| Optimizing biochemical markers as endpoints for clinical trials in primary biliary cirrhosis. | |
| | |
MedLine Citation:
|
PMID: 22136310 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
|
BACKGROUND: Biochemical tests have been recommended as endpoints for clinical trials in primary biliary cirrhosis (PBC) because the use of liver transplantation and death as endpoints in ursodeoxycholic acid (UDCA) therapeutic trials is unfeasible. The best inclusion criteria cut-off values and cut-off for demonstrating treatment success have not been defined. AIM: Our aim was to determine the optimal biochemical values for patient inclusion and to define values for treatment success in therapeutic trials. METHODS: We performed a retrospective review of 73 patients with PBC treated with UDCA followed over 36 months. Following one year of UDCA therapy, the likelihood of developing clinical endpoints of varices, ascites, encephalopathy, death or transplantation over the ensuing two years, based on degrees of elevation of biochemical markers, was analyzed using chi-square or Fisher's exact test. RESULTS: Patients with ALP≥2 X upper limit of normal (ULN) had a 2-fold greater likelihood of developing endpoints compared to patients with lower values (23% versus 11%), (p < 0.05). Patients with bilirubin > 1 mg/dL were 4 times more likely to develop endpoints compared to those with lower values (33% versus 8%), (p = 0.02). These values help identify the patient population for adjunctive therapy trials. Patients with ALP ≤1.67 X ULN and bilirubin ≤1mg/dL demonstrated the least likelihood of reaching adverse clinical endpoints and can be used to define treatment success. CONCLUSION: Optimal ALP and Bilirubin levels can be used as appropriate biochemical criteria for patient selection and defining treatment success in future clinical trials in patients with PBC. |
| | |
Authors:
|
Njideka Momah; Marina G Silveira; Roberta Jorgensen; Emmanouil Sinakos; Keith D Lindor |
Publication Detail:
|
Type: JOURNAL ARTICLE Date: 2011-12-4 |
Journal Detail:
|
Title: Liver international : official journal of the International Association for the Study of the Liver Volume: - ISSN: 1478-3231 ISO Abbreviation: - Publication Date: 2011 Dec |
Date Detail:
|
Created Date: 2011-12-5 Completed Date: - Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 101160857 Medline TA: Liver Int Country: - |
Other Details:
|
Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
|
© 2011 John Wiley & Sons A/S. |
Affiliation:
|
Department of Internal Medicine, Wright State University, Dayton, OH, USA. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Dysregulation of Melanocyte Function by Th17-related Cytokines: Significance of Th17 Cell Infiltrati...
Next Document: The degree of erythema in melasma leson is associated with the severity of disease and the response ...