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*
Hodges–Lehmann median difference between TYVASO treatment and placebo groups.
EVEN GREATER IMPROVEMENTS IN 6MWD WERE SEEN IN NEARLY 1/3 OF PATIENTS AT WEEK 122,3
*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 TYVASO1
TRIUMPH Study: Adverse events in ≥4% of PAH patients receiving TYVASO and more frequent than placebo.1,2
Adverse Event
Treatment n (%)
TYVASO (n=115)
Placebo (n=120)
Cough
62 (54%)
35 (29%)
Headache
47 (41%)
27 (23%)
Throat irritation/pharyngolaryngeal pain
29 (25%)
17 (14%)
Nausea
22 (19%)
13 (11%)
Flushing
17 (15%)
1 (<1%)
Syncope
7 (6%)
1 (<1%)
- 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