Treatment of PAH

In PAH, Stayveer 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 Stayveer and placebo groups. However, Stayveer decreased the resistance to blood flow by 23%, indicating a widening of the blood vessels, compared with placebo after 6 months of treatment.

Treatment of systemic sclerosis with digital ulcers

Stayveer 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 Stayveer 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 Stayveer on digital ulcer healing in 190 patients did not find any effect.