Only 21% of liver transplantation patients who received ursodeoxycholic acid (UDCA) after surgery developed recurrent primary biliary cirrhosis, compared with 62% of patients who did not receive the bile acid, researchers reported in the Journal of Hepatology.
The results provide strong evidence that routinely giving liver transplant patients UDCA can prevent or delay recurrent primary biliary cirrhosis, said Alexie Bosch at Hôpital Edouard Herriot in Lyon, France, and his associates.
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Primary biliary cirrhosis can recur after liver transplantation and increases the chances of graft dysfunction, the researchers noted. UDCA is the only approved medical treatment for primary biliary cirrhosis in the United States or Europe, but no research team has studied its potential to prevent recurrent primary biliary cirrhosis after liver transplantation, they added. Therefore, they retrospectively studied 90 patients with primary biliary cirrhosis who underwent liver transplantation at five centers in France and Switzerland between 1988 and 2010. In all, 21% of patients received oral UDCA (10-15 mg/kg per day in two divided doses) within 2 weeks after their operation, while the rest received it only if they developed biopsy-confirmed recurrent primary biliary cirrhosis. Biopsies were taken at posttransplant year 1 and every 5 years after that, or when clinically indicated, the investigators noted (J Hepatol. 2015 Aug. 14. doi: 10.1016/j.jhep.2015.07.038).
Patients who received preventive UDCA had a lower cumulative rate of recurrence throughout 15 years of postsurgical follow-up (P = .014), the researchers reported. The chances of recurrent primary biliary cirrhosis at 5, 10, and 15 years after transplantation were 11%, 21%, and 40% in the UDCA group, compared with 32%, 53%, and 70% for patients who did not receive prophylactic UDCA, they added. A multivariable analysis showed that recurrent primary biliary cirrhosis was associated with not receiving prophylactic UDCA (hazard ratio, 0.32; 95% confidence interval, 0.11, 0.91), but was not linked to donor age, Model For End-Stage Liver Disease (MELD) score, or sex mismatch between donor and recipient, the investigators said. Preventive UDCA also was tied to a 1.6-year longer median time to recurrence, although the trend did not reach statistical significance.
Although the study was retrospective and most patients who received UDCA were treated at one transplant center, all centers had similar histologic findings for recurrent primary biliary cirrhosis, said the researchers. Biopsies also were histologically similar regardless of whether they were event driven or obtained based on the study protocol, and time to recurrence did not vary based on biopsy type, they added. “In our multivariate analysis, we took care to account for all risk factors and confounders, as well as to test multilevel models in order to exclude potential misleading results and center effects,” they emphasized. “Given the extremely limited feasibility of prospective studies and the good tolerance and acceptability of long-term UDCA therapy, these results support the extended use of UDCA as prophylaxis for primary biliary cirrhosis recurrence after liver transplantation.”
The researchers declared no funding sources and reported having no conflicts of interest.