you can look this up in the published phase 3 paper as easily as I can, I don't know what you mean, are you asking if there were more discontinuations in patients taking sparsentan than irbesartan (the comparator), or are you asking if there are more discontinuations in their trial overall compared with DXB trial? As the DXB trial is some way from completion, if your question is the second one it's a bit pointless to compare.
I don't have any vested interest in Travere or their drug, but I do think there's been misinformation/disinformation on this forum saying their drug is seriously unsafe. I'm not sure if this has been started by any DXB communications in the past or by posters here (
@vintage)
If sparsentan is unsafe, no way would FDA and EU have approved it for IgA nephropathy. And DXB200 safety is not proven at this point as the numbers treated are still quite low.
People are looking at the long list of warnings and think it must be terrible but have no frame of reference. Even the "hepatotoxicity" warning if it's read properly it's not terrible and won't put off nephrologists. Only a minority of sparsentan treated patients (3.5%, 1 in 30) had some liver enzyme elevation in their trial, they could have had other medical conditions that made this more likely to occur (by the way if people read the phase 3 studies, a small % of patients in the control arm of irbesartan also had some liver enzyme rises). The cautionary wording saying don't use in patients with pre-existing liver disease is normal and applies to lot of pharmaceuticals where some live enzyme changes are seen which is more common that's you'd think. Very unlikely to have much effect on their market. The recommendation to monitor liver tests is also standard and not a big deal as these patients are likely to have regular blood tests anyway as part of their FSGS kidney management.
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