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For the week ending September 28, 2012
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Last week 332 articles were evaluated via DynaMed's Systematic Literature Surveillance and 158 were added to DynaMed content.
Based on the editors' criteria of selecting "articles most likely to change clinical practice," one article of significant interest was selected for the DynaMed Weekly Update.
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| Feature Article | |
Dimethyl Fumarate May Decrease Risk of Relapse in Relapsing-Remitting Multiple Sclerosis
Parenteral agents including interferon and glatiramer are the most common treatments for relapsing-remitting multiple sclerosis (MS), but adherence can be a concern. Oral alternatives to daily subcutaneous injection have been studied including the FDA-approved drugs fingolimod (Gilenya) and teriflunomide (Aubagio). Other oral agents that have shown benefit for reducing relapse rates but are not yet FDA-approved for this use include cladribine (Leustatin) (N Engl J Med 2010 Feb 4;362(5):416) and laquinimod (N Engl J Med 2012 Mar 15;366(11):1000). Another oral drug, dimethyl fumarate (BG-12), an antiinflammatory and cytoprotective agent, was submitted for FDA approval for use in relapsing-remitting MS in February 2012. Two recent randomized trials evaluated its efficacy.
In the CONFIRM trial, 1,430 adults with relapsing-remitting MS were randomized to dimethyl fumarate 240 mg orally (2 times daily vs. 3 times daily) vs. glatiramer 20 mg subcutaneously daily vs. oral placebo for 96 weeks. Relapse was defined as new or recurrent neurologic symptoms (not associated with fever or infection) lasting for ≥ 24 hours and new objective neurologic findings. About 20% of patients withdrew during follow-up and 1% discontinued the study drug but completed the trial. The intention-to-treat analysis included 99% of randomized patients who received at least 1 dose of the study drug.
Both doses of dimethyl fumarate were associated with significantly reduced annualized relapse rates compared to placebo. The estimated 2-year risk of relapse was 29% for 2 times daily dosing (p < 0.05 vs. placebo, NNT 9), 24% for 3 times daily dosing (p < 0.05 vs. placebo, NNT 6), and 41% for placebo (level 2 [mid-level] evidence). Glatiramer was also associated with a significantly reduced risk of relapse (p < 0.05 vs. placebo). There were no significant differences in progression of disability at 2 years.The most common adverse events with dimethyl fumarate were flushing and gastrointestinal symptoms (N Engl J Med 2012 Sep 20;367(12):1087).
In the DEFINE trial, 1,237 adults were randomized to the same doses of oral dimethyl fumarate as above vs. placebo for 96 weeks. About 23% withdrew from the trial but were included in the intention-to-treat analysis. As in the CONFIRM trial, both doses of dimethyl fumarate were associated with significant reduction in annualized relapse rates compared to placebo. The estimated 2-year risk of relapse was 27% for 2 times daily dosing (p < 0.05 vs. placebo, NNT 6), 26% for 3 times daily dosing (p < 0.05 vs. placebo, NNT 5), and 46% for placebo (level 2 [mid-level] evidence). Unlike the CONFIRM trial, dimethyl fumarate was also associated with reduced risk of disability progression at 2 years, with estimated rates of 16% for 2 times daily dosing (p < 0.05, NNT 9), 18% for 3 times daily dosing (p < 0.05, NNT 12), and 27% for placebo (N Engl J Med 2012 Sep 20;367(12):1098).
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For more information on this educational activity, see the CME sidebar. | |
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First International Conference on Evidence Based HealthCare (ISEHCON), October 7th - 8th, 2012
Editor-in-Chief Dr. Brian Alper will be leading a workshop at the First International Conference on Evidence Based Healthcare at the India International Centre in New Delhi, India. The topic of the workshop will be "Best Sources for Evidence-Based Literature for Healthcare Practitioners".
Visit the International Society for Evidence Based Health Care website to learn more about the event and for registration information.
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We are currently seeking reviewers for:
Eastern equine encephalitis
Brachial plexopathy
Learn more about the DynaMed Contribution Opportunities: DynaMed Peer Review Editorial Policies for Reviewers |
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CME Information
CREDITS
Physicians: 0.25 AMA PRA Category I Credit(s)™
Family Physicians: 0.25 Prescribed credits
Nurse Practitioners: 0.25 Contact hours
Release Date: October 03, 2012
Expiration Date: October 03, 2013
Estimated Completion Time:
15 minutes
There is no fee for this activity.
To Receive Credit
In order to receive your certificate of participation, you should read the information about this activity, including the disclosure statements, review the entire activity, take the post-test, and complete the evaluation form. You may then follow the directions to print your certificate of participation. To begin, click the CME icon at the end of the article.
Program Overview
Learning Objectives
Upon successful completion of this educational program, the reader should be able to:
1. Discuss the significance of this article as it relates to your clinical practice.
2. Be able to apply this knowledge to your patient's diagnosis, treatment and management.
Faculty Information Alan Ehrlich, MD - Assistant Clinical Professor in Family Medicine, University of Massachusetts Medical School, Worcester, Massachusetts, USA; Senior Deputy Editor, DynaMed, Ipswich, Massachusetts, USA Michael Fleming, MD, FAAFP - Assistant Clinical Professor of Family Medicine and Comprehensive Care, LSU Health Science Center School of Medicine, Shreveport, Louisiana, USA; Assistant Clinical Professor of Family Medicine, Department of Family and Community Medicine, Tulane University Medical School, New Orleans, Louisiana, USA; Chief Medical Officer, Amedisys, Inc. & Antidote Education Company
Disclosures
Dr. Ehrlich, Dr. Fleming, DynaMed Editorial Team members, and the staff of Antidote Education Company have disclosed that they have no relevant financial relationships or conflicts of interest with commercial interests related directly or indirectly to this educational activity.
No commercial support has been received for this activity.
Accreditation Statements
ACCME: This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of Antidote Education Company and EBSCO Publishing. Antidote is accredited by the ACCME to provide continuing medical education for physicians. Antidote Education Company designates this enduring activity for a maximum of 0.25 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.
AAFP: Enduring Material activity, DynaMed Weekly Update, has been reviewed and is acceptable for up to 13 Prescribed credits by the American Academy of Family Physicians. AAFP certification begins March 7, 2012. Term of approval is for one year from this date with the option of yearly renewal. Each Weekly Update is worth .25 Prescribed credits. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
AANP: This program is approved for 0.25 contact hour of continuing education by the American Academy of Nurse Practitioners.
Program ID: 1102073E
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