Primary EndpointImpact earlier with Orenitram to delay the time to clinical worsening1

The risk of clinical worsening decreased by 25% compared with placebo1
Patients on Orenitram were at a higher risk at baseline vs placebo (P=0.0017)2‡
- As part of a post hoc analysis, when adjusted for baseline risk stratification, patients on Orenitram had a 39% reduction in the risk of a clinical worsening event (P=0.0006*; HR=0.61; 95% CI, 0.46-0.81; P=0.0006†)2
- Using the French methodology2,3§:
- 25.2% of patients on Orenitram had 0 low-risk factors, 33.2% had 1 low-risk factor, 30.3% had 2 low-risk factors, and 11.3% had 3 low-risk factors
- 17.7% of patients on placebo had 0 low-risk factors, 32.9% had 1 low-risk factor, 28.1% had 2 low-risk factors, and 21.3% had 3 low-risk factors
- P-value was calculated with log-rank test stratified by background PAH therapy and baseline 6MWD category.
- Hazard ratio and 95% CI were calculated with proportional hazard model with treatment, background PAH therapy, and baseline 6MWD as explanatory variables.
- Randomization (1:1) was stratified by type of background therapy (ie, PDE-5i or sGCS vs ERA) and by baseline 6MWD (breakpoint ≤350 m).2
- Low-risk status criteria included WHO functional class I/II, 6MWD >440 m, and NT-proBNP <300 pg/mL.2
Delayed disease progression
Clinical Worsening Event Category as the First Event, n (%)1,2
Orenitram n=346 |
Placebo n=344 |
|
---|---|---|
All adjudicated events | 90 (26%) | 124 (36%) |
Unsatisfactory long-term clinical response | 19 (5.5%) | 20 (5.8%) |
Disease progression | 19 (5.5%) | 50 (14.5%) |
Initiation of inhaled or infused prostacyclin | 2 (0.6%) | 5 (1.5%) |
Hospitalization due to PAH | 35 (10.1%) | 35 (10.2%) |
Death (all causes) | 15 (4.3%) | 14 (4.1%) |
HR (95% CI)† (Orenitram – Placebo) |
0.75 (0.57-0.99) P=0.039* |
- P-value was calculated with log-rank test stratified by background PAH therapy and baseline 6MWD category.
- Hazard ratio and 95% CI were calculated with proportional hazard model with treatment, background PAH therapy, and baseline 6MWD as explanatory variables.