In pulmonary hypertension (PHT), 10 mg macitentan plus 40 mg tadalafil is recommended as a safe combination therapy for newly diagnosed patients or in a significant proportion of patients during follow-up. Using a tablet with a fixed drug combination (FDC) could simplify treatment.
The aim of this study was to evaluate the efficacy and safety of macitentan/tadalafil in FDC vs. macitentan and tadalafil monotherapy in patients with PHT. It was a randomized, prospective, multicenter, double-blind, phase III study, with a 16-week follow-up.
The study included patients who were treatment-free or who had stable doses of endothelin receptor antagonists or stable doses of phosphodiesterase-5 inhibitors, with a subsequent 1:2 randomization to macitentan 10 mg, macitentan/tadalafil, or tadalafil 40 mg.
Efficacy outcomes were studied at 16 weeks. The primary endpoint was change in pulmonary vascular resistance (PVR) from baseline. The secondary endpoint was change in the 6-minute walk test (6MWT). The safety and tolerability of the treatment were also evaluated.
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The study enrolled 187 randomized patients. The combination in FDC decreased PVR by 45% from baseline, in contrast to macitentan, which decreased it by 23% (mean ratio: 0.71: 95% confidence interval [CI]: 0.71-0.82; p ≤ 0.0001). When compared with tadalafil, the difference in pulmonary resistance was 28% better (average ratio: 0.72, 95% CI: 0.64-0.80; p ≤ 0.0001). However, there was a nonsignificant difference from baseline when analyzing the 6MWT (p = 0.380).
Conclusions: The combination of macitentan and tadalafil at fixed doses significantly decreased (28%) pulmonary vascular resistance.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Original Title: “Efficacy And Safety Of Macitentan Tadalafil Fixed Dose Combination In Pulmonary Arterial Hypertension: Results From The Randomized Controlled Phase III A DUE Study”.
Reference: Presentado por Kelly Chin en Late Breaking Trials del ACC.23/WCC Marzo 4-6, 2023, en New Orleans.
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