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Message: Re: 250 MACE scenario question
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Jan 23, 2019 05:12PM
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Jan 23, 2019 05:34PM
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Jan 23, 2019 07:27PM
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Jan 23, 2019 08:10PM
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Jan 24, 2019 05:11PM
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Jan 24, 2019 06:04PM
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Jan 24, 2019 06:35PM

"And I'm not up to speed on what happened to this?   Are most on rosuvastatin?"

As for the rosuvastatin vs. atorvastatin split in BETonMACE.....in the AHA 2018 BETonMACE baseline measures poster from November 2018 it states that 51% were treated with atorvastatin and 49% with rosuvastatin.

"Can you point to where atorvastatin vs rosuvastatin is part of the prespecified analysis. ???"

A few examples. You'll have to take my word on the first two.

My own email correspondence with Sarah October 2015 specifically asked about atorvastatin vs. rosuvastatin issue. I asked "And a couple more question for Michael. Is there a pre-defined comparison between those patients on rosuvastatin vs. atorvastatin, or will that comparison be a post-hoc analysis after BETonMACE has ended?

Sarah responded "As for your last two questions - yes the rosuvastatin/atorvastatin will be a pre-specified analysis. The study is powered for a 30% RRR but a statistically significant RRR of a lower magnitude will mean that the study is a success."

In the R&D Day Presentation from 10/13/2016, Michael Sweeney had the pre-specified analysis slide described below (I have the slides right in from on me).

Most recently, the same pre-specified analysis slide was presented in the ERA-EDTA presentation by Dr. Kam Kalantar-Zadeh. 

The latter two examples above both state that pre-specified subgroup analyses for the primary endpoint in BETonMACE include those analyses listed below. I also had a post on this in July of last year.

– Rosuvastatin/Atorvastatin

– < 30 days/> 30 days post-acute coronary syndrome

– LDL/HDL/TG’s above and below median

– HbA1c above and below median

– eGFR >60 mL/min and < 60 mL/min

• Also change in eGFR for all patients with eGFR <60 mL/min

Lastly, I wouldn't take the information listed on ClinicalTrials.gov as comprehensive or completely accurate. There are certain elements missing and/or outdated and/or incorrect. 

BearDownAZ

 

 

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Jan 24, 2019 08:21PM
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