Ann: Positive Top-Line Results in DKD Phase 2 Clinical Study, page-331

Originally posted by RLGphd

hey OvF,

sure I can try to explain more clearly, and yes I was on the call. What I believed they said on the call was that there was no statistical difference between placebo and drug in the lower albuminuria group - this is not to say that placebo correction was not positive across this whole subgroup. And it must be positive in order for these numbers reported to be possible. Keep in mind that only one arm should experience a legacy effect while the other should not as it starts with placebo so the net of the two arms should somewhat cancel each other out... but it does not come close for the low albuminuria subgroup.

so:
26 patients with an average reduction of 18%
14 patients with an average of x
40 total patients with an average reduction of 2%

14 patients would therefore have an average albuminuria increase of >25% in order for this 40 patient cohort to have an overall reduction of 2%

As mentioned before, without seeing exactly which patients are in which groups it’s not conclusive, but it is concerning that this is how the math has to work out overall

a legacy effect would be pretty easy to detect (if strong) once graphing individual patient data in each arm, yet they only shared one select group with us and didn’t tell us which patients were in which arm (and left out a point) even though they would definitely have done this for each patient - there’s only 40 patients total and it’s very fast

i just feel data is being withheld which makes me think it’s very messy and therefore unlikely to give us clear answers of what’s happening which makes me not want to bet on the subanalysis solving all our problems

I think there is an error in your calculation. 40 total patients with an average reduction of 14%, not 2 %.
I won't read too much into the supposedly 'failure' of this trial due to a number of factors
- small sample size
- the trial is of very short duration- 6 months or so, the landmark trial for irbersartan (

N Engl J Med

. 2001 Sep 20;345(12):870-8.

doi: 10.1056/NEJMoa011489.)