Selexipag improves pulmonary vascular resistance, other hemodynamics in CTEPH

Selexipag improved pulmonary vascular resistance and other hemodynamic variables among patients with chronic thromboembolic pulmonary hypertension, according to results published in European Respiratory Journal.

However, there was no change in exercise capacity after treatment.

“The results of this study suggest that selexipag is well tolerated and safe, and that it improves pulmonary hemodynamics in [chronic thromboembolic pulmonary hypertension] patients who cannot undergo [pulmonary endarterectomy] or those with persistent or recurrent [pulmonary hypertension] after [pulmonary endarterectomy] and/or [balloon pulmonary angioplasty],” Takeshi Ogo, MD, chief physician in the division of pulmonary circulation at the National Cerebral and Cardiovascular Center in Suita, Japan, and colleagues wrote.

The multicenter, randomized, double-blind, placebo-controlled study enrolled 78 patients in Japan with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent or recurrent pulmonary hypertension following pulmonary endarterectomy and/or balloon pulmonary angioplasty. Patients were randomly assigned to treatment with twice-daily selexipag (Uptravi, Actelion; n = 39; mean age, 66 years; 74.4% women) 200 µg or placebo (n = 39; mean age, 68 years; 74.4% women) for 20 weeks. Selexipag dose could go up to 1,600 µg twice daily if tolerability was acceptable.

The primary outcome was change in pulmonary vascular resistance from baseline to 20 weeks. Secondary outcomes included changes in other hemodynamic parameters, including 6-minute walk distance, Borg dyspnea scale score, WHO functional class, EQ-5D-5L and N-terminal pro-B-type natriuretic peptide.

Change in pulmonary vascular resistance change was –98.2 dyne second/cm^-5 in the selexipag group compared with –4.6 dyne second/cm^-5 in the placebo group (P = .006).

Researchers also observed improvement in cardiac index (P < .001) and Borg dyspnea scale score (P = .036) in the selexipag group compared with placebo. There was no significant change in 6-minute walk distance and WHO functional class.

Adverse events in the selexipag group corresponded with those generally observed after administrating a prostacyclin analogue, according to the researchers. More than half (53.8%) of patients reported headache, 41% diarrhea, 33.3% nausea and 23.1% malaise.

“Further large-scale investigation is necessary to prove the role of selexipag in CTEPH,” the researchers wrote.