DR. WYNE: I think the problem comes in, as we want to do the simple
study and isolate the effects of a single drug, isolating the effect of the single drug is not
supposed to answer that question. The problem is, is in the newly diagnosed population,
which is what the UKPDS was, the CV event rate was so low it took them 25 years to
reach significance and even then it was only microvascular. So you do have an example
where you have people like the ACORD trial who have events, but the UKPDS who
don’t have events and we still don’t have an answer on whether Sulfonylureas kill people.
Can he jump in now, if he wants?
clinical reality because we really need to know does it make a difference in the context of
usual care? So, for example, in the VADT they mandated blood pressure and lipid
control and then ask the question of what does glucose control do? So I think like Dr.
Teerlink keeps saying that, not seeing an increase of events in this young, early diagnosis,
low risk group can be reassuring but because you don’t have a high risk group, you don’t
know if it truly makes a difference. The analogy there would be the original lipid studies.
started this 30 years ago, it is the UGDP and the UKPDS. In one group, a small
group, a Sulfonylurea was associated with cardiovascular events.
DR. BURMAN: If you’re done.
DR. WYNE: No, I’m not done.
DR. BURMAN: Okay. Please.
who had the events and the idea is if we could study a small population with a very high
risk we could then go on and do our 10,000 to 20,000 person study. All we have the
answer to is that we don’t have an increase in risk in the low risk population, which is
So we set up a study, the UKPDS which, among other things, was
They were done in the population with FH because those are the people
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