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Message: Re: eGFR and Cognition?
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Nov 22, 2019 10:48PM

Not sure if Cabel was referring to Phase 2 or Phase 3. As Jupiter summarized for Phase 2 patients with eGFR<60:

"Patients who received apabetalone (n=35) versus placebo (n=13) over 6 months showed significantly (p=0.02) lowered serum ALP -14.0% (p<0.0001 versus baseline) versus -6.3% (p=0.9 versus baseline). The eGFR in the apabetalone group increased by 3.4% (1.7 mL/min/1.73 m2) (p=0.04 versus baseline) and decreased by 5.8% (2.9 mL/min/1.73 m2) (p=0.6 versus baseline) in the placebo group. Apabetalone was well tolerated."

Here's the link to the paper:

https://www.ncbi.nlm.nih.gov/pubmed/29566379

All we know right now for Phase 3 BETonMACE is for the TOTAL 2425 patient population eGFR increased in placebo by 2.1 & decreased in apabetalone by 0.4. Median eGFR in TOTAL population is ~99, so these changes in TOTAL population seem tiny and clinically insignificant. 

Although the direction of change for the TOTAL population is opposite of what was seen in CKD Phase 2 and what is expected in CKD Phase 3, we have zero information available to us as to have apabetalone affected eGFR in healthy Phase 2 patients. Jury still out for the ~250 CKD patients in BETonMACE with eGFR<60. I am expecting a replication of Phase 2 with benefit (increase) in apabetalone group and no benefit (decrease) in placebo group.

BearDownAZ

 

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