GRIPHON: The Largest Pivotal Trial Conducted in PAH (N=1156)1-3
The safety and efficacy of UPTRAVI was demonstrated in a multicenter, double-blind, placebo-controlled, parallel-group, event-driven study in patients with symptomatic PAH (>98% WH FC II or III). The primary endpoint was the time to first disease progression event.* Treatment with UPTRAVI resulted in a 40% risk reduction† (99% CI: 22% to 54%; P<0.0001; HR 0.60) in disease progression compared with placebo (27% [155/574] vs 41.6% [242/582], respectively). Adverse reactions occurring more frequently (≥5%) on UPTRAVI compared with placebo are headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in extremity, and flushing.1,4
GRIPHON OPEN-LABEL EXTENSION:
10 Years of Data: The Longest Follow-up Period of Any PAH Therapy5*
Estimates of survival for patients across GRIPHON and open-label extension studies (95% CI)6†
UPTRAVI (selexipag) demonstrated consistent, long-term safety across GRIPHON (N=1156) and open-label extension1,5
These data are from long-term follow-up and an open-label extension study. These uncontrolled observations do not allow comparison with a control group not given UPTRAVI and cannot be used to determine the long-term effect of UPTRAVI on mortality.
At Year 10, 408 patients had been censored. Participant is said to be censored when information on time to event is not available due to loss to follow-up or non-occurrence of outcome event before the trial end.6,7
A long-term follow-up was conducted in patients who were treated with UPTRAVI in the pivotal trial and OLE (N=574).6
