Hypotension incidence — Velorant vs. endothelin receptor antagonist (ERA — a class of drugs that block endothelin receptors to reduce blood vessel narrowing) class
Hypotension incidence (%) by drug — unadjusted
Unadjusted comparison: Velorant appears 19% above the ERA class average.
But: Velorant's trial had a much higher rate of diagnostic procedure co-administration (74% of patients) compared to the class average (41%). The comparator trials enrolled fewer patients who underwent RHC (Right Heart Catheterization — gold-standard diagnostic test for pulmonary arterial hypertension) during the study period.
Sources: Ambrisenpar SmPC Rev. 7, §4.8 [¹] · Velorant PSUR §3.2 [²] · Macitenbar EU SmPC Rev. 4 [³]
iSAT identified a confounding factor that explains this difference.
See temporal analysis →