Treatment of PAH 

In PAH, Tracleer film-coated tablets added to patient’s current therapy was more effective than placebo (a dummy treatment) in improving the distance patients could walk in 6 minutes (a way of measuring exercise capacity) after 16 weeks of treatment.

This is based on two studies in a total of 245 adults with class III or IV disease that was either primary or caused by scleroderma. In the larger study patients were able to walk 44 metres further. Similar results were seen in a study in 54 adults with class III PAH that was associated with congenital heart defects. There were too few patients with class IV disease to support the use of the medicine in this group.

In a study in 185 patients with class II disease the distance the patients could walk over 6 minutes was similar in the Tracleer and placebo groups. However, Tracleer decreased the resistance to blood flow  by 23%, indicating a widening of the blood vessels, compared with placebo after 6 months of treatment.

Improvements were also seen in a study of 19 children aged between 3 and 15 years taking the film- coated tablets.

Two additional studies looked at the effects of Tracleer dispersible tablets in children: the first study included 36 children with PAH aged between 2 and 11 years, while the second study included 64 children with PAH aged from 3 months up to 11 years. The PAH seemed to remain stable in almost all of the children during the 12 or 24 weeks of treatment.

Treatment of systemic sclerosis with digital ulcers 

Tracleer was more effective than placebo at reducing the development of new digital ulcers based on two studies in a total of 312 adults. In the first study, patients taking Tracleer had an average of 1.4 new digital ulcers after 16 weeks, compared with 2.7 in the patients taking placebo. Similar results were seen in the second study after 24 weeks. The second study which also looked at the effect of Tracleer on digital ulcer healing in 190 patients did not find any effect.