Re: Rationale and Design of Apabetalone BETonMACE Trial
in response to
by
posted on
Dec 03, 2018 04:03PM
Over on Stockhouse last week there was a discussion thread about number needed to treat (NNT). Esopbykelso posted that the NNT for Vascepa in REDUCE-IT was 21 and wondered by kind of NNT we may expect to see for apabetalone. Recall, REDUCE-IT's primary endpoint was 5-point MACE and secondary endpoint was 3-point MACE. The NNT of 21 was for the 5-point MACE. For 3-point MACE in REDUCE-IT the NNT was 28:
"A key secondary efficacy end-point event (Figure 1B) occurred in 11.2% of the patients in the icosapent ethyl group, as compared with 14.8% of the patients in the placebo group (hazard ratio, 0.74; 95% CI, 0.65 to 0.83; P<0.001), corresponding to an absolute between-group difference of 3.6 percentage points (95% CI, 2.1 to 5.0); the number needed to treat to avoid one key secondary end-point event was 28 (95% CI, 20 to 47) over a median follow-up 4.9 years."
NNT is the inverse of the absolute risk reduction (ARR). Here's a link to an easy web tool for calculating NNT. ARR is the difference in actual event rates between the placebo and test group. The NNT should also state the duration and the adverse outcome being prevented. An NNT in the 20-30 range is completely possible for BETonMACE. Importantly, the median follow up period for BETonMACE should be less than half of the 4.9 years in REDUCE-IT. So hypothetically if both apabetalone and Vascepa end up with NNTs of 28 for their respective trials, the duration of treatment needed to achieve this is much shorter with apabetalone for the BETonMACE high-risk population.
BearDownAZ