Selexipag for the Treatment of Pulmonary Arterial Hypertension

• Published in: The New England journal of medicine Vol. 373; no. 26; pp. 2522 - 2533
• Main Authors: Sitbon, Olivier, Channick, Richard, Chin, Kelly M, Frey, Aline, Gaine, Sean, Galiè, Nazzareno, Ghofrani, Hossein-Ardeschir, Hoeper, Marius M, Lang, Irene M, Preiss, Ralph, Rubin, Lewis J, Di Scala, Lilla, Tapson, Victor, Adzerikho, Igor, Liu, Jinming, Moiseeva, Olga, Zeng, Xiaofeng, Simonneau, Gérald, McLaughlin, Vallerie V
• Format: Journal Article
• Language: English
• Published: United States Massachusetts Medical Society 24.12.2015
• Subjects: Acetamides - adverse effects; Acetamides - therapeutic use; Aged; Circulatory system; Clinical trials; Committees; Diarrhea; Disease Progression; Double-Blind Method; Double-blind studies; Drug Administration Schedule; Drug dosages; Drug therapy; Endothelins; Fees & charges; Female; Headache; Hospitalization - statistics & numerical data; Humans; Hypertension; Hypertension, Pulmonary - complications; Hypertension, Pulmonary - drug therapy; Hypertension, Pulmonary - mortality; Jaw; Kaplan-Meier Estimate; Male; Middle Aged; Nausea; Pain; Patients; Pharmaceuticals; Phosphodiesterase; Prodrugs - adverse effects; Prodrugs - therapeutic use; Prostacyclin; Pulmonary arteries; Pulmonary hypertension; Pyrazines - adverse effects; Pyrazines - therapeutic use; Statistical analysis; Substance abuse treatment
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJMoa1503184

Among over 1100 patients with pulmonary arterial hypertension who received selexipag, an oral selective IP prostacyclin-receptor agonist, or placebo, the risk of the composite end point of death or complication was lower with selexipag than with placebo at 1.3 years of follow-up. Pulmonary arterial hypertension is a severe disease with a poor prognosis despite available treatment options. 1 Current recommendations support the use of a combination of therapies that target the endothelin, nitric-oxide, and prostacyclin pathways. 2 , 3 Despite the benefits of intravenous prostacyclin therapy, 2 , 4 many patients with pulmonary arterial hypertension die without ever receiving this treatment. 5 , 6 The burden and risks related to the administration of prostacyclin therapy are probably contributing factors. 7 Selexipag is an oral selective IP prostacyclin-receptor agonist that is structurally distinct from prostacyclin. 8 – 11 In a placebo-controlled, phase 2 trial involving patients who were already receiving treatment for pulmonary . . .