Selexipag Linked to Reduced Risk of Death, Complications in PAH

Reduced risk of composite of death or pulmonary arterial hypertension-linked complications

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WEDNESDAY, Dec. 23, 2015 (HealthDay News) -- For patients with pulmonary arterial hypertension, selexipag is associated with a reduced risk of a composite end point of death or pulmonary arterial hypertension-related complications, according to a study published in the Dec. 24 issue of the New England Journal of Medicine.

Olivier Sitbon, M.D., from Assistance Publique-Hôpitaux de Paris, and colleagues conducted a phase 3 trial involving 1,156 patients with pulmonary arterial hypertension. Participants who were not receiving treatment for pulmonary arterial hypertension or were receiving a stable dose of an endothelin-receptor antagonist, a phosphodiesterase type 5 inhibitor, or both, were randomized to receive placebo or selexipag in individualized doses (maximum dose, 1,600 µg twice daily).

The researchers found that a primary end point event (a composite of death from any cause or a complication related to pulmonary arterial hypertension up to the end of the treatment period) occurred in 41.6 and 27.0 percent of those in the placebo and selexipag groups, respectively (hazard ratio, 0.60; P < 0.001). Overall, 81.9 percent of the events were due to disease progression and hospitalization. One hundred five and 100 patients in the placebo and selexipag groups, respectively, had died from any cause by the end of the study.

"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," the authors write.

Several authors disclosed financial ties to pharmaceutical companies, including Actelion Pharmaceuticals, which manufactures selexipag and funded the study.

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