Pulmonary hypertension · Prostacyclin pathway agents
Selexipag for the Treatment of Pulmonary Arterial Hypertension
| Design | Event-driven, randomised, double-blind, placebo-controlled trial |
|---|---|
| Treatment | Oral selexipag |
| Control | Placebo |
| Population | 1156 patients with pulmonary arterial hypertension, both treatment-naive and already on therapy |
| Follow-up | Event-driven |
| Primary endpoint | Composite of death or a complication related to pulmonary arterial hypertension |
| Result | A primary endpoint event occurred in 41.6% of the placebo group and 27.0% of the selexipag group — hazard ratio 0.60 (99% CI 0.46 to 0.78, p<0.001). Disease progression and hospitalisation accounted for 81.9% of events. The effect was similar whether or not patients were already on treatment. There was no significant difference in mortality. |
| Secondary endpoints | Death from any cause, hospitalisation for PAH, six-minute walk distance |
Among patients with pulmonary arterial hypertension, the risk of the primary composite end point of death or a complication related to pulmonary arterial hypertension was significantly lower with selexipag than with placebo. There was no significant difference in mortality between the two study groups.
The trial authors, in the published abstract
An oral prostacyclin pathway agent, which matters in a disease whose most effective drugs have historically required continuous infusion. The composite is driven by progression and hospitalisation rather than death, and the authors say so — a distinction worth keeping when the 40% is quoted.
Sitbon O, Channick R, Chin KM, et al. Selexipag for the Treatment of Pulmonary Arterial Hypertension. N Engl J Med 2015 Dec 24;373(26):2522-33.