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The condition is the sixth leading cause of death in the United States, and the only one in the top 10 without a cure or reversible treatment.

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Azathioprine and 6-MP-induced inflammation of the liver (hepatitis) and pancreas (pancreatitis) are rare.

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Serum aminotransferase levels remained normal on azathioprine alone but ANA became weakly positive.

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Treatment with azathioprine alone at a dose of 2 mg per kilogram per day reversed the cushingoid facies and weight gain that had been associated with prednisolone therapy in 44 percent of our patients (other complications were rare), and most of the patients reported that they felt better (or at least did not feel worse), despite the development of arthralgias after the prednisolone had been withdrawn.

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These observations, coupled with no evidence of physiological or clinical benefit for combination therapy, prompted the independent data and safety monitoring board to recommend termination of the combination-therapy group at a mean follow-up of 32 weeks.

Case-control studies were initially analyzed by testing whether or not there were significant differences between the proportion of exposed subjects among cases and controls.

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Findings on high-resolution CT were sufficient to diagnose definite idiopathic pulmonary fibrosis in 66 patients (86%) in the combination-therapy group and 61 (78%) in the placebo group.

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IVIg or prednisone); lack of adequate power due to small sample size (azathioprine, interferon B1a trials) to detect a significant response; and a surprisingly high placebo response in patients assigned to the placebo arm of several studies (up to 44% in the methotrexate and interferon B1a trials), suggesting many patients randomized to placebo may have had inactive disease and therefore did not relapse as anticipated when IVIg was discontinued.

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Patients with low or absent TPMT activity are at an increased risk of developing severe, life-threatening myelotoxicity if receiving conventional doses of Imuran.

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We found no evidence of two other potential side effects of high doses of azathioprine or long-term treatment with the drug: teratogenesis and carcinogenesis.

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