United Therapeutics announced additional positive data from the phase 3 FREEDOM-EV trial of Orenitram (treprostinil extended-release) demonstrating improved hemodynamic parameters and risk status in patients with pulmonary arterial hypertension (PAH).
The phase 3, multicenter, double-blind, placebo-controlled, FREEDOM-EV trial evaluated the effect of Orenitram on the progression of PAH in 690 patients receiving background PAH monotherapy (PDE-5 inhibitor, endothelin receptor antagonist or soluble guanylate cyclase stimulator). Findings from the trial showed Orenitram decreased the risk of adjudicated clinical worsening events by 25% compared to placebo (hazard ratio [HR] 0.75; 95% CI; 0.57, 0.99; P =.039). This effect was attributed to a 61% decrease in the risk of disease progression compared with placebo (HR 0.39; 95% CI; 0.23, 0.66; P =.0002).
Additional data from the FREEDOM-EV hemodynamic sub-study showed 61 patients treated with Orenitram demonstrated significant changes in hemodynamic parameters including pulmonary vascular resistance (20% reduction; P =.0241), pulmonary vascular resistance index (21% reduction; P =.0295), cardiac output (19% increase; P =.0051), cardiac index (17% increase; P =.0128), and stroke volume (13% increase; P =.043).
Further analyses showed treatment with Orenitram was associated with significant improvements in risk status as assessed by the REVEAL 2.0 risk score (RRS) and French noninvasive risk profile. At week 36, the mean RRS in patients treated with Orenitram decreased by 0.61, compared with a decrease of 0.01 in the placebo arm (mean difference: -0.599; P =.002).
Moreover, the primary end point results of time to first clinical worsening were adjusted by baseline risk score. Adjusting by the RRS and French noninvasive risk profile, Orenitram was found to decrease the risk of clinical worsening events by 33% (HR 0.67; P =.0047) and 39% (HR 0.61; P =.0006), respectively, compared with placebo.
As for cost effectiveness, a retrospective database analysis of US health insurance claims revealed that compared with Orenitram, treatment with selexipag, an oral prostacyclin receptor agonist, was associated with 67% higher PAH-related patient healthcare costs, despite similar adherence, persistence, and rate of PAH-related hospitalizations. The study was recently published in the journal Drugs – Real World Outcomes.
“FREEDOM-EV demonstrated that Orenitram treatment not only delays disease progression, but also leads to durable improvement in clinically relevant components of risk, including six-minute walk distance, NT-proBNP, and functional class,” said Andrew Nelsen, PharmD, United Therapeutics’ Head of Global Medical Affairs. “These additional analyses, coupled with the hemodynamic improvements, should bolster PAH physician confidence in treatment.”
Orenitram, an oral prostacyclin mimetic, is currently indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in patients with WHO functional Class II–III symptoms, to delay disease progression and improve exercise capacity.
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