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Presentation Outline ICHP Annual Meeting September 13-15

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Rationale for “Front-Loaded” Approach<br />

• PAH not always a “one drug” disease<br />

• Redundancy of pathways<br />

• Chemotherapeutic or induction approach<br />

AMBITION Trial<br />

A randomized, multicenter study of first-line<br />

AMBrisentan and Tadalafil combination<br />

therapy in subjects with pulmonary arterial<br />

hypertensION<br />

To compare 2 treatment strategies upfront<br />

combo (amb + tad) vs. mono (amb or tad)<br />

Event-driven trial<br />

Primary objective: time to clinical failure<br />

Secondary objectives: safety & tolerability,<br />

6MWD at peak and trough levels<br />

NCT01178073. http://www.clinicaltrials.gov/ct2/show/NCT01178073. Accessed Feb 2012.<br />

REVEAL Registry: Independent Predictors of<br />

Mortality Based on a Multivariate Model<br />

Parameter a Hazard ratio P value<br />

Connective tissue–associated PAH 1.59

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