Triumph Ole Study

The Benefit of Earlier Initiation with Tyvaso

Patients who started TYVASO 12 weeks earlier had greater improvement in 6MWD1

Tyvaso bar graphTyvaso bar graph

TRIUMPH OLE STUDY: an open-label extension (OLE) of the TRIUMPH study to evaluate the efficacy, safety, and dosing of TYVASO over time. Patients (n=206) from the placebo-controlled study initiated TYVASO after completing the 12-week TRIUMPH study, entering the long-term, non-controlled OLE study.1,2

Delays in treatment initiation may impact improvements in 6MWD1

Without a control group, data must be interpreted cautiously.

SURVIVAL EXCEEDED 80% AT 3 YEARS2

In the long-term follow-up of patients who were treated with TYVASO in the pivotal study and the OLE, Kaplan-Meier estimates of survival were:

PAH life expectancy rates in TRIUMPH OLE StudyPAH life expectancy rates in TRIUMPH OLE Study

Uncontrolled survival observations do not allow comparison with a control group and cannot be used to determine the long-term effect of TYVASO on mortality.



ADVERSE EVENTS FROM THE TRIUMPH OLE STUDY2:

  • Serious adverse events included pneumonia (n=15) and hemoptysis (n=3)
  • The adverse events observed during this chronic dosing study were qualitatively similar to those observed in the 12-week placebo-controlled trial
  • The most common AEs seen with TYVASO in 4% of PAH patients and more frequently than placebo in the placebo-controlled clinical study were cough (54% vs 29%), headache (41% vs 23%), throat irritation/pharyngolaryngeal pain (25% vs 14%), nausea (19% vs 11%), flushing (15% vs <1%), and syncope (6% vs <1%), respectively
  • In addition, adverse events occurring in ≥10% of patients were dizziness and diarrhea2

Remind patients to talk to you or your staff about any adverse reactions and not to discontinue treatment without your direction.

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