So, it's a consistent theme in these diabetes presentations emphasizing how important the
relationship is between diabetes and cardiovascular events and how this is really, really
an important issue and we really need to know about this, and yet consistently, when you
look at the enrollment criteria and event rates stay base, most of these trials are assiduous
in excluding patients with cardiovascular disease and enrolling patients with
extraordinarily low event rates. When I look at the inclusion ratios, there is - these
exclusions of significant cardiovascular events within six months and heart failure and
ejection fraction less than 40%.
the middle of the description of each endpoint, there are two descriptions of the
incidence rate ratio. The first one is based upon an exact method, for instance, rate ratio
and the second for the Mantel-Haenszel. At least in our hands, these analyses give fairly
comparable results for the upper bound the conference interval regardless of method.
agreeing that Saxagliptin should be not given to any patient with a history of
cardiovascular event within six months and not given to patients with heart failure either
diastolic or systolic or any patient with an EF less than 40%, and since we have no
experience in what happens to patients once they develop these things, that if a patient
develops heart failure that they should be removed from Saxagliptin or if they have a
cardiovascular event they should be removed from Saxagliptin for at least six months and
then could be considered to be restarted on it. Do you have any - am I misinterpreting the
So I assume since we have no experience in these patients that you are
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DR. FLEGAL: Yeah, those are rate ratios.
DR. WOLF: Correct, yes.
DR. BURMAN: Thank you. Dr. Teerlink, did you have a question?
DR. TEERLINK: Yes, I actually have a - yes, I have a series of questions.