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Combined Therapy with Azathioprine, Prednisolone, and Ursodiol in Patients with Primary Sclerosing Cholangitis: A Case Series

Christoph Schramm, MD; Peter Schirmacher, MD; Ilka Helmreich-Becker, MD; Guido Gerken, MD; Karl Heinz Meyer zum Büschenfelde, MD, PhD; and Ansgar W. Lohse, MD
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From Johannes Gutenberg University, Mainz, Germany.

Requests for Reprints: Ansgar W. Lohse, MD, I. Department of Medicine, Johannes Gutenberg-University, Langenbeckstrasse 1, 55131 Mainz, Germany. For reprint orders in quantities exceeding 100, please contact the Reprints Coordinator; phone, 215-351-2657; e-mail, reprints@mail.acponline.org.

Current Author Addresses: Dr. Schirmacher: Department of Pathology, University of Cologne, Josef Stelzmann Strasse 9, 50931 Köln, Germany.

Dr. Gerken: Department of Gastroenterology and Hepatology, University of Essen, Hufelandstrasse 55, 45147 Essen, Germany.

Drs. Schramm, Helmreich-Becker, Meyer zum Büschenfelde, and Lohse: Department of Internal Medicine, University of Mainz, Langenbeckstrasse 1, 55101 Mainz, Germany.

Ann Intern Med. 1999;131(12):943-946. doi:10.7326/0003-4819-131-12-199912210-00006
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Background: No established medical therapy alters the progressive course of primary sclerosing cholangitis.

Objective: To explore the potential usefulness of combined therapy with azathioprine, steroids and ursodeoxycholic acid (UDCA) in primary sclerosing cholangitis.

Design: Case series.

Setting: University hospital in Mainz, Germany.

Patients: 15 patients with primary sclerosing cholangitis.

Intervention: Azathioprine (1 to 1.5 mg/kg of body weight per day), prednisolone (1 mg/kg per day initially, tapering to 5 to 10 mg per day) and UDCA (500 to 750 mg per day).

Measurements: Clinical and laboratory evaluation, liver biopsy, and endoscopic retrograde cholangiography (a >30% change in stenosis was considered significant).

Results: After a median observation period of 41 months (range, 3 to 81 months), liver enzyme levels declined significantly in all patients. Six of 10 patients with follow-up liver biopsies showed histologic improvement. Significant radiographic deterioration was seen in only 1 of 10 patients who had endoscopic retrograde cholangiography. In 7 patients previously treated with UDCA alone, liver enzyme levels declined significantly only after immunosuppressive therapy was added. Adverse drug reactions led to the withdrawal of study medications in 2 patients.

Conclusions: Combined immunosuppressive therapy may alter the progression of primary sclerosing cholangitis. Our observations suggest a benefit from adding immunosuppressive drugs to UDCA therapy. A randomized trial is warranted.


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Biochemical changes under immunosuppressive therapy. Left.Right.

Decline in alkaline phosphatase, alanine aminotransferase (α = 0.01), and total bilirubin (α = 0.02) levels after start of combined immunosuppressive therapy. Data were collected after 20 ± 3 months, 34 ± 3 months, and 40 ± 3 months. Number of patients: 13 at 20 months, 10 at 34 months, 5 at 40 months. In 7 patients being treated with ursodeoxycholic acid, immunosuppressive therapy was added at month 30. Three months afterward, levels of alkaline phosphatase, alanine aminotransferase (α = 0.02), and total bilirubin (α = 0.05) declined significantly. To convert alanine aminotransferase values to nkat/L, multiply by 16.667. To convert alkaline phosphatase values to µkat/L, multiply by 0.01667. To convert bilirubin values to µmol, multiply by 17.104. Error bars represent the SE.

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Summary for Patients

Combination Therapy for Patients with Primary Sclerosing Cholangitis

The summary below is from the full report titled “Combined Therapy with Azathioprine, Prednisolone, and Ursodiol in Patients with Primary Sclerosing Cholangitis. A Case Series.” It is in the 12 December 1999 issue of Annals of Internal Medicine (volume 131, pages 943-946). The authors are C. Schramm, P. Schirmacher, I. Helmreich-Becker, G. Gerken, K.H. Meyer zum Büschenfelde, and A.W. Lohse.


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