Key result
Macitentan-tadalafil combination therapy reduces pulmonary vascular resistance by ~50% versus macitentan monotherapy in PAH.
Why the study?
Macitentan and tadalafil single-tablet combination therapy was evaluated globally in the A DUE study, but outcomes specifically in Chinese participants had not been reported.
Does macitentan plus tadalafil single-tablet combination therapy improve pulmonary vascular resistance compared to monotherapies in Chinese patients with pulmonary arterial hypertension?
RCT (n=23)
Double-blind
Patients were randomized 2:1:1 to M/T STCT, macitentan, or tadalafil if treatment-naïve, and 2:1 to M/T STCT or monotherapy depending on their prior background PAH therapy
Yes
Does macitentan plus tadalafil single-tablet combination therapy improve pulmonary vascular resistance compared to monotherapies in Chinese patients with pulmonary arterial hypertension?
A single-tablet combination of macitentan and tadalafil significantly reduced pulmonary vascular resistance compared to monotherapies, validating initial double-combination therapy strategies in Chinese patients with PAH.
Answers are grounded in this paper and cite their sources.
Supports upfront macitentan-tadalafil combination in Chinese PAH patients; extends global A DUE efficacy to this population.
Macitentan 10 mg and tadalafil 40 mg single‐tablet combination therapy (M/T STCT) has been evaluated in the global A DUE study (NCT03904693). Here, we report the results of a subgroup analysis in participants from China. This double‐blind, active‐controlled, Phase 3 A DUE study randomized patients with symptomatic pulmonary arterial hypertension (PAH) to receive M/T STCT, macitentan, or tadalafil depending on their baseline PAH treatment (treatment‐naïve, endothelin receptor antagonist, or phosphodiesterase Type 5 inhibitor monotherapy). The primary end point was change in pulmonary vascular resistance (PVR) expressed as the ratio of geometric means (GMR) of Week 16 to baseline. A total of 187 patients were randomized, including 23 patients in China. PVR reduction was significantly greater with M/T STCT compared with macitentan (50%) and tadalafil (41%) (adjusted GMRs were 0.50; 95% confidence level [CL]: 0.35–0.72; p = 0.0017 and 0.59; 95% CL: 0.43–0.80; p = 0.0040, respectively) in Chinese patients. M/T STCT was well tolerated in Chinese patients; the safety profile was consistent with that of macitentan and tadalafil monotherapies, and that of the overall population. In conclusion, in Chinese patients with PAH, PVR was reduced with M/T STCT versus either monotherapy after 16 weeks of treatment; the safety profile of M/T STCT was in line with the known safety profile of the individual components and appeared consistent with the overall population, although data should be interpreted with caution due to the small sample size. Our findings support the use of M/T STCT for PAH in China. Trial registration : ClinicalTrials.gov https://clinicaltrials.gov/ NCT03904693 (April 5, 2019).
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Fan et al. (2025) conducted an RCT in Pulmonary Arterial Hypertension (PAH) (n=23). Macitentan plus tadalafil single-tablet combination therapy vs. Macitentan 10 mg monotherapy or tadalafil 40 mg monotherapy was evaluated on Change in pulmonary vascular resistance (PVR) expressed as the ratio of geometric means (GMR) of Week 16 to baseline (Adjusted GMR 0.50 vs macitentan, 95% CI 0.35-0.72, p=0.0017). Macitentan plus tadalafil single-tablet combination therapy significantly reduced pulmonary vascular resistance by 50% compared to macitentan and 41% compared to tadalafil at 16 weeks in Chinese patients with pulmonary arterial hypertension.
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