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Message: Re: BETonMACE Enrollment
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Aureus over on IV was alluding to a previous study by Callahan A as a comparison for possible event rates to expect in the BETonMACE placebo group. I think this is the study he/she was talking about (a sub-study of the SPARCL trial), but I'm not sure. I still think the EXAMINE trial is the better comparison (see links below). From a previous post in this thread:

EXAMINE Trial Event 3-point MACE Rate Estimates: Estimates of BETonMACE event rates are estimated from the EXAMINE trial in patients with diabetes and an ACS event within the past 90 days. BETonMACE patients will also be diabetic and recent ACS, but also will have low-HDL (see #2 below). The study drug, Alogliptin, in EXAMINE didn't work to increase or decrease 3-point MACE events, so both placebo and Alogliptin groups behaved more or less the same. The percentage of patients experiencing their first 3-point MACE event was ~11% over the median follow up of 18 months based upon graphs and statements from sources below. Additionally, eye-balling the primary outcome graph, I estimate a percent of: ~13% at 24 months, ~11% at 18 months, ~8% at 12 months, ~5% at 6 months, and ~2.5% at 3 months. So the event rate (first 3-point MACE event/month of follow up) is highest during the first 6 months of the follow up, and then the rate drops a bit in each of the subsequent 6 month periods.

http://www.nejm.org/doi/full/10.1056/NEJMoa1305889#t=article

https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM444148.pdf

http://secardiologia.es/images/rec/blog/EXAMINE.pdf

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