MARKETED BY ACTELION IN THE US ONLY

Ventavis (iloprost), an inhaled formulation of iloprost, is a synthetic compound structurally similar to prostacyclin (PGI2).

 

CURRENT INDICATIONS

In the US, Ventavis is indicated for the treatment of 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 diseases (23%).

PRODUCT AVAILABILITY AND REGULATORY STATUS

Actelion has marketed Ventavis in the US since 2007. Bayer Healthcare markets Ventavis elsewhere.

AVAILABLE CLINICAL DATA

In a controlled clinical trial, Ventavis improved a composite endpoint consisting of exercise tolerance, symptoms (NYHA Class), and the absence of clinical deterioration.

For patients with PAH (WHO Group 1) with NHYA Class III or IV symptoms, Ventavis has been shown to:

  • Significantly increase (p = 0.0033) patient improvement after 12 weeks of treatment compared to baseline on a composite endpoint of improved exercise capacity 30 minutes after dosing, improvement of at least one NHYA class and no clinical deterioration.
  • Significantly improve 6-minute walk distance at week 12 with a 10% or greater increase in individual walk distance (p < 0.01).
  • Significantly improve patients' functional class at week 12 (p = 0.03).

Most common (>3% placebo adjusted) adverse reactions are vasodilation (flushing), cough increased, headache, trismus, insomnia, nausea, hypotension, vomiting, alkaline phosphatase increased, flu syndrome, back pain, tongue pain, palpitations, syncope, GGT increased, muscle cramps, hemoptysis, and pneumonia.

In December 2006, data from the Phase II/III clinical trial STEP, evaluating the use of Ventavis (iloprost) inhalation solution therapy in patients with PAH already undergoing treatment with bosentan were published. The analysis of this study showed that the combination of Ventavis added to bosentan therapy was well tolerated, and was consistent with the safety profile observed in patients receiving only iloprost.

KEY SCIENTIFIC LITERATURE

Ivy et al. Short- and long-term effects of inhaled iloprost therapy in children with pulmonary arterial hypertension. J Am Coll Cardiol. 51(2):161-9; 2008.

McLaughlin et al. Randomized study of adding inhaled iloprost to existing bosentan in pulmonary arterial hypertension. Am J Respir Crit Care Med. 174(11):1257-63; 2006.

Hoeper et al. Goal-oriented treatment and combination therapy for pulmonary arterial hypertension. Eur Respir J. 26(5):858-63; 2005.

Hossein A. et al. Oral sildenafil as long-term adjunct therapy to inhaled iloprost in severe pulmonary arterial hypertension. J Am Coll Card. 42 (1): 158-64; 2003.

Olschewski et al. Inhaled iloprost for severe pulmonary hypertension. N Engl J Med. 1;347(5):322-9; 2002.

US RESIDENTS

Please note that the information contained in this section of the website is not intended for US residents. Please visit our US webpage.

Please note that the information contained in this section of the website is not intended for US residents. Please visit our US webpage.