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DR. WYNE: I think the problem comes in, as we want to do the simple

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study and isolate the effects of a single drug, isolating the effect of the single drug is not

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supposed to answer that question. The problem is, is in the newly diagnosed population,

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which is what the UKPDS was, the CV event rate was so low it took them 25 years to

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reach significance and even then it was only microvascular. So you do have an example

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where you have people like the ACORD trial who have events, but the UKPDS who

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don’t have events and we still don’t have an answer on whether Sulfonylureas kill people.

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Can he jump in now, if he wants?

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clinical reality because we really need to know does it make a difference in the context of

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usual care? So, for example, in the VADT they mandated blood pressure and lipid

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control and then ask the question of what does glucose control do? So I think like Dr.

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Teerlink keeps saying that, not seeing an increase of events in this young, early diagnosis,

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low risk group can be reassuring but because you don’t have a high risk group, you don’t

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know if it truly makes a difference. The analogy there would be the original lipid studies.

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started this 30 years ago, it is the UGDP and the UKPDS. In one group, a small

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group, a Sulfonylurea was associated with cardiovascular events.

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DR. BURMAN: If you’re done.

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DR. WYNE: No, I’m not done.

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DR. BURMAN: Okay. Please.

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who had the events and the idea is if we could study a small population with a very high

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risk we could then go on and do our 10,000 to 20,000 person study. All we have the

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answer to is that we don’t have an increase in risk in the low risk population, which is

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So we set up a study, the UKPDS which, among other things, was

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They were done in the population with FH because those are the people

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