Table 4.
Patients, etiology, end points, treatment effects, and adverse reactions of the US Food and Drug Administration approved soluble guanylate cyclase stimulators in the pivotal Phase III randomized controlled trials for treatment of pulmonary arterial hypertension in adults.
| PATENT-1 [34] | CHEST-1 [35] | |
|---|---|---|
| Patients (no.) | 443 | 261 |
| Drug | RIOCIGUAT | |
| Dosing/route | 0.5–2.5 mg tid/os | |
| Follow-up (months) | 3 | 4 |
| Etiology (%)* | ||
| IPAH | 63 | — |
| CTD | 25 | — |
| CHD | 8 | — |
| Portopulmonary | 3 | — |
| Anorexigen use | 1 | — |
| CTEPH | ||
| Inoperable | — | 70 |
| Postoperative | — | 30 |
| Functional class | ||
| NYHA/WHO I | 3 | 2 |
| NYHA/WHO II | 40 | 32 |
| NYHA/WHO III | 56 | 62 |
| NYHA/WHO IV | 1 | 5 |
| Primary end point | 6MWD | 6MWD |
| Treatment effects | ||
| Δ6MWD (m) | 30 | 39 |
| Hemodynamics | Improved | Improved |
| Clinical worsening | Reduced | No change |
| Adverse reactions | Headache, peripheral edema, hypotension, dizziness, and syncope | |
PATENT: Pulmonary Arterial hyperTENsion Soluble Guanylate-Cyclase-Stimulator Trial; CHEST: CHronic thromboEmbolic Pulmonary Hypertension Soluble Guanylate-Cyclase-Stimulator Trial; tid: three times daily; os: oral; *sum of percentage may not be 100% for rounding to the nearest unit; 0.5 is rounded to the upper unit; IPAH: idiopathic pulmonary arterial hypertension; CTD: connective tissue disease; CHD: congenital heart disease (congenital systemic-to-pulmonary shunts); CTPEH: chronic thromboembolic pulmonary hypertension; NYHA: New York Heart Association; WHO: World Health Organization; 6MWD: 6 min walk distance; Δ: mean (or median) change from baseline.