Selexipag for the treatment of pulmonary arterial hypertension

GRIPHON Investigators

Research output: Contribution to journalArticle

301 Citations (Scopus)

Abstract

Background: In a phase 2 trial, selexipag, an oral selective IP prostacyclin-receptor agonist, was shown to be beneficial in the treatment of pulmonary arterial hypertension. Methods: In this event-driven, phase 3, randomized, double-blind, placebo-controlled trial, we randomly assigned 1156 patients with pulmonary arterial hypertension to receive placebo or selexipag in individualized doses (maximum dose, 1600 μg twice daily). Patients were eligible for enrollment if they were not receiving treatment for pulmonary arterial hypertension or if they were receiving a stable dose of an endothelin-receptor antagonist, a phosphodiesterase type 5 inhibitor, or both. The primary end point was a composite of death from any cause or a complication related to pulmonary arterial hypertension up to the end of the treatment period (defined for each patient as 7 days after the date of the last intake of selexipag or placebo). Results: A primary end-point event occurred in 397 patients - 41.6% of those in the placebo group and 27.0% of those in the selexipag group (hazard ratio in the selexipag group as compared with the placebo group, 0.60; 99% confidence interval, 0.46 to 0.78; P

Original languageEnglish (US)
Pages (from-to)2522-2533
Number of pages12
JournalNew England Journal of Medicine
Volume373
Issue number26
DOIs
StatePublished - Dec 24 2015

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Pulmonary Hypertension
Placebos
Epoprostenol Receptors
Therapeutics
Phosphodiesterase 5 Inhibitors
Cause of Death
selexipag
Confidence Intervals

ASJC Scopus subject areas

  • Medicine(all)

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Selexipag for the treatment of pulmonary arterial hypertension. / GRIPHON Investigators.

In: New England Journal of Medicine, Vol. 373, No. 26, 24.12.2015, p. 2522-2533.

Research output: Contribution to journalArticle

GRIPHON Investigators. / Selexipag for the treatment of pulmonary arterial hypertension. In: New England Journal of Medicine. 2015 ; Vol. 373, No. 26. pp. 2522-2533.
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abstract = "Background: In a phase 2 trial, selexipag, an oral selective IP prostacyclin-receptor agonist, was shown to be beneficial in the treatment of pulmonary arterial hypertension. Methods: In this event-driven, phase 3, randomized, double-blind, placebo-controlled trial, we randomly assigned 1156 patients with pulmonary arterial hypertension to receive placebo or selexipag in individualized doses (maximum dose, 1600 μg twice daily). Patients were eligible for enrollment if they were not receiving treatment for pulmonary arterial hypertension or if they were receiving a stable dose of an endothelin-receptor antagonist, a phosphodiesterase type 5 inhibitor, or both. The primary end point was a composite of death from any cause or a complication related to pulmonary arterial hypertension up to the end of the treatment period (defined for each patient as 7 days after the date of the last intake of selexipag or placebo). Results: A primary end-point event occurred in 397 patients - 41.6{\%} of those in the placebo group and 27.0{\%} of those in the selexipag group (hazard ratio in the selexipag group as compared with the placebo group, 0.60; 99{\%} confidence interval, 0.46 to 0.78; P",
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AU - Chin, Kelly M.

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AU - Gaine, Sean

AU - Galiè, Nazzareno

AU - Ghofrani, Hossein Ardeschir

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AU - Lang, Irene M.

AU - Preiss, Ralph

AU - Rubin, Lewis J.

AU - Di Scala, Lilla

AU - Tapson, Victor

AU - Adzerikho, Igor

AU - Liu, Jinming

AU - Moiseeva, Olga

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AU - Simonneau, Gérald

AU - McLaughlin, Vallerie V.

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