Impact of Obeticholic acid Exposure on Decompensation and Mortality in Primary Biliary Cholangitis and Cirrhosis
Obeticholic acid (OCA) is approved for the treatment of patients with primary biliary cholangitis (PBC) who are partial responders or intolerant to ursodeoxycholic acid. Reports of serious liver injury have raised concerns about its safety in cirrhosis. We investigated the effects of treatment with...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wolters Kluwer Health/LWW
2021-08-01
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| Series: | Hepatology Communications |
| Online Access: | https://doi.org/10.1002/hep4.1720 |
| _version_ | 1797935503624896512 |
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| author | Binu V. John Kaley Schwartz Cynthia Levy Bassam Dahman Yangyang Deng Paul Martin Tamar H. Taddei David E. Kaplan |
| author_facet | Binu V. John Kaley Schwartz Cynthia Levy Bassam Dahman Yangyang Deng Paul Martin Tamar H. Taddei David E. Kaplan |
| author_sort | Binu V. John |
| collection | DOAJ |
| description | Obeticholic acid (OCA) is approved for the treatment of patients with primary biliary cholangitis (PBC) who are partial responders or intolerant to ursodeoxycholic acid. Reports of serious liver injury have raised concerns about its safety in cirrhosis. We investigated the effects of treatment with OCA on hepatic decompensation and liver‐related mortality or transplantation in a cohort with compensated PBC cirrhosis. This was a retrospective cohort study using national data of US veterans with PBC and cirrhosis. We performed a propensity score model using variables associated with OCA prescription to control for baseline risk of decompensation. New OCA users were matched to nonusers. We identified 509 subjects with compensated PBC cirrhosis. We developed a propensity score model using variables associated with OCA prescription; 21 OCA users were matched with 84 nonusers. Over 569 and 3,847 person‐months, respectively, of follow‐up, 5 (23.8%) OCA users and 22 (26.2%) OCA nonusers decompensated. The C‐statistic of the propensity score model was 0.87. On multivariable analysis, after adjusting for potential confounders, OCA use was associated with an increased risk of hepatic decompensation (adjusted hazard ratio, 3.9; 95% confidence interval, 1.33‐11.57; P = 0.01). There was no association between OCA use and liver‐related mortality or transplantation (adjusted hazard ratio, 1.35; 95% confidence interval, 0.35‐5.21; P = 0.66). Conclusion: OCA use was associated with an increase in hepatic decompensation but not liver‐related mortality or transplantation in patients with compensated PBC cirrhosis. Additional studies are recommended to prospectively investigate these findings. |
| first_indexed | 2024-04-10T18:15:18Z |
| format | Article |
| id | doaj.art-e52c318199354e8384535aedfb7cbf35 |
| institution | Directory Open Access Journal |
| issn | 2471-254X |
| language | English |
| last_indexed | 2024-04-10T18:15:18Z |
| publishDate | 2021-08-01 |
| publisher | Wolters Kluwer Health/LWW |
| record_format | Article |
| series | Hepatology Communications |
| spelling | doaj.art-e52c318199354e8384535aedfb7cbf352023-02-02T09:07:49ZengWolters Kluwer Health/LWWHepatology Communications2471-254X2021-08-01581426143610.1002/hep4.1720Impact of Obeticholic acid Exposure on Decompensation and Mortality in Primary Biliary Cholangitis and CirrhosisBinu V. John0Kaley Schwartz1Cynthia Levy2Bassam Dahman3Yangyang Deng4Paul Martin5Tamar H. Taddei6David E. Kaplan7Division of Hepatology Bruce W Carter VA Medical Center Miami FL USADivision of Hepatology Bruce W Carter VA Medical Center Miami FL USADivision of Digestive Health and Liver Diseases University of Miami Miller School of Medicine Miami FL USADepartment of Health Behavior and Policy Virginia Commonwealth University Richmond VA USADepartment of Health Behavior and Policy Virginia Commonwealth University Richmond VA USADivision of Digestive Health and Liver Diseases University of Miami Miller School of Medicine Miami FL USASection of Digestive Diseases Yale School of Medicine New Haven CT USADivision of Gastroenterology and Hepatology University of Pennsylvania Philadelphia PA USAObeticholic acid (OCA) is approved for the treatment of patients with primary biliary cholangitis (PBC) who are partial responders or intolerant to ursodeoxycholic acid. Reports of serious liver injury have raised concerns about its safety in cirrhosis. We investigated the effects of treatment with OCA on hepatic decompensation and liver‐related mortality or transplantation in a cohort with compensated PBC cirrhosis. This was a retrospective cohort study using national data of US veterans with PBC and cirrhosis. We performed a propensity score model using variables associated with OCA prescription to control for baseline risk of decompensation. New OCA users were matched to nonusers. We identified 509 subjects with compensated PBC cirrhosis. We developed a propensity score model using variables associated with OCA prescription; 21 OCA users were matched with 84 nonusers. Over 569 and 3,847 person‐months, respectively, of follow‐up, 5 (23.8%) OCA users and 22 (26.2%) OCA nonusers decompensated. The C‐statistic of the propensity score model was 0.87. On multivariable analysis, after adjusting for potential confounders, OCA use was associated with an increased risk of hepatic decompensation (adjusted hazard ratio, 3.9; 95% confidence interval, 1.33‐11.57; P = 0.01). There was no association between OCA use and liver‐related mortality or transplantation (adjusted hazard ratio, 1.35; 95% confidence interval, 0.35‐5.21; P = 0.66). Conclusion: OCA use was associated with an increase in hepatic decompensation but not liver‐related mortality or transplantation in patients with compensated PBC cirrhosis. Additional studies are recommended to prospectively investigate these findings.https://doi.org/10.1002/hep4.1720 |
| spellingShingle | Binu V. John Kaley Schwartz Cynthia Levy Bassam Dahman Yangyang Deng Paul Martin Tamar H. Taddei David E. Kaplan Impact of Obeticholic acid Exposure on Decompensation and Mortality in Primary Biliary Cholangitis and Cirrhosis Hepatology Communications |
| title | Impact of Obeticholic acid Exposure on Decompensation and Mortality in Primary Biliary Cholangitis and Cirrhosis |
| title_full | Impact of Obeticholic acid Exposure on Decompensation and Mortality in Primary Biliary Cholangitis and Cirrhosis |
| title_fullStr | Impact of Obeticholic acid Exposure on Decompensation and Mortality in Primary Biliary Cholangitis and Cirrhosis |
| title_full_unstemmed | Impact of Obeticholic acid Exposure on Decompensation and Mortality in Primary Biliary Cholangitis and Cirrhosis |
| title_short | Impact of Obeticholic acid Exposure on Decompensation and Mortality in Primary Biliary Cholangitis and Cirrhosis |
| title_sort | impact of obeticholic acid exposure on decompensation and mortality in primary biliary cholangitis and cirrhosis |
| url | https://doi.org/10.1002/hep4.1720 |
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