Tiffany Wu, Omar Y Mousa, Tasha Kulai, Cori Larson, Amy Olofson, Patrick S Kamath, Vijay H Shah, Timucin Taner, William Sanchez, Douglas A Simonetto
{"title":"阿坎普罗酸治疗酒精相关性肝病的安全性：一项单组2期试验","authors":"Tiffany Wu, Omar Y Mousa, Tasha Kulai, Cori Larson, Amy Olofson, Patrick S Kamath, Vijay H Shah, Timucin Taner, William Sanchez, Douglas A Simonetto","doi":"10.1016/j.mayocp.2024.12.013","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To investigate the safety of acamprosate, a Food and Drug Administration-approved medication for alcohol use disorder, in patients with alcohol-associated liver disease.</p><p><strong>Methods: </strong>In this phase 2 open-label study, 12 patients with alcohol use disorder and alcohol-associated liver disease were enrolled between September 2020 and May 2022. Participants received acamprosate for 12 weeks and were followed up to 24 weeks. The primary end point was drug safety profile; secondary end points included alcohol craving, measured by the Penn Alcohol Craving Scale, and relapse. All safety data were reviewed by the Data and Safety Monitoring Board.</p><p><strong>Results: </strong>Patients were enrolled sequentially with Model for End-Stage Liver Disease-Sodium score below 20 (n=6) and 20 and above (n=6). Median age was 50 years, and 7 (58.3%) were female. Seven patients confirmed initiation of acamprosate, whereas 5 were lost to follow-up. There were no significant adverse events; only 1 patient reported pruritus, and no patients demonstrated worsening of liver disease. All patients experienced a decrease in or unchanged craving score from baseline to end of study.</p><p><strong>Conclusion: </strong>Acamprosate may be safe for and well tolerated by patients with alcohol-associated liver disease. Further studies are needed to assess the long-term efficacy of acamprosate.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT04287920.</p>","PeriodicalId":18334,"journal":{"name":"Mayo Clinic proceedings","volume":" ","pages":""},"PeriodicalIF":6.9000,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Safety of Acamprosate in Patients With Alcohol-Associated Liver Disease: A Single-Arm Phase 2 Trial.\",\"authors\":\"Tiffany Wu, Omar Y Mousa, Tasha Kulai, Cori Larson, Amy Olofson, Patrick S Kamath, Vijay H Shah, Timucin Taner, William Sanchez, Douglas A Simonetto\",\"doi\":\"10.1016/j.mayocp.2024.12.013\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To investigate the safety of acamprosate, a Food and Drug Administration-approved medication for alcohol use disorder, in patients with alcohol-associated liver disease.</p><p><strong>Methods: </strong>In this phase 2 open-label study, 12 patients with alcohol use disorder and alcohol-associated liver disease were enrolled between September 2020 and May 2022. Participants received acamprosate for 12 weeks and were followed up to 24 weeks. The primary end point was drug safety profile; secondary end points included alcohol craving, measured by the Penn Alcohol Craving Scale, and relapse. All safety data were reviewed by the Data and Safety Monitoring Board.</p><p><strong>Results: </strong>Patients were enrolled sequentially with Model for End-Stage Liver Disease-Sodium score below 20 (n=6) and 20 and above (n=6). Median age was 50 years, and 7 (58.3%) were female. Seven patients confirmed initiation of acamprosate, whereas 5 were lost to follow-up. There were no significant adverse events; only 1 patient reported pruritus, and no patients demonstrated worsening of liver disease. All patients experienced a decrease in or unchanged craving score from baseline to end of study.</p><p><strong>Conclusion: </strong>Acamprosate may be safe for and well tolerated by patients with alcohol-associated liver disease. Further studies are needed to assess the long-term efficacy of acamprosate.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier: NCT04287920.</p>\",\"PeriodicalId\":18334,\"journal\":{\"name\":\"Mayo Clinic proceedings\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":6.9000,\"publicationDate\":\"2025-03-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Mayo Clinic proceedings\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1016/j.mayocp.2024.12.013\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Mayo Clinic proceedings","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.mayocp.2024.12.013","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Safety of Acamprosate in Patients With Alcohol-Associated Liver Disease: A Single-Arm Phase 2 Trial.
Objective: To investigate the safety of acamprosate, a Food and Drug Administration-approved medication for alcohol use disorder, in patients with alcohol-associated liver disease.
Methods: In this phase 2 open-label study, 12 patients with alcohol use disorder and alcohol-associated liver disease were enrolled between September 2020 and May 2022. Participants received acamprosate for 12 weeks and were followed up to 24 weeks. The primary end point was drug safety profile; secondary end points included alcohol craving, measured by the Penn Alcohol Craving Scale, and relapse. All safety data were reviewed by the Data and Safety Monitoring Board.
Results: Patients were enrolled sequentially with Model for End-Stage Liver Disease-Sodium score below 20 (n=6) and 20 and above (n=6). Median age was 50 years, and 7 (58.3%) were female. Seven patients confirmed initiation of acamprosate, whereas 5 were lost to follow-up. There were no significant adverse events; only 1 patient reported pruritus, and no patients demonstrated worsening of liver disease. All patients experienced a decrease in or unchanged craving score from baseline to end of study.
Conclusion: Acamprosate may be safe for and well tolerated by patients with alcohol-associated liver disease. Further studies are needed to assess the long-term efficacy of acamprosate.
期刊介绍：
Mayo Clinic Proceedings is a premier peer-reviewed clinical journal in general medicine. Sponsored by Mayo Clinic, it is one of the most widely read and highly cited scientific publications for physicians. Since 1926, Mayo Clinic Proceedings has continuously published articles that focus on clinical medicine and support the professional and educational needs of its readers. The journal welcomes submissions from authors worldwide and includes Nobel-prize-winning research in its content. With an Impact Factor of 8.9, Mayo Clinic Proceedings is ranked #20 out of 167 journals in the Medicine, General and Internal category, placing it in the top 12% of these journals. It invites manuscripts on clinical and laboratory medicine, health care policy and economics, medical education and ethics, and related topics.
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