Exploring Early Combination Therapy in PAH

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Presentation transcript:

Exploring Early Combination Therapy in PAH

Program Overview

Assessing Risk of Disease Progression in PAH

A Multi-Parameter Risk Assessment Is Needed

Comprehensive Prognostic Evaluation and Risk Assessment

Risk Assessment in PAH

Risk Assessment Is Fundamental for Determining an Optimal Treatment Strategy

Case Example: 25-Year-Old Woman With Heritable PAH*

2015 ESC/ERS Guidelines: Risk Stratification in PAH

Mortality in PAH: Prediction by the 2015 European PH Guidelines Risk Stratification Model

PAH Risk Assessment and Survival in COMPERA

PAH Risk Assessment and Survival in COMPERA

Risk Assessment, Prognosis, and Guideline Implementation in PAH

Risk Assessment and Survival: The French Registry

Variables Associated With a Higher Risk of Death or Transplantation

Variables Associated With a Higher Risk of Death or Transplantation (cont)

Risk Assessment and Survival: The French Registry (cont)

2015 ESC/ERS Guidelines: Goal of Therapy

Using the Risk Stratification Table From the ESC/ERS PH Guidelines: Practical Recommendations

Patient Risk: NYHA FC I/II Is Still Advanced Disease

Patient Risk: NYHA FC Is Still Advanced Disease (cont)

AMBITION: Disease Severity at Baseline*

AMBITION*: Significant Improvement in Outcomes With Initial Ambrisentan + Tadalafil

AMBITION: Initial Combination Therapy in Patients With FC II or III PAH

24-Year-Old "Asymptomatic" BMPR 2 Mutation Carrier Diagnosed With PAH During Screening

24-Year-Old "Asymptomatic" BMPR 2 Mutation Carrier Diagnosed With PAH During Screening (cont)

24-Year-Old "Asymptomatic" BMPR 2 Mutation Carrier Diagnosed With PAH During Screening (cont)

PAH Progresses Rapidly in Patients on Monotherapy

AMBITION: First Adjudicated Clinical Failure by Subgroup

2015 ESC/ERS Guidelines: Combination Therapy Is Widely Recommended and Supported by Clinical Trial Data

Hemodynamic Effects of Different Types of Initial Oral Combination Therapy in PAH

Ambrisentan + Tadalafil: Improved Outcomes With Initial Combination Therapy vs Monotherapy*

Bosentan + Tadalafil: Improved Outcomes With Initial Combination Therapy vs Monotherapy*

Initial Dual Oral Combination Therapy: All Regimens Were Associated With Improved HDs

OPTIMA*: Combination Therapy With Macitentan and Tadalafil Led to Improvements in HDs and FC

Summary: Treatment Recommendations

Residual Role of Monotherapy in a Minority of PAH Subsets

Potential Barriers to Starting Initial Combination Therapy

AMBITION: AEs Leading to Treatment Discontinuation

Potential Barriers to Starting Initial Combination Therapy (cont)

Potential Barriers to Starting Initial Combination Therapy (cont)

Potential Barriers to Starting Initial Combination Therapy (cont)

Potential Barriers to Starting Initial Combination Therapy (cont)

Common AEs of Initial Combination Therapy

Managing Potential AEs

Conclusions

Abbreviations

Abbreviations (cont)

Abbreviations (cont)

Abbreviations (cont)