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Mycophenolate mofetil for the treatment of primary biliary cirrhosis in patients with an incomplete response to ursodeoxycholic acid.

AbstractBACKGROUND & AIMS:
Despite evidence for therapeutic efficacy with ursodeoxycholic acid (UDCA) in primary biliary cirrhosis (PBC), only 30-50% of patients achieve complete biochemical remission within 1 year of therapy. Mycophenolate mofetil (MMF) is an immunosuppressive medication that inhibits T and B lymphocyte proliferation. The aim of this investigation was to determine the safety and estimated efficacy of MMF in patients with PBC.
METHODS:
Twenty-five patients with incomplete responses to UDCA (defined as persistent elevation of serum alkaline phosphatase > or =2 times the upper limit of normal) received MMF 1 g daily to a maximum of 3 g daily with UDCA (13-15 mg/kg per day) for 1 year. Liver biochemistries were determined at 3-month intervals with Mayo Risk Score calculated at baseline and end of therapy.
RESULTS:
Nineteen (76%) patients completed 1 year of therapy. Despite improvements in serum alkaline phosphatase (920 +/- 308 vs. 709 +/- 242 IU/L, P = 0.001) and AST (65 +/- 31 vs. 51 +/- 19 IU/L, P = 0.007) levels, these findings were clinically insignificant. Exploratory analysis revealed a strong correlation between advanced PBC defined by higher Mayo Risk Score and reduction in serum alkaline phosphatase levels (r = -0.74, P = 0.006). Six patients (24%) did not complete therapy; adverse drug events were responsible for study withdrawal in 3 individuals. Adverse reactions that resolved spontaneously or by dose reduction occurred in 13 patients.
CONCLUSIONS:
MMF is not associated with important clinical benefits in PBC based on the results of this pilot investigation.
AuthorsJayant A Talwalkar, Paul Angulo, Jill C Keach, Janice L Petz, Roberta A Jorgensen, Keith D Lindor
JournalJournal of clinical gastroenterology (J Clin Gastroenterol) Vol. 39 Issue 2 Pg. 168-71 (Feb 2005) ISSN: 0192-0790 [Print] United States
PMID15681915 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Comparative Study, Journal Article)
Chemical References
  • Autoantibodies
  • Cholagogues and Choleretics
  • Immunosuppressive Agents
  • Ursodeoxycholic Acid
  • Alkaline Phosphatase
  • Mycophenolic Acid
Topics
  • Administration, Oral
  • Adolescent
  • Adult
  • Aged
  • Alkaline Phosphatase (blood)
  • Autoantibodies (blood)
  • Cholagogues and Choleretics (administration & dosage, therapeutic use)
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Humans
  • Immunosuppressive Agents (administration & dosage, therapeutic use)
  • Liver Cirrhosis, Biliary (blood, drug therapy, pathology)
  • Male
  • Middle Aged
  • Mitochondria, Liver (immunology)
  • Mycophenolic Acid (administration & dosage, analogs & derivatives, therapeutic use)
  • Pilot Projects
  • Risk Factors
  • Treatment Outcome
  • Ursodeoxycholic Acid (administration & dosage, therapeutic use)

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