Key result
Sildenafil lowers mean systolic pulmonary artery pressure by ~10 mmHg versus placebo in secondary pulmonary hypertension.
Why the study?
Does sildenafil improve functional class and hemodynamics in patients with secondary pulmonary hypertension?
RCT (n=40)
Placebo-controlled
Randomized
Does sildenafil improve functional class and hemodynamics in patients with secondary pulmonary hypertension?
Absolute Event Rate: 43% vs 53%
p-value: p=0.02
Short-term sildenafil therapy improves functional class and reduces pulmonary artery systolic pressure in patients with secondary pulmonary hypertension.
Supports short-term sildenafil for sPAP reduction in secondary PH; extends RCT evidence to this population.
To study the short term effects of sildenafil citrate therapy in patients with secondary pulmonary hypertension. Forty patients with known symptomatic secondary pulmonary hypertension due to valvular heart disease, chronic thromboembolic disease, chronic obstructive pulmonary disease, interstitial pulmonary fibrosis, and idiopathic dilated cardiomyopathy were included in this phase II study. Patients were allocated in a randomized, placebo controlled design to either sildenafil or placebo for 6 weeks. Baseline and 6 week follow up included assessment of hemodynamic parameters, functional class using the NYHA classification, echocardiographic measurements of pulmonary artery systolic pressure and left ventricular ejection fraction. The mean NYHA class at 6 weeks was 2.05 ± 0.4 in the sildenafil group versus 2.6 ± 0.6 in the placebo group, p = 0.02. The mean systolic pulmonary artery pressure significantly decreased in the sildenafil group at 6 weeks (43 ± 4 mmHg), compared to placebo patients (53 ± 7 mmHg), p = 0.02. Ejection fraction was higher in the sildenafil group, 59 ± 12% versus 54 ± 14% in the placebo group, but did not reach statistically significant difference. Sildenafil was well tolerated with minimal side effects. Our data suggest that sildenafil therapy may provide benefits to selected patients with pulmonary hypertension secondary to cardiac or pulmonary diseases.
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Salem et al. (2013) conducted an RCT in Secondary pulmonary hypertension (n=40). Sildenafil citrate vs. Placebo was evaluated on Mean systolic pulmonary artery pressure at 6 weeks (p=0.02). Sildenafil therapy for 6 weeks significantly reduced mean systolic pulmonary artery pressure compared to placebo (43 vs 53 mmHg, p=0.02) in patients with secondary pulmonary hypertension.
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