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Naltrexone for alcohol use disorder: Hepatic safety in patients with and without liver disease
Naltrexone is an approved drug for management of alcohol use disorder (AUD), but data in patients with liver disease (LD) are limited. We aimed to evaluate the safety of naltrexone in those with LD. This is a retrospective cohort of adults with and without LD who were prescribed naltrexone for AUD f...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9701476/ https://www.ncbi.nlm.nih.gov/pubmed/36281979 http://dx.doi.org/10.1002/hep4.2080 |
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author | Ayyala, Divya Bottyan, Thomas Tien, Christine Pimienta, Michael Yoo, Jennie Stager, Kelli Gonzalez, Jose Luis Stolz, Andrew Dodge, Jennifer L. Terrault, Norah A. Han, Hyosun |
author_facet | Ayyala, Divya Bottyan, Thomas Tien, Christine Pimienta, Michael Yoo, Jennie Stager, Kelli Gonzalez, Jose Luis Stolz, Andrew Dodge, Jennifer L. Terrault, Norah A. Han, Hyosun |
author_sort | Ayyala, Divya |
collection | PubMed |
description | Naltrexone is an approved drug for management of alcohol use disorder (AUD), but data in patients with liver disease (LD) are limited. We aimed to evaluate the safety of naltrexone in those with LD. This is a retrospective cohort of adults with and without LD who were prescribed naltrexone for AUD from 2015 to 2019 in a safety‐net setting. Naltrexone hepatic safety was determined by liver enzyme changes during and after compared to before naltrexone prescription as well as rates of subsequent hospitalization and death by Kaplan‐Meier methods. Factors associated with hospitalization were examined by Cox regression. Of 160 patients prescribed naltrexone for AUD, 100 (63%) had LD and 47 (47%) of those with LD had cirrhosis (47% decompensated). The total cohort, LD, and cirrhosis groups had lower adjusted mean aspartate aminotransferase and alanine aminotransferase levels after versus before naltrexone prescription (p < 0.001). Two‐year survival was 97.7% (95% confidence interval [CI], 84.6–99.7), 95.4% (95% CI, 82.8–98.8), 90.8% (95% CI, 73.5–97.0), and 81.3% (95% CI, 41.2–93.8) in those without LD, LD without cirrhosis, cirrhosis, and decompensated cirrhosis groups (p = 0.46), respectively. Alcohol‐related 2‐year hospitalization rates were 8.2% (95% CI, 2.7–24), 27.7% (95% CI, 16.6–44.0), 40.5% (95% CI, 24.8–61.6), and 41.7% (95% CI, 23.3–66.6) for the groups without LD, LD without cirrhosis, cirrhosis, and decompensated cirrhosis (p = 0.007), respectively. Independent predictors of subsequent hospitalization were LD, (hazard ratio [HR], 3.70; 95% CI, 1.19–11.51; p = 0.02), cirrhosis (HR, 5.16; 95% CI, 1.69–15.75), and shorter duration (≤30 days) of naltrexone prescription (HR, 2.50; 95% CI, 1.l2–5.20; p = 0.01). Conclusion: Naltrexone is safe to use in patients with underlying LD, including those with compensated cirrhosis. Although encouraging, more safety data are needed for those with decompensated cirrhosis. |
format | Online Article Text |
id | pubmed-9701476 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-97014762022-11-28 Naltrexone for alcohol use disorder: Hepatic safety in patients with and without liver disease Ayyala, Divya Bottyan, Thomas Tien, Christine Pimienta, Michael Yoo, Jennie Stager, Kelli Gonzalez, Jose Luis Stolz, Andrew Dodge, Jennifer L. Terrault, Norah A. Han, Hyosun Hepatol Commun Original Articles Naltrexone is an approved drug for management of alcohol use disorder (AUD), but data in patients with liver disease (LD) are limited. We aimed to evaluate the safety of naltrexone in those with LD. This is a retrospective cohort of adults with and without LD who were prescribed naltrexone for AUD from 2015 to 2019 in a safety‐net setting. Naltrexone hepatic safety was determined by liver enzyme changes during and after compared to before naltrexone prescription as well as rates of subsequent hospitalization and death by Kaplan‐Meier methods. Factors associated with hospitalization were examined by Cox regression. Of 160 patients prescribed naltrexone for AUD, 100 (63%) had LD and 47 (47%) of those with LD had cirrhosis (47% decompensated). The total cohort, LD, and cirrhosis groups had lower adjusted mean aspartate aminotransferase and alanine aminotransferase levels after versus before naltrexone prescription (p < 0.001). Two‐year survival was 97.7% (95% confidence interval [CI], 84.6–99.7), 95.4% (95% CI, 82.8–98.8), 90.8% (95% CI, 73.5–97.0), and 81.3% (95% CI, 41.2–93.8) in those without LD, LD without cirrhosis, cirrhosis, and decompensated cirrhosis groups (p = 0.46), respectively. Alcohol‐related 2‐year hospitalization rates were 8.2% (95% CI, 2.7–24), 27.7% (95% CI, 16.6–44.0), 40.5% (95% CI, 24.8–61.6), and 41.7% (95% CI, 23.3–66.6) for the groups without LD, LD without cirrhosis, cirrhosis, and decompensated cirrhosis (p = 0.007), respectively. Independent predictors of subsequent hospitalization were LD, (hazard ratio [HR], 3.70; 95% CI, 1.19–11.51; p = 0.02), cirrhosis (HR, 5.16; 95% CI, 1.69–15.75), and shorter duration (≤30 days) of naltrexone prescription (HR, 2.50; 95% CI, 1.l2–5.20; p = 0.01). Conclusion: Naltrexone is safe to use in patients with underlying LD, including those with compensated cirrhosis. Although encouraging, more safety data are needed for those with decompensated cirrhosis. John Wiley and Sons Inc. 2022-10-25 /pmc/articles/PMC9701476/ /pubmed/36281979 http://dx.doi.org/10.1002/hep4.2080 Text en © 2022 The Authors. Hepatology Communications published by Wiley Periodicals LLC on behalf of American Association for the Study of Liver Diseases. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Original Articles Ayyala, Divya Bottyan, Thomas Tien, Christine Pimienta, Michael Yoo, Jennie Stager, Kelli Gonzalez, Jose Luis Stolz, Andrew Dodge, Jennifer L. Terrault, Norah A. Han, Hyosun Naltrexone for alcohol use disorder: Hepatic safety in patients with and without liver disease |
title | Naltrexone for alcohol use disorder: Hepatic safety in patients with and without liver disease |
title_full | Naltrexone for alcohol use disorder: Hepatic safety in patients with and without liver disease |
title_fullStr | Naltrexone for alcohol use disorder: Hepatic safety in patients with and without liver disease |
title_full_unstemmed | Naltrexone for alcohol use disorder: Hepatic safety in patients with and without liver disease |
title_short | Naltrexone for alcohol use disorder: Hepatic safety in patients with and without liver disease |
title_sort | naltrexone for alcohol use disorder: hepatic safety in patients with and without liver disease |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9701476/ https://www.ncbi.nlm.nih.gov/pubmed/36281979 http://dx.doi.org/10.1002/hep4.2080 |
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