Long-term ExperienceOpen-label Extension Study AC-052-353

• Overall exposure to bosentan
  • 29 patients: 21 of 21 ex-bosentan 8 of 11 ex-placebo
  • 485 ? 97 days (range 105 – 595 days)
  • 28 patients with ? 1 year  7 patients with ? 1.5 years
• Outcomes:
  • No deaths
  • 1 d/c for worsening PAH (epoprostenol)
  • 4 patients up-titrated to 250 mg bid(after 348 – 548 days of treatment)

9069.01

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