Pulmonary vascular disease & thromboembolismRandomised controlled trial
Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension
- Randomised controlled trial
- multicentre
- double-blind
- adaptive
- phase 3
Authors' conclusion
Macitentan and tadalafil FDC significantly improved PVR vs monotherapies in PAH patients, with a safety and tolerability profile consistent with the individual components.
Study context
- Population
- WHO functional class II–III pulmonary arterial hypertension (PAH), treatment-naïve or on prior endothelin receptor antagonist (ERA) or PDE5i monotherapy
- Participants
- 187 participants
- Comparison
- Macitentan/tadalafil single-tablet FDC vs macitentan or tadalafil monotherapy
- M/T FDCn = 108
- Macitentann = 35reference
- Tadalafiln = 44reference
- Primary endpoint
- Change in pulmonary vascular resistance (PVR)
- Follow-up
- Week 16
Primary result
As reported in the abstract
PVR reduction
- M/T FDC vs Macitentan · 29% greater reduction
- geometric mean ratio 0.71 (95% CI 0.61–0.82); P < 0.0001
- M/T FDC vs Tadalafil · 28% greater reduction
- geometric mean ratio 0.72 (95% CI 0.64–0.80); P < 0.0001
Further findings
| Outcome | M/T FDC | Macitentan | Tadalafil |
|---|---|---|---|
| Deaths · judged unrelated to treatment | 3 events | Not reported in the abstract | Not reported in the abstract |
Safety
Adverse events (AEs) leading to discontinuation, serious AEs, AEs of special interest (anemia, hypotension, edema)
- More frequent with M/T FDC
Original publication
Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension. J Am Coll Cardiol. Published 30 January 2024. doi:10.1016/j.jacc.2023.10.045
Summarised from the published abstract; every number is checked against it