Pulmonary vascular disease & thromboembolismRandomised controlled trial
Randomized, Multicenter Study to Assess the Effects of Different Doses of Sildenafil on Mortality in Adults With Pulmonary Arterial Hypertension
- Randomised controlled trial
- double-blind
- multicentre
- non-inferiority
- prespecified interim analyses
Authors' conclusion
Sildenafil at 80 mg was noninferior to sildenafil at 5 mg when examining all-cause mortality in adults with PAH. Secondary efficacy end points favored 80 mg of sildenafil over 5 mg.
Study context
- Population
- Adults with pulmonary arterial hypertension78 died
- Participants
- 385 adults
- Comparison
- Sildenafil 80 mg TID vs 5 mg TID
- Primary endpoint
- All-cause mortality (non-inferiority of 80 mg vs 5 mg)
Primary result
Overall survival
Hazard ratio
0.51
99.7% CI 0.22–1.21
P < 0.001 for non-inferiority
80 mg vs 5 mg
HR 0.51 (99.7% CI 0.22–1.21); P for non-inferiority < 0.001
As reported in the abstract
Secondary outcomes
| Outcome | HR (99.7% CI) | P value | |
|---|---|---|---|
| Time to clinical worsening | 0.44 (0.22–0.89) | P < 0.001 | |
| 0.20.5125Hazard ratio (log scale) |
| Outcome | least square mean change (m) (95% CI) | P value | |
|---|---|---|---|
| Change in 6-minute walk distance from baseline · 6 months | 18.9 (2.99–34.86) | P = 0.0201 | |
| −2002040Difference, m (linear scale) |
Mortality, clinical worsening, 6-minute walk distance: 80 mg vs 20 mg
- No significant differences between 80 mg and 20 mg
Original publication
Randomized, Multicenter Study to Assess the Effects of Different Doses of Sildenafil on Mortality in Adults With Pulmonary Arterial Hypertension. Circulation. Published 16 May 2024. doi:10.1161/circulationaha.123.068107
Summarised from the published abstract; every number is checked against it