RCT of oral treprostinil monotherapy for treatment of pulmonary arterial hypertension

Source: Circulation Area: News Parenteral and inhaled prostacyclin analogue therapies are effective for the treatment of pulmonary arterial hypertension (PAH), but complicated administration requirements can limit the use of these therapies in patients with less severe disease.   The Freedom-M trial study was designed to evaluate the safety and efficacy of the oral prostacyclin analogue, treprostinil diolamine, as initial treatment for de novo PAH. The study involved 349 patients (intent-to-treat population [ITT]) who were randomised to treprostinil, (n=233) or placebo (n=116). Study drug was administered every 12 hours with dose escalation of an additional 0.25 to 0.5 mg BD every 3 days and a maximum possible dose of 12 mg BD. Patients unable to tolerate the 0.25 mg dose or requiring an intermediate dose were allowed to utilise the 0.125 mg tablet once this strength was made available later in the study.   The primary analysis population (modified ITT [mITT]) included 228 patients ...
Source: NeLM - Cardiovascular Medicine - Category: Cardiology Source Type: news