suggesting some treatment effect differences between males and females, and younger
and older. Actually the estimate for males and females was about 0.11 and 0.17 for this
comparison. I want to point out that none of these estimates provide evidence of
significant increased risk. I also would like to add at the end here that the analyses by
FDA pharmacologists’ suggested higher exposure based on AUC for elderly patients than
younger patients. Thank you for your attention and now Dr. Lowy will return to
risk would also be seen in a higher risk subgroup. I am showing here the results by
type of study, here at the top by gender and by age. As Dr. Lowy showed earlier, the
add-on studies were comprised of patients who had a longer history of diabetes than the
patients in the monotherapy trials and all had been previously treated with anti diabetic
drugs. So the control event rate of one is much higher for those studies in monotherapy.
The control event rate is 1.8% for the add-on trials compared to six times - which is about
six times the rate seen for the monotherapy trials, but what we see is that the odds ratios
are essentially the same.
mentioned. I summarize with this slide to place the FDA requested analyses in the
context of the Sponsors analysis, particularly when comparing the point estimate of 0.5,
an upper limit of 1.2 in the Sponsors analysis, to the custom MACE numbers already
presented. A consistency of results is seen. Therefore, in summary, we have shown you
that patient populations were comparable across the studies used in the MACE analysis.
With this, low event rates were seen in all studies. Consistent results for Custom MACE
and SMQ broad MACE were seen particularly when excluding the preferred term of
For gender and age test for inner actions yielded P values under 0.2
DR. LOWY: The Sponsors own initial MACE analysis has already been
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