possible, for point number one, before we move to point number two. So the issue with
point number one is whether the low cardiovascular event rate in Saxagliptin clinical
trials permit a reliable assessment of cardiovascular safety. This is a summary, albeit
imperfect, that the studies only examine patients with low cardiovascular risk for a
relatively short period of time, which may not be applicable to longer studies and higher
a pre-clinical signal for a molecular basis for this. Also, as has been said, in diabetes
this is a continuum disease and a complex disease, so even the ATP 3 guidelines talk
about patients at high risk and very high risk. So if you have coronary disease and
diabetes, just like if you have ACS and smoke, that’s a very high risk population as
supposed to just a diabetic without CAD who is basically a CAD equivalent. So I think
its complex, its complex.
risk done in post-hoc adjudication. There is question whether this low risk will apply to
larger studies in patients who have a higher risk. It seems that many on the committee,
maybe the majority, think that it may apply, or put in another way as Mike had said, the
risk from a statistical standpoint of missing a significant cardiovascular event is low.
Anyone have any, Mark, disagreement with that or modifications? All right, thank you.
DR. BURMAN: Thank you. Let me try to summarize this discussion, if
Nonetheless, it appears that there is an acceptable cardiovascular safety
Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com
Question No. 2
Under the recent guidance regarding evaluation of cardiovascular risk for
diabetes therapies ongoing and future diabetes drug development programs will be
Then let’s move on to Question No. 2 and we will go for about a half an
hour on this. This is a long question. Oh, you have it on a slide, thank you.