The limits of oral therapy in pulmonary arterial hypertension management.

32 Oral treprostinil, a tricyclic benzidine analog of epoprostenol, has been evaluated in two RCTs in PAH patients on background therapy with bosentan and/or sildenafil (FREEDOM C1 and C2) and in both the primary endpoint 6MWD did not reach statistical significance. 33 , 34 An additional RCT of oral treprostinil in PAH naïve patients showed improvement in 6MWD by 26 m at peak dose. 35 However, all studies thus far with oral prostacyclin analogs, such as beraprost, have failed to show a persistent treatment effect as determined by the primary efficacy end-point. 36 , 37 Beraprost, an orally active prostanoid, has not been approved in the United States or Europe for PAH due to lack of long-term efficacy but was approved in Japan and South Korea.

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