Efficacy of macitentan/tadalafil single-tablet combination therapy vs pooled monotherapy in pulmonary arterial hypertension (PAH): A DUE post hoc analysis
Abstract
Combination of an endothelin receptor antagonist and a phosphodiesterase 5 inhibitor is recommended in low/intermediate risk PAH. In A DUE, a single-tablet, fixed-dose combination of macitentan 10mg and tadalafil 40mg (M/T FDC) significantly improved pulmonary vascular resistance (PVR; primary endpoint) in PAH patients vs macitentan and vs tadalafil monotherapy. The safety profile of M/T FDC was in line with macitentan and tadalafil. To assess the benefit of a combination therapy strategy vs monotherapy at treatment initiation and at escalation, this post hoc analysis examined the effect of M/T FDC vs a pooled monotherapy group (receiving either macitentan or tadalafil) in patients who were either treatment-naïve or on prior monotherapy at randomisation. A DUE ( NCT03904693 ) randomised WHO functional class II/III PAH patients to M/T FDC, macitentan or tadalafil. Changes from baseline to Week 16 in PVR, 6-minute walk distance (6MWD), and N-terminal pro-brain natriuretic peptide (NT-proBNP) were analysed. Consistent with the primary analysis, in this post hoc analysis of treatment-naïve and prior monotherapy patients, single-tablet macitentan/tadalafil fixed-dose combination improved PVR, 6MWD and NT-proBNP to a greater extent than pooled monotherapy (Table), supporting the effectiveness of a combination therapy approach over monotherapy in PAH. erj;64/suppl_68/PA4306/F1 F1 F1
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis. 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.
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