Users of Copaxone aren't likely to be very happy about this article done by Italian researchers. These docs have been involved in MS research for a long time and have a good reputation in this area.
Glatiramer Acetate Provides No Significant Effect in the Treatment of Multiple Sclerosis
Research News from The Cochrane Library
MILAN, Italy, May 27 /PRNewswire/ -- One of the currently most widely
prescribed treatments for multiple sclerosis (MS), glatiramer acetate
(Copaxone(R), Teva / Aventis), may provide no significant benefit on the main
outcomes measures in the disease, namely either slowing the progression of MS
or substantially affecting the risk of clinical relapses over time. "At
present there is insufficient evidence to support future routine use of
glatiramer acetate in clinical practice and more data from randomised clinical
trials are needed," said Dr Munari, neurologist and member of the Cochrane MS
The review, carried out by members of the Cochrane MS Group, incorporated
the results of 646 patients with MS who participated in four randomized,
placebo-controlled clinical trials. The review included both patients with
relapsing-remitting MS and chronic progressive MS (CPMS).
Glatiramer acetate is a random mixture of polypeptides derived from the
synthesis of four amino acids. It has structural properties similar to myelin,
the basic protein within the sheaths surrounding nerves. Its mechanism of
action is actually unknown, as it is for beta-interferons. It is prescribed
as a secondary alternative to beta interferon, which is well established in
the treatment of MS, a chronic disease of the nervous system that affects
young and middle-aged adults and can lead to permanent disability.
Currently available data do not provide definite evidence that glatiramer
acetate shows any significant effect on disease progression, measured as a
sustained worsening in the Expanded Disability Status Scale (EDSS). No
benefit was shown in CPMS patients (progression at two years: RR=0.69, 95% CI
[0.33 to 1.46]).
The most common systemic adverse events of glatiramer acetate were a
transient and self-limiting patterned reaction of flushing, chest tightness,
sweating, palpitations, and anxiety (relative risk = 3.40 (95% CI [2.22 to
5.21], p <0.00001]). Local injection-site reactions were observed in up to a
half of the patients treated with glatiramer acetate, thus making a blind
assessment of outcomes questionable.
"The trials in this review tended to focus on the effect of glatiramer on
the rate of relapses, whereas the outcome that people with MS are particularly
concerned about is the progression of their disease," said Dr. Filippini, Co-
ordinating Editor of the MS Review Group. "The absence of clinical benefit
with glatiramer reinforces the need for further research looking at clinically
significant outcomes and reliable measures such as patient disability over
time and quality of life."
Notes to Editors
Munari L, Lovati R, Boiko A. Therapy with glatiramer acetate for multiple
sclerosis (Cochrane Review). In: The Cochrane Library, Issue 1, 2004.
Systematic Reviews bring together research on the effects of health care
and are considered the gold standard for determining the relative
effectiveness of different interventions. The Cochrane Collaboration is the
world's leading producer of these reviews.
The Cochrane Collaboration started in 1992. It is an international
organization with bases and participants throughout the world. The Cochrane
) aims to help people make well-informed
decisions about healthcare by preparing, maintaining and promoting the
accessibility of up-to-date systematic reviews of the effects of healthcare
interventions. It is a not-for-profit organization, established as a company,
limited by guarantee, and registered as a charity. It serves the information
needs of physicians, clinical researchers, nurses, midwives, dentists,
patients and healthcare policymakers at medical institutions, universities,
corporations, and healthcare organizations around the world,. The
Collaboration encompasses an established network of 50 research groups
worldwide that prepare and maintain Cochrane reviews, covering a range of
medical specialties. Approximately 10,000 people are actively involved in the
work of The Cochrane Collaboration, almost all on a voluntary basis.
The url address by which the Library can be accessed is
SOURCE Dr Luca M. Munari, M.D.
Web Site: http://www.nicsl.com.au/cochrane/index.asp
More news from PR Newswire...
Issuers of news releases and not PR Newswire are solely responsible for the accuracy of the content.
Terms and conditions, including restrictions on redistribution, apply.
Copyright © 1996-2004 PR Newswire Association LLC. All Rights Reserved.
A United Business Media company.
PR Newswire web sites - MEDIA - Media Site ProfNet - INFORMATION - Brazil Canada Europe Germany North America Disclose eWatch™ (UK) eWatch™ (US) Media Insider MultiVu™ Online MEDIAtlas™ PR AUDiT - CLIENTS - PRN Direct - NEWS - Brazil Canada China Europe France Israel North America