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A panel of 19 international pulmonary arterial hypertension (PAH) experts clarified and combined international guidelines on the initiation of oral prostacyclin pathway agents (PPAs) in the treatment of patients with PAH and World Health Organization (WHO) functional class (FC) II/III symptoms.
The expert consensus opinion identified 13 patient profiles where early initiation of UPTRAVI® (selexipag) could benefit treatment outcomes
.[1]

Forming the consensus opinion

The expert consensus opinion is the first comprehensive set of consensus statements put together by an international PAH expert panel focusing on when to initiate treatment with oral prostacyclin pathway agents (PPAs) in patients with pulmonary arterial hypertension (PAH).[1]

International PAH expert panel
Uptravi_5pixel_table

The expert panel combined the best available scientific evidence to identify and form a consensus on 13 patient profiles in which early initiation of UPTRAVI® could benefit treatment outcomes.[1]

To develop the consensus statements, the panel identified and agreed on 5 clinical assessments commonly used to make the treatment decision on initiating an oral PPA:[1]

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The 13 patient profiles identified as benefiting from early UPTRAVI® initiation belonged to the following groups:[1]

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*Haemodynamic risk assessed with ESC/ERS thresholds.[1]
Hospitalisation within the past 6 months; yes or no.[1]
§RV function within previous month; normal or moderate/severe based on echocardiogram or MRI.[1]
#
BNP or NT-proBNP within previous month; normal or abnormal based on local standards.[1]
^6MWD within previous month ≤440 m or >440 m.[1]

The 13 patient profiles

Your next World Health Organization (WHO) functional class (FC) II/III pulmonary arterial hypertension (PAH) patient on double-combination therapy could benefit from early initiation of UPTRAVI®:[1]

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Adapted from McLaughlin et al. 2020[1]

*Panelists were asked questions sequentially about the appropriateness of adding an oral PPA in patients in each clinical scenario regarding clinical factors in the following order: (1) haemodynamic risk assessed with ESC/ERS thresholds, (2) hospitalisation within the past 6 months, yes or no, (3) RV function within previous month, normal, moderate/severe based on echocardiogram or MRI, (4) BNP or NT-proBNP within previous month; normal, abnormal based on local standards, (5) 6MWD within previous month ≤440 m or >440 m.[1]

What does the expert consensus mean?

Dr V. McLaughlin and Dr S. Gaine, two of the experts on the panel, were interviewed by the European Medical Journal. They highlighted the importance of the consensus in making real-world treatment decisions and identifying patients that could benefit from early UPTRAVI® treatment.[2]

“This paper helps exemplify which patients are appropriate for oral PPA based on risk assessment, and I think it goes into some granular detail of even patients at lower risk that might be appropriate candidates for oral PPA.”

Expert consensus opinion author Dr V. McLaughlin[2]

The importance of regular risk assessment

The goal of pulmonary arterial hypertension (PAH) treatment is to increase the quality of life and lower the risk profile for patients in the long term.[3]

To achieve this, Dr V. McLaughlin and Dr S. Gaine stress the importance of continuous multiparameter risk assessment, as well as taking into consideration the longer-term implications of treatment when evaluating patients with PAH.[2]

This not only allows the optimisation of care but also increases the number of patients that could achieve a low-risk status, as recommended by the European Society of Cardiology (ESC)/European Respiratory Society (ERS) guidelines.[3]

“It’s helpful to focus on the long-term benefits a patient will have, based on the data we have from a large clinical trial, rather than to focus and look for potentially short-term symptomatic improvements.”

Expert consensus opinion author Dr S. Gaine[2]

*This is a hypothetical risk assessment and does not reflect parameters from a real patient.

Assessing patient risk*[3]
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Continue reading

Efficacy

Discover how UPTRAVI® can provide long-term benefits for patients with PAH.[4]

Safety and tolerability

UPTRAVI® has a well-characterised and generally manageable safety profile.[4][5]

Initiation and dosing

Adding UPTRAVI® is recommended at the first sign of intermediate risk.[3][6]

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BNP, B-type natriuretic peptide; CTD, connective tissue disease; ERA, endothelin receptor antagonist; ERS, European Respiratory Society; ESC, European Society of Cardiology; FC, functional class; MRI, magnetic resonance imaging; NT-proBNP, N-terminal pro-B-type natriuretic peptide; PAH, pulmonary arterial hypertension; PDE-5i, phosphodiesterase type-5 inhibitor; PPA, prostacyclin pathway agent; RV, right ventricular; 6MWD, 6-minute walk distance; WHO, World Health Organization

UPTRAVI® PRESCRIBING INFORMATION AND ADVERSE EVENT REPORTING

CP-220222 | May 2021

References

McLaughlin V et al. Chest 2020; 157(4):955–965.
EMJ 2020; 5(2):47–52.
Galiè N et al. Eur Heart J 2016; 37(1):67–119.
Sitbon O et al. N Engl J Med 2015; 373:2522–2533.
UPTRAVI® SmPC, February 2021. Available at: https://www.ema.europa.eu/en/documents/product-information/uptravi-epar-product-information_en.pdf (last accessed May 2021).
Galiè N et al. Eur Respir J 2019; 53(1):1801889.