Pulmonary vascular disease & thromboembolism
Randomized Trial of Macitentan/Tadalafil Single-Tablet Combination Therapy for Pulmonary Arterial Hypertension
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
Methodological detailsmulticentre, double-blind, adaptive, phase 3
- Multicentre
- Double-blind
- Adaptive
- Phase 3
Primary result
As reported in the abstract
PVR reduction
Geometric mean ratio (95% CI)P value
M/T FDC vs Macitentan29% greater reduction
0.71(0.61–0.82)
P < 0.0001M/T FDC vs Tadalafil28% greater reduction
0.72(0.64–0.80)
P < 0.0001Further findings
| Outcome | M/T FDC | Macitentan | Tadalafil | |
|---|---|---|---|---|
| Deaths · judged unrelated to treatment | 3 events | Not reported in the abstract | Not reported in the abstract | Macitentan, Tadalafil: 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.
Summarised from the published abstract; every number is checked against it