Frequency of elevated aminotransferases according to subgroups
| Subjects n | Exposure yrs | Elevated aminotransferases | ||
| Crude rate | Annual rate | |||
| All bosentan-naïve patients | 4623 | 0.57; 0.74±0.63 | 7.6 | 10.1 |
| Patients aged <2 yrs# | 23 | 0.17; 0.41±0.65 | 4.3 | |
| Patients aged 2–11 yrs | 146 | 0.56; 0.69±0.58 | 2.7 | 3.9 |
| Patients aged ≥12 yrs | 4443 | 0.57; 0.75±0.63 | 7.8 | 10.3 |
| Subgroups according to aetiology | ||||
| Idiopathic PAH | 1583 | 0.68; 0.84±0.69 | 8.4 | 10 |
| PAH-scleroderma | 1017 | 0.55; 0.73±0.60 | 9.4 | 12.7 |
| PAH-mixed connective tissue disease | 121 | 0.47; 0.69±0.61 | 16.5 | 23.5 |
| PAH-lupus | 100 | 0.69; 0.84±0.67 | 10 | 10.7 |
| PAH-congenital heart disease | 579 | 0.57; 0.74±0.62 | 2.8 | 3.8 |
| PAH-HIV | 102 | 0.64; 0.74±0.59 | 8.8 | 12.1 |
| CTEPH | 470 | 0.52; 0.65±0.56 | 5.5 | 8.4 |
| PH-pulmonary fibrosis¶ | 85 | 0.33; 0.43±0.41 | 3.5 | 8.2 |
| Portopulmonary hypertension | 82 | 0.50; 0.66±0.56 | 4.9 | 5.6 |
| PH-other | 461 | 0.37; 0.58±0.57 | 7.6 | 12.5 |
| Subgroups according to concomitant medication | ||||
| Sildenafil at BL | 119 | 0.34; 0.58±0.56 | 7.6 | 12 |
| Prostanoids at BL | 751 | 0.51; 0.74±0.65 | 7.2 | 9.5 |
| Oral anticoagulants at BL | 2877 | 0.64; 0.80±0.66 | 8.0 | 10.2 |
| Not receiving oral anticoagulants+ | 1514 | 0.40; 0.58±0.56 | 5.2 | 8.6 |
Data are presented as median; mean±sd or %, unless otherwise stated. There were 24 subjects for which no aetiology was assigned to 24 patients and no date of birth was available for 11 patients. PAH: pulmonary arterial hypertension; CTEPH: chronic thromboembolic pulmonary hypertension; PH: pulmonary hypertension; BL: baseline. #: could not be computed as numbers too small for evaluation; ¶: 1 patient had CTEPH and PH-pulmonary fibrosis; +: for the duration of the post-marketing surveillance.