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Selexipag for inoperable CTEPH: why meeting a primary endpoint simply isn't enough

Hossein-Ardeschir Ghofrani
European Respiratory Journal 2022 60: 2200581; DOI: 10.1183/13993003.00581-2022
Hossein-Ardeschir Ghofrani
1Department of Internal Medicine, Justus-Liebig-University Giessen, Universities of Giessen and Marburg Lung Center (UGMLC), Giessen, Germany
2German Center of Lung Research (DZL), Germany
3Department of Medicine, Imperial College London, London, UK
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Extract

In the current issue of the European Respiratory Journal, Ogo et al. [1] report the results of a randomised, placebo-controlled, multicentre trial (RCT) from Japan, in which the effects of selexipag in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) were investigated. All patients had previously been treated by either surgery (i.e. pulmonary endarterectomy; PEA) or intervention (i.e. balloon pulmonary angioplasty; BPA) [2], and were suffering from persistent or recurrent pulmonary hypertension. The primary objective of the trial was the change in pulmonary vascular resistance (PVR). In fact, PVR was significantly reduced; however, the effect was at best moderate, and notably many relevant secondary endpoints, such as the 6-min walking distance (6MWD), serum N-terminal pro-brain natriuretic peptide (NT-proBNP), and World Health Organization functional class did not change in a meaningful manner. The adverse events profile corroborated the known side-effect profile of selexipag, as previously reported from trials in the field of pulmonary arterial hypertension (PAH). Based on the results of this study, selexipag was approved for patients with inoperable CTEPH in Japan.

Abstract

Though this study met its primary endpoint and oral selexipag was approved as a treatment for inoperable CTEPH patients in Japan, the overall results and scope of this study do not justify a valid position for selexipag in the treatment armamentarium. https://bit.ly/3INAYgO

Footnotes

  • Conflict of interest: H-A. Ghofrani reports grants paid to institution from German Research Foundation (DFG), German Ministry for Research and Education (BMBF), Actelion/Janssen and Bayer; consulting fees from Actelion/Janssen, Bayer, MSD, Accelleron, MorphogenIX and Gossamer Bio; lecture honoraria from Actelion/Janssen, Bayer, MSD and Gossamer Bio; travel support from Actelion/Janssen, Bayer, Gossamer and MSD; outside the submitted work.

  • Received March 17, 2022.
  • Accepted March 18, 2022.
  • Copyright ©The authors 2022. For reproduction rights and permissions contact permissions{at}ersnet.org
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Selexipag for inoperable CTEPH: why meeting a primary endpoint simply isn't enough
Hossein-Ardeschir Ghofrani
European Respiratory Journal Jul 2022, 60 (1) 2200581; DOI: 10.1183/13993003.00581-2022

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Selexipag for inoperable CTEPH: why meeting a primary endpoint simply isn't enough
Hossein-Ardeschir Ghofrani
European Respiratory Journal Jul 2022, 60 (1) 2200581; DOI: 10.1183/13993003.00581-2022
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