Functional Class Improvement
Significantly improved functional class status14
During the course of the AIR pivotal trial, 93% of patients on VENTAVIS® (iloprost) Inhalation Solution maintained or improved their NYHA Functional Class, compared with 88% in the placebo arm.14
Seventy-eight patients were treated with placebo. In these patients, 59% were functional class III and 41% were functional class IV at baseline. At Week 12, 4% improved to functional class II, while 46% were functional class III and 50% were functional class IV.14
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
New York Heart Association (NYHA) Functional Assessment24
| NYHA Functional Assessment† | ||
|---|---|---|
| Functional Class I: | No symptoms with ordinary physical activity. | |
| Functional Class II: | Symptoms with ordinary activity. Slight limitation of activity | |
| Functional Class III: | Symptoms with less than ordinary activity. Marked limitation of activity. | |
| Functional Class IV: | Symptoms with any activity or even at rest. |
†The effectiveness of VENTAVIS was established predominantly in patients with NYHA Functional Class III-IV symptoms.