Clinical Trials
The composite primary endpoint was clinical response at 12 weeks, defined as:
- At least 10% increase vs. baseline in 6-minute walk distance1
- Improvement by at least one NYHA Class vs. baseline1,2
- Lack of clinical deterioration or death
Studied as combination therapy
- In a small study, 34 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 5.6.2
- Safety trends in patients receiving concomitant bosentan and iloprost were consistent with those observed in the larger Phase 3 study (AIR) in patients receiving only iloprost.2
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