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URSODIOL FOR PRIMARY BILIARY CIRRHOSIS.

In 1991, a French randomized study of 145 patients showed that the bile acid ursodiol slows the short-term progression of primary biliary cirrhosis. At the end of the two-year study, all ursodiol recipients continued their treatment and 79 percent of placebo recipients agreed to take ursodiol in an open trial. This report presents the four-year outcome of these patients.

The patients who had taken ursodiol for all four years had significantly fewer treatment failures (hyperbilirubinemia, variceal bleeding, ascites, or encephalopathy) than the patients initially assigned to placebo (9 vs. 20); they also had significantly fewer liver transplantations or referrals for transplantations (4 vs. 13).

Comment: The differences between these two groups are impressive, since most placebo recipients took ursodiol during the third and fourth years. An editorialist concludes that most patients with primary biliary cirrhosis who do not have advanced disease should receive ursodiol. However, ongoing studies are testing combinations of drugs (e.g., ursodiol, methotrexate, and colchicine) because no single agent reliably halts progression of the disease.

— AS Brett

Published in Journal Watch General Medicine May 27, 1994

Citation(s):

Kaplan MM. Primary biliary cirrhosis -- a first step in prolonging survival. N Engl J Med 1994 May 12 330 1386-1387.

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• Medline abstract (Free)

Poupon RE et al. Ursodiol for the long-term treatment of primary biliary cirrhosis. N Engl J Med 1994 May 12 330 1342-1347.

• Original article (Subscription may be required)
• Medline abstract (Free)