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So, it's a consistent theme in these diabetes presentations emphasizing how important the

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relationship is between diabetes and cardiovascular events and how this is really, really

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an important issue and we really need to know about this, and yet consistently, when you

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look at the enrollment criteria and event rates stay base, most of these trials are assiduous

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in excluding patients with cardiovascular disease and enrolling patients with

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extraordinarily low event rates. When I look at the inclusion ratios, there is - these

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exclusions of significant cardiovascular events within six months and heart failure and

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ejection fraction less than 40%.

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the middle of the description of each endpoint, there are two descriptions of the

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incidence rate ratio. The first one is based upon an exact method, for instance, rate ratio

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and the second for the Mantel-Haenszel. At least in our hands, these analyses give fairly

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comparable results for the upper bound the conference interval regardless of method.

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agreeing that Saxagliptin should be not given to any patient with a history of

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cardiovascular event within six months and not given to patients with heart failure either

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diastolic or systolic or any patient with an EF less than 40%, and since we have no

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experience in what happens to patients once they develop these things, that if a patient

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develops heart failure that they should be removed from Saxagliptin or if they have a

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cardiovascular event they should be removed from Saxagliptin for at least six months and

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then could be considered to be restarted on it. Do you have any - am I misinterpreting the

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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.

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DR. WOLF: Correct, yes.

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DR. BURMAN: Thank you. Dr. Teerlink, did you have a question?

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DR. TEERLINK: Yes, I actually have a - yes, I have a series of questions.

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