Document Detail


Evidence Report: The efficacy and safety of mitoxantrone (Novantrone) in the treatment of multiple sclerosis: Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology.
MedLine Citation:
PMID:  20439849     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: The chemotherapeutic agent mitoxantrone was approved for use in multiple sclerosis (MS) in 2000. After a review of all the available evidence, the original report of the Therapeutics and Technology Assessment Subcommittee in 2003 concluded that mitoxantrone probably reduced clinical attack rates, MRI activity, and disease progression. Subsequent reports of decreased systolic function, heart failure, and leukemia prompted the US Food and Drug Administration to institute a "black box" warning in 2005. This review was undertaken to examine the available literature on the efficacy and safety of mitoxantrone use in patients with MS since the initial report.
METHODS: Relevant articles were obtained through a review of the medical literature and the strength of the available evidence was graded according to the American Academy of Neurology evidence classification scheme.
RESULTS: The accumulated Class III and IV evidence suggests an increased incidence of systolic dysfunction and therapy-related acute leukemia (TRAL) with mitoxantrone therapy. Systolic dysfunction occurs in approximately 12% of patients with MS treated with mitoxantrone, congestive heart failure occurs in approximately 0.4%, and leukemia occurs in approximately 0.8%. The number needed to harm is 8 for systolic dysfunction and 123 for TRAL. There is no new efficacy evidence that would change the recommendation from the previous report.
CONCLUSIONS: The risk of systolic dysfunction and leukemia in patients treated with mitoxantrone is higher than suggested at the time of the previous report, although comprehensive postmarketing surveillance data are lacking.
Authors:
James J Marriott; Janis M Miyasaki; Gary Gronseth; Paul W O'Connor;
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Review    
Journal Detail:
Title:  Neurology     Volume:  74     ISSN:  1526-632X     ISO Abbreviation:  Neurology     Publication Date:  2010 May 
Date Detail:
Created Date:  2010-05-04     Completed Date:  2010-05-25     Revised Date:  2013-05-29    
Medline Journal Info:
Nlm Unique ID:  0401060     Medline TA:  Neurology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1463-70     Citation Subset:  AIM; IM    
Affiliation:
The Multiple Sclerosis Clinic, St. Michael's Hospital, Division of Neurology, University of Toronto, Canada.
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MeSH Terms
Descriptor/Qualifier:
Adult
Cardiotoxins / adverse effects,  pharmacology,  therapeutic use
Controlled Clinical Trials as Topic
Databases, Factual
Female
Humans
Leukemia / chemically induced
Male
Middle Aged
Mitoxantrone / adverse effects,  therapeutic use*
Multiple Sclerosis / drug therapy*
Multiple Sclerosis, Relapsing-Remitting / drug therapy*
Systole / drug effects
United States
Young Adult
Grant Support
ID/Acronym/Agency:
1 U01 NS 45719-01 A1/NS/NINDS NIH HHS
Chemical
Reg. No./Substance:
0/Cardiotoxins; 65271-80-9/Mitoxantrone
Comments/Corrections
Comment In:
Neurology. 2010 May 4;74(18):1410-1   [PMID:  20439842 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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