Pulmonary vascular disease & thromboembolismMeta-analysis
Initial Combination Therapy with Macitentan and Tadalafil in Patients with Pulmonary Arterial Hypertension, with and without Cardiac Comorbidities
- Pooled analysis of the TRITON and REPAIR clinical trials
- subgroup analysis
Authors' conclusion
Initial double combination therapy with macitentan plus tadalafil is efficacious in patients with PAH with 1-2 cardiac comorbidities and those without, with similar safety and tolerability profiles between the two groups.
Study context
- Population
- Pulmonary arterial hypertension (PAH) patients on initial macitentan and tadalafil double combination therapyoverall set
- Participants
- 148 patients
- Comparison
- Without cardiac comorbidities vs 1-2 cardiac comorbidities
- Without cardiac comorbiditiesn = 62reference
- 1-2 cardiac comorbiditiesn = 78
Pooled result
As reported in the abstract
Change in pulmonary vascular resistance · Week 26
Without cardiac comorbidities
−55%
1-2 cardiac comorbidities
−50%
Further pooled results
Duration of combined macitentan and tadalafil exposure (overall set)
- Median (Q1-Q3) exposure 513.0 (364.0-778.0) days; similar between subgroups
PAH risk status (non-invasive four-strata and REVEAL Lite 2.0) · Week 26
- Majority of patients had improved PAH risk status
Safety
Safety profile
- Consistent with the known profiles of the two drugs and similar between the subgroups
Original publication
Initial Combination Therapy with Macitentan and Tadalafil in Patients with Pulmonary Arterial Hypertension, with and without Cardiac Comorbidities. Eur J Heart Fail. Published 5 July 2024. doi:10.1002/ejhf.3319
Summarised from the published abstract; every number is checked against it