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Long-Term Hemodynamic Improvements in PH with Ambrisentatn Therapy

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Conference: 2014 International PHA Conference and Scientific Sessions

Release Date: 06.22.2014

Presentation Type: Abstracts

File Download: 2014 Conference Abstract - Klinger JR

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Purpose: Ambrisentan (ABS) is an ETA-selective endothelin receptor antagonist approved for the treatment of pulmonary arterial hypertension (PAH). Patients in the placebo-controlled, 12-week PAH studies (ARIES-1 and ARIES-2) continued treatment with ABS in a long-term study, ARIES-E. This post-hoc analysis examined hemodynamic changes following treatment with long-term ambrisentan monotherapy (2.5, 5, or 10 mg oral once-daily).

Methods: Sixty-eight patients who received long-term ABS treatment in the ARIES-E study had post-baseline right heart catheterization (RHC) data; 58 of these 68 patients (85%) were receiving ABS monotherapy. Historical baseline hemodynamic data were assessed prior to the first dose of ABS (mean = 2.8 ± 3.7 months; median = 1.4 months) and follow-up RHC data was collected at various intervals after the first dose of ABS (mean = 15.4 ± 8.5 months; median = 13.5 months).

Results: Baseline hemodynamic data were consistent with moderate PAH; mean pulmonary arterial pressure (mPAP) = 50.8 ± 1 2.8 mmHg; cardiac index = 2.5 ± 0.7 L/min/m2; right atrial pressure = 7.7 ± 4.8 mmHg; pulmonary vascular resistance (PVR) = 856 ± 488 dyn×s×cm-5. Clinically relevant improvements were observed for mPAP (−8.2 mmHg; 95% CI: −11.0 to −5.5), cardiac index (+0.5 L/min/m2; 95% CI: 0.3 to 0.7) and PVR (−297 dyn×s×cm-5; 95% CI: −384 to −200). Right atrial pressure did not change significantly with long-term treatment (−0.1 mmHg; 95% CI: −1.7 to 1.4).

Conclusion: Clinically relevant improvements in mPAP, cardiac index, and PVR, were observed in PAH patients receiving long-term treatment with ambrisentan.

Clinical Implications: Ambrisentan may provide sustained pulmonary hemodynamic benefits for patients with PAH.