Patients were either New York Heart Association (NYHA) Functional Class III or IV and were treated with 2.5 or 5.0 mcg of iloprost 6 to 9 times per day.
The combined primary endpoint was clinical response at 12 weeks, defined as:
At least 10% increase vs baseline in 6-minute walk distance1,4
Improvement by at least one NYHA Functional Class vs baseline1,4
In a small study (STEP), 34 Functional Class III-IV patients treated with bosentan 125 mg bid for at least 16 weeks tolerated the addition of inhaled iloprost (up to 5 mcg 6 to 9 times per day during waking hours). The mean daily inhaled dose was 27 mcg and the mean number of inhalations per day was 5.6.1,15
Safety trends in patients receiving concomitant bosentan and iloprost were consistent with those observed in the larger pivotal study (AIR) in patients receiving only VENTAVIS® (iloprost) Inhalation Solution.1