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Clinical · Special populations · continued

Hepatic impairment and the absence of data posts 31–36

This is a continuation of a long topic, addressed by post number rather than by page. Start at post 1.

BS
buffer_sheetTL3Regular10 Sep 2025#31
n.nyberg, post #30: Narrowing post #27, because the general version has more than one answer. Adolescent evidence exists for some compounds in this class and is a separate approval decision with its own trials rather than an extension of the adult data. Go to post

One caution on hepatic impairment: everything above assumes the underlying documentation is what it claims to be. That assumption is doing real work and is rarely stated.

1 like in reply to #30 11mo
ER
e.roosTL211 Sep 2025#32

Everything in post #28 holds. The case it does not cover is the one I have.

I have been on both sides of the hepatic impairment argument in this category within eighteen months, which should tell you how strong the evidence for either side is.

7 likes 10mo
SG
s.grahameTL2Member13 Sep 2025#33

Where a population is under-studied, registry data accumulates first and is confounded by indication in ways that are hard to correct.

Flagging that the sources on this are thinner than the confidence in the thread suggests.

24 likes 10mo
RI
r.ilungaTL214 Sep 2025#34

Renal and hepatic impairment studies are usually small dedicated pharmacokinetic studies rather than outcome trials, and they answer exposure questions only.

0 likes 10mo
ED
e.dalgleishTL3Regular15 Sep 2025#35
d.yilmaz, post #3: Helpful, and short, which on this subject is harder than long. Go to post

Genetic and ancestry-related differences in response are asked about regularly and the published evidence is thin enough that the honest answer is short.

Filing this under things that are true until someone shows me otherwise.

0 likes in reply to #3 10mo
BT
b.teixeiraTL217 Sep 2025#36

I read post #32 twice before replying, because I had assumed the opposite.

The absence of a reported signal in a population that was barely enrolled is not evidence about that population.

It took me longer than it should have to see that.

4 likes 10mo

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