Completed Clinical Trials

AIR: Randomized, double-blind, multicenter, placebo-controlled phase 3 trial1,4

Patients were either NYHA 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:

  1. At least 10% increase vs baseline in 6-minute walk distance1
  2. Improvement by at least one NYHA Class vs baseline1,4
  3. Lack of clinical deterioration or death

STEP: Randomized, double-blind, placebo-controlled phase 2 trial

Safety in combination with an ERA

  • In a small study, 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
  • 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.1

Read about:

Respironics and I-neb Adaptive Aerosol Delivery (AAD) are trademarks of or belonging to Koninklijke Philips Electronics N.V.

The Ventavis 20 mcg/mL concentration order form is intended for patients who are maintained at the 5 mcg dose and who have repeatedly experienced extended treatment times which could result in incomplete dosing. Ventavis 10 mcg/mL ampules are still available. Ventavis should be taken 6 to 9 times daily, at least 2 hours apart.

For more information about Ventavis, please call 1-866-ACTELION (1-866-228-3546).

Indication and Important Safety Information

 OPEN CLOSE

Indication:

Ventavis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III-IV symptoms and etiologies of idiopathic or heritable PAH (65%) or PAH associated with connective tissue disease (23%).

Important Safety Information

  • Hypotension leading to syncope has been observed; Ventavis should therefore not be initiated in patients with systolic blood pressure less than 85 mmHg.
  • Stop Ventavis immediately if signs of pulmonary edema occur; this may be a sign of pulmonary venous hypertension.
  • Ventavis inhalation may cause bronchospasm and patients with a history of hyperreactive airway disease may be more sensitive.
  • Serious adverse events reported at a rate of less than 3% included congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure. Vital signs should be monitored while initiating Ventavis.
  • In clinical studies, the most common adverse events occurring more often (≥6%) in Ventavis-treated patients than in patients taking placebo included vasodilation (flushing) (27% vs 9%), cough (39% vs 26%), headache (30% vs 20%), trismus (12% vs 3%), and insomnia (8% vs 2%).
  • Ventavis has the potential to increase the hypotensive effect of vasodilators and antihypertensive agents.
  • Ventavis also has the potential to increase risk of bleeding, particularly in patients maintained on anticoagulants.

Please see full Prescribing Information.