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.
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