Cyclosporin A treatment in primary biliary cirrhosis: results of a long-term placebo controlled trial

Gastroenterology. 1993 Feb;104(2):519-26. doi: 10.1016/0016-5085(93)90422-9.


Background: Effective treatment for primary biliary cirrhosis (PBC) resulting in slower progression and improved survival remains elusive. Cyclosporin A (CyA), which has been so effective in preventing human allograft rejection, has shown promise in small numbers of patients in early studies.

Methods: Three hundred forty-nine patients with PBC were randomized to receive CyA, 3, or placebo in a multicenter study with follow-up for 6 years. The end point was death or liver transplantation.

Results: Cox multivariate analysis showed time from entry to death or transplantation was significantly prolonged (by up to 50%) in the CyA-treated group. Liver-related mortality was also significantly lower. However, a univariate analysis of survival showed no statistical differences between the two groups. Biochemical liver indices deteriorated more slowly in the CyA-treated group, but serum creatinine concentration was elevated > 150 mumol/L in 9%, necessitating permanent discontinuation in half of these. A reduction in the dose of CyA was required in 11% because of hypertension.

Conclusions: CyA has some therapeutic potential in primary biliary cirrhosis, providing blood pressure and renal function are closely monitored.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Cyclosporine / therapeutic use*
  • Female
  • Follow-Up Studies
  • Humans
  • Liver Cirrhosis, Biliary / drug therapy*
  • Liver Cirrhosis, Biliary / mortality
  • Male
  • Middle Aged
  • Prognosis
  • Survival Rate


  • Cyclosporine