Effects of macitentan and selexipag across prognostic age groups in patients with pulmonary arterial hypertension

Effects of macitentan and selexipag across prognostic age groups in patients with pulmonary arterial hypertension

BACKGROUND: Age affects disease severity and patient outcomes in pulmonary arterial hypertension. This post-hoc analysis identified prognostic age groups and associated macitentan/selexipag treatment effects. METHODS: Randomized trials evaluated macitentan (SERAPHIN; NCT00660179) and selexipag (GRIP...

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Main Authors: Richard Channick, MD, Sarah Medrek, MD, Marion Delcroix, MD, Sean Gaine, MD, Pavel Jansa, MD, PhD, Irene Lang, MD, Vallerie McLaughlin, MD, Sanjay Mehta, MD, Tomas Pulido, MD, Bhagavatula Sastry, MD, Rogerio Souza, MD, PhD, Adam Torbicki, MD, Carol Zhao, MS, Paul Strachan, MD, Peter Agron, PhD, Joseph Yen, PhD, Olivier Sitbon, MD, PhD
Format: Article
Language:English
Published: Elsevier 2025-02-01
Series:JHLT Open
Subjects:
Pulmonary arterial hypertension
SERAPHIN
GRIPHON
Selexipag
Macitentan
Online Access:http://www.sciencedirect.com/science/article/pii/S2950133424001472
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Summary:BACKGROUND: Age affects disease severity and patient outcomes in pulmonary arterial hypertension. This post-hoc analysis identified prognostic age groups and associated macitentan/selexipag treatment effects. METHODS: Randomized trials evaluated macitentan (SERAPHIN; NCT00660179) and selexipag (GRIPHON; NCT01106014) versus placebo (primary endpoint: time to morbidity/mortality [M/M]). This analysis defined age thresholds differentiating M/M risk in patients randomized to placebo (Cox regression determining treatment effect by age). RESULTS: Three age groups (< 35, 35–64, ≥ 65 years) showed good M/M risk discrimination (c-statistic 0.69, SERAPHIN; 0.66, GRIPHON). M/M risk was higher in placebo patients < 35 versus 35–64 years (SERAPHIN: hazard ratio [HR] 1.73, 95% confidence interval [CI] 1.10–2.72, p = 0.02; GRIPHON: HR 1.81, 95% CI 1.28–2.56, p < 0.001). M/M risk trended higher in patients ≥ 65 versus 35–64 years (SERAPHIN: HR 1.55, 95% CI 0.89–2.69, p = 0.12; GRIPHON (HR 1.08, 95% CI 0.75–1.55, p = 0.69). M/M risk was lower with macitentan/selexipag versus placebo: macitentan < 35 (HR 0.44, 95% CI 0.25–0.78; p = 0.005), 35–64 (HR 0.50, 95% CI 0.33–0.76; p < 0.001), ≥ 65 years (HR 0.69, 95% CI 0.30–1.58; p = 0.38); selexipag < 35 (HR 0.50, 95% CI 0.32–0.78; p = 0.002), 35–64 (HR 0.72, 95% CI 0.54–0.96; p = 0.03), ≥ 65 years (HR 0.55, 95% CI 0.33–0.91; p = 0.02). Adverse-event discontinuations were similar. CONCLUSIONS: The benefit (vs placebo) of macitentan/selexipag on reducing risk of M/M events was consistent across all ages, including the younger group where significant treatment effects were observed.
ISSN:2950-1334

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