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 Functional 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 | Improvement in NYHA Functional Class | ≥10% increase in 6-minute walk distance (6MWD) |
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96% VENTAVIS 87% placebo |
25% VENTAVIS 8% placebo |
43% VENTAVIS 26% placebo |