Clinical Gastroenterology and Hepatology最新文献

筛选
英文 中文
Non-colorectal Cancer Screening and Vaccinations in Patients with Inflammatory Bowel Disease: Expert Review.
IF 11.6 1区 医学
Clinical Gastroenterology and Hepatology Pub Date : 2025-01-10 DOI: 10.1016/j.cgh.2024.12.011
Freddy Caldera, Sunanda Kane, Millie Long, Jana G Hashash
{"title":"Non-colorectal Cancer Screening and Vaccinations in Patients with Inflammatory Bowel Disease: Expert Review.","authors":"Freddy Caldera, Sunanda Kane, Millie Long, Jana G Hashash","doi":"10.1016/j.cgh.2024.12.011","DOIUrl":"https://doi.org/10.1016/j.cgh.2024.12.011","url":null,"abstract":"<p><strong>Description: </strong>The aim of this American Gastroenterological Association (AGA) Clinical Practice Update (CPU) is to provide best practice advice (BPA) statements for gastroenterologists and other health care providers who provide care to patients with inflammatory bowel disease (IBD). The focus is on IBD-specific screenings (excluding colorectal cancer screening, which is discussed separately) and vaccinations. We provide guidance to ensure that patients are up to date with the disease-specific cancer screenings, vaccinations, as well as advice for mental health and general wellbeing.</p><p><strong>Methods: </strong>This expert review was commissioned and approved by the AGA CPU Committee and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership and underwent internal peer review by the CPU Committee and external peer review through standard procedures of Clinical Gastroenterology and Hepatology. The BPA statements were drawn from reviewing existing literature combined with expert opinion to provide practical advice on the screening for non-colorectal cancers and vaccinations in patients with IBD. Because this was not a systematic review, formal rating of the quality of evidence or strength of the presented considerations was not performed.</p><p><strong>Best practice advice statements: </strong>BPA 1. All adult patients with IBD should receive age-appropriate cancer screening. BPA 2. Adult women with IBD should follow age-appropriate screening for cervical dysplasia. Data are insufficient to determine whether patients receiving combined immunosuppression or thiopurines require more frequent screening. Shared decision making and individual risk stratification are encouraged. BPA 3. All adult patients with IBD should follow skin cancer primary prevention practices by avoiding excessive exposure to the sun's ultraviolet radiation. Patients on immunomodulators, anti-tumor necrosis factor (anti-TNF) biologic agents, or small molecules should undergo yearly total body skin exam (TBSE). Patients with any history of thiopurine use should continue with yearly TBSE even after thiopurine cessation. BPA 4. At every colonoscopy, a thorough perianal and anal examination should be performed. Special attention should be made to inspection of the anal canal of patients with perianal Crohn's disease, anal stricture, human papilloma virus (HPV), human immunodeficiency virus (HIV), and those who engage in anoreceptive intercourse. BPA 5. Gastroenterology clinicians should discuss age-appropriate vaccines with adult patients who have IBD and share responsibility with primary care providers for administering these vaccines. Patients with IBD should follow the adult immunization schedule recommended by the Centers for Disease Control and Prevention (CDC) for all vaccines with the exception of live vaccines; Patients receiving immune modifying agents should be counseled against receiving live va","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969338","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Lifestyle and Pharmacologic Approaches to Prevention of MASLD-related HCC.
IF 11.6 1区 医学
Clinical Gastroenterology and Hepatology Pub Date : 2025-01-10 DOI: 10.1016/j.cgh.2024.09.041
Makan Cheraghpour, Behzad Hatami, Amit G Singal
{"title":"Lifestyle and Pharmacologic Approaches to Prevention of MASLD-related HCC.","authors":"Makan Cheraghpour, Behzad Hatami, Amit G Singal","doi":"10.1016/j.cgh.2024.09.041","DOIUrl":"https://doi.org/10.1016/j.cgh.2024.09.041","url":null,"abstract":"<p><p>Hepatocellular carcinoma (HCC) is a major concern for public health. Fatty liver disease, related to alcohol misuse or metabolic syndrome, has become the leading cause of chronic liver disease and HCC. The strong association between type 2 diabetes mellitus and HCC can be partly attributed to the development of metabolic dysfunction associated steatotic liver disease (MASLD). There is a strong interest in strategies that may mitigate HCC risk and reduce HCC incidence in this growing population of at-risk individuals. In this review, we describe the pathogenesis of HCC in patients with MASLD and discuss potential emerging pharmacological and lifestyle interventions for MASLD-related HCC. HCC risk has been observed to be lower with healthy lifestyle behaviors, such as healthy dietary patterns, e.g., high consumption of vegetables, whole grains, fish, and poultry, yogurt, and olive oil, and low consumption of red and processed meats and dietary sugar) and increased physical activity. Selecting an appropriate anti-diabetic therapy for individuals with liver disease and diabetes may also decrease the occurrence of HCC. Metformin, PPAR activators, sodium-glucose cotransporter 2 (SGLT2) inhibitors, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 receptor agonists (GLP-1RA), aspirin, and statins have all shown promise to reduce the risk of HCC, although guidelines do not recommend their use for the sole purpose of chemoprevention at this time given a dearth of data defining their risk-benefit ratio.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142969040","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Point-of-care ultrasound in Gastroenterology and Hepatology.
IF 11.6 1区 医学
Clinical Gastroenterology and Hepatology Pub Date : 2025-01-08 DOI: 10.1016/j.cgh.2024.09.040
Nagasri Shankar, Lily Kuo, Noa Krugliak Cleveland, Benjamin Galen, Nicholas S Samel, Ariadna Perez-Sanchez, Robert Nathanson, Elizabeth Coss, Juan Echavarria, David T Rubin, Nilam J Soni
{"title":"Point-of-care ultrasound in Gastroenterology and Hepatology.","authors":"Nagasri Shankar, Lily Kuo, Noa Krugliak Cleveland, Benjamin Galen, Nicholas S Samel, Ariadna Perez-Sanchez, Robert Nathanson, Elizabeth Coss, Juan Echavarria, David T Rubin, Nilam J Soni","doi":"10.1016/j.cgh.2024.09.040","DOIUrl":"https://doi.org/10.1016/j.cgh.2024.09.040","url":null,"abstract":"<p><p>Point-of-care ultrasound (POCUS) is changing the practice of nearly all specialties and is increasingly being incorporated as a bedside tool by more gastroenterologists and hepatologists. POCUS is most often used to answer focused clinical questions, supplement the traditional physical examination, and guide performance of invasive bedside procedures. This review describes several common POCUS applications used in gastroenterology and hepatology, as well as some novel applications that warrant further investigation.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142963975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Twin Pregnancies in Inflammatory Bowel Disease are Associated with Increased Adverse Outcomes.
IF 11.6 1区 医学
Clinical Gastroenterology and Hepatology Pub Date : 2025-01-03 DOI: 10.1016/j.cgh.2024.12.005
Elena F Cattaneo, Eugenia Shmidt, Ariella Bar-Gil Shitrit, Pranavi Nara, Raina Shivashankar, Sunanda Kane
{"title":"Twin Pregnancies in Inflammatory Bowel Disease are Associated with Increased Adverse Outcomes.","authors":"Elena F Cattaneo, Eugenia Shmidt, Ariella Bar-Gil Shitrit, Pranavi Nara, Raina Shivashankar, Sunanda Kane","doi":"10.1016/j.cgh.2024.12.005","DOIUrl":"https://doi.org/10.1016/j.cgh.2024.12.005","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":""},"PeriodicalIF":11.6,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Preparing the Next Generation of Gastroenterologists to Tackle Climate Change. 培养下一代消化内科医生应对气候变化。
IF 11.6 1区 医学
Clinical Gastroenterology and Hepatology Pub Date : 2025-01-01 Epub Date: 2024-10-04 DOI: 10.1016/j.cgh.2024.07.043
Amisha Ahuja, Nitin K Ahuja
{"title":"Preparing the Next Generation of Gastroenterologists to Tackle Climate Change.","authors":"Amisha Ahuja, Nitin K Ahuja","doi":"10.1016/j.cgh.2024.07.043","DOIUrl":"10.1016/j.cgh.2024.07.043","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":"7-10"},"PeriodicalIF":11.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142380167","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Role of Sex, Anxiety, and Resilience in the Association Between Adverse Childhood Experiences and Irritable Bowel Syndrome. 性别、焦虑和复原力在童年不良经历与肠易激综合征之间的关联中的作用。
IF 11.6 1区 医学
Clinical Gastroenterology and Hepatology Pub Date : 2025-01-01 Epub Date: 2024-06-13 DOI: 10.1016/j.cgh.2024.05.041
Anna H Lee, Swapna Mahurkar-Joshi, Bruce Naliboff, Arpana Gupta, Jennifer Labus, Kirsten Tillisch, Emeran Mayer, Lin Chang
{"title":"Role of Sex, Anxiety, and Resilience in the Association Between Adverse Childhood Experiences and Irritable Bowel Syndrome.","authors":"Anna H Lee, Swapna Mahurkar-Joshi, Bruce Naliboff, Arpana Gupta, Jennifer Labus, Kirsten Tillisch, Emeran Mayer, Lin Chang","doi":"10.1016/j.cgh.2024.05.041","DOIUrl":"10.1016/j.cgh.2024.05.041","url":null,"abstract":"<p><strong>Background & aims: </strong>Adverse childhood experiences (ACE) are associated with increased risk of irritable bowel syndrome (IBS), a female-predominant chronic abdominal disorder. Factors contributing to this association have not been well-studied. We compared sex differences in ACE for adults with and without IBS and evaluated the impact of anxiety and resilience on the relationship between ACE and IBS.</p><p><strong>Methods: </strong>Sex and disease differences in total score and ACE subtypes from the ACE Questionnaire in subjects with IBS and control subjects were assessed. Cross-sectional mediation analysis determined if anxiety (Hospital Anxiety and Depression Scale) and resilience (Connor-Davidson Resilience Scale or Brief Resilience Scale) mediated the relationship between ACE and IBS.</p><p><strong>Results: </strong>Of 798 participants studied, 368 met IBS diagnostic criteria (265 women, 103 men) and 430 were healthy control subjects (277 women, 153 men). Prevalence and number of ACE were higher in IBS versus control subjects (P < .001) but similar between IBS women and men. Household mental illness increased odds of having IBS in women (odds ratio [OR], 1.95; 95% confidence interval [CI], 1.35-2.85; false discovery rate [FDR], 0.002) and men (OR, 2.32; 95% CI, 1.26-4.33; FDR, 0.014). Emotional abuse increased odds of having IBS in women (OR, 1.94; 95% CI, 1.23-3.09; FDR, 0.019) and sexual abuse increased odds of IBS in men (OR, 3.54; 95% CI, 1.35-10.38; FDR, 0.027). Anxiety mediated 54% (P < .001) of ACE's effect on IBS risk and resilience mediated 12%-14% (Connor-Davidson Resilience Scale, P = .008; Brief Resilience Scale, P = .018).</p><p><strong>Conclusions: </strong>Both men and women with a history of ACE are twice as likely to have IBS than those without an ACE. Anxiety mediated the relationship between ACE and IBS in men and women and resilience mediated this relationship only in women.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":"154-162.e2"},"PeriodicalIF":11.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11648812/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141327277","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Venture Capital in Retreat: Funding Trends in Gastroenterology Over the Past Decade. 撤退中的风险投资:过去十年胃肠病学的融资趋势。
IF 11.6 1区 医学
Clinical Gastroenterology and Hepatology Pub Date : 2025-01-01 Epub Date: 2024-10-16 DOI: 10.1016/j.cgh.2024.08.043
Jonathan A Busam, Eric D Shah
{"title":"Venture Capital in Retreat: Funding Trends in Gastroenterology Over the Past Decade.","authors":"Jonathan A Busam, Eric D Shah","doi":"10.1016/j.cgh.2024.08.043","DOIUrl":"10.1016/j.cgh.2024.08.043","url":null,"abstract":"","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":"11-13"},"PeriodicalIF":11.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11663690/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459527","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Underwater Endoscopic Mucosal Resection Vs Conventional Endoscopic Mucosal Resection for Superficial Nonampullary Duodenal Epithelial Tumors in the Western Setting. 水下 EMR 与传统 EMR 在西方国家治疗浅表非髓质十二指肠上皮肿瘤的对比。
IF 11.6 1区 医学
Clinical Gastroenterology and Hepatology Pub Date : 2025-01-01 Epub Date: 2024-05-22 DOI: 10.1016/j.cgh.2024.05.011
Rui Morais, José Amorim, Renato Medas, Bernardo Sousa-Pinto, João Santos-Antunes, Romain Legros, Jérémie Albouys, Frédéric Moll, Margarida Marques, Filipe Vilas-Boas, Eduardo Rodrigues-Pinto, Irene Gullo, Fátima Carneiro, Elisa Gravito Soares, Pedro Amaro, Pedro Mesquita, Jaime Rodrigues, Gianluca Andrisani, Sandro Sferrazza, Sara Archer, Ricardo Kuttner-Magalhães, Francisco Manzano, Enrique Rodríguez de Santiago, Alessandro Rimondi, Alberto Murino, Edward Despott, Mathieu Pioche, Jérémie Jacques, Guilherme Macedo
{"title":"Underwater Endoscopic Mucosal Resection Vs Conventional Endoscopic Mucosal Resection for Superficial Nonampullary Duodenal Epithelial Tumors in the Western Setting.","authors":"Rui Morais, José Amorim, Renato Medas, Bernardo Sousa-Pinto, João Santos-Antunes, Romain Legros, Jérémie Albouys, Frédéric Moll, Margarida Marques, Filipe Vilas-Boas, Eduardo Rodrigues-Pinto, Irene Gullo, Fátima Carneiro, Elisa Gravito Soares, Pedro Amaro, Pedro Mesquita, Jaime Rodrigues, Gianluca Andrisani, Sandro Sferrazza, Sara Archer, Ricardo Kuttner-Magalhães, Francisco Manzano, Enrique Rodríguez de Santiago, Alessandro Rimondi, Alberto Murino, Edward Despott, Mathieu Pioche, Jérémie Jacques, Guilherme Macedo","doi":"10.1016/j.cgh.2024.05.011","DOIUrl":"10.1016/j.cgh.2024.05.011","url":null,"abstract":"<p><strong>Background & aims: </strong>Conventional endoscopic mucosal resection (C-EMR) is established as the primary treatment modality for superficial nonampullary duodenal epithelial tumors (SNADETs), but recently underwater endoscopic mucosal resection (U-EMR) has emerged as a potential alternative. The majority of previous studies focused on Asian populations and small lesions (≤20 mm). We aimed to compare the efficacy and outcomes of U-EMR vs C-EMR for SNADETs in a Western setting.</p><p><strong>Methods: </strong>This was a retrospective multinational study from 10 European centers that performed both C-EMR and U-EMR between January 2013 and July 2023. The main outcomes were the technical success, procedure-related adverse events (AEs), and the residual/recurrent adenoma (RRA) rate, evaluated on a per-lesion basis. We assessed the association between the type of endoscopic mucosal resection and the occurrence of AEs or RRAs using mixed-effects logistic regression models (propensity scores). Sensitivity analyses were performed for lesions ≤20 mm or >20 mm.</p><p><strong>Results: </strong>A total of 290 SNADETs submitted to endoscopic resection during the study period met the inclusion criteria and were analyzed (C-EMR: n = 201, 69.3%; U-EMR: n = 89, 30.7%). The overall technical success rate was 95.5% and comparable between groups. In logistic regression models, compared with U-EMR, C-EMR was associated with a significantly higher frequency of overall delayed AEs (odds ratio [OR], 4.95; 95% CI, 2.87-8.53), postprocedural bleeding (OR, 7.92; 95% CI, 3.95-15.89), and RRAs (OR, 3.66; 95% CI, 2.49-5.37). Sensitivity analyses confirmed these results when solely considering either small (≤20 mm) or large (>20 mm) lesions.</p><p><strong>Conclusions: </strong>Compared with C-EMR, U-EMR was associated with a lower rate of overall AEs and RRAs, regardless of lesion size. Our results confirm the possible role of U-EMR as an effective and safe technique in the management of SNADETs.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":"79-88.e4"},"PeriodicalIF":11.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141086740","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effects of Intermittent Calorie Restriction in Nondiabetic Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease. 间歇性卡路里限制对患有代谢功能障碍相关脂肪肝的非糖尿病患者的影响。
IF 11.6 1区 医学
Clinical Gastroenterology and Hepatology Pub Date : 2025-01-01 Epub Date: 2024-08-23 DOI: 10.1016/j.cgh.2024.06.051
Han Ah Lee, Hyeyoung Moon, Yuri Kim, Jeong Kyong Lee, Hye Ah Lee, Hwi Young Kim
{"title":"Effects of Intermittent Calorie Restriction in Nondiabetic Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease.","authors":"Han Ah Lee, Hyeyoung Moon, Yuri Kim, Jeong Kyong Lee, Hye Ah Lee, Hwi Young Kim","doi":"10.1016/j.cgh.2024.06.051","DOIUrl":"10.1016/j.cgh.2024.06.051","url":null,"abstract":"<p><strong>Background & aims: </strong>We compared the effects of a 12-week intermittent calorie restriction (ICR) and standard-of-care (SOC) diet on liver fat content (LFC) in metabolic dysfunction-associated steatotic liver disease patients.</p><p><strong>Methods: </strong>This randomized controlled trial included patients with magnetic resonance imaging-proton density fat fraction ≥8%. Patients were randomly assigned to the ICR (5:2 diet) or SOC (80% of the recommended calorie intake) groups and stratified according to the body mass index (≥25 or <25 kg/m<sup>2</sup>). The primary outcome was the proportion of patients who achieved a relative LFC reduction as measured by magnetic resonance imaging-proton density fat fraction ≥30%.</p><p><strong>Results: </strong>Seventy-two participants underwent randomization (36 patients with and 36 without obesity), and 63 (34 patients with and 29 without obesity) completed the trial. At week 12, a higher proportion of patients in the ICR arm achieved a relative LFC reduction of ≥30% compared with the SOC arm (72.2% vs 44.4%; P = .033), which was more prominent in the group with obesity (61.1% vs 27.7%; P = .033) than in the group without obesity (83.3% vs 61.1%; P = .352). The relative weight reduction was insignificant between the ICR and SOC arms (-5.3% vs -4.2%; P = .273); however, it was higher in the ICR arm compared with the SOC arm (-5.5% vs -2.9%; P = .039) in the group with obesity. Changes in fibrosis, muscle and fat mass, and liver enzyme levels were similar between the 2 groups (all P > .05).</p><p><strong>Conclusions: </strong>The ICR diet reduced LFC more effectively than SOC in patients with metabolic dysfunction-associated steatotic liver disease, particularly in patients with obesity. Additional studies are warranted in larger and more diverse cohorts.</p><p><strong>Clinicaltrials: </strong>gov, Number: NCT05309642.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":"114-123.e13"},"PeriodicalIF":11.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142055141","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Safety and Efficacy of Efruxifermin in Combination With a GLP-1 Receptor Agonist in Patients With NASH/MASH and Type 2 Diabetes in a Randomized Phase 2 Study. 在一项随机 2 期研究中,埃福昔明与 GLP-1 受体激动剂联用对 NASH/MASH 和 2 型糖尿病患者的安全性和疗效。
IF 11.6 1区 医学
Clinical Gastroenterology and Hepatology Pub Date : 2025-01-01 Epub Date: 2024-03-04 DOI: 10.1016/j.cgh.2024.02.022
Stephen A Harrison, Juan P Frias, K Jean Lucas, Gary Reiss, Guy Neff, Sureka Bollepalli, Yan Su, Doreen Chan, Erik J Tillman, Ali Moulton, Brittany de Temple, Arian Zari, Reshma Shringarpure, Timothy Rolph, Andrew Cheng, Kitty Yale
{"title":"Safety and Efficacy of Efruxifermin in Combination With a GLP-1 Receptor Agonist in Patients With NASH/MASH and Type 2 Diabetes in a Randomized Phase 2 Study.","authors":"Stephen A Harrison, Juan P Frias, K Jean Lucas, Gary Reiss, Guy Neff, Sureka Bollepalli, Yan Su, Doreen Chan, Erik J Tillman, Ali Moulton, Brittany de Temple, Arian Zari, Reshma Shringarpure, Timothy Rolph, Andrew Cheng, Kitty Yale","doi":"10.1016/j.cgh.2024.02.022","DOIUrl":"10.1016/j.cgh.2024.02.022","url":null,"abstract":"<p><strong>Background & aims: </strong>In phase 2 studies, efruxifermin, an Fc-FGF21 analog, significantly reduced steatohepatitis and fibrosis in patients with non-alcoholic steatohepatitis, now called metabolic dysfunction-associated steatohepatitis (MASH), for which there is no approved treatment. Type 2 diabetes (T2D) and obesity are prevalent among patients with MASH and increasingly treated with glucagon-like peptide-1 receptor agonists (GLP-1RAs). This study evaluated the safety and efficacy of efruxifermin in patients with MASH, fibrosis, and T2D taking a GLP-1RA.</p><p><strong>Methods: </strong>Cohort D was a double-blind, placebo-controlled, phase 2b study in adults with T2D and MASH with fibrosis (F1-F3) on stable GLP-1RA therapy randomized (2:1) to receive efruxifermin 50 mg or placebo, once weekly for 12 weeks. The primary endpoint was safety and tolerability of efruxifermin added to a stable dose of GLP-1RA. Secondary endpoints included changes in hepatic fat fraction (HFF), markers of liver injury and fibrosis, and metabolic parameters.</p><p><strong>Results: </strong>Adults (N = 31) with T2D and MASH fibrosis (F1-F3) on a stable GLP-1RA (semaglutide, 48.4%; dulaglutide, 45.2%; liraglutide, 6.5%) received efruxifermin 50 mg (n = 21) or placebo (n = 10) for 12 weeks. The addition of efruxifermin to a GLP-1RA appeared safe and well-tolerated. The most frequent efruxifermin-related adverse events were mild to moderate gastrointestinal events. One patient receiving efruxifermin discontinued due to nausea, and another withdrew consent. There were no treatment-related serious adverse events. After 12 weeks, efruxifermin reduced HFF by 65% (P < .0001 vs placebo) compared with a 10% reduction for placebo (GLP-1RA alone). Efruxifermin also improved noninvasive markers of liver injury, fibrosis, glucose, and lipid metabolism while maintaining GLP-1RA-mediated weight loss.</p><p><strong>Conclusions: </strong>The tolerability profile of efruxifermin added to GLP-1RA appeared comparable to that of either drug alone, while also significantly reducing HFF and noninvasive markers of fibrosis in patients with MASH and T2D. Liver health in patients already on a GLP-1RA may be further improved by addition of efruxifermin.</p><p><strong>Clinicaltrials: </strong>gov, Number: NCT05039450.</p>","PeriodicalId":10347,"journal":{"name":"Clinical Gastroenterology and Hepatology","volume":" ","pages":"103-113"},"PeriodicalIF":11.6,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140048950","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
相关产品
×
本文献相关产品
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信