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Senior Citizen Health & Medicine
Avandia Drug Maker Disagrees with Study Saying the
Diabetes Drug Increases Heart Attacks, Deaths
GlaxoSmithKline says it's highly effective
treatment for type 2 diabetes
May 22, 2007 The maker of the diabetes drug
Avandia, GlaxoSmithKline, responded quickly to an online study published
Tuesday by the New England Journal of Medicine indicating the drug,
highly popular for treating type 2 diabetes, significantly increased the
risk of heart attack and death.
Statement Monday from GlaxoSmithKline
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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