Re: ESPR results
in response to
by
posted on
Aug 26, 2018 12:58AM
Bfw,
The Esperion bempedoic acid clinical trial results that you cited are for a 52 week long term tolerability, safety and LDL cholesterol lowering efficacy trial. It was not the bempedoic acid cardiovascular outcomes trial, which is still ongoing until 2022. The trial that you quoted was not designed or powered to be a CVOT trial. Consistent with the top line data release in May, the full trial results presented at ESC this weekend by Dr. Ray report no statistically significant difference in serious adverse events, including MACE, between bempedoic acid and placebo groups. Stay tuned for top line data from ESPR's remaining LDL cholesterol lowering and safety trials between now and end of next month. Esperion will be filing NDA/MMA for LDL cholesterol lowering in H1 2019. The verdict on the properly powered and designed CVOT trial will not be until 2022.
There is room for both apabetalone and bempedoic acid for managing cardiovascular risk. LDL cholesterol lowering has been cemented as an effective strategy, so bempedoic acid may help here. However, the residual risk that remains can hopefully be managed by a novel and effective therapy like apabetalone, which does not affect LDL cholesterol.
BearDownAZ