VENTAVIS SUMMARY
Ventavis®
(iloprost) Inhalation Solution
Rx Only
Ventavis (iloprost) Inhalation Solution is a clear, colorless, sterile solution containing 10 mcg/mL iloprost formulated for inhalation via either of two pulmonary drug delivery devices: the I-neb™ AAD® (Adaptive Aerosol Delivery) System or the Prodose® AAD® System. Ventavis is supplied in 2 ampule configurations, a 2 mL and a 1 mL single-use glass ampule. Both ampule sizes contain 10 mcg/1 mL. Each mL of the aqueous solution contains 0.01 mg iloprost, 0.81 mg ethanol, 0.121 mg tromethamine, 9.0 mg sodium chloride, and approximately 0.51 mg hydrochloric acid (for pH adjustment to 8.1) in water for injection. The solution contains no preservatives.
Ventavis is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in patients with NYHA Class III or IV symptoms. In controlled trials, it improved a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and lack of deterioration (see CLINICAL PHARMACOLOGY, Clinical Trials).
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NEWS HIGHLIGHTS
Published Studies Related to Ventavis (Iloprost Inhalation)
Effects of inhaled iloprost on right ventricular contractility, right ventriculo-vascular coupling and ventricular interdependence: a randomized placebo-controlled trial in an experimental model of acute pulmonary hypertension. [2008.09.10]
ABSTRACT: INTRODUCTION: Prostacyclin inhalation is increasingly used to treat acute pulmonary hypertension and right ventricular failure, although its pharmacodynamic properties remain controversial. Prostacyclins not only affect vasomotor tone but may also have cAMP-mediated positive inotropic effects and modulate autonomic nervous system tone. We studied the role of these different mechanisms in the overall haemodynamic effects produced by iloprost inhalation in an experimental model of acute pulmonary hypertension... CONCLUSIONS: In animals with acute pulmonary hypertension, inhaled iloprost improved global haemodynamics primarily via selective pulmonary vasodilatation and restoration of left ventricular preload. The reduction in right ventricular afterload is associated with a paradoxical decrease in right ventricular contractility. Our data suggest that this reflects an indirect mechanism by which ventriculo-vascular coupling is maintained at the lowest possible energetic cost. We found no evidence for a direct negative inotropic effect of iloprost.
A randomized trial of iloprost in patients with intermittent claudication. [2008.02]
Prostanoids, which promote vasodilation and reduce platelet aggregation, have been proposed as candidate therapies for intermittent claudication due to peripheral arterial disease (PAD). However, studies of these medications have yielded inconsistent results... These results indicate that oral iloprost is not effective in improving exercise performance or quality of life in patients with PAD who have intermittent claudication.
Inhaled iloprost to control pulmonary artery hypertension in patients undergoing mitral valve surgery: a prospective, randomized-controlled trial. [2008.01]
BACKGROUND: Pulmonary hypertension (PHT) is common in patients undergoing mitral valve surgery and is an independent risk factor for the development of acute right ventricular (RV) failure. Inhaled iloprost was shown to improve RV function and decrease RV afterload in patients with primary PHT. However, no randomized-controlled trials on the intraoperative use of iloprost in cardiac surgical patients are available. We therefore compared the effects of inhaled iloprost vs. intravenous standard therapy in cardiac surgical patients with chronic PHT... CONCLUSIONS: In patients with pre-existing PHT undergoing mitral valve surgery, inhaled iloprost is superior to intravenous nitrogylycerine by acting as a selective pulmonary vasodilator, reducing RV afterload and moderately improving RV-pump performance.
Effects of inhaled iloprost on right ventricular contractility, right ventriculo-vascular coupling and ventricular interdependence: a randomized placebo-controlled trial in an experimental model of acute pulmonary hypertension. [2008]
INTRODUCTION: Prostacyclin inhalation is increasingly used to treat acute pulmonary hypertension and right ventricular failure, although its pharmacodynamic properties remain controversial. Prostacyclins not only affect vasomotor tone but may also have cAMP-mediated positive inotropic effects and modulate autonomic nervous system tone. We studied the role of these different mechanisms in the overall haemodynamic effects produced by iloprost inhalation in an experimental model of acute pulmonary hypertension... CONCLUSIONS: In animals with acute pulmonary hypertension, inhaled iloprost improved global haemodynamics primarily via selective pulmonary vasodilatation and restoration of left ventricular preload. The reduction in right ventricular afterload is associated with a paradoxical decrease in right ventricular contractility. Our data suggest that this reflects an indirect mechanism by which ventriculo-vascular coupling is maintained at the lowest possible energetic cost. We found no evidence for a direct negative inotropic effect of iloprost.
Inhaled iloprost to control pulmonary artery hypertension in patients undergoing mitral valve surgery: a prospective, randomized-controlled trial. [2007.11.01]
Background: Pulmonary hypertension (PHT) is common in patients undergoing mitral valve surgery and is an independent risk factor for the development of acute right ventricular (RV) failure. Inhaled iloprost was shown to improve RV function and decrease RV afterload in patients with primary PHT.Conclusions: In patients with pre-existing PHT undergoing mitral valve surgery, inhaled iloprost is superior to intravenous nitrogylycerine by acting as a selective pulmonary vasodilator, reducing RV afterload and moderately improving RV-pump performance.
Clinical Trials Related to Ventavis (Iloprost Inhalation)
Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis [Terminated]
This study compared the efficacy of different dosages of long-term iloprost treatment on
Raynaud's phenomenon, ulcer healing, skin thickening, and progression of internal organ
sclerosis in systemic sclerosis (SSc).
Methods. 50 SSc patients were 1: 1 randomised either for maximally tolerated dose up to 2
ng/kg body weight [bw] per minute or low dose (0. 5 ng/kg bw per minute) intravenous iloprost
administration, for six hours daily over 21 days. The effect on RP, ulcer healing, skin
thickness, oesophagus function, lung involvement as assessed by lung function parameters FVC
and DLCO, and side effects were measured.
Conclusions. The efficacy of prolonged administration of iloprost is also achieved with low
dose iloprost by long term treatment. The effects suggest a disease-modifying capability of
iloprost, but further studies are needed to proof this hypothesis.
Transitioning To IV Remodulin From Ventavis in Patients With PAH: Safety, Efficacy and Treatment Satisfaction [Terminated]
The purpose of this study is to compare the effects of switching from inhaled Ventavis to
intravenous Remodulin in PAH patients who are considered to be failing inhaled Ventavis
therapy. This study is intended to provide information on the safe transition from Ventavis
to Remodulin as well as the impact intravenous Remodulin may have on overall quality of life
and treatment satisfaction compared to Ventavis.
Aerosolized Randomized Iloprost Study II (AIR – II) Long-Term Safety, Tolerability, and Clinical Effects of Iloprost Inhalation in Patients With Primary or Secondary Pulmonary Hypertension [Completed]
The purpose of this study is to determine whether the study drug is effective in the
long-term treatment of primary or secondary pulmonary hypertension
The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension [Active, not recruiting]
The purpose of this multi-center international trial is to evaluate the safety and
effectiveness of adding iloprost or placebo (an inactive substance that contains no active
study drug) to sildenafil therapy for pulmonary arterial hypertension (PAH). The study will
also examine whether patients on sildenafil can reduce the number of iloprost inhalations
from the approved 6 doses per day to 4 doses per day.
Ventavis® Registry Protocol [Recruiting]
The Ventavis® (iloprost) Registry is a multicenter, observational, U. S.-based study that
longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been
receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I
PAH who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2
years from the time of enrollment. Data will be collected via patient interview and review
of the medical record. Quarterly data collection will include capture of medications and
Ventavis® adherence data.
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