TYVASO showed sustained improvements in 6MWD1
TRIUMPH OLE Study Design: an OLE of the TRIUMPH study to evaluate the safety and dosing of TYVASO over time. Patients (N=206) from the placebo-controlled 12-week TRIUMPH study initiated TYVASO and entered the long-term, uncontrolled OLE study. NYHA FC II (11%), III (86%), IV (3%) at baseline.1,2
IMPROVEMENTS IN 6MWD OVER 18 MONTHS1
Without a control group, data must be interpreted cautiously.
LONG-TERM BENEFITS BEYOND 6MWD1,3
SUSTAINED IMPROVEMENTS IN NYHA FUNCTIONAL CLASS1
maintained or improved NYHA FC from baseline at 2 years (n=120)1,2
36% of patients had improvement in functional class from baseline at 6 months (n=174) and at 2 years (n=120)1,2
SURVIVAL EXCEEDED 80% AT 3 YEARS2
survival rate at 3 years (n=69)2
Based on a long-term follow-up of patients who were treated with TYVASO in the pivotal study and the OLE (Kaplan–Meier estimates of survival).2
These data are from an OLE study. Without a control group, data must be interpreted cautiously.
Safety from the OLE study2
- AEs observed during this chronic dosing study were qualitatively similar to those observed in the 12-week placebo-controlled trial2
- Serious AEs included pneumonia (n=15) and hemoptysis (n=3)2