Document Detail

Lack of effect of intravenous administration on time to respond to azathioprine for steroid-treated Crohn's disease. North American Azathioprine Study Group.
MedLine Citation:
PMID:  10464128     Owner:  NLM     Status:  MEDLINE    
BACKGROUND & AIMS: Azathioprine is effective for Crohn's disease but acts slowly. A loading dose may decrease the time to response. METHODS: A placebo-controlled study was conducted in patients with active Crohn's disease despite prednisone treatment. Patients were randomized to a 36-hour infusion of azathioprine, 40 mg/kg (51 patients), or placebo (45 patients) followed by oral azathioprine, 2 mg/kg, for 16 weeks. Prednisone was tapered over 5 weeks. The primary outcome measure was complete remission at week 8, defined by discontinuation of prednisone and a Crohn's Disease Activity Index of </=150 points. Erythrocyte concentrations of the azathioprine active metabolite, 6-thioguanine nucleotide, were measured. RESULTS: At week 8, 13 patients (25%) were in complete remission in the azathioprine-loaded group compared with 11 patients (24%) in the placebo group. The frequency of complete remission did not increase after 8 weeks in either group. Both groups achieved steady state of 6-thioguanine nucleotide by week 2, and no differences were found in mean concentrations between the groups. There were no significant differences in the frequency of adverse events between the groups. CONCLUSIONS: A loading dose does not decrease the time to response in patients with steroid-treated Crohn's disease beginning azathioprine therapy. Steady state of erythrocyte 6-thioguanine nucleotide and complete response occurred earlier than previously reported.
W J Sandborn; W J Tremaine; D C Wolf; S R Targan; C A Sninsky; L R Sutherland; S B Hanauer; J W McDonald; B G Feagan; R N Fedorak; K L Isaacs; M G Pike; D C Mays; J J Lipsky; S Gordon; C S Kleoudis; R H Murdock
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Gastroenterology     Volume:  117     ISSN:  0016-5085     ISO Abbreviation:  Gastroenterology     Publication Date:  1999 Sep 
Date Detail:
Created Date:  1999-09-16     Completed Date:  1999-09-16     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0374630     Medline TA:  Gastroenterology     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  527-35     Citation Subset:  AIM; IM    
Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota, USA.
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MeSH Terms
Administration, Oral
Azathioprine / administration & dosage*,  therapeutic use
Crohn Disease / blood,  drug therapy*
Dose-Response Relationship, Drug
Double-Blind Method
Glucocorticoids / therapeutic use
Immunosuppressive Agents / administration & dosage*,  therapeutic use
Infusions, Intravenous
Leukocyte Count
Methyltransferases / blood
Middle Aged
Prednisone / therapeutic use
Remission Induction
Thioguanine / blood
Reg. No./Substance:
0/Glucocorticoids; 0/Immunosuppressive Agents; 154-42-7/Thioguanine; 446-86-6/Azathioprine; 53-03-2/Prednisone; EC 2.1.1.-/Methyltransferases; EC methyltransferase
Comment In:
Gastroenterology. 2000 Jun;118(6):1281-2   [PMID:  10866522 ]

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