Abstract | OBJECTIVE: DESIGN: One year placebo controlled double blind trial of withdrawal or continuation of azathioprine. SETTING: Outpatient clinics of five hospitals. SUBJECTS: MAIN OUTCOME MEASURE: Rate of relapse. Relapse was defined as worsening of symptoms or sigmoidoscopic appearance. RESULTS: For the remission group the one year rate of relapse was 36% (12/33) for patients continuing azathioprine and 59% (20/34) for those taking placebo (hazard rate ratio 0.5, 95% confidence interval 0.25 to 1.0). For the subgroup of 54 patients in long term remission (greater than six months before entry to trial) benefit was still evident, with a 31% (8/26) rate of relapse with azathioprine and 61% (17/28) with placebo (p less than 0.01). For the small group of patients with chronic stable colitis (six were corticosteroid dependent and six had low grade symptoms) no benefit was found from continued azathioprine therapy. Adverse events were minimal. CONCLUSIONS:
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Authors | A B Hawthorne, R F Logan, C J Hawkey, P N Foster, A T Axon, E T Swarbrick, B B Scott, J E Lennard-Jones |
Journal | BMJ (Clinical research ed.)
(BMJ)
Vol. 305
Issue 6844
Pg. 20-2
(Jul 04 1992)
ISSN: 0959-8138 [Print] England |
PMID | 1638191
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Azathioprine
(adverse effects, therapeutic use)
- Chronic Disease
- Colitis, Ulcerative
(drug therapy)
- Double-Blind Method
- Humans
- Long-Term Care
- Recurrence
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