Key result
Selexipag cuts death or PAH complications by ~40% versus placebo.
Why the study?
In a phase 2 trial, selexipag was shown to be beneficial in pulmonary arterial hypertension, prompting further evaluation in a phase 3 trial.
Does selexipag reduce the composite of death or PAH-related complications in patients with pulmonary arterial hypertension?
RCT (n=1,156)
double-blind
randomly assigned
Does selexipag reduce the composite of death or PAH-related complications in patients with pulmonary arterial hypertension?
Hazard Ratio: 0.6 (95% CI 0.46–0.78)
Absolute Event Rate: 27% vs 41.6%
p-value: p=<0.001
Selexipag significantly reduced the risk of death or PAH-related complications in patients with pulmonary arterial hypertension, driven primarily by reductions in disease progression and hospitalization.
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Supports selexipag addition in PAH to reduce events; confirms benefit in large Phase 3 RCT.
Sitbon et al. (2015) conducted an RCT in pulmonary arterial hypertension (n=1,156). Selexipag vs. placebo was evaluated on composite of death from any cause or a complication related to pulmonary arterial hypertension (HR 0.60, 95% CI 0.46-0.78, p=<0.001). Selexipag significantly reduced the risk of death or a complication related to pulmonary arterial hypertension compared with placebo (27.0% vs 41.6%; HR 0.60; 99% CI 0.46-0.78; P<0.001).
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