Efficacy Haemodynamics were improved after 12 weeks of Tracleer treatment; a decrease in mean PAP was observed in 15 18 patients and an increase in cardiac index in 11 17 patients with measurements. In the group as a whole, statistically significant decreases were observed in the following parameters: - mean PAP mean and median changes of -8.0 and -7.0 mmHg, respectively, p 0.0003 ; , - PVR -389 and -266 dynsec cm5, p 0.0021 ; , - PVRI -300 and -274 dynsecm2 cm5, p 0.0026 ; , - mean SAP -8.6 and -7.0 mmHg, p 0.0003 ; , - SVR -517 and -322 dynsec cm5, p 0.0032 ; , - SVRI -426 and -384 dynsecm2 cm5, p 0.0067 ; . Statistically significant increases were obtained in cardiac output 0.61 and 0.50 L min, p 0.0490 ; and stroke index 0.006 and 0.009 ml m2, p 0.0267 ; . There was no overall effect on heart rate -2.4 and 0.3 bpm, p 0.6935 ; . Haemodynamic variables were generally similar between subpopulations treated with bosentan alone and bosentan + epoprostenol. Patterns between the two subpopulations were generally consistent, but there was a larger percentage decrease in the PVRI compared to the SVRI and a larger percentage increase in cardiac index among patients on bosentan alone. Although not significant because of the small number of patients, this suggests that there may have been a more selective pulmonary vasodilation with bosentan alone than with the combination therapy. Additionally, an increase in pulmonary arterial oxygen saturation was observed in patients on bosentan alone. Exercise parameters were evaluated for exploratory purposes in 12 patients who were at least 8 years of age. Changes in exercise test parameters at week 12 from baseline were highly variable and none were significant, although some patients showed beneficial trends. The mean and median changes from baseline in peak VO2 were 53.0 and -3.5 ml min, respectively p 0.4697 ; . The investigator based on knowledge of the patient and parental input assessed WHO Functional Class. During the 12 weeks of treatment 3 patients improved from class III to II, and 2 from class II to I. One patient deteriorated class II to III ; . The other 13 remained in the same functional class 12 class II, 1 class III ; . At one site the investigator chose to reduce the concomitant epoprostenol dose in 3 patients with stable class II, starting at Week 13 or 14 bosentan treatment not per protocol ; . Epoprostenol dosages were gradually reduced from 97 to 83, from 72 to 40 and from 146.5 to 100 ng kg min day in the 3 patients, while the protocol-stipulated Tracleer dose was continued. Follow-up assessments in these patients showed no deterioration in their clinical status stable WHO class II ; during or following epoprostenol reduction. Safety Patients were exposed to bosentan for a mean and median of 23.9 weeks; 13 patients had 16 weeks of treatment, and 9 patients had 6 months of bosentan treatment in the study. The following AEs were considered probably or possibly related to treatment: abnormal hepatic function 3 patients ; , flushing, headache, oedema, nausea, hypotension 1 patient each ; , and the moderate tachycardia, hypertension, tremor, and dizziness in one patient reported as SAEs because they prolonged hospitalisation ; . Flushing was noted only in patients also on epoprostenol. Aggravated PAH, pyrexia, and a variety of infections occurred in 2 patients each. Mild fluid retention was reported for 2 patients and moderate oedema for 1; however, unlike in previous studies, it did not occur early in treatment but rather after at least 79 days of treatment. The incidences of these and other AEs events did not appear to have any relationship to weight group, nor did they particularly occur in the patients with the highest exposures AUC0- and Cmax ; . No clinically relevant change in mean heart rate or PQ, QRS, QT, or QTc interval was observed. In addition, further to the CHMP assessment of the ENABLE studies the MAH was requested to include information for prescribers warning them of the dangers of fluid retention especially in patients with severe systolic dysfunction. The MAH was also requested to state that no experience is.

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