The long-term effect of ursodeoxycholic acid on laboratory liver parameters in biochemically non-advanced primary biliary cirrhosis

Kuiper, Edith M. M.; Hansen, Bettina E.; Lesterhuis, Wilco; Robijn, R. J.; Thijs, J. C.; Engels, L.G.J.B.; Koek, Ger H.; Aparicio, M; Kerbert-Dreteler, M.J.; Buuren, Henk R. van

doi:10.1016/j.gcb.2010.07.018

Cited by 19 publications

(13 citation statements)

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“…The long‐term evolution of laboratory liver parameters beyond 1 year UDCA therapy has been documented, suggesting that biochemical response to UDCA can be maintained for up to 15 years 3, 16. In contrast, laboratory parameters within the first year were seldom reported in a large cohort of patients.…”

Section: Discussionmentioning

confidence: 99%

Early biochemical response to ursodeoxycholic acid and long-term prognosis of primary biliary cirrhosis: Results of a 14-year cohort study

et al. 2013

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The biochemical response to ursodeoxycholic acid (UDCA) in primary biliary cirrhosis is a strong predictor of long‐term outcome and thus facilitates the rapid identification of patients needing new therapeutic approaches. Numerous criteria for predicting outcome of treatment have been studied based on biochemical response to UDCA at 1 year. We sought to determine whether an earlier biochemical response at 3 or 6 months could as efficiently identify patients at risk of poor outcome, as defined by liver‐related death, liver transplantation, and complications of cirrhosis. We analyzed the prospectively collected data of 187 patients with a median follow‐up of 5.8 years (range, 1.3‐14 years). The survival rates without adverse outcome at 5 years and 10 years were 86% and 63%. Under UDCA therapy, laboratory liver parameters experienced the most prominent improvement in the first 3 months (P < 0.0001) and then stayed relatively stable for the following months. The Paris, Barcelona, Toronto, and Ehime definitions, but not the Rotterdam definition, applied at 3, 6, and 12 months significantly discriminated the patients in terms of long‐term outcome. Compared with biochemical responses evaluated after 1 year of UDCA therapy, biochemical responses at the third month demonstrated higher positive predictive value (PPV) but lower negative predictive value (NPV) and increased negative likelihood ratio (NLR) by all definitions; biochemical responses at the sixth month showed higher or the same PPV and NPV and lower NLR by all definitions. Conclusion: For the previously published criteria, biochemical responses at the sixth month can be used in place of those evaluated after 1 year of UDCA therapy. Our findings justify a more rapid identification of patients who need new therapeutic approaches. (HEPATOLOGY 2013)

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Section: Discussionmentioning

confidence: 99%

Early biochemical response to ursodeoxycholic acid and long-term prognosis of primary biliary cirrhosis: Results of a 14-year cohort study

et al. 2013

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“…40 In another study on PBC patients, the duration of treatment was indicated as an important predictor of biochemical response to UDCA as the highest response rate was observed following 3 years of treatment. 13 Other factors modulating therapeutic response to UDCA have been noted as the severities of underlying diseases 37 and the duration of follow up period post-treatment. 13 Furthermore, differential responses may be seen in individual biochemical markers as different patterns were reported for ALP and AST compared with ALT, bilirubin and albumin in long-term follow up.…”

Section: Discussionmentioning

confidence: 99%

“…4 Transient hepatotoxicity has been reported in 15-30% of patients treated with VPA. 5 Ursodeoxycholic acid (UDCA) is a hydrophilic bile acid used for treating various liver disorders such as cholestasis, 6 non-alcoholic steatohepatitis (NASH), [7][8][9] non-alcoholic fatty liver disease (NAFLD), 10,11 intrahepatic cholestasis of pregnancy (ICP), 12 primary biliary cirrhosis (PBC), 13 and hepatitis C virus (HCV) infection. 14,15 The protective effects of UDCA on biochemical and cytological parameters of liver function have been demonstrated.…”

Section: Introductionmentioning

confidence: 99%

Protective Effects of Ursodeoxycholic Acid on Valproic Acid Induced Hepatotoxicity in Epileptic Children with Recurrent Seizure; A Double-Blinded Randomized Clinical Trial

et al. 2020

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Background : There are controversies regarding the protective role of ursodeoxycholic acid (UDCA) against valproic acid (VPA)-induced hepatotoxicity in children. In the present clinical trial, we assessed the potential role of UDCA in preventing VPA-induced fluctuations of hepatic enzymes in epileptic children with recurrent seizures. Methods: Two-hundred children with epileptic seizures were randomly allocated into either intervention (VPA+UDCA) or control (VPA+ placebo) group. Fluctuations of liver enzymes were recorded at baseline, as well as 48 hours, 1 month, and 3 months following the interventions. Results: The mean age of the patients was 7.33±2.96 years (the range of 4-16). Males and females constituted 43 (43%) and 57 (57%) subjects in each group respectively. There were no significant differences in the baseline levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) between the intervention and control groups. At 48 hours post-intervention, AST and ALT increased 1.7% and 11.05% (23.18±7.91 and 30.75±4.20 IU/l) in the intervention group and 21.3% and 35% (28.46±3.71 and 35.62±7.72 IU/l) in the control group respectively (P<0.0001). Both AST (P<0.001) and ALT (P=0.03) levels were significantly lower in the intervention than placebo group at 1-month post-intervention. At 3-month post-intervention; however, while AST level still was significantly higher in the control (29.87±5.41 IU/l) than intervention (21.63±6.87 IU/l, P<0.0001), ALT level was not significantly different between the two groups (32.72±5.59 IU/l and 32.01±7.89 IU/l respectively, P=0.5). Conclusion: UDCA can be an effective drug to manage VPA-induced fluctuations of hepatic enzymes in children with recurrent epileptic seizures.

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“…So entspricht nach einem Jahr UDCA-Behandlung eine Normalisierung oder ein Abfall der AP um mindestens 40 % entsprechend den Barcelona-Kriterien einem Ansprechen [330], während eine Normalisierung von Albumin und Bilirubin den Rotterdam-Kriterien [336] oder eine AP und AST kleiner das 1,5-Fache des oberen Normwerts bei gleichzeitigem Abfall des Bilirubins unter 1,0 mg/dL den Paris-II-Kriterien entspricht [337]. Ein Nicht-Ansprechen auf UDCA war in der Rotterdam-Kohorte mit einem erhöhten HCC-Risiko assoziiert [338]. Erst die Etablierung multizentrischer Kohorten mit mehreren tausend Patienten hat deutlich gemacht, dass diese Kriterien unterschiedlich gut den Krankheitsverlauf diskriminieren können.…”

Section: Kommentarunclassified

S2k Leitlinie Autoimmune Lebererkrankungen

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et al. 2017

Z Gastroenterol

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The long-term effect of ursodeoxycholic acid on laboratory liver parameters in biochemically non-advanced primary biliary cirrhosis

Cited by 19 publications

References 18 publications

Early biochemical response to ursodeoxycholic acid and long-term prognosis of primary biliary cirrhosis: Results of a 14-year cohort study

Early biochemical response to ursodeoxycholic acid and long-term prognosis of primary biliary cirrhosis: Results of a 14-year cohort study

Protective Effects of Ursodeoxycholic Acid on Valproic Acid Induced Hepatotoxicity in Epileptic Children with Recurrent Seizure; A Double-Blinded Randomized Clinical Trial

S2k Leitlinie Autoimmune Lebererkrankungen

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