Treatment effect of selexipag on time to disease progression when initiated early in pulmonary arterial hypertension (PAH) patients: GRIPHON and TRITON pooled analysis
Abstract
In PAH clinical practice, drugs targeting the prostacyclin pathway, including the oral prostacyclin receptor agonist selexipag, are often initiated years after diagnosis. The GRIPHON (NCT01106014) and TRITON (NCT02558231) randomised controlled trials examined the impact of selexipag on disease progression, primary and secondary endpoints, respectively. In GRIPHON, selexipag significantly reduced the risk of disease progression (composite primary endpoint) in a PAH population (N=1156) with a mean time from diagnosis of 2.4 years, as part of an oral triple, double or monotherapy regimen versus placebo. In TRITON, a potential signal for reduced risk of disease progression was observed with initial triple oral therapy (selexipag, macitentan, tadalafil) versus initial double oral therapy (placebo, macitentan, tadalafil) in a population of 247 newly diagnosed, treatment naïve patients.
To investigate the impact of initiating selexipag within 6 months of diagnosis on disease progression in a large PAH population.
We selected patients from GRIPHON and TRITON diagnosed within 6 months of randomization and compared those on active therapy with selexipag (selexipag group) versus those on control therapy with placebo (control group). Disease progression endpoints were defined as in the GRIPHON and TRITON studies, respectively. Hazard ratios (HR) and 95% CI for time to first disease progression event up to end of double-blind treatment (selexipag/placebo) + 7 days were estimated using a…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 1,156 participants or records.
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