Table 2.
Least squares means change secondary endpoints from baseline to Week 24 (Period 1).
| PlaceboLS mean (SE) | TadalafilLS mean (SE) | Placebo-adjusted differencesLS mean (SE); 95% CI | |
|---|---|---|---|
| Echocardiography: | |||
| TAPSE | –0.10 (0.111) | 0.33 (0.130) | 0.43 (0.136); 0.14 to 0.71 |
| Left ventricular EI-systolic | 0.11 (0.194) | –0.29 (0.218) | –0.40 (0.225); –0.87 to 0.07 |
| Left ventricular EI-diastolic | 0.08 (0.106) | –0.08 (0.122) | –0.17 (0.124); –0.43 to 0.09 |
| TRVmax | 17.01 (28.472) | 1.68 (31.066) | –15.33 (29.443); –78.48 to 47.82 |
| Pericardial effusion | Two patients in Period 1 | 0 patient in Period 1 | |
| WHO functional class | 20% improved | 40% improved | NA |
| CGI-I (over symptoms) | 46.7% improved | 64.3% improved | NA |
| CHQ-PF28 (summary score) | |||
| Physical | 9.28 (3.78) | 8.34 (4.52) | –0.94 (4.26); –9.75 to 7.86 |
| Psychosocial | 2.56 (1.06) | 0.86 (1.28) | –1.70 (1.19); –4.16 to 0.76 |
CGI-I: Clinical Global Impression of Improvement; CHQ-PF28: Child Health Questionnaire Parent Form 28; CI: confidence interval; EI: eccentricity index; NA: not applicable; SE: standard error; TAPSE: tricuspid annular plane systolic excursion; TRVmax: maximal tricuspid regurgitant velocity; WHO: World Health Organization; LS: least square.