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Table 3 Summary of First Clinical Failure Events and First PAH Hospitalizations by WHO Functional Class and Treatment Group (Primary Analysis Set)

From: Clinical outcomes stratified by baseline functional class after initial combination therapy for pulmonary arterial hypertension

  Combination Therapy Pooled Monotherapy Ambrisentan Monotherapy Tadalafil Monotherapy
(n = 253) (n = 247) (n = 126) (n = 121)
Baseline Functional Class FC II FC III FC II FC III FC II FC III FC II FC III
(n = 76) (n = 177) (n = 79) (n = 168) (n = 38) (n = 88) (n = 41) (n = 80)
First Clinical Failure Events
 Number (%) of patients with event 4 (5) 42 (24) 17 (22) 60 (36) 9 (24) 34 (39) 8 (20) 26 (33)
  Death 3 (4) 6 (3) 1 (1) 7 (4) 0 2 (2) 1 (2) 5 (6)
  PAH Hospitalization 0 10 (6) 8 (10) 22 (13) 5 (13) 13 (15) 3 (7) 9 (11)
  Disease Progression 0 10 (6) 5 (6) 11 (7) 3 (8) 9 (10) 2 (5) 2 (3)
  ULTCR 1 (1) 16 (9) 3 (4) 20 (12) 1 (3) 10 (11) 2 (5) 10 (13)
Hazard ratio (95% CI) combination vs. 0.211 (0.071,0.629) 0.576 (0.388,0.855) 0.190 (0.058,0.619) 0.551 (0.350,0.866) 0.247 (0.074,0.823) 0.602 (0.368,0.983)
First PAH Hospitalizationsa
 Number (%) of patients with event 0 19 (11) 11 (14) 33 (20) 7 (18) 20 (23) 4 (10) 13 (16)
Hazard ratio (95% CI) combination vs. N/A 0.484 (0.275,0.852) N/A 0.435 (0.232,0.815) N/A 0.554 (0.273,1.124)
  1. CI Confidence interval, FC Functional class, N/A Not applicable, PAH Pulmonary arterial hypertension, ULTCR Unsatisfactory long-term clinical response, WHO World Health Organization
  2. aPost-hoc analysis