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Adverse events (AEs) are unintended, harmful effects that occur in clinical trials, particularly in early-phase oncology clinical trials (EPOCT), where the risk of adverse effects from experimental therapies is high. Effective AE identification and management are essential for ensuring patient safety, improving outcomes, and advancing research. Advanced practice providers (APPs) play a key role in detecting and managing AEs, serving as a bridge between clinical care and research. However, their full impact on EPOCT remains underexplored. This integrative review examines existing literature on AE identification, reporting, and management in EPOCT. It explores the role of APPs in managing AEs, emphasizing their impact on patient outcomes, clinical trial efficiency, and oncology science. A systematic search of peer-reviewed literature from 2020 to 2025 was conducted using various databases. Inclusion criteria were studies addressing AE management in EPOCT, patient-reported outcomes (PROs), and APP roles. Studies unrelated to oncology, AE management, or health-care providers were excluded. Findings highlight the variability in AE reporting and the growing utility of electronic PRO tools in capturing timely and accurate data. Advanced practice providers contribute significantly to outpatient AE management, reducing emergency visits and improving treatment adherence. However, challenges remain, including underreporting with clinician-based tools, lack of standardized APP training, and limited comparison to physician-led AE management. APPs serve as key players in enhancing AE reporting and improving clinical trial processes. Future research should focus on standardizing structured training programs for APPs and comparative studies assessing the effectiveness of APP-led care.

Time and Personnel Costs Associated with Adverse Event (AE) Management Among Patients with Chronic Lymphocytic Leukemia (CLL) Treated with Acalabrutinib, Ibrutinib, or Venetoclax

BackgroundChimeric antigen receptor (CAR) T-cell therapy has been a major innovative breakthrough for hematologic malignancies. These therapies are associated with unique and potentially serious toxicities, including cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity (ICANS), that require vigilance, prompt recognition, and appropriate management to ensure patient safety and optimal therapeutic benefit. We developed an online tool to give healthcare providers (HCPs) case-specific, evidence-based expert guidance on the management of adverse events (AEs) from CAR T-cell therapy. Here, we report an updated analysis comparing CAR T-cell toxicity management among HCPs using the tool vs the expert consensus recommendations.1MethodsIn March 2019, 5 experts provided consensus guidance for the screening, prophylaxis, monitoring, and management of CRS and ICANS in patients considering or receiving CAR T-cell therapy. This information was used to build the interactive online tool. To use this tool, HCPs enter the AE of interest, the severity of the event,2 and their planned management approach. The HCPs were then shown the expert recommendation for that specific scenario. After viewing the expert recommendation, HCPs were asked if it affected their intended approach.ResultsBetween May 2019 and July 2020, 282 HCPs entered 431 unique case scenarios into the tool. Of the entered cases, 56% were HCPs seeking expert recommendations on pretreatment screening and prophylaxis/monitoring strategies for patients not yet experiencing an AE. Of 188 cases entered for patients who received CAR T-cell therapy and experienced an AE, 67% were CRS and 33% were neurotoxicity/ICANS. Overall the planned toxicity management strategy of HCPs matched the expert recommendations in 57% of cases, with a similar rate of concordance for both CRS and ICANS events. There was no significant difference in concordance rates with expert recommendations by toxicity severity (figure 1) nor among HCPs who indicated they practiced at authorized centers vs those who did not (P = 0.7184). Among HCPs who answered the optional survey on the impact of the tool on their management plan, 30% indicated that the expert recommendations changed their approach.Abstract 655 Figure 1Planned management of HCPs compared with expert recommendations, by gradeConclusionsThese data suggest that many HCPs are challenged to optimally manage CAR T-cell therapy toxicities in concordance with expert recommendations. Use of an online tool providing easy access to evidence-based consensus expert recommendations may improve care and safety in patients treated with CAR T-cell therapy. A detailed analysis of the tool including planned management vs expert recommendations for each toxicity and grade will be presented.ReferencesFrigault MJ, Cartwright M, Marcello K, Quill T, DeAngelo DJ, Galinsky IA, Paul S, Park JH. Management of CAR T-Cell toxicities: concordance and divergence between healthcare providers and expert recommendations. Blood 2019:134:2199.Lee DW, Santomasso BD, Lock FL, Ghobadi A, Turtle CJ, Brudno JN, Maus MV, Park JH, Mead E, Pavletic S, Go WY, Eldjerou L, Gardner RA, Frey N, Curran KJ, Peggs K, Pasquini M, DiPersio JF, van den Brink MRM, Komanduri KV, Grupp SA, Neelapu SS. ASTCT Consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells. Biol Blood Marrow Transplant 2019;25:625–638.

Introduction. In the past two decades, among the various international initiatives aimed at enhancing the quality of medical care, the greatest number of them is aimed at improving the patient's safety situation. Scientific sources suggest that severe evadable adverse events complicate up to 15% of all hospitalizations, of which approximately 0.7-0.9% of cases can lead to death. It is considered that in perinatal practice, mistakes less frequently lead to adverse events and harm, due to a healthier contingent of patients and the modern paradigm of support for normal and physiological processes, instead of diseases. However, according to scientific literature, up to 1-4% of births are complicated by adverse events, of which up to 2/3 can be considered as preventative.The aim of the research is to determine the content of the major modern organizational tools for identification and registration of adverse events and medical errors in perinatal medicine.Materials and methods. We conducted the content analysis of scientific medical and methodological literature, aimed at identifying the key characteristics and content of organizational instruments for identification and registration of medical errors in perinatal medicine.Research results. Content analysis of printed materials and electronic Internet resources allowed us to determine the main requirements for incident reporting system. The subject of analysis can be any incident of patient safety: a medical error and an adverse event. The review of literature allowed us to reveal the evolution of organizational instruments for registration of adverse events in perinatal medicine. At the lower level, there is the analysis of all cases of deaths of mothers, fetuses and newborns, at the second level – registration of all adverse events with causing harm to the patient; at the third level –registration of near-misses events, the list of which can be personally developed by the department / institution management, adapting the already known tools to their own conditions and to the level of the existing patient safety culture; at the fourth level – registration of the so-called triggers, identification of which in the medical documentation is the basis for its detailed analysis in order to identify the adverse event that occurred during the treatment of patient, and, finally, the fifth level – voluntary reporting of medical errors, occurring at the department. The next, higher level of registration of adverse events and medical errors in perinatal medicine is identification and registration of the so-called uncompleted, timely prevented adverse events. The literature review has shown that most countries have implemented the WHO Maternal Near Miss Tool at the national level. However, it is noted that the main disadvantage of this tool is the lack of registration of uncompleted adverse events associated with the newborn. The standard for detecting adverse medical events was a voluntary incident-reporting system. Yet, these systems in a large number of cases do not reveal the actual frequency of adverse events. Public health researchers found that medical staff volunteered to report only 10-20% of errors, of which from 90 to 95% did not cause any harm to patients. Therefore, hospitals need a more effective way of detecting events that harm patients in order to quantify their degree and severity, as well as determine the effectiveness of the measures taken to improve the patient's safety during the treatment and diagnostic process. In this aspect, the Global Trigger Tool, developed by the Institute for Healthcare Improvement (USA), could be the most effective in assessing the safety of in-patient care provision. This methodology represents a list of triggers (prompts) that are defined for their purpose-oriented search in medical paper / electronic documentation. Perinatal trigger tool includes 8 indicators that may indicate an adverse event associated with pregnancy and childbirth. Currently, the global trigger methodology provides for prospective monitoring of clearly defined indicators online in the application of electronic medical documentation, and retrospective monitoring – in the analysis of medical records after the patient's discharge from the hospital.Conclusions. The latest global trends in the provision of medical care, namely the emphasis on patient safety, require new approaches to address the problem of medical errors and adverse events in perinatal medicine. Incident-reporting systems and the culture of patient safety, essential for their successful operation, should be the key elements of patient safety systems, which are implemented at the hospital, regional and national levels.

134 Background: Understanding and gaining familiarity with the adverse event (AE) and drug-drug interaction (DDI) potential of novel agents can be challenging, cumbersome, and time consuming for clinicians. A comprehensive and secure AE management/DDI mobile application (CT Scholar [Novartis Pharmaceuticals Corp]) was developed to ease the management of clinical trial participants with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer receiving ribociclib. Methods: CT Scholar was designed specifically for the ribociclib clinical program to provide easy access to information on AE and DDI management. The AE management module characterizes and quickly informs drug-specific AE management based on protocol guidelines and supportive care guidance. The DDI module includes a database of > 100 drugs searchable by both trade and generic name. Number of application visits, unique users, and screen views were monitored from Jan to Sept 2016. Results: There were 1055 visits to CT Scholar (117/month) by 145 unique users (28/month), with 5764 screen views (640/month) and 5.5 screens viewed/visit. Among the most-viewed modules were hematologic AE management (1132 views), gastrointestinal AE management (771), and DDI (734). Diarrhea, neutropenia, and nausea were the most viewed submodules (308, 230, and 205 views, respectively). The information on CT Scholar was consistently shown to be accessed more quickly than information obtained from printed clinical protocols. No patients discontinued from the ribociclib studies due to AEs following the introduction of CT Scholar. Conclusions: CT Scholar was widely used by clinicians, and it responded to their needs by providing essential information, especially on prevalent AEs, which could be easily updated and rapidly accessed. Additionally, CT Scholar provides a platform showing how technology can assist clinicians and patients in managing care during a trial, which can inform the development of future supportive materials.

Background:Retrospective analyses of large databases of treated patients can provide useful links to the presence of drug misuse or rare and infrequent adverse effects, such as agranulocytosis, diabetic ketoacidosis or neuroleptic malignant syndrome. The aim of this study is to describe the adverse effects to antipsychotics reported in the Australian Database of Adverse Event Notifications (DAEN).Methods:Data were collected from the DAEN – a spontaneous reporting database. The database, which covered the period from January 2004 to December 2017, was obtained from the Therapeutic Goods Administration (TGA) website (www.TGA.gov). The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide. All data were analysed descriptively. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant.Results:A total of 7122 adverse events associated with the antipsychotics aripiprazole, clozapine, haloperidol, olanzapine, paliperidone, pimozide, quetiapine and risperidone were reported to the TGA between January 2004 and December 2017. On average, there were 2.6 adverse events reported for each case. The most common adverse event reported for antipsychotics was neuroleptic malignant syndrome. There were no significant differences in the number of co-medications, formulations, indications, therapeutic dose, hospital admission and overdose among the antipsychotics between paediatric and adult populations. However, there were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years) (p < 0.05, chi squared test).Conclusion:The antipsychotic drug associated with the highest adverse events in adults was clozapine, followed by olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine.Plain language summaryAdverse events reported of antipsychoticsBackground: Retrospective analyses of large databases of treated patients can provide useful clues to the presence of drug misuse or rare and infrequent adverse effects associated with antipsychotics. The drugs selected for this investigation are the following: aripiprazole, clozapine, olanzapine, paliperidone, risperidone, ziprasidone, quetiapine, haloperidol and pimozide.Methods: All data were analysed descriptively and investigated for any associations between the variables collected. Comparison of reporting and management of adverse events between adults (older than 20 years) and children (5–19 years) was undertaken using chi squared test, where p < 0.05 is significant.Results: The antipsychotic drug associated with the highest adverse events was clozapine, followed by olanzapine. In children, the highest numbers of adverse events reported in the database were associated with risperidone, clozapine and olanzapine. The most common adverse event in adults, and reported with a number of antipsychotic drugs, was neuroleptic malignant syndrome.Conclusion: There were significant differences between causality, death and the management of adverse events between adult and paediatric populations (5–19 years).Keywords: Antipsychotics, adverse effects, adverse events, safety

Management of BTK Inhibitor Associated Adverse Events: Current Practice Trends Among Healthcare Providers and Concordance with Expert Recommendations

In the EV-302/KEYNOTE-A39 trial (NCT04223856), enfortumab vedotin + pembrolizumab (EV + P) became the first treatment in decades to demonstrate significant survival benefit compared with platinum-based chemotherapy in the first-line setting for patients with locally advanced or metastatic urothelial cancer. The safety profile of EV + P in EV-302/KEYNOTE-A39 was consistent with previous clinical studies and with the expected safety profiles of each agent alone; however, real-world experience in the management of adverse events (AEs) resulting from treatment with EV + P in patients with locally advanced or metastatic urothelial cancer is still evolving. Historically, healthcare professionals have been familiar with the management of EV and pembrolizumab as monotherapies, with guidance available for management of AEs with either drug alone. However, management of AEs with EV + P can sometimes be more complex since some of the AEs associated with EV also occur with pembrolizumab. Such AEs include skin reactions, hyperglycemia, and pneumonitis, all of which have been reported with either therapy alone and with increased incidence with the combination. In this podcast, we discuss the management of AEs with EV + P on the basis of our personal experiences with clinical trials and in our practices and provide perspectives for healthcare professionals on practical management of common AEs and effective dose management strategies. This may help improve the patient experience and allow patients to stay on therapy for longer, leading to optimized treatment outcomes.Podcast video (MP4 3,14,449 kb)Supplementary InformationThe online version contains supplementary material available at 10.1007/s40487-025-00369-9.

BackgroundAmikacin liposome inhalation suspension (ALIS), a nebulized formulation of amikacin, is the first treatment approved in the United States, as part of a combination therapy, for adults with refractory Mycobacterium avium complex lung disease (MAC-LD) who have limited or no alternative treatment options. In clinical studies, ALIS treatment was associated with adverse events (AEs) of mild or moderate severity which led to treatment discontinuation in up to 24.4% of patients. In clinical practice, inadequate management of AEs may lead to decreased treatment adherence and early discontinuation.An expert steering committee (SC) convened to establish practice-based, and expert-agreed recommendations for the mitigation strategies of ALIS-related AEs for patients with MAC-LD, with the aim of providing up-to-date practical recommendations for healthcare professionals.MethodsThe SC included: 7 pulmonologists, 2 infectious disease specialists, 1 otolaryngologist, 1 nurse practitioner, and 1 patient advocate. The SC aligned on clinical topics and identified critical unanswered questions. Recommendations were drafted to address each question based on a comprehensive literature review and clinical experience with patients. Consensus on recommendations for each statement was achieved via modified Delphi methodology voting on a 9-point scale.ResultsThe SC identified the following clinical topics: preparing the patient before the start of treatment; preventing AEs; monitoring AEs; mitigating AEs and incorporating the assistance of a multidisciplinary team. Due to the paucity of publications, most recommendations are expert-opinion based.ConclusionThe SC made recommendations based on literature, healthcare experience, and patient perspectives for the management of ALIS-associated AEs. A standardized team approach and involvement of a multidisciplinary team, including pulmonologists, infectious disease specialists and otolaryngologists, may help facilitate adherence to treatment. It is expected that successful recognition and management of AEs will be aided by educating patients and caregivers, and informed members of the clinical care team before and during ALIS treatment.This initiative was funded by Insmed Inc. with no input on the recommendations.DisclosuresColin Swenson, MD, Insmed Inc.: Advisor/Consultant Charles L. Daley, MD, AN2: Advisor/Consultant|AN2: Grant/Research Support|Bill and Melinda Gates Foundation: Advisor/Consultant|Bugworks: Grant/Research Support|Galapagos: Advisor/Consultant|Grifols: Advisor/Consultant|Hyfe: Advisor/Consultant|Insmed Inc.: Advisor/Consultant|Insmed Inc.: Grant/Research Support|Juvabis: Grant/Research Support|MannKind: Advisor/Consultant|MannKind: Grant/Research Support|Matinas BioPharma Holdings, Inc.: Advisor/Consultant|Monaghan: Advisor/Consultant|Nob Hill: Advisor/Consultant|Ostuka Pharmaceutical: Advisor/Consultant|Paratek Pharmaceuticals: Advisor/Consultant|Paratek Pharmaceuticals: Grant/Research Support|Shionogi: Advisor/Consultant|Spero Therapeutics: Advisor/Consultant|Spero Therapeutics: Grant/Research Support Jennifer Faber-Gerling, NP, Insmed Inc.: Advisor/Consultant Patrick A. Flume, MD, Insmed Inc.: Advisor/Consultant|Insmed Inc.: Grant/Research Support Shannon H. Kasperbauer, MD, AN2: Advisor/Consultant|COPD Foundation: Advisor/Consultant|Insmed Inc.: Advisor/Consultant|Paratek: Advisor/Consultant|Zambon: Advisor/Consultant H. Jeffrey Kim, MD, Insmed Inc.: Advisor/Consultant Amy Leitman, N/A, MicuRx: Advisor/Consultant Theodore K. Marras, MD, Insmed Inc.: Advisor/Consultant|Mannkind Corp: Advisor/Consultant|Partner Therapeutics: Advisor/Consultant Kenneth N. Olivier, MD, Insmed. Inc: Advisor/Consultant|Mannkind Corporation: Advisor/Consultant|Paratek Pharma: Advisor/Consultant|Paratek Pharma: Site PI|ReCode Therapeutics: Grant/Research Support|Spero Therapeutics: Advisor/Consultant|Spero Therapeutics: Site PI|Verona Pharma: Site PI Kevin L. Winthrop, MD, MPH, Insmed Inc.: Grant/Research Support Juzar Ali, MD; FRCP(C); FCCP , EuroImmun: Honoraria|Insmed Inc.: Advisor/Consultant

Background Comprehensive cancer care uses complementary approaches alongside specific anticancer therapy. Using a dedicated questionnaire, the Calista 2 national survey sought to assess the importance of supportive care and activities among breast cancer (BC) patients, how often these services are made available, the uptake rate, and the proportion of unmet needs. Methods Of the 82 physicians who accepted to take part in the survey, 29 recruited 257 patients with BC of whom 210 answered the patient-reported questionnaire. Patients meeting the inclusion criteria were adult females already on specific therapy for early or advanced BC. The patient-reported questionnaires covered drug management of pain, fatigue, adverse events (AE), sleep disorders, social and psychological support, physical activities, and complementary and alternative medicines. Items were rated on a scale of 0 – 10. Questionnaires were collected between September 2016 and October 2017. Results After exclusion of non-valid patient questionnaires, 197 were analyzed. The mean age of these patients was 56.8 years (SD 12.6); 53% had early stage disease and 41% advanced stage disease. Patients perceived the management of AE and pain, and self-image improvement techniques as the three most important items (8.0, 7.5, 6.7, respectively), followed by physical activity (6.3) and the management of fatigue (6.0), while preservation of fertility (2.3), spiritual support (2.5), counselling with regards to employment (3.2), and art therapy (3.3) were the least important. Most facilities were available at the point of care. Physicians frequently suggested management AE and pain (83% and 73%, respectively), self-image improvement techniques (73%) and psychological support for the patient (70%). Management of fatigue was however far less frequently proposed (30%). Management of AE (75%) and pain (60%), and self-image improvement (50%) were the most widely used support techniques. Only 19% of patients who were offered support in the management of fatigue declared actually using it. The management of fatigue nevertheless represented one of the three main unmet needs (for 27% of patients), together with complementary medicines (37%) and relaxation (29%). Conclusion These key findings highlight the fact that support for the management of AE and pain, together with self-image improvement techniques, are important for patients, are available, suggested and used. Although management of fatigue is available, it is rarely suggested by physicians and is therefore seen by patients as an unmet need. Patients also expressed the need for complementary medicines and relaxation techniques; these are however less frequently available at the point of care and seldom proposed. Citation Format: Simon H, Viguier J, Naman H, Touboul C, Lhomel C, Ganem G, Eisinger F, Morère J-F. Patient care in breast cancer: Unmet and fulfilled needs [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-11-23.

BACKGROUND Pediatric low-grade gliomas (pLGGs) can become a chronic disease requiring multiple courses of therapy. Emerging mitogen-activated protein kinase (MAPK) inhibitors (MAPKi) are targeted therapies that are effective in patients with pLGGs harboring mutations in the MAPK/extracellular signal-regulated kinase 1/2 (ERK) signaling pathway. Successful management of adverse events (AEs) that occur with MAPKi is important to optimize clinical benefit. A modified Delphi consensus initiative was conducted to provide recommendations on the monitoring and management of AEs that occur with MAPKi in patients with pLGG. METHODS A steering committee (n=9) of healthcare professionals (HCPs) from five countries was convened to develop statements based on the findings of a comprehensive literature review of AEs reported with use of MAPKi in pediatric cancers. Consensus on statements was determined via two online surveys completed by a large, global panel of experts in pLGG. RESULTS From the literature review, 117 articles and 31 abstracts containing information on the toxicity and tolerability profiles of MAPKi were relevant for the development of statements. Of the 129 statements drafted, consensus (≥75% agreement) amongst 82 global experts in pLGG from 29 countries was reached for 50 statements. Most of the consensus statements were related to the general management of AEs occurring with MAPKi and the management of cutaneous AEs. Guidance on skin care and specific cutaneous conditions was developed. Other AEs occurring with MAPKi, such as gastrointestinal, cardiac, endocrine, and ophthalmologic, were drug class or drug-specific, seen rarely, or had limited evidence or experience from which to achieve consensus recommendations. CONCLUSIONS Guidance and recommendations for the management of common AEs in patients with pLGG treated with MAPKi were developed. Sharing this knowledge amongst HCPs may lead to patients with pLGG achieving optimal benefit from MAPKi, while minimizing and effectively managing AEs.

Background: We investigated the role of pharmacists in adverse event (AE) management during renal cell carcinoma (RCC) drug therapy by surveying patients, physicians, and pharmacists. We identified the types of AEs for which pharmacist involvement is beneficial and explored measures to promote pharmacist intervention. Methods: This was an ad hoc analysis of a questionnaire-based cross-sectional web survey conducted from May to June 2022 among patients undergoing RCC drug therapy, physicians prescribing RCC treatments, and pharmacists involved in oncology care in Japan. Results: A total of 83 patients with metastatic RCC, 165 physicians, and 218 pharmacists were included. Among patients, 28.9% reported experiencing AEs or symptoms requiring pharmacist intervention. Most physicians (78.2%) and pharmacists (96.3%) supported pharmacist involvement in AE management. Notably, 35.6% of patients who reported no AEs or symptoms requiring pharmacist intervention acknowledged difficulty in communicating AEs to their physicians. Regarding desired pharmacist interventions for AEs, patients prioritized rash/pruritus, fatigue, and diarrhea; physicians emphasized stomatitis and anorexia; pharmacists identified constipation, stomatitis, and diarrhea. The most common reason patients valued pharmacist involvement was the reassurance of support from multiple healthcare providers. Physicians and pharmacists valued pharmacists' greater familiarity with AE management, particularly considering physicians' limited time. Raising awareness among patients and healthcare professionals, patient requests, and improving institutional support were strategies to enhance pharmacist involvement. Over 86% of healthcare professionals considered pharmaceutical outpatient clinics necessary to strengthen interdisciplinary collaboration. Conclusions: This study highlights widespread support among patients, physicians, and pharmacists for pharmacist involvement in managing AEs during RCC drug therapy.

PurposesPasireotide is the first medical therapy officially approved for adult patients with Cushing’s disease (CD) experiencing failure of pituitary surgery or not candidates for surgery. The current study aimed at investigating pasireotide effects on clinical picture and metabolic profile in patients enrolled in the phase III CSOM230B2305 trial at Naples center. In addition, the current study focused on safety issues encountered during the study, detailing the management of the different adverse events associated with the treatment with pasireotide in Naples center.MethodsFourteen patients entered the study; eight patients, receiving pasireotide for at least 6 months, were considered for the efficacy analysis, whereas the entire cohort of 14 patients was considered for the safety analysis.ResultsFull or partial disease control was obtained in 85.7% of patients, according to a “per-protocol” methodology analysis, and in 42.9% of patients, according to an “intention-to-treat” methodology analysis, after 12 months of treatment. A relevant improvement in clinical signs and symptoms, mainly in facial rubor, supraclavicular fat pad, bruising, hirsutism, and muscle strength was observed; body weight, body mass index, and waist circumference significantly reduced, and a slight non-significant reduction was observed in the prevalence of visceral obesity, hypercholesterolemia, and hypertriglyceridemia. Deterioration of glucose metabolism represented the most common adverse event, occurring in 71.4% of patients, and requiring a dietary regimen as first step, metformin therapy and/or long-acting insulin as second step, and short-acting insulin, as third step; no patients discontinued treatment for hyperglycaemia. Additional adverse events of interest were nausea (21.4%), and vomiting (14.3%), spontaneously resolved in few weeks or some months, except in one patient unsuccessfully treated with metoclopramide and ondansetron, and diarrhoea (14.3%), improved with loperamide treatment. Millimetric gallstones and biliary sludge (7.1%) were managed with ursodeoxycholic acid, inducing lithiasis and biliary sludge resolution, whereas hypocortisolism-related adverse events (7.1%) were resolved with a reduction in the pasireotide dose.ConclusionsThe current study on a limited series of patients contributes to confirm that pasireotide may be considered a valid option for treatment of patients with CD, although it requires an appropriate management of adverse events, especially hyperglycaemia.

Endoscopic devices and techniques for the management of bariatric surgical adverse events (with videos)

Health Care Economic Burden of Treatment and Rehabilitation for Neurogenic Lower Urinary Tract Dysfunction: A Systematic Review.