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Selexipag: an oral, selective prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension

Gérald Simonneau, Adam Torbicki, Marius M. Hoeper, Marion Delcroix, Kristóf Karlócai, Nazzareno Galiè, Bruno Degano, Diana Bonderman, Marcin Kurzyna, Michela Efficace, Ruben Giorgino, Irene M. Lang
European Respiratory Journal 2012 40: 874-880; DOI: 10.1183/09031936.00137511
Gérald Simonneau
*AP-HP Hôpital Antoine Béclère, Dept of Pneumology, Clamart, France
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  • For correspondence: gerald.simonneau@abc.aphp.fr
Adam Torbicki
#Dept of Pulmonary Circulation and Thromboembolic Diseases, Postgraduate Medical School, ECZ-Otwock, Warsaw, Poland
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Marius M. Hoeper
¶Hannover Medical School, Hannover, Germany
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Marion Delcroix
+University Hospitals (UZ) Leuven, Leuven, Belgium
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Kristóf Karlócai
§Semmelweis University, Budapest, Hungary
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Nazzareno Galiè
fUniversity of Bologna, Institute of Cardiology, Bologna, Italy
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Bruno Degano
*AP-HP Hôpital Antoine Béclère, Dept of Pneumology, Clamart, France
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Diana Bonderman
**Medical University of Vienna, Dept of Internal Medicine II, Division of Cardiology, Vienna, Austria
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Marcin Kurzyna
#Dept of Pulmonary Circulation and Thromboembolic Diseases, Postgraduate Medical School, ECZ-Otwock, Warsaw, Poland
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Michela Efficace
##Actelion Pharmaceuticals Ltd, Allschwil, Switzerland
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Ruben Giorgino
##Actelion Pharmaceuticals Ltd, Allschwil, Switzerland
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Irene M. Lang
**Medical University of Vienna, Dept of Internal Medicine II, Division of Cardiology, Vienna, Austria
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Abstract

In this phase 2 proof-of-concept study we examined the safety and efficacy of selexipag, an orally available, selective prostacyclin receptor (IP receptor) agonist, as a treatment for pulmonary arterial hypertension (PAH).

43 adult patients with symptomatic PAH (receiving stable endothelin receptor antagonist and/or a phosphodiesterase type-5 inhibitor therapy) were randomised three to one to receive either selexipag or placebo. Dosage was up-titrated in 200-μg increments from 200 μg twice daily on day 1 to the maximum tolerated dose by day 35 (maximum allowed dose of 800 μg twice daily). Change in pulmonary vascular resistance at week 17 expressed as a percentage of the baseline value was the primary efficacy end-point, and was analysed in the per protocol set first and then in the all-treated set to assess robustness of results.

A statistically significant 30.3% reduction in geometric mean pulmonary vascular resistance was observed after 17 weeks' treatment with selexipag compared with placebo (95% confidence limits -44.7– -12.2; p=0.0045, Wilcoxon rank sum test). This was supported by a similar result from the all-treated set. Selexipag was well tolerated with a safety profile in line with the expected pharmacological effect.

Our results encourage the further investigation of selexipag for the treatment of PAH.

  • Haemodynamics
  • prostacyclin
  • pulmonary arterial hypertension
  • randomised controlled trial

Footnotes

  • This article has supplementary material available fromwww.erj.ersjournals.com

  • Clinical Trial

    This study is registered at clinicaltrials.gov with identifier number NCT00993408.

  • Statement of Interest

    Statements of interest for G. Simonneau, A. Torbicki, M.M. Hoeper, M. Delcroix, K. Karlócai, N. Galiè, M. Kurzyna, M. Efficace, R. Giorgino and I.M. Lang, and for the study itself can be found at www.erj.ersjournals.com/site/misc/statements.xhtml

  • Received August 11, 2011.
  • Accepted January 11, 2012.
  • ©ERS 2012
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Selexipag: an oral, selective prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension
Gérald Simonneau, Adam Torbicki, Marius M. Hoeper, Marion Delcroix, Kristóf Karlócai, Nazzareno Galiè, Bruno Degano, Diana Bonderman, Marcin Kurzyna, Michela Efficace, Ruben Giorgino, Irene M. Lang
European Respiratory Journal Oct 2012, 40 (4) 874-880; DOI: 10.1183/09031936.00137511

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Selexipag: an oral, selective prostacyclin receptor agonist for the treatment of pulmonary arterial hypertension
Gérald Simonneau, Adam Torbicki, Marius M. Hoeper, Marion Delcroix, Kristóf Karlócai, Nazzareno Galiè, Bruno Degano, Diana Bonderman, Marcin Kurzyna, Michela Efficace, Ruben Giorgino, Irene M. Lang
European Respiratory Journal Oct 2012, 40 (4) 874-880; DOI: 10.1183/09031936.00137511
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