Table 2.
Safety findings in the GRIPHON [20] trial
| No PAH therapy | PDE-5i monotherapy | ERA monotherapy | ERA and PDE-5i combination | |||||
|---|---|---|---|---|---|---|---|---|
| Placebo (n = 100) | Selexipag (n = 103) | Placebo (n = 166) | Selexipag (n = 168) | Placebo (n = 68) | Selexipag (n = 81) | Placebo (n = 174) | Selexipag (n = 157) | |
| Patients with ≥ 1 AE (%) | 32.0 | 53.4 | 40.4 | 70.2 | 50.0 | 75.3 | 60.3 | 84.7 |
| AE > 3% selexipag vs placebo (%) | ||||||||
| Headache | 20.0 | 28.2 | 10.2 | 32.7 | 20.6 | 38.3 | 27.6 | 56.1 |
| Diarrhea | 5.0 | 9.7 | 11.4 | 30.4 | 5.9 | 25.9 | 22.4 | 43.9 |
| Pain in jaw | 2.0 | 7.8 | 1.2 | 16.1 | 1.5 | 18.5 | 8.6 | 35.0 |
| Nausea | 5.0 | 10.7 | 9.0 | 13.7 | 7.4 | 21.0 | 14.9 | 31.2 |
| Flushing | 1.0 | 2.9 | 1.8 | 8.9 | 2.9 | 4.9 | 5.7 | 19.1 |
| Pain in extremity | 1.0 | 8.7 | 4.2 | 11.9 | 13.2 | 8.6 | 8.0 | 19.1 |
| Myalgia | 4.0 | 8.7 | 4.2 | 9.5 | 1.5 | 13.6 | 2.3 | 7.6 |
| Vomiting | 3.0 | 1.9 | 4.2 | 6.5 | 5.9 | 11.1 | 8.0 | 10.8 |
| Arthralgia | 3.0 | 8.7 | 4.8 | 9.5 | 5.9 | 8.6 | 6.9 | 9.6 |
| Premature discontinuations due to an AE (%) | 9.2 | 0.9 | 4.3 | 14.2 | 9.2 | 21.3 | 7.6 | 19.0 |
Safety population, patients treated in both titration and maintenance periods
AE adverse event, ERA endothelin receptor antagonist, PAH pulmonary arterial hypertension, PDE-5i phosphodiesterase type 5 inhibitor