Improved Hemodynamics

Significantly improved hemodynamics for 3 key parameters (PVR, CO, mPAP)1,4

Adapted from Olschewski4
For Ventavis, P<0.001 for change from baseline in PVR, CO, and mPAP at week 12*4; for Ventavis, 3% increase (P=NS) in SVO2 from baseline at week 12 postinhalation4
*Placebo corrected

*AIR Pivotal Trial Randomized, double-blind, multicenter, placebo-controlled trial to evaluate the efficacy and safety of Ventavis in the treatment of PAH 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


Baseline values

Parameter Ventavis Placebo
PVR (dyn * sec/cm5) 1029±390 1041±493
mPAP (mmHg) 53±12 54±14
CO (L/min) 3.8±1.1 3.8±0.9
SVO2(%) 60±8 60±8

In the AIR pivotal trial hemodynamics were assessed at week 12 before inhalation in both groups (at least 2 hours after previous dose, trough) and after inhalation in the Ventavis group (approximately 15 minutes after dose, peak). The study included patients with chronic thromboembolic disease (CTEPH) and all etiologies of PAH.4

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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 predominately 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

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 accompanying full Prescribing Information.