Selexipag did not significantly reduce pulmonary vascular resistance compared to placebo after 17 weeks in Japanese patients with chronic thromboembolic pulmonary hypertension (mean difference -130 dyn·s/cm5, p=0.1553).
RCT (n=34)
Double-blind
3:1 ratio
Yes
Does selexipag improve pulmonary vascular resistance in Japanese patients with chronic thromboembolic pulmonary hypertension?
Selexipag was well-tolerated and improved pulmonary hemodynamics in Japanese patients with CTEPH, particularly in those not on background pulmonary vasodilators, though it did not meet the primary endpoint of significantly reducing PVR in the overall cohort.
Mean Difference: -130 (95% CI -299–39)
Absolute Event Rate: -104% vs 26%
p-value: p=0.1553
BACKGROUND: Selexipag is an oral prostacyclin receptor (IP receptor) agonist with a non-prostanoid structure. This study examined its efficacy and safety in Japanese patients with non-operated or persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH). METHODS AND RESULTS: (P=0.1553). Although the primary endpoint was not met, for the group not concomitantly using a pulmonary vasodilator the PVR in the selexipag group was significantly decreased compared with placebo group (P=0.0364). The selexipag group also showed improvement in total pulmonary resistance and cardiac index. CONCLUSIONS: Selexipag treatment improved pulmonary hemodynamics in Japanese patients with CTEPH, but PVR did not show a significant difference between the selexipag and placebo groups. (Trial registration: JAPIC Clinical Trials Information JapicCTI-111667).
Tanabe et al. (Wed,) conducted a rct in Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (n=34). Selexipag vs. Placebo was evaluated on Change in pulmonary vascular resistance (PVR) from baseline to week 17 (MD -130 dyn·s/cm5, 95% CI -299 to 39, p=0.1553). Selexipag did not significantly reduce pulmonary vascular resistance compared to placebo after 17 weeks in Japanese patients with chronic thromboembolic pulmonary hypertension (mean difference -130 dyn·s/cm5, p=0.1553).
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