Optimizing biochemical markers as endpoints for clinical trials in primary biliary cirrhosis

Liver International

Volumn 32, Issue 5, 2012, Pages 790-795

  Momah, Njideka ^a   Silveira, Marina G ^b   Jorgensen, Roberta ^b   Sinakos, Emmanouil ^b   Lindor, Keith D ^b  

^a WRIGHT STATE UNIVERSITY   (United States)

^b MAYO CLINIC   (United States)

Author keywords

Adjunctive therapy trials; Primary biliary cirrhosis; UDCA(urso deoxycholic acid)

Indexed keywords

ALKALINE PHOSPHATASE; BILIRUBIN; URSODEOXYCHOLIC ACID;

ADULT; ALKALINE PHOSPHATASE BLOOD LEVEL; ARTICLE; ASCITES; BILIRUBIN BLOOD LEVEL; CLINICAL TRIAL (TOPIC); FEMALE; FOLLOW UP; HEPATIC ENCEPHALOPATHY; HUMAN; LIVER TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; MEDICAL RECORD REVIEW; MORTALITY; PRIMARY BILIARY CIRRHOSIS; PROGNOSIS; REFERENCE VALUE; RETROSPECTIVE STUDY; VARICOSIS;

ALKALINE PHOSPHATASE; ASCITES; BILIRUBIN; BIOLOGICAL MARKERS; CHOLAGOGUES AND CHOLERETICS; CLINICAL TRIALS AS TOPIC; DISEASE PROGRESSION; ENDPOINT DETERMINATION; FEMALE; HEPATIC ENCEPHALOPATHY; HUMANS; LIVER CIRRHOSIS, BILIARY; LIVER TRANSPLANTATION; MALE; MIDDLE AGED; MULTICENTER STUDIES AS TOPIC; RETROSPECTIVE STUDIES; TREATMENT OUTCOME; URSODEOXYCHOLIC ACID; VARICOSE VEINS;

EID: 84859442823     PISSN: 14783223     EISSN: 14783231     Source Type: Journal    
DOI: 10.1111/j.1478-3231.2011.02678.x     Document Type: Article

References (12)

1. Poupon RE, Balkau B, Eschwege E, Poupon R. A multicenter, controlled trial of ursodiol for the treatment of primary biliary cirrhosis. Udca-pbc study group. N Engl J Med 1991; 324: 1548-54.
2. Lindor KD, Dickson ER, Baldus WP, et al. Ursodeoxycholic acid in the treatment of primary biliary cirrhosis. Gastroenterology 1994; 106: 1284-90.
3. Heathcote EJ, Cauch-Dudek K, Walker V, et al. The canadian multicenter double-blind randomized controlled trial of ursodeoxycholic acid in primary biliary cirrhosis. Hepatology 1994; 19: 1149-56.
4. Poupon RE, Lindor KD, Cauch-Dudek K, et al. Combined analysis of randomized controlled trials of ursodeoxycholic acid in primary biliary cirrhosis. Gastroenterology 1997; 113: 884-90.
5. Kuiper EM, Hansen BE, de Vries RA, et al. Improved prognosis of patients with primary biliary cirrhosis that have a biochemical response to ursodeoxycholic acid. Gastroenterology 2009; 136: 1281-7.
6. Pares A, Caballeria L, Rodes J. Excellent long-term survival in patients with primary biliary cirrhosis and biochemical response to ursodeoxycholic acid. Gastroenterology 2006; 130: 715-20.
7. Huet PM, Vincent C, Deslaurier J, et al. Portal hypertension and primary biliary cirrhosis: effect of long-term ursodeoxycholic acid treatment. Gastroenterology 2008; 135: 1552-60.
8. Corpechot C, Abenavoli L, Rabahi N, et al. Biochemical response to ursodeoxycholic acid and long-term prognosis in primary biliary cirrhosis. Hepatology 2008; 48: 871-7.
9. Silveira MG, Brunt EM, Heathcote J, et al. American association for the study of liver diseases endpoints conference: design and endpoints for clinical trials in primary biliary cirrhosis. Hepatology 2010; 52: 349-59.
10. Kumagi T, Guindi M, Fischer SE, et al. Baseline ductopenia and treatment response predict long-term histological progression in primary biliary cirrhosis. Am J Gastroenterol 2010; 10: 2186-94.
11. Angulo P, Lindor KD, Therneau TM, et al. Utilization of the mayo risk score in patients with primary biliary cirrhosis receiving ursodeoxycholic acid. Liver 1999; 19: 115-21.
12. Lindor KD, Gershwin ME, Poupon R, et al. Primary biliary cirrhosis. Hepatology 2009; 50: 291-308.