Abstract
Haemodynamic (HD) parameters are important determinants of prognosis in PAH. This post-hoc analysis of SERAPHIN (NCT00660179) examined the effect of macitentan 10mg on the risk of morbidity and mortality in PAH patients with baseline HD values suggestive of impaired RV function. Criteria were: mean right atrial pressure (mRAP) >10 mmHg (Group A), cardiac index <2.5 L/min/m2 (Group B), or both (Group C). Cox regression models were used to calculate unadjusted hazard ratios between treatment arms in each group. Of the patients randomised to placebo (n=250) or macitentan 10mg (n=242) q.d., 63% were on PAH-specific therapy. Patients in Groups A, B and C had worse baseline characteristics (6-min walk test, WHO functional class, NT-proBNP) than those not meeting these criteria. Interaction tests showed no evidence of a difference in the reduction of risk of morbidity and mortality with macitentan 10mg vs placebo irrespective of HD criteria (Figure). Except for a higher frequency of hypotension-related adverse events in macitentan-treated patients with elevated mRAP, the safety profile of macitentan was similar irrespective of HD criteria. Macitentan 10mg was well tolerated and significantly reduced the risk of morbidity and mortality in PAH patients irrespective of the presence or absence of RV impairment.
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