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 |
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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: 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
