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Message: Trying to understand placebo rste of MACE

BearDownAZ,

We know that all patients in the BETonMACE trial are using thd current standard of care to prevent MACE. We know that if we knew the MACE event rate for the standard of care we could better estimate the placebo rate of our trial and therefore better estimate the MACE event rate of our drug in our trial.

So we look at past trials with similar patient groups,... ie the EXAMINE trial. You have stated in rhe past that the standard level of care for that  trial is not the same as our trial because the standard of care has probably improved. Can i assume that the drug part of the standard of care is the same as the EXAMINE trial, as the statin drugs the placebo group was taking in the EXAMINE trial were the same as our trial, unless the statin drugs underwent new trials to improve their makeup and efficacy their placebo rate would bd the same..

I am assuming a drug's makeup can not change unless it is tested in a new trial.

Thanks

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Mar 19, 2019 08:45AM
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Mar 19, 2019 10:44AM
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Mar 19, 2019 11:28AM
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