New Avandia Study Doesn't Prove Safety
Editorial Says Avandia ‘Potentially Dangerous’; GSK Says Study ‘Reassuring’
WebMD News Archive
But editorials published alongside the study paint a far different
The study has several flaws, notes David M. Nathan, MD, director of the
diabetes center at Massachusetts General Hospital and professor of medicine at
Harvard Medical School in Boston.
"The interim results of the RECORD trial do not provide any assurance of
the safety of treatment with [Avandia]," Nathan writes. "Physicians may
find it difficult to explain to patients why they are starting treatment with a
potentially dangerous drug when other choices with longer and better safety
records are available."
The other editorial is by Bruce M. Psaty, MD, PhD, of the University of
Washington in Seattle and Curt D. Furberg, MD, PhD, of Wake Forest University
in Winston-Salem, N.C. Psaty and Furberg's previous editorial on Avandia
questioned the FDA's wisdom in approving the drug.
Now Psaty and Furberg say the very low number of heart disease events in the
RECORD trial is suspicious. Coupled with the study's high dropout rate, they
suggest this leaves the study without enough statistical power to achieve its
goal of proving that Avandia is not inferior in heart safety to standard
Moreover, they suggest that when the study findings are combined with data
from previous studies, Avandia is still associated with significant risk of
"The level of risk, a hazard ratio of 1.33 (a 33% increase in heart
attack risk), is substantial and approximately equivalent in magnitude -- but
in the opposite direction - to the health benefits of lipid-lowering statin
drugs," Psaty and Furberg write.
And an editorial by NEJM Editor Jeffrey M. Drazen, MD, and
colleagues, states "even a small increase in cardiovascular risk in a
fragile population of patients with type 2 diabetes is of considerable
"There is continued uncertainty about the cardiovascular safety of
[Avandia]," Drazen and colleagues conclude.
Krall and Glaxo Vice President of Clinical Development Murray Stewart, FRCP,
say that these conclusions distort the RECORD findings.
"It would be very unfortunate if doctors tried to make decisions based
on these very small differences between Avandia and standard diabetes
drugs," Krall said. "The best interpretation of these findings would be
that there are no differences between Avandia and sulfonylurea with