Table 2.
Summary of key published studies evaluating tadalafil for the treatment of children and adolescents with PAH
| Study | Design | Treatment arms | Key findings |
|---|---|---|---|
| Takatsuki et al84 | Retrospective chart review of 33 children (age, 4–18 y) with PAH a | Tadalafil (mean dose, 1.0 mg/kg/day) | • In 14 patients who underwent repeat catheterization, improvements after switching from sildenafil were observed in mPAP (53.2 vs 47.4 mm Hg; P < .05) and PVRI (12.2 vs 10.6; P < .05) |
| • In four treatment‐naïve patients, clinical improvement was noted | |||
| • Side effect profiles were similar in treatment‐naïve and switched patients | |||
| • Two patients discontinued tadalafil due to adverse events (migraine; allergic reaction) | |||
| Sabri et al85 | Prospective open‐label study of 18 children and young adults (age, 4–24 y) with PAH previously receiving sildenafil | Tadalafil 1 mg/kg/day (maximum: 40 mg/day) | • No change in FC after 6 wk, despite some symptom improvement |
| • Mean oxygen saturation improved compared with baseline before and after 6‐minute walk test (P = .005 and .036, respectively) | |||
| • Mean 6MWD improved (P = .005) | |||
| • No significant side effects of tadalafil | |||
| Shiva et al83 | Prospective open‐label study of 25 children (age, 2 mo‐5 y) with PAH | Tadalafil 1 mg/kg/day | • Significant improvements in mPAP at all four monthly visits (P < .01), including in six patients who had previously received sildenafil for >6 mo |
| • Tadalafil was generally safe and well tolerated; nausea was the most frequently reported adverse event (n = 3) | |||
| Sabri et al76 | Randomized, open‐label study in 42 Infants (age, 3–24 mo) with a large septal defect and PAH | Sildenafil | • No significant difference in pulmonary artery‐to‐aortic pressure ratio and sPAP in the first 48 h after surgery |
| 1–3 mg/kg/day pre‐ and post surgery | • No significant differences in ICU stay, mechanical ventilation time, clinical findings of low cardiac output state, and echocardiographic data | ||
| Tadalafil 1 mg/kg/day pre‐ and post surgery | • Both treatments were well tolerated |
Abbreviations: 6MWD, 6‐minute walking distance; FC, functional class; ICU, intensive care unit; mPAP, mean pulmonary artery pressure; PAH, pulmonary arterial hypertension; PVRI, pulmonary vascular resistance index; sPAP, systolic pulmonary artery pressure.
a
29 patients switched from sildenafil (mean, 3.4 mg/kg/day) to tadalafil.