title: Cyclosporin A treatment in primary biliary cirrhosis: results of a long-term placebo controlled trial.
abstract: 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 mg.kg-1.day-1, 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.
authors.affiliation: Institute of Liver Studies, King's College Hospital, London, England.
authors.forename: M
authors.initials: M
authors.lastname: Lombard
authors.forename: B
authors.initials: B
authors.lastname: Portmann
authors.forename: J
authors.initials: J
authors.lastname: Neuberger
authors.forename: R
authors.initials: R
authors.lastname: Williams
authors.forename: N
authors.initials: N
authors.lastname: Tygstrup
authors.forename: L
authors.initials: L
authors.lastname: Ranek
authors.forename: H
authors.initials: H
authors.lastname: Ring-Larsen
authors.forename: J
authors.initials: J
authors.lastname: Rodes
authors.forename: M
authors.initials: M
authors.lastname: Navasa
authors.forename: C
authors.initials: C
authors.lastname: Trepo
mesh_terms: D000328:Adult; D000368:Aged; D016572:Cyclosporine / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008105:Liver Cirrhosis, Biliary / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D015996:Survival Rate
chemical_list: D016572:Cyclosporine