Long-term Experience Open-label Extension Study AC-052-354
- Overall exposure to bosentan
- 200 patients: 138 of 144 ex-bosentan 62 of 69 ex-placebo
- 171 ? 73 days (range 25 – 321 days)
- 100 patients with ? 6 months 13 patients with ? 9 months
- Outcomes:
- 2 deaths (pulmonary hemorrhage)
- 2 d/c for worsening PAH (epoprostenol)
- 6 d/c for elevated ALT/AST
- 4 d/c for AE/administrative reasons