Chronic thromboembolic pulmonary hypertension (CTEPH) is a progressive form of pulmonary hypertension (PH) caused by blood clots that don’t dissolve in the lungs. Treprostinil is a prostacyclin analog that has been found effective in the treatment of severe non-operable CTEPH. This study aims to evaluate the efficacy and safety of subcutaneous treprostinil in patients with CTEPH.
This double-blind, randomized, controlled trial included a total of 105 patients with non-operable CTEPH or CTEPH with persistent or recurrent PH. The patients were randomly assigned in a 1:1 ratio to receive continuous high-dose subcutaneous treprostinil (n=53) or low-dose subcutaneous treprostinil (n=52). The primary outcome of the study was the change from baseline in 6-min walk distance at week 24.
At week 24, the marginal mean change in 6-min walk distance was +44.98 m in the high-dose group and +4.29 m in the low-dose group. The rate of serious adverse events was 19% (10 patients) in the low-dose group and 17% (9 patients) in the high-dose group. Infusion site pain and infusion site reactions were the most common treatment-related adverse events.
The research concluded that treatment with both high-dose and low-dose subcutaneous treprostinil was safe and efficacious in patients with severe non-operable CTEPH.