Clinical InvestigationCongestive Heart FailureA randomized, placebo-controlled, double-blind, crossover study to evaluate the efficacy of oral sildenafil therapy in severe pulmonary artery hypertension
Section snippets
Study design
A randomized, double-blind, placebo-controlled, crossover trial was carried out to study the efficacy and safety of oral sildenafil in PAH patients in the Department of Cardiology of our institution. The trial was approved by the National Drug Regulatory Authority (The Drug Controller General) and the ethics committee of our institution. Informed written consent was taken before inclusion in the study from all the participants. Consent from parents or legal guardians was obtained in case of
Results
The baseline characteristics of the enrolled patients are given in Table I. All patients had a peak PAP of >80 mm Hg and NYHA class II or above. Among patients with shunt lesions, 6 cases were with ventricular septal defect, 2 with patent ductus arteriosus, 1 with aortopulmonary window, and 1 with endocardial cushion defect.
In 6MWT, the mean distance walked at baseline was 262 ± 99 m, which increased to 293.4 ± 89.4 m after placebo administration and increased to 358.9 ± 96.5 m after sildenafil
Discussion
In several uncontrolled studies, oral sildenafil has been shown to cause significant and sustained improvement in clinical status and hemodynamic parameters.6, 7, 8, 9, 10 We have recently shown that results obtained in observational studies may not be replicated in randomized clinical trials,11 which in this case have been few.12 Sildenafil, a selective PDE-5 inhibitor, facilitates nitric oxide cGMP–induced vasodilatation in lungs by inhibiting degradation of cGMP. Thus, there is a theoretical
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