PHILADELPHIA, June 5 /PRNewswire-FirstCall/ -- The following is
GlaxoSmithKline's (NYSE: GSK) response to editorials written in the New
England Journal of Medicine (NEJM) regarding Avandia for the treatment of
type 2 diabetes.
We believe the NEJM editorials are selective in their use of data to
support a biased view, and therefore do a disservice to patients,
physicians, science and public health.
Dr. Home's paper as published in the NEJM, clearly shows that the
hypotheses in Dr Nissen's paper have not been validated. The paper says the
data do not allow a conclusion regarding myocardial infarction; yet the
editorials largely ignore this point, and seem to assume this risk is self-
evident. None of the editorials mention the fact that RECORD refutes the
second element of Dr. Nissen's hypothesis, a suggested 64% increase in
cardiovascular deaths. RECORD shows a 17% decrease in risk of
cardiovascular death.
Editorial comments on ADOPT also selectively ignore the fact that
cardiovascular events with metformin -- the gold standard therapy -- were
comparable to those on Avandia. This ignores the experience of one-third of
the patients in this trial.
Dr. Home's peer reviewed paper also concludes: "There is no evidence of
any increase in death from either cardiovascular causes or all causes." In
addition to not referencing that patients on Avandia had 17% fewer deaths
from cardiovascular events, the editorials also ignore the fact that there
was no increase in all-cause mortality, and no increase in the MACE
endpoint, comprised of CV mortality, myocardial infarction and stroke.
These endpoints are very relevant for patients and their physicians.
The editorials continue to place equal emphasis on a meta-analysis
compared with a much more rigorous, prospectively designed trial to look at
cardiovascular safety, such as RECORD.
Though criticized by the editorials, cardiovascular event rates in the
RECORD study are low because of the appropriate and intensive management of
patients' type 2 diabetes, including glucose, blood pressure and lipids.
This is a good thing for diabetes patients. The impact of the improved
medical care for type 2 diabetic patients should be applauded and
supported, because it represents a very important advance in the treatment
of diabetic patients and public health.
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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CONTACT:
US Media inquiries: Nancy Pekarek,
+1-215-751-7709, Mary Anne Rhyne, +1-919-483 2839 or Alice Hunt,
+1-215-751-7709; UK Media inquiries: Phil Thomson, Joss
Mathieson, or Gwenan White, all at (020) 8047 5502; US
Analyst/Investor inquiries: Frank Murdolo, +1-215-751-7002 or Tom
Curry, +1-215-751-5419; European Analyst/Investor inquiries:
Anita Kidgell (020) 8047 5542, David Mawdsley, (020) 8047 5564 or
Sally Ferguson (020) 8047 5543, all of GlaxoSmithKline
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