A controlled trial of cyclosporine in the treatment of primary biliary cirrhosis

Russell H. Wiesner, Jurgen Ludwig, Keith D. Lindor, Roberta A. Jorgensen, William P. Baldus, Henry A. Homburger, E. Rolland Dickson

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Abstract

Primary biliary cirrhosis is a progressive disease of the liver characterized by the immunologic destruction of bile ducts; effective therapy is lacking. We therefore evaluated the safety and efficacy of low-dose cyclosporine in 29 patients with primary biliary cirrhosis without evidence of damage to the lobular architecture (precirrhotic disease) or portal hypertension. The patients were randomly assigned to receive either cyclosporine (4 mg per kilogram of body weight per day) or placebo. After one year 17 of the 19 patients assigned to cyclosporine had improvement or stability in their degree of fatigue, and 18 in their degree of pruritus. In contrast, among the 10 patients assigned to placebo, fatigue increased in 4 (P<0.06) and pruritus worsened in 6 (P<0.001). Those assigned to cyclosporine also had significant decreases in serum levels of bilirubin, alanine aminotransferase, alkaline phosphatase, gamma globulin, and the titer of antimitochondrial antibodies. For the 20 patients who have completed two years in the study, liver biopsies (coded specimens) showed evidence of histologic progression in only 1 of 13 patients in the cyclosporine group, as compared with 5 of 7 in the placebo group (P<0.003). No patient has permanently discontinued cyclosporine because of side effects; however, signs of nephrotoxicity developed in 12 of 19, and 9 of 19 had increased blood pressure. We conclude that in patients with precirrhotic primary biliary cirrhosis, immunosuppressive therapy with cyclosporine is promising and deserves further evaluation.

Original languageEnglish (US)
Pages (from-to)1419-1424
Number of pages6
JournalNew England Journal of Medicine
Volume322
Issue number20
StatePublished - May 17 1990

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Biliary Liver Cirrhosis
Cyclosporine
Placebos
Therapeutics
Pruritus
Fatigue
gamma-Globulins
Portal Hypertension
Immunosuppressive Agents
Bile Ducts
Alanine Transaminase
Bilirubin
Alkaline Phosphatase
Liver Diseases
Body Weight
Blood Pressure
Biopsy
Safety
Antibodies
Liver

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Wiesner, R. H., Ludwig, J., Lindor, K. D., Jorgensen, R. A., Baldus, W. P., Homburger, H. A., & Dickson, E. R. (1990). A controlled trial of cyclosporine in the treatment of primary biliary cirrhosis. New England Journal of Medicine, 322(20), 1419-1424.

A controlled trial of cyclosporine in the treatment of primary biliary cirrhosis. / Wiesner, Russell H.; Ludwig, Jurgen; Lindor, Keith D.; Jorgensen, Roberta A.; Baldus, William P.; Homburger, Henry A.; Dickson, E. Rolland.

In: New England Journal of Medicine, Vol. 322, No. 20, 17.05.1990, p. 1419-1424.

Research output: Contribution to journalArticle

Wiesner, RH, Ludwig, J, Lindor, KD, Jorgensen, RA, Baldus, WP, Homburger, HA & Dickson, ER 1990, 'A controlled trial of cyclosporine in the treatment of primary biliary cirrhosis', New England Journal of Medicine, vol. 322, no. 20, pp. 1419-1424.
Wiesner RH, Ludwig J, Lindor KD, Jorgensen RA, Baldus WP, Homburger HA et al. A controlled trial of cyclosporine in the treatment of primary biliary cirrhosis. New England Journal of Medicine. 1990 May 17;322(20):1419-1424.
Wiesner, Russell H. ; Ludwig, Jurgen ; Lindor, Keith D. ; Jorgensen, Roberta A. ; Baldus, William P. ; Homburger, Henry A. ; Dickson, E. Rolland. / A controlled trial of cyclosporine in the treatment of primary biliary cirrhosis. In: New England Journal of Medicine. 1990 ; Vol. 322, No. 20. pp. 1419-1424.
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