What is the clinical evidence from this study?

Study design: RCT. Population: Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (n=34). Intervention: Selexipag vs. Placebo. Primary outcome: Change in pulmonary vascular resistance (PVR) from baseline to week 17 (MD -130 dyn·s/cm5, 95% CI -299 to 39, p=0.1553).

September 2, 2020Open Access

Selexipag for Chronic Thromboembolic Pulmonary Hypertension in Japanese Patients　― A Double-Blind, Randomized, Placebo-Controlled, Multicenter Phase II Study ―

Key Result

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).

Study Design

Type

RCT (n=34)

Blinding

Double-blind

Randomization

3:1 ratio

Multicenter

Yes

Structured PICO

Does selexipag improve pulmonary vascular resistance in Japanese patients with chronic thromboembolic pulmonary hypertension?

Population

34 Japanese adults aged 20-75 years with chronic thromboembolic pulmonary hypertension and resting PVR >400 dyn·s/cm5, followed for 17 weeks.

Intervention

Selexipag oral twice daily, initiated at 100 μg and titrated up to a maximum tolerated dose of 800 μg twice daily, administered for 17 weeks.

Comparator

Matching placebo oral twice daily for 17 weeks.

Outcome

Change in pulmonary vascular resistance (PVR) from baseline to week 17.surrogate

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.

Main Result

Mean Difference: -130 (95% CI -299–39)

Absolute Event Rate: -104% vs 26%

p-value: p=0.1553

Limitations

Small sample size
Short study duration
Maximum dose was one-half of that approved for PAH treatment
No patient was administered concomitant treatment with riociguat
None had a history of balloon pulmonary angioplasty (BPA)

Abstract

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).

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Cite This Study

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).

synapsesocial.com/papers/6a33007d34a6649adc7080ae https://doi.org/https://doi.org/10.1253/circj.cj-20-0438