Long-Term Ambrisentan Therapy for the Treatment of Pulmonary Arterial Hypertension
Ronald J. Oudiz, MD*,*,
Nazzareno Galiè, MD ,
Horst Olschewski, MD ,
Fernando Torres, MD ,
Adaani Frost, MD||,
Hossein A. Ghofrani, MD¶,
David B. Badesch, MD#,
Michael D. McGoon, MD**,
Vallerie V. McLaughlin, MD,
Ellen B. Roecker, PhD,
Brooke C. Harrison, PhD,
Darrin Despain, MS,
Christopher Dufton, PhD,
Lewis J. Rubin, MD|||| for the ARIES Study Group
* LA Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California
Cardiology Institute, University of Bologna, Bologna, Italy
Medical University-Graz, Graz, Austria
University of Texas Southwestern Medical Center, Dallas, Texas
|| Baylor College of Medicine, Houston, Texas
¶ University of Giessen Lung Center, Giessen, Germany
# University of Colorado, Denver, Colorado
** Mayo Clinic, Rochester, Minnesota
University of Michigan, Ann Arbor, Michigan
University of Wisconsin, Madison, Wisconsin
Gilead Sciences, Inc., Boulder, Colorado
|||| UCSD, La Jolla, California
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Figure 2 Mean (± 95% Confidence Interval) Change From Baseline in 6MWD Through Year 2 by Randomized Ambrisentan Dose
(A) The 6-min walk distance (6MWD) with imputation of missing data using last observation carried forward for all patients with post-baseline data. (B) The 6MWD with no imputation of data (observed case only) for all patients in the analysis population. The number of observations at each time point is presented below each graph.
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Figure 3 Mean (± 95% Confidence Interval) Change From Baseline in BDI Through Year 2 (Last Observation Carried Forward)
The number of observations at each time point is presented below the graph. BDI = Borg Dyspnea Index.
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Figure 4 Kaplan-Meier Survival Analysis by Randomized Ambrisentan Dose and by All Treatment Groups Combined
Kaplan-Meier survival analysis by randomized ambrisentan dose (dashed lines) and by all treatment groups combined (solid line), with point estimates of survival shown for years 1 and 2 (all treatment groups combined). The number at risk at each time point is presented below the graph. ABS = all ambrisentan treatment groups combined.
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Figure 5 Kaplan-Meier Analysis of Time to Clinical Worsening by Randomized Ambrisentan Dose and All Treatment Groups Combined
Kaplan-Meier analysis of time to clinical worsening by randomized ambrisentan dose (dashed lines) and all treatment groups combined (solid line), with point estimates for the years 1 and 2 risk of remaining clinical worsening event-free (all treatment groups combined). The number at risk at each time point is presented below the graph. ABS = all ambrisentan treatment groups combined.
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Figure 6 Kaplan-Meier Analysis of Time to ALT/AST >3x ULN by Randomized Ambrisentan Dose and All Treatment Groups Combined
Kaplan-Meier analysis of time to ALT/AST >3x ULN by randomized ambrisentan dose (dashed lines) and all treatment groups combined (solid line), with point estimates for the years 1 and 2 risk of remaining ALT/AST >3x ULN event-free (all treatment groups combined). One patient was not included in this analysis because of ALT and AST >3x ULN at baseline before receiving the first dose of ambrisentan (former placebo patient in the ARIES-2 [Ambrisentan in Pulmonary Arterial Hypertension, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Studies] trial). The number at risk at each time point is presented below the graph. ABS = all ambrisentan treatment groups combined; ALT = alanine aminotransferase; AST = aspartate aminotransferase; ULN = upper limit of normal.
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