Re: The synergy of rosuvastatin (Crestor) with apabetalone
in response to
by
posted on
Oct 06, 2019 10:14AM
Bear,
yes my mind is indeed made up. It is not from knowing more than what is publicly available...it is from running spreadsheets on all permutations and combinations.
For example, I arrive at 5000 patient years by back calculating the median 27 months and extrapolating the patients known to be in the trial as given by Dr Sweeney. Second, I am assuming a 10% end drop out rate. Even if you do +/-5% sensitivity analysis on the 10%, it does not significantly impact end results as cumulative patient years don't radically change. Note that a smaller number of patient years means less MACE from placebo patients. Therefore, logically the data also skews more to 5,000 patient years than to 4,000 patient years: an independent "check" if you will.
I am assuming a 20 to 30% RRR. But no matter how much I play around with the numbers, it is impossible to get a significant gap in Crestor vs Lipitor groups MACE rates. This is purely on statistical grounds, as Jupiter explained earlier.
The only way my spreadsheets get to the 30% RRR that is bandied about on this board is a much lower MACE rate for the placebo group than the trial design of 7%. Allow for that, and it all makes sense. Tada's explanation of changing standard of care over time, goes a long way to explaining why.
Finally, I want to trot out my notes from talking to DM several months ago: MACE rates came in much lower than RVX itself expected. Again, that skews realized placebo rates much lower than design.