EFFICACY & SAFETY

EFFICACY

TYVASO provides significant improvements in 6MWD1-3

TRIUMPH Study Design: a 12-week, placebo-controlled, multicenter, randomized, double-blind trial of TYVASO or placebo added to an ERA (bosentan) or a PDE-5i (sildenafil) in 235 clinically stable patients who were NYHA FC III (98%) or IV (2%) at baseline.1,2

CHANGES IN 6MWD AS EARLY AS DAY 11,2*

TYVASO efficacy resultsTYVASO efficacy results

Hodges–Lehmann median difference between TYVASO treatment and placebo groups.1,2

EVEN GREATER IMPROVEMENTS IN 6MWD WERE SEEN IN NEARLY 1/3 OF PATIENTS AT WEEK 122,3

31% of patients increased 6MWD by >50 m with TYVASO compared with 12% receiving placebo.31% of patients increased 6MWD by >50 m with TYVASO compared with 12% receiving placebo.

*6MWD was measured at peak exposure (10-60 minutes after dosing) and trough exposure (≥4 hours after dosing) at week 12 (trough data not shown).1

SAFETY

The most common adverse events with TYVASO

TRIUMPH study: adverse events in ≥4% of PAH patients receiving TYVASO and more frequent than placebo1,2*

TYVASO adverse events vs placeboTYVASO adverse events vs placebo
  • Of the 23 total discontinuations, 7 patients from the TYVASO group discontinued due to adverse events, compared with 4 from the placebo group2
  • In addition, AEs occurring in ≥10% of patients were dizziness and diarrhea2

*Not a comprehensive list.

More than 3% greater than placebo.

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