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Azathioprine for primary biliary cirrhosis
Y Gong1, E Christensen, C Gluud
1Copenhagen Trial Unit, Centre for Clinical Intervention Research, Cochrane Hepato-Biliary Group, Rigshospitalet, Dept. 3344, Blegdamsvej 9, Copenhagen, Denmark, DK-2100. ygong@ctu.rh.dk
The Cochrane Database of Systematic Reviews
|July 20, 2007
Summary
Azathioprine does not improve outcomes for primary biliary cirrhosis patients and increases adverse events. Further research should consider these risks, as evidence does not support its use.
Area of Science:
- Hepatology
- Clinical Pharmacology
- Immunosuppression
Background:
- Primary biliary cirrhosis (PBC) is a chronic liver disease.
- Azathioprine is an immunosuppressive drug sometimes used for PBC.
- Previous randomized clinical trials (RCTs) on azathioprine for PBC have yielded conflicting results.
Purpose of the Study:
- To systematically evaluate the efficacy and safety of azathioprine in patients with primary biliary cirrhosis.
- To synthesize evidence from randomized clinical trials to inform clinical practice and future research.
Main Methods:
- A comprehensive literature search was conducted across multiple databases up to September 2005.
- Included RCTs compared azathioprine against placebo, no intervention, or other drugs.
- Primary outcomes included mortality and liver transplantation; secondary outcomes included pruritus, cirrhosis development, and quality of life. Risk ratios (RR) and confidence intervals (CI) were calculated.
Main Results:
- Two RCTs involving 293 patients were analyzed, with only one trial deemed low risk of bias.
- Azathioprine did not significantly reduce mortality (RR 0.80, 95% CI 0.49 to 1.31).
- No significant improvements were observed in pruritus, cirrhosis development, or quality of life. However, azathioprine significantly increased adverse events (RR 2.44, 95% CI 1.14 to 5.20), including rash, diarrhea, and bone marrow depression.
Conclusions:
- Current evidence does not support the use of azathioprine for treating primary biliary cirrhosis.
- The increased risk of adverse events associated with azathioprine necessitates caution.
- Future research on azathioprine for PBC should carefully consider and monitor potential harms.
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