Connected Therapy
Demonstrating clinical benefits with proven results1-2
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:
VENTASTEP is the first study to track physical activity with a smartwatch and smartphone while simultaneously tracking intake of PH medication
While PH treatment is often guided by clinical measurements such as the 6-minute walk test to assess improvements in physical activity, this snapshot in time provides limited insight
Continuous monitoring of physical activity may help to inform appointments with healthcare professionals, better assess a patient’s response to treatment, and improve outcomes compared to clinical visits
Digital tracking of adherence to therapy was achieved by monitoring inhalation data from the Breelib nebuliser in patients starting treatment with Ventavis
This is a study summary; please read the paper in full for complete details
To investigate the association between results obtained using device-based digital tracking compared with traditional monitoring*
Primary objective:
Investigate correlations between changes in digital physical activity measures and changes in traditional clinical measures and health-related quality of life over 3 months
Secondary objectives:
Evaluate inhalation behaviour, adverse events, and changes in heart rate and sleep quality
TRADITIONAL MEASURES:
DIGITAL MEASURES:
Inclusion criteria:
An inclusion criteria of this study was World Health Organization (WHO) class III patients. In practice, the WHO and NYHA classification systems are used interchangeably when characterising patients with PH7
*This study was not designed to investigate or confirm the effectiveness and safety of Ventavis
Study design:
Prospective, observational, single-arm cohort study
Study period:
12 weeks
Multi-centre:
7 German centres
Population:
18* patients with PH FC III†
*30 patients were initially included in the safety analysis set
†According to the WHO Classification system
| Digital measures* | Median change from baseline |
|---|---|
| Distance walked per day (km) | + 0.4 |
| Number of steps per day | + 591 |
| Number of standing up events per day | + 1.7 |
| Traditional measures | Median change from baseline |
|---|---|
| N-terminal pro–B-type natriuretic peptide level (ng/L) | − 749 |
| B-type natriuretic peptide level (ng/L) | − 16 |
| Borg dyspnoea index | − 0.5 |
| EQ-5D | + 0.02 |
| 6-minute walk distance (m) | + 26 |
Adapted from Stollfuss2
Descriptive statistics only, no statistical analysis performed
Efficacy:
Changes from baseline in traditional and digital 6-minute walk distance were moderately correlated (r=0.57)
An additional secondary traditional measure included change in FC†, which improved from III to II in 4 patients (22%), and remained unchanged in the other 14 patients
While there were concordant changes between digital and traditional measures, a complete correlation analysis could not be performed because of the low volume of data
Safety:
The most common observed adverse events (≥ 10%) in patients receiving iloprost in clinical trials are headache, flushing, nausea, vomiting and hyperhidrosis. These undesirable effects are likely to occur during the dose titration at the start of treatment to identify the best tolerable dose for the individual patient. Usually these undesirable effects resolve with dose reduction.
Please consult the SmPC for full information on safety and adverse events.
*6-minute walk distance was measured incorrectly for patients with PH and therefore excluded
†According to the WHO Classification system
Though not designed to assess the effectiveness and safety profile of Ventavis, this study suggests that digital monitoring of physical activity is feasible in patients with PH
Moreover, despite an absence of correlations in the small sample size, the study demonstrated the general feasibility of performing digital assessments in patients with pulmonary arterial hypertension
Please note real-world evidence cannot be confirmatory and should only be used to support data from randomised clinical trials
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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: 07.08.2024. 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
