| A placebo-controlled, randomized, double-masked, variable dosage, clinical trial of azathioprine with and without methylprednisolone in multiple sclerosis. | |
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MedLine Citation:
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PMID: 2668784 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Ninety-eight patients with multiple sclerosis (MS) in the chronic progression phase entered a 3-year clinical trial to determine if azathioprine (AZ) alone or with adrenal cortical steroids stabilizes the course of MS. In group AM, the patients took AZ throughout and methylprednisolone (MP) for the first 36 weeks. Group AP received AZ and placebo instead of MP. Group PP took placebos for both drugs. We adjusted the AZ to maintain the total white blood cell count within 3,000 to 4,000/mm3; we gave the MP in a fixed dose "pulse" and alternate-day regimen. The "intent-to-treat" groups had no statistically significant differences in the rates of progression among the 3 treatments. Subgroup analysis suggests that patients in the AM group who completed treatment exactly according to protocol did statistically significantly better than the placebo recipients using the sum of Standard Neurological Examination scores, slightly better using the quantitative neuro-performance tests, but no better using Mickey's Illness Severity Scores or Kurtzke's Disability Status Scale. Also, the AZ-treated groups had half the relapse rate of the placebo-treated group. Adverse reactions to AZ accounted for most withdrawals. Hematologic and hepatic abnormalities were significantly associated with AZ, but serious non-MS abnormalities were uncommon and were equally distributed among the 3 groups. Addition of MP to the AZ slightly improved the efficacy of the treatment, but also increased the adverse effects. The benefits of AZ with or without steroids did not outweigh the risks, and therefore we do not recommend this treatment for patients with chronic progressive MS. |
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Authors:
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G W Ellison; L W Myers; M R Mickey; M C Graves; W W Tourtellotte; K Syndulko; M I Holevoet-Howson; C D Lerner; M V Frane; P Pettler-Jennings |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S. |
Journal Detail:
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Title: Neurology Volume: 39 ISSN: 0028-3878 ISO Abbreviation: Neurology Publication Date: 1989 Aug |
Date Detail:
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Created Date: 1989-09-08 Completed Date: 1989-09-08 Revised Date: 2007-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0401060 Medline TA: Neurology Country: UNITED STATES |
Other Details:
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Languages: eng Pagination: 1018-26 Citation Subset: AIM; IM |
Affiliation:
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Department of Neurology, School of Medicine, University of California, Los Angeles. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Azathioprine / administration & dosage, adverse effects, therapeutic use* Clinical Trials as Topic Double-Blind Method Drug Therapy, Combination Female Humans Male Methylprednisolone / administration & dosage* Multiple Sclerosis / drug therapy* Random Allocation Time Factors |
| Grant Support | |
ID/Acronym/Agency:
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NS-08711/NS/NINDS NIH HHS; NS-16776/NS/NINDS NIH HHS |
| Chemical | |
Reg. No./Substance:
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446-86-6/Azathioprine; 83-43-2/Methylprednisolone |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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