Table 3

Clinical Worsening: Cumulative Incidence of Events Through 1 and 2 Years of Treatment

Treatment Group
2.5 mg (n = 96)5 mg (n = 190)10 mg (n = 97)All (n = 383)
1 Year2 Years1 Year2 Years1 Year2 Years1 Year2 Years
Patients with at least 1 clinical worsening event17 (18)27 (28)28 (15)47 (25)16 (17)25 (26)61 (16)99 (26)
Hospitalization for PAH13 (14)20 (21)22 (12)35 (18)13 (13)21 (22)48 (13)76 (20)
Death3 (3)13 (14)12 (6)21 (11)5 (5)8 (8)20 (5)42 (11)
Addition of approved prostacyclin analog therapy5 (5)7 (7)9 (5)18 (9)4 (4)9 (9)18 (5)34 (9)
Study withdrawal because of addition of other PAH therapy4 (4)4 (4)3 (2)3 (2)1 (1)1 (1)8 (2)8 (2)
Early escape2 (2)2 (2)1 (1)1 (1)2 (2)2 (2)5 (1)5 (1)
Atrial septostomy0 (0)0 (0)0 (0)1 (1)0 (0)0 (0)0 (0)1 (1)
Lung transplantation0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)0 (0)

Values are n (%). Patients can be included in more than 1 category of clinical worsening. Early escape was defined by the presence of 2 or more of the following criteria: 1) a decrease of >20% in the 6-min walk distance; 2) an increase of 1 or more WHO functional class; 3) worsening right ventricular failure (as indicated by increased jugular venous pressure, new/worsening hepatomegaly, ascites, or peripheral edema); 4) rapidly progressing hepatic or renal failure; and 5) refractory systolic hypotension (systolic blood pressure <85 mm Hg). All data are presented by randomized ambrisentan dose.

Abbreviations as in Table 1.