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This page is intended for UK Healthcare Professionals. Prescribing information can be found here Adverse events reporting can be found at the bottom of the page.

Connected Therapy

Demonstrating clinical benefits with peer reviewed research1-2

Ventavis is indicated for the treatment of adult patients with primary pulmonary hypertension (PH), classified as New York Heart Association (NYHA) functional class (FC) III, to improve exercise capacity and symptoms3

 

The efficacy and safety profile of Ventavis (iloprost trometamol) as a treatment for PH is supported by extensive clinical trial data and real-world evidence

Choose from the studies below to see a summary:

    AIR (Aerosolised Iloprost Randomised) is a key clinical study investigating the efficacy of Ventavis (iloprost trometamol) as a therapy for PH

    While continuous infusion of a prostacyclin analogue has been shown to reduce mortality in patients with severe PH, there are limitations associated with intravenous administration

     

    Designed to combine the beneficial effects of prostacyclin analogues with those of an inhalational application, aerosolised iloprost was developed as an alternative form of prostacyclin analogue therapy5,6

     

     

     

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    To evaluate the effects of Ventavis using a rigorous combined primary endpoint of clinical efficacy:

     

    Secondary endpoints included:

    Changes in values for the 6-minute walk test, the NYHA class, Mahler Dyspnoea scores and quality of life

     

     

     

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    Study design:

    Double-blind, randomised, placebo-controlled trial followed by an open-label extension

     

    Study period:

    12 weeks

     

    Multi-centre:

    37 European centres

     

    Population:

    203 patients with PH FC III/IV*

     

    This study contains an off-label patient population (NYHA FC IV, 41.4%, n=84)

     

    *According to the NYHA Classification system

    Ventavis is indicated for the treatment of adult patients with primary PH, classified as NYHA FC III, to improve exercise capacity and symptoms3

     

     

     

    Download Summary

    Efficacy:

    The combined primary endpoint was met by 17% of patients treated with Ventavis compared with 5% of those receiving placebo (p=0.007)

     

    When assessed separately, the mean change from baseline after 12 weeks of treatment in the 6-minute walking distance was an increase of 22 meters in the Ventavis group compared to -3.3 meters in the placebo group3

     

    The NYHA FC was improved with Ventavis in 26% of patients (placebo: 15%) (p=0.032), unchanged in 67.7% of patients (placebo: 76%) and deteriorated in 6.3% of patients (placebo: 9%)

     

    Patients who improved by at least one NYHA functional class (secondary endpoint)

    Alt tag

     

    Safety:

    The total number of adverse events did not differ significantly between the groups. The most common adverse events in the Ventavis group (n=101) were increased cough (38.6%), headache (29.7%) and flushing (26.7%)

     

    *p=0.032 for the comparison of rates of improvement with the placebo group

     

     

     

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    The clinical efficacy of Ventavis was demonstrated in this placebo-controlled trial, with further improvements in NYHA class compared with placebo observed during the open-label phase compared to the double-blind phase

     

     

     

    Download Summary

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    Reporting adverse events and quality complaints

    Adverse events should be reported. Reporting forms and information can be found at
    yellowcard.mhra.gov.uk
    Adverse events should also be reported to Bayer plc.

     

    If you want to report an adverse event or quality complaint, reports can be directed to:
    Tel.: 0118 2063500 or email: pvuk@bayer.com
    Further information is available on the "contact" tab at www.bayer.co.uk

    References

    • Olschewski H et al. N Eng J Med 2002; 347(5): 322-9. Return to content
    • Stollfuss B et al. Med Internet Res 2021; 23(10): e25163. Return to content
    • Ventavis Summary of Product Characteristics. Return to content
    • McLaughlin VV et al. Am J Respir Crir Care Med 2006; 174(11): 1257-63. Return to content
    • Gomberg-Maitland M, Olschewski H. Eur Respir J 2008; 31(4): 891-901. Return to content
    • Hill NS et al. Respir Care 2015; 60(6): 794-805. Return to content
    • Mathier MA. Medscape 2006. Available at: https://www.medscape.org/viewarticle/544175#:~:text=As%20part%20of%20that%20effort%2C%20the%20NYHA%20functional,syncope%20in%20the%20symptom%20complex%20of%20these%20patients Accessed on: 03.10.22. Return to content

    Abbreviations
    FC: functional class
    NYHA: New York Heart Association
    PH: pulmonary hypertension
    WHO: World Health Organization

    Ventavis is indicated for the treatment of adult patients with primary PH, classified as NYHA FC III, to improve exercise capacity and symptoms3