For the b-ALSFRS-R, a non-significant trend towards improvement was observed. The RULM score improved after 12 months of risdiplam therapy, but not the HFMSE score. HFMSE and RULM scores did not correlate with the SSQ but the b-ALSFRS-R score at baseline. CONCLUSIONS: The improvement in subjective swallowing quality under risdiplam treatment, despite an advanced disease stage with severe motor deficits, strengthens the importance of a standardized bulbar assessment in addition to established motor scores. This may reveal relevant treatment effects and help individualize treatment decisions in the future.

Swallowed topical corticosteroids for eosinophilic esophagitis: Utilization and real-world efficacy from the EoE CONNECT registry.

BACKGROUND: Swallowed topical corticosteroids (tC) are common therapy for patients with eosinophilic esophagitis (EoE). Widely heterogeneous results have occurred due to their active ingredients, formulations and doses. OBJECTIVE: To assess the effectiveness of topical corticosteroid therapy for EoE in real-world practice. METHODS: Cross-sectional study analysis of the multicentre EoE CONNECT registry. Clinical remission was defined as a decrease of ≥50% in dysphagia symptom scores; histological remission was defined as a peak eosinophil count below 15 per high-power field. The effectiveness in achieving clinico-histological remission (CHR) was compared for the main tC formulations. RESULTS: Overall, data on 1456 prescriptions of tC in monotherapy used in 866 individual patients were assessed. Of those, 904 prescriptions with data on formulation were employed for the induction of remission; 234 reduced a previously effective dose for maintenance. Fluticasone propionate formulations dominated the first-line treatment, while budesonide was more common in later therapies. A swallowed nasal drop suspension was the most common formulation of fluticasone propionate. Doses ≥0.8 mg/day provided a 65% CHR rate and were superior to lower doses. Oral viscous solution prepared by a pharmacist was the most common prescription of budesonide; 4 mg/day provided no benefit over 2 mg/day (CHR rated being 72% and 80%, respectively). A multivariate analysis revealed budesonide orodispersible tablets as the most effective therapy (OR 18.9, p < 0.001); use of higher doses (OR 4.3, p = 0.03) and lower symptom scores (OR 0.9, p = 0.01) were also determinants of effectiveness. CONCLUSION: Reduced symptom severity, use of high doses, and use of budesonide orodispersible tablets particularly were all independent predictors of tC effectiveness.

Polypharmacy, Potentially Inappropriate Medications, and Dysphagia in Older Inpatients: A Multi-Center Cohort Study.

BACKGROUND: Although the relationship between medication status, symptomatology, and outcomes has been evaluated, data on the prevalence of polypharmacy and potentially inappropriate medications (PIMs) and the association of polypharmacy and PIMs with swallowing function during follow-up are limited among hospitalized patients aged ≥65 years with dysphagia. METHODS: In this 19-center cohort study, we registered 467 inpatients aged ≥65 years and evaluated those with the Food Intake LEVEL Scale (FILS) scores ≤8 between November 2019 and March 2021. Polypharmacy was defined as prescribing ≥5 medications and PIMs were identified based on the 2023 Updated Beers Criteria. We applied a generalized linear regression model to examine the association of polypharmacy and PIMs with FILS score at discharge. RESULTS: We analyzed 399 participants (median age, 83.0 years; males, 49.8%). The median follow-up was 51.0 days (interquartile range, 22.0-84.0 days). Polypharmacy and PIMs were present in 67.7% of and 56.1% of patients, respectively. After adjusting for covariates, neither polypharmacy (ß = 0.05; 95% confidence interval [CI], -0.04-0.13, p=0.30) nor non-steroidal anti-inflammatory medications (ß = 0.09; 95% CI, -0.02-0.19; p=0.10) were significantly associated with FILS score at discharge. CONCLUSION: The results of this study indicated a high proportion of polypharmacy and PIMs among inpatients aged ≥65 years with dysphagia. Although these prescribed conditions were not significantly associated with swallowing function at discharge, our findings suggest the importance of regularly reviewing medications to ensure the appropriateness of prescriptions when managing older inpatients.

Safety and Effectiveness of Prucalopride in Children with Functional Constipation with and without Upper Symptoms.

INTRODUCTION: Pediatric prucalopride studies for treatment of gastrointestinal (GI) disorders have reported mixed results. We aimed to assess the safety and effectiveness of prucalopride in functional constipation (FC) with and without upper GI symptoms. METHODS: Retrospective data on patients with FC receiving combined prucalopride and conventional therapy was compared with those receiving conventional therapy alone within 12 months. Thirty patients on combined therapy and those on conventional therapy were each matched on the basis of age, gender, race, and presence of fecal soiling. Response (complete, partial, or no resolution) was compared. Similarly, response to concurrent functional upper GI symptoms (postprandial pain, bloating, weight loss, vomiting, early satiety, or nausea) and dysphagia, as well as adverse effects, were evaluated in the combined group. RESULTS: Mean age of 57 cases was 14.7 ± 4.9 years and 68% were female. Comorbidities included functional upper GI (UGI) symptoms (84%), dysphagia (12%), mood disorders (49%), and hypermobility spectrum disorder (37%). Unmatched cases reported 63% improvement to FC; response did not differ between the matched cohorts (70% versus 76.6%, p = 0.84). Cases showed a 56% improvement in functional UGI symptoms and 100% in dysphagia. Adverse effects were reported in 30%, abdominal cramps being most common. Four (7%) patients with a known mood disorder reported worsened mood, of which two endorsed suicidal ideation. CONCLUSION: Prucalopride efficaciously treated concurrent UGI symptoms and dysphagia in constipated pediatric patients and was overall well tolerated. Preexisting mood disorders seemed to worsen in a small subset of cases.

Modified medication use in dysphagia: the effect of thickener on drug bioavailability-a systematic review.

INTRODUCTION: Dysphagia is associated with long-term conditions including strokes, dementia, Parkinson's disease and frailty. Dysphagia affects 30-40% of the population aged over 65 years-old. Adults with dysphagia often experience long-term conditions requiring multiple medications (often > 5) to manage these. The thickening of liquids is a common compensatory strategy in dysphagia management. Studies suggest that immersion in thickened liquids affects medicines' solubility in vitro. Clinicians and pharmacists are unaware of the pharmacokinetic/therapeutic effects of thickened liquids on oral medicines. We conducted a systematic review of existing literature on thickeners' effects on drug bioavailability. METHODOLOGY: We performed a literature search of MEDLINE & EMBASE. Search terms included: dysphagia/thickened diet (EMBASE only)/ bioavailability or absorption of medicines or pharmacokinetics; excluded: NG feeds/animal studies. STUDIES INCLUDED: all genders, countries, > 18 years, community and hospital settings. PRISMA guidance was followed. RESULTS: Five hundred seventy results were found, and 23 articles identified following the reference list review. Following an abstract and full-text review, 18 were included. Most articles evaluated thickeners on dissolution profiles in-vitro, with a few investigating in-vivo. Most studies were single-centre prospective studies identifying that thickeners generally affect dissolution rates of medications. Few studies assessed bioavailability or used clinical outcomes. CONCLUSION: Dysphagia and polypharmacy are common in older adults, but little is known about the effects of altering liquid viscosity on the therapeutic effect of most medications. Further larger-scale studies are required to evaluate the therapeutic impact of thickener, on a bigger range of medications, factoring in other variables such as type of thickener, viscosity of thickener and duration of immersion.

Diagnosis and evaluation of elderly-onset myasthenia gravis: A case report.

RATIONALE: Patients with elderly-onset myasthenia gravis can have a good prognosis with appropriate diagnosis and response, although it is difficult to differentiate between exacerbations of myasthenia gravis in elderly patients and age-related changes. Therefore, it is important for physicians to understand the clinical characteristics and safe assessment methods for patients with elderly-onset myasthenia gravis. PATIENT CONCERNS: An 82-year-old male diagnosed with myasthenia gravis 6 months prior had no difficulty in daily living. After falling on a golf course, he was diagnosed with a right femoral neck fracture on the 1st day and underwent right total hip replacement surgery on the 12th day, being transferred to our hospital for rehabilitation therapy on the 32nd day. However, immediately after transfer, the patient showed fatigability during training and difficulty swallowing food. DIAGNOSES: This case was diagnosed as an exacerbation of myasthenia gravis. INTERVENTIONS: Pyridostigmine was initiated with the expectation of immediate effect on the 54th day. OUTCOMES: His symptoms and physical functions improved immediately, and walking distance and food intake increased. From this clinical course, it was judged that immunosuppressive therapy was indicated as a transition to generalized myasthenia gravis. For this reason, he was discharged after arranging postdischarge visits to the department of neurology, accordingly. LESSONS: A better understanding of the characteristics of elderly-onset myasthenia gravis may allow for relatively safe assessment of the condition and improve its diagnosis and treatment.

Use of botox for sialorrhea and dysphagia in the neonatal population.

INTRODUCTION: Botox is frequently used for sialorrhea in patients with compromised airways and those with etiologies causing difficulty with secretion management (i.e. strokes, neurologic disorders, etc.). There are no published studies regarding the use of botulinum toxin (BoNT) in the neonate population. We aim to discuss our experience and safety of BoNT use in the neonate population in regards to alleviating secretion management and airway protection. METHODS: Retrospective review of neonates admitted to the neonatal intensive care unit (NICU) ≤12 months of age who received BoNT injection to submandibular (SMG) and parotid (PG) glands for sialorrhea/dysphagia. BoNT was administered under ultrasound (u/s) guidance by interventional radiology. RESULTS: 6 children were examined. 2 (33 %) were male. Avg NICU stay was 87.5 ± 33.1 days. 2 underwent surgical airway intervention prior to injection. Mean age at initial BoNT was 1.5 ± 0.7 months. Avg weight at injection was 4 ± 1.1 kg. Each PG and SMG were injected in 5/6 cases. Bilateral SMG were unidentified on u/s in 1 case and thus not injected. Dose range injected per gland was 5-15u. 100 % required tube feeds, 50 % with tubes distal to stomach (NJT/NDT). 83 % were completely NPO prior to injection and there was no noted clinical improvement in oral skills post injection. All had noted desats/apneas prior to injection and 83 % had reported decreased events post injection. 50 % had reported decrease O2 requirements and frequent suctioning 2wks after injection, however 2 (33 %) required surgical airway intervention after injection (trach, SGP/MDO). 4/6 (67 %) trialed medical therapy, anticholinergics being the most common. 50 % underwent 2nd injection (age = 6.5 ± 0.3 months) avg. 4.7 ± 0.7mo after 1st injection, and the same 3pts underwent 3rd injection (age = 12.5 ± 2.4 months) avg. 6.1 ± 2.5mo after 2nd injection. 1 pt. had a total 6 injections. There were no injection related complications. CONCLUSION: BoNT injection is a safe, non-invasive alterative for management of sialorrhea in neonates. Further extensive study needs to be performed to identify the optimal dose per gland in this population.

Dupilumab demonstrated efficacy and was well tolerated regardless of prior use of swallowed topical corticosteroids in adolescent and adult patients with eosinophilic oesophagitis: a subgroup analysis of the phase 3 LIBERTY EoE TREET study.

OBJECTIVE: To assess the effect of long-term dupilumab on histological, symptomatic and endoscopic aspects of eosinophilic oesophagitis (EoE) in adolescent and adult patients with and without prior use of swallowed topical corticosteroids (STC) or prior inadequate response, intolerance or contraindication to STC. DESIGN: Pre-specified analysis of data from the phase 3 LIBERTY EoE TREET study on patients who received dupilumab 300 mg once a week or placebo for 24 weeks (W24) in parts A and B, and an additional 28 weeks (W52) in part C. Patients were categorised as with/without prior STC use and with/without inadequate/intolerance/contraindication to STC. The proportion of patients achieving ≤6 eosinophils per high-power field (eos/hpf), absolute change in Dysphagia Symptom Questionnaire (DSQ) score, mean change in Endoscopic Reference Score and Histologic Scoring System grade/stage scores were assessed for each subgroup. RESULTS: Regardless of prior STC use, dupilumab increased the proportion of patients achieving ≤6 eos/hpf and improved DSQ score versus placebo at W24, with improvements maintained or improved at W52. The DSQ score and the proportion of patients achieving ≤6 eos/hpf after switching from placebo to dupilumab at W24 were similar to those observed in the dupilumab group at W24, regardless of prior STC use or inadequate/intolerance/contraindication to STC. Improvements in other outcomes with dupilumab were similar in patients with/without prior STC use or inadequate/intolerance/contraindication to STC. CONCLUSION: Dupilumab 300 mg once a week demonstrated efficacy and was well tolerated in patients with EoE regardless of prior STC use or inadequate response, intolerance and/or contraindication to STC. TRIAL REGISTRATION NUMBER: NCT03633617.

Implementing a medication lubricant for pill dysphagia on an acute care ward using Plan-Do-Study-Act cycles.

BACKGROUND: Pill dysphagia, the difficulty in swallowing solid oral medications, is a common problem that can affect medication adherence and increase pill modifications. Current practices of crushing medications or using food vehicles have limitations and potential risks. This report describes the implementation of a medication lubricant, Gloup, for pill dysphagia on an acute care ward using Plan-Do-Study-Act cycles. OBJECTIVE: The objective of this project was to evaluate the implementation of Gloup in the acute care ward setting and assess its acceptability and uptake by patients and ward nurses during medication administration. METHODS: The project involved chart audits of medication administration records, collection of patient feedback, and staff feedback through meetings. Patient characteristics and medication administration practices were documented. The implementation process included education and training sessions for staff, development of a medication chart sticker for evaluation data collection and small-scale testing of Gloup with patients before ward-level implementation. RESULTS: The implementation of Gloup on the acute care ward showed high uptake and acceptability. The majority of patients using Gloup had crushed medications, and the use of Gloup varied based on patient needs. CONCLUSION: The implementation of Gloup as a medication lubricant for pill dysphagia on an acute care ward was successful and well received by patients and staff. The use of Gloup appeared to improve medication administration practices and reduce the need for crushing medications or using food vehicles. This project highlights the importance of addressing pill dysphagia in acute care settings and provides insights for other wards considering similar interventions.

Development of an Administration Guideline of Oral Medicines to Patients with Dysphagia.

Background and Objectives: There is increasing evidence that patients with dysphagia often have limited access to suitable oral dosage forms, especially when administered via an enteral feeding tube (FT). In addition, there is a lack of clear and readily available information from drug manufacturers on how to administer medications to patients with dysphagia. This study aimed to develop a practical guide for healthcare professionals to increase the safe and effective administration of oral medications to patients with dysphagia. Materials and Methods: The data were collected from existing English databases and handbooks available to develop an easy-to-use tabular guideline presenting all relevant information using keywords and short expressions. The working group differentiated 514 formulation types, and the information was collected and added to the guideline separately. In addition, the instructions for the patients taking the medicines orally or via FT were described separately. Results: The guideline consisted of 24 keywords or short expressions developed by the working group and described the instructions to use them. The guideline contained 343 active pharmaceutical ingredients and 19 fixed-dose combinations. Conclusions: Knowledge about proper medication preparation and administration for patients with swallowing difficulties is limited but essential. It is crucial to encourage drug manufacturers to provide this information as a standard to ensure the safe and effective use of medications for all patient groups.

[Translated article] Deglufarm: Mobile application with recommendations for the safe administration of drugs in patients with dysphagia or swallowing disorders.

OBJECTIVE: Develop an App to use in healthcare practice, with updated and accurate information on the handling of medications in patients with dysphagia or deglution disorders, as well as their compatibility with food and thickeners. METHODS: The development of the Deglufarm® App was based on the CRONOS, Nutrition and Techno working groups of the Sociedad Española de Farmacia Hospitalaria. A group of specialist pharmacists was created from different care areas for patients with dysphagia. The creation of Deglufarm® consisted of several stages: selection of active drugs, literature review, content development, design (an expert company in App design was contacted), testing, launch, content update and follow-up. RESULTS: Deglufarm® is available for Android and IOS free of charge from July 2022. It has been tested among the members of the research group and collaborators, Currently, 540 monographs of active drugs have been reviewed and registered in Deglufarm. The first version is aimed at healthcare professionals. CONCLUSIONS: Deglufarm® is an easy tool to consult, with the most current evidence on handling the medicines it contains.

Safety and Effectiveness of OnabotulinumtoxinA in Patients with Laryngeal Dystonia: Final Report of a 52-Week, Multicenter Postmarketing Surveillance Study.

This postmarketing surveillance study was conducted to evaluate the safety and effectiveness of onabotulinumtoxinA in Japanese patients with laryngeal dystonia (LD). Patients receiving onabotulinumtoxinA for the first time were enrolled and observed for up to 12 months following the first injection. Safety assessment included adverse drug reactions (ADRs), and effectiveness assessments included the Voice Handicap Index-10 (VHI-10) and physician's global assessment (PGA). ADRs were observed in 48 (5.8%) of 834 patients in the safety analysis set, including dysphonia in 43 (5.2%) patients and dysphagia in 7 (0.8%) patients. The change in total VHI-10 score (mean) in 790 patients included in the effectiveness analysis set showed that improvement in adductor LD peaked at 2 months after the first injection, while patients with abductor or mixed LD showed a gradual attenuation of effect 2-4 weeks post-injection. The change in total VHI-10 score in subsequent injections was generally similar to that following the first injection. The overall effectiveness rate according to the PGA was 93.4% (738/790 patients). The results demonstrate that onabotulinumtoxinA is a well-tolerated and effective treatment for LD in real-world clinical practice.

Crushed Tablet Administration for Patients with Dysphagia and Enteral Feeding: Challenges and Considerations.

Dysphagia is increasingly common in older adults; it is especially prevalent in long-term care settings. Patients with dysphagia likely require pharmacologic treatment for multiple comorbidities but may find it difficult or impossible to swallow oral medications. Administering crushed medications mixed with a soft food or liquid vehicle, or via a feeding tube, is a common strategy to circumvent swallowing difficulties in patients with dysphagia. However, inappropriate medication use and improper crushing technique can reduce the medication dose a patient receives, alter medication pharmacokinetics and pharmacodynamics, and compromise treatment efficacy and patient safety. Clinical judgment is needed to identify medications that can and cannot be crushed, select a crushing methodology and vehicle for administering crushed medications, and create a strategy for administering multiple medications. A coordinated effort from the entire care team-including physicians, pharmacists, nurses, advanced practice providers, speech therapists, patients, and caregivers-is necessary to develop and implement an individualized plan for administering medications to patients with dysphagia. This review details the current literature regarding the administration of medications that have been altered, such as by crushing tablets or opening capsules, for patients with dysphagia or who are receiving enteral feeding and provides recommendations on best practices.

Dysphagia, or difficulty swallowing, is common in hospitals and in places that provide long-term care. People who live at home may also have a hard time swallowing pills. In this review, we talk about how people who have a hard time swallowing pills can best take their medicines. A speech-language pathologist can help people with dysphagia find ways to eat and drink safely. Their healthcare provider and pharmacist should make sure all their medicines are needed and check if any of their medicines come in a form that does not need to be swallowed, like a patch. It is sometimes okay to take a medicine by crushing a pill and then mixing with food. However, some medicines may be dangerous or less effective if they are crushed or mixed with some foods. Mixing multiple crushed medicines may also be unsafe or make them less effective. People in hospitals and long-term care settings who have a hard time swallowing pills should have an individual plan in place for taking medicines. Physicians, pharmacists, speech-language pathologists, and front-line care staff should work with patients and caregivers to make the plan. The plan should be written down in their patient record. People who have a hard time swallowing medicines should talk to their doctor or pharmacist about how best to take their medicines. People should not alter their medicines without talking to a healthcare professional.

Pooled Phase 2 and 3 Efficacy and Safety Data on Budesonide Oral Suspension in Adolescents with Eosinophilic Esophagitis.

OBJECTIVES: The objective of this study was to evaluate the efficacy and safety of budesonide oral suspension (BOS) in adolescents with eosinophilic esophagitis (EoE). METHODS: This post hoc analysis pooled data from two 12-week, randomized, double-blind, placebo-controlled studies of BOS 2.0 mg twice daily (b.i.d.) (phase 2, NCT01642212; phase 3, NCT02605837) in patients aged 11-17 years with EoE and dysphagia. Efficacy endpoints included histologic (≤6, ≤1, and <15 eosinophils per high-power field [eos/hpf]), dysphagia symptom (≥30% reduction in Dysphagia Symptom Questionnaire [DSQ] scores from baseline), and clinicopathologic (≤6 eos/hpf and ≥30% reduction in DSQ scores from baseline) responses at week 12. Change from baseline to week 12 in peak eosinophil counts, DSQ scores, EoE Histology Scoring System (EoEHSS) grade (severity) and stage (extent) total score ratios (TSRs), and total EoE Endoscopic Reference Scores (EREFS) were assessed. Safety outcomes were also examined. RESULTS: Overall, 76 adolescents were included (BOS, n = 45; placebo, n = 31). Significantly more patients who received BOS than placebo achieved histologic responses (≤6 eos/hpf: 46.7% vs 6.5%; ≤1 eos/hpf: 42.2% vs 0.0%; <15 eos/hpf: 53.3% vs 9.7%; P < 0.001) and a clinicopathologic response (31.1% vs 3.2%; P = 0.003) at week 12. More BOS-treated than placebo-treated patients achieved a dysphagia symptom response at week 12 (68.9% vs 58.1%; not statistically significant P = 0.314). BOS-treated patients had significantly greater reductions in EoEHSS grade and stage TSRs ( P < 0.001) and total EREFS ( P = 0.021) from baseline to week 12 than placebo-treated patients. BOS was well tolerated, with no clinically meaningful differences in adverse events versus placebo. CONCLUSIONS: BOS 2.0 mg b.i.d. significantly improved most efficacy outcomes in adolescents with EoE versus placebo.