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Major hepatic complications in ursodeoxycholic acid-treated patients with primary biliary cholangitis: Risk factors and time trends in incidence and outcome
| dc.creator | Harms M.H., Lammers W.J., Thorburn D., Corpechot C., Invernizzi P., Janssen H.L.A., Battezzati P.M., Nevens F., Lindor K.D., Floreani A., Ponsioen C.Y., Mayo M.J., Dalekos G.N., Bruns T., Parés A., Mason A.L., Verhelst X., Kowdley K.V., Goet J.C., Hirschfield G.M., Hansen B.E., Van Buuren H.R. | en |
| dc.date.accessioned | 2023-01-31T08:27:53Z | |
| dc.date.available | 2023-01-31T08:27:53Z | |
| dc.date.issued | 2018 | |
| dc.identifier | 10.1038/ajg.2017.440 | |
| dc.identifier.issn | 00029270 | |
| dc.identifier.uri | http://hdl.handle.net/11615/73906 | |
| dc.description.abstract | Objectives: In this era of near universal ursodeoxycholic acid (UDCA) treatment for primary biliary cholangitis (PBC), progression to cirrhosis still occurs in an important proportion of patients. The aim of this study was to describe the incidence of cirrhosis-associated complications in patients with PBC and assess risk factors and impact on survival. Methods: Cohorts of UDCA-treated patients from 16 European and North-American liver centers were included. We used Cox proportional hazards assumptions and Kaplan-Meier estimates. Results: During 8.1 years' median follow-up, 278 of 3,224 patients developed ascites, variceal bleeding, and/or encephalopathy (incidence rate of 9.7 cases/1,000 patient years). The overall cumulative incidence was 9.1% after 10 years of follow-up, but decreased over time to 5.8% after the year 2000. Earlier calendar year of diagnosis (P<0.001), high aspartate aminotransferase to platelets ratio index (APRI; P<0.001) and biochemical non-response (P<0.001) were independently associated with future complications. Patients with both biochemical non-response and an APRI >0.54 after 12 months of UDCA had a 10-year complication rate of 37.4%, as compared to 3.2% in biochemical responders with an APRI ≤0.54. The 10-year transplantation-free survival after a complication was 9% (time-dependent hazard ratio 21.5; 20.1-22.8). Prognosis after variceal bleeding has improved over time. Conclusions: In this large international cohort, up to 15% of UDCA-treated PBC patients developed major non-neoplastic, cirrhosis-associated hepatic complications within 15 years, but cumulative incidence has decreased over time. Biochemical non-response to UDCA and APRI were independent risk factors for these complications. Subsequent long-term outcome after complications is generally poor, but has improved over the past decades. © 2018 by the American College of Gastroenterology. | en |
| dc.language.iso | en | en |
| dc.source | American Journal of Gastroenterology | en |
| dc.source.uri | https://www.scopus.com/inward/record.uri?eid=2-s2.0-85042464929&doi=10.1038%2fajg.2017.440&partnerID=40&md5=a4da0ad9b8d16795f67584485498eb69 | |
| dc.subject | aspartate aminotransferase | en |
| dc.subject | ursodeoxycholic acid | en |
| dc.subject | aspartate aminotransferase | en |
| dc.subject | cholagogue | en |
| dc.subject | ursodeoxycholic acid | en |
| dc.subject | adult | en |
| dc.subject | Article | en |
| dc.subject | ascites | en |
| dc.subject | brain disease | en |
| dc.subject | cohort analysis | en |
| dc.subject | controlled study | en |
| dc.subject | disease course | en |
| dc.subject | European | en |
| dc.subject | female | en |
| dc.subject | hepatic encephalopathy | en |
| dc.subject | human | en |
| dc.subject | incidence | en |
| dc.subject | Kaplan Meier method | en |
| dc.subject | liver disease | en |
| dc.subject | long term care | en |
| dc.subject | major clinical study | en |
| dc.subject | male | en |
| dc.subject | North American | en |
| dc.subject | primary biliary cirrhosis | en |
| dc.subject | priority journal | en |
| dc.subject | prognosis | en |
| dc.subject | proportional hazards model | en |
| dc.subject | risk factor | en |
| dc.subject | survival | en |
| dc.subject | treatment outcome | en |
| dc.subject | aged | en |
| dc.subject | ascites | en |
| dc.subject | biliary cirrhosis | en |
| dc.subject | blood | en |
| dc.subject | disease exacerbation | en |
| dc.subject | esophagus varices | en |
| dc.subject | Europe | en |
| dc.subject | gastrointestinal hemorrhage | en |
| dc.subject | hepatic encephalopathy | en |
| dc.subject | middle aged | en |
| dc.subject | North America | en |
| dc.subject | platelet count | en |
| dc.subject | population growth | en |
| dc.subject | Adult | en |
| dc.subject | Aged | en |
| dc.subject | Ascites | en |
| dc.subject | Aspartate Aminotransferases | en |
| dc.subject | Cholagogues and Choleretics | en |
| dc.subject | Cohort Studies | en |
| dc.subject | Disease Progression | en |
| dc.subject | Esophageal and Gastric Varices | en |
| dc.subject | Europe | en |
| dc.subject | Female | en |
| dc.subject | Gastrointestinal Hemorrhage | en |
| dc.subject | Hepatic Encephalopathy | en |
| dc.subject | Humans | en |
| dc.subject | Incidence | en |
| dc.subject | Kaplan-Meier Estimate | en |
| dc.subject | Liver Cirrhosis, Biliary | en |
| dc.subject | Male | en |
| dc.subject | Middle Aged | en |
| dc.subject | North America | en |
| dc.subject | Platelet Count | en |
| dc.subject | Population Growth | en |
| dc.subject | Prognosis | en |
| dc.subject | Proportional Hazards Models | en |
| dc.subject | Risk Factors | en |
| dc.subject | Ursodeoxycholic Acid | en |
| dc.subject | Nature Publishing Group | en |
| dc.title | Major hepatic complications in ursodeoxycholic acid-treated patients with primary biliary cholangitis: Risk factors and time trends in incidence and outcome | en |
| dc.type | journalArticle | en |
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