Key result
Sildenafil citrate gains approval for PAH therapy based on two clinical safety and efficacy studies.
Why the study?
Does sildenafil citrate improve safety and efficacy in patients with pulmonary arterial hypertension?
Does sildenafil citrate improve safety and efficacy in patients with pulmonary arterial hypertension?
Sildenafil citrate is a recently approved phosphodiesterase-5 inhibitor for the treatment of pulmonary arterial hypertension.
Approval based on two studies supports cautious PAH use; leaves open need for larger confirmatory trials on durability.
Pulmonary arterial hypertension is a life-threatening, progressive disease that is characterised by an increase of pulmonary artery pressure leading to right heart failure and death. Conventional therapy (e.g., anticoagulants, diuretics, cardiac glycoside) has until recently represented the mainstay of pulmonary arterial hypertension treatment, but newer specific therapies have become available in the meantime. Among them, are the endothelin receptor antagonists (e.g., bosentan), prostacyclin and prostanoid derivatives (e.g., epoprostenol, iloprost, beraprost, treprostinil) or phosphodiesterase-5 inhibitors (e.g. sildenafil citrate). Sildenafil citrate has recently been approved for pulmonary arterial hypertension therapy, and the two discussed clinical studies assessed its safety and efficacy.
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Sabina A Antoniu (2006) conducted a review in Pulmonary arterial hypertension. Sildenafil citrate was evaluated. Sildenafil citrate has recently been approved for pulmonary arterial hypertension therapy, with two clinical studies assessing its safety and efficacy.
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