Pulmonary vascular disease & thromboembolismRandomised controlled trial
Ralinepag for the treatment of pulmonary arterial hypertension (ADVANCE OUTCOMES): a randomised, double-blind, placebo-controlled phase 3 study
- Randomised controlled trial
- double-blind
- placebo-controlled
- event-driven
- phase 3
Median follow-up 85.0 weeks (IQR 27.6-160.9) with ralinepag and 78.4 weeks (34.6-137) with placebo
Authors' conclusion
In patients with PAH receiving contemporary background therapy, ralinepag significantly reduced the risk of first clinical worsening compared with placebo, but was associated with more adverse-event-related treatment discontinuations.
Study context
- Population
- Adults with pulmonary arterial hypertension (PAH) (2022 ESC/ERS criteria) on contemporary background therapy687 analysed
- Participants
- 728 adults
- Comparison
- Ralinepag vs placebo
- Ralinepagn = 350
- Placebon = 337reference
- Primary endpoint
- Time to first clinical worsening event:
- Death from any cause
- Hospital admission for worsening PAH or right HF
- Initiation of parenteral or inhaled prostacyclin-pathway therapy
- Disease progression
- Unsatisfactory long-term clinical response
Primary result
First clinical worsening event
Hazard ratio
0.45
95% CI 0.33–0.62
P < 0.0001
Events by treatment group
As reported in the abstract
Further findings
Components of the composite outcome
- Largest numerical between-group differences for disease progression, initiation of parenteral or inhaled prostacyclin-pathway therapy, and unsatisfactory long-term clinical response
Safety
Treatment discontinuation primarily due to adverse event
Serious adverse events
Adverse events leading to death
Original publication
Summarised from the published abstract; every number is checked against it