Efficacy

Ventavis® (iloprost) Inhalation Solution is the first pulmonary arterial hypertension (PAH) therapy in which clinical improvement was the primary endpoint of study design. In a placebo-controlled, randomized, double-blind, multicenter study, patients in the Ventavis group saw a nearly 5-fold improvement in clinical endpoint versus patients in the placebo group.1

Demonstrated Significant clinical improvement through a combined endpoint*1

Approximately
5 to 1 improvement vs placebo in a combined endpoint at week 121

*AIR Pivotal Trial Randomized, double-blind, multicenter, placebo-controlled trial to evaluate the efficacy and safety of Ventavis monotherapy compared with placebo in the treatment of PAH (WHO Group 1) NYHA Class III or IV (n=146). Clinical improvement is a combined endpoint defined as ≥ 10% increase in 6MWD, improvement in NYHA functional class, and absence of clinical deterioration or death.1,4

Clinical improvement: A combined endpoint covering a spectrum of PAH efficacy1

Response rates1

Ventavis has demonstrated significant clinical improvement through a combined endpoint: 19% Ventavis vs 4% placebo (P=0.0033). The combined endpoint consisted of 3 factors:

Absence of clinical deterioration or death
Improvement in NYHA functional class
≥10% increase in 6-minute walk distance (6MWD)
  • Absence of clinical deterioration or death: 96% Ventavis vs 87% placebo
  • Improvement in NYHA functional class: 25% Ventavis vs 8% placebo
  • ≥10% increase in 6-minute walk distance (6MWD): 43% Ventavis vs 26% placebo

Ventavis also has extensive clinical experience:

  • Prescribed to over 25,000 patients worldwide as of January 201218
  • 8 years of inhaled PAH treatment
    • EMEA approval in 2003
    • FDA approval in 2004

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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

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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.