know, something that was a submission before the guidelines were in place. How do we
look at it? I was overall very sanguine about this particular treatment but I wanted to
point out that we are talking about lots of diabetics with lots of different needs, with lots
of risks that they have to assess. I am not sure where I am wondering off to there but I
just wanted to bring that back up to the panel. Thanks.
‘one size fits all’ is a little disadvantaging a certain increasing population of diabetics
who are younger at onset and face many, many years of treatment. They face these
increased cardiovascular risks because of their diagnosis. If you are developing diabetes
at 35 instead of 55, you are going to have a good 20 years of treatment ahead of you
before you really start to focus on the cumulative effect of your diagnosis, your treatment,
your ability to control your diabetes.
bringing them up. Diabetes is a complex disease and for purposes of discussion we
divided into the Type 1 and Type 2 but obviously it’s much more complex than that.
John, did you have a comment as well?
DR. BURMAN: Thank you. I agree with your points and thank you for
plays in morbidity for diabetics. We don’t want to burden an increasing population who
may not have access to drugs, you know, or have delayed access to treatments because
we are overly focused on this risk. When I looked at this question and I thought, ‘okay,
we have this low event rate, that’s one question’.
So what are our populations? What’s our definition of a diabetic? This
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So, cardiovascular risk is very important because we know the part that it
We have this gap period where we are trying to fit this study into, you
DR. TEERLINK: So partly in response to Mark’s comments, in direct
discussion of the question, I think the data that’s been presented does give us some good