PHILADELPHIA, May 21 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE:
GSK) today issued the following response to an article in the New England
Journal of Medicine (NEJM) on Avandia(R) (rosiglitazone maleate), a widely
used and highly effective treatment for type 2 diabetes:
GSK strongly disagrees with the conclusions reached in the NEJM
article, which are based on incomplete evidence and a methodology that the
author admits has significant limitations.
The NEJM paper is based on an analysis of summary information that
combines a number of studies - a meta-analysis - which is not the most
rigorous way to reach definite conclusions about adverse events. Each study
is designed differently and looks at unique questions: for example,
individual studies vary in size and length, in the type of patients who
participated, and in the outcomes they investigate. The data compiled from
these varied studies is complex and can be conflicting.
Importantly, the editorial in the NEJM states: "A few events either way
might have changed the findings for myocardial infarction or for death from
cardiovascular causes. In this setting, the possibility that the findings
were due to chance cannot be excluded. In their discussion, the authors
properly emphasize the fragility of their findings."
In contrast to a meta-analysis, the most scientifically rigorous way to
examine the safety and benefits of a medicine is to conduct large scale,
long- term clinical trials in patients with the disease. Several trials of
this type have been ongoing for many years. To date concerns regarding
patient safety have not been identified by the independent Safety
Monitoring Boards for these trials. Several trials have been completed and
the results published. For example, GSK's long-term, landmark study 'ADOPT'
(A Diabetes Outcome Progression Trial) - one of the longest clinical trials
in people with type 2 diabetes to date - directly compared both the safety
and effectiveness of Avandia with other oral anti-diabetic medicines in
over 4,300 patients studied for up to 6 years.
Data from ADOPT showed that the overall risk of serious, cardiovascular
events (CV death, myocardial infarction, and stroke, or MACE endpoint) for
patients on Avandia was comparable to metformin and sulfonylurea
(glyburide) - two of the most commonly used medicines to treat type 2
diabetes. ADOPT showed comparable rates of cardiovascular deaths: Avandia -
5 reports out of 1,456 patients, or 0.34%; metformin - 4 out of 1,454, or
0.28%; and glyburide - 8 out of 1,441 or 0.56%. The ADOPT clinical trial
did show a small increase in reports of myocardial infarction among the
Avandia-treated group (Avandia: 24 out of 1,456 or 1.65%) vs metformin (20
out of 1,454 or 1.38%) vs glyburide (14 out of 1,441 or 0.97%); however,
the number of events is too small to reach a reliable conclusion about the
role any of the medicines may have played in this finding. Importantly,
ADOPT also demonstrated that Avandia was superior to metformin and
sulfonylurea regarding long-term control of blood sugar over five years,
which is a key goal in managing diabetes to avoid the long-term
complications of the disease.
In another long-term study, DREAM - which followed over 5,200 patients
at high risk of developing of type 2 diabetes for a period of three to five
years - Avandia monotherapy showed no increase in cardiovascular risk when
compared to placebo.
Furthermore, in 2000, GSK initiated RECORD - a large, long-term
clinical trial in people with diabetes- which has been prospectively
designed to look at cardiovascular outcomes. The independent Safety
Monitoring Boards responsible for overseeing the safety of this trial
monitors patients closely, and in its regular operations has not found any
safety risk that would interrupt continuation of the study.
In addition, in a comprehensive analysis of patients in a US managed
care database of more than 33,000 people with diabetes - performed by
independent investigators - there was no difference in ischemic
cardiovascular events (including myocardial infarction) among patients
taking Avandia-containing regimens versus other oral anti-diabetic
medicines.
The totality of the data show that Avandia has a comparable
cardiovascular profile to other oral anti-diabetic medicines. GSK stands
firmly behind the safety of Avandia when used appropriately, and we believe
its significant benefits continue to outweigh any treatment risks.
Because Avandia has been shown to control blood sugar for longer than
other standard oral anti-diabetic medicines, it is an important treatment
option for physicians who often need to prescribe two or three medicines to
help their patients maintain their blood sugar levels. Type 2 diabetes is
chronic, relentlessly progressive and life threatening; yet, two-thirds of
diabetic patients suffer with uncontrolled disease. If left uncontrolled,
diabetes can lead to heart disease, and is the leading cause of blindness,
kidney disease and non-traumatic amputations in the US.
GSK has consistently shared its data on Avandia from meta-analyses and
controlled studies with the FDA and other regulatory agencies. Data is also
posted publicly on the company's Clinical Trial Register. We continue to
work closely with regulatory authorities and physicians to keep them fully
informed so they can make the best decisions for patients based on both the
safety and benefit of the medicine.
GlaxoSmithKline - one of the world's leading research-based
pharmaceutical and healthcare companies - is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For company information, visit GlaxoSmithKline on the World Wide
Web at http://www.gsk.com.
SOURCE GlaxoSmithKline
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+1-215-751-7709, or Mary Anne Rhyne, +1-919-483-2839, or Alice
Hunt, +1-215-751-7709; or UK Media inquiries, Phil Thomson, (020)
8047 5502, or Joss Mathieson, (020) 8047 5502, or Gwenan White,
(020) 8047 5502; or US Analyst - Investor inquiries, Frank
Murdolo, +1-215-751-7002, or Tom Curry, +1-215-751-5419; or
European Analyst - Investor inquiries, Anita Kidgell, (020) 8047
5542, or David Mawdsley, (020) 8047 5564, or Sally Ferguson,
(020) 8047 5543, all of GlaxoSmithKline
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