Long-term BREEZE safety study of Tyvaso DPI in pulmonary arterial hypertension
Long-term BREEZE safety study of Tyvaso DPI in pulmonary arterial hypertension published in Pulmonary Circulation journal.- United Therapeutics
United Therapeutics announced the publication of additional clinical and long-term safety data from the BREEZE study evaluating Tyvaso DPI (treprostinil) in patients with pulmonary arterial hypertension (PAH) in the journal Pulmonary Circulation.
The publication evaluated the BREEZE study and its ongoing optional extension phase (OEP), and concluded: Tyvaso DPI’s delivery device, along with the clinical results from BREEZE, may facilitate the introduction of inhaled treprostinil earlier in the clinical course of PAH for appropriate patients.
Doses of Tyvaso DPI above the current recommended dose of nebulized Tyvaso (9-12 breaths four times daily) were well tolerated, potentially allowing for titration to higher dose levels without resulting in prolonged treatment sessions; A simplified dosing regimen could potentially increase patient compliance; and Tyvaso DPI has a pharmacokinetic (PK) profile comparable to nebulized Tyvaso, such that patients will not have to use more drug than nebulized Tyvaso to get the same treprostinil blood concentration or treatment effect.
See: “BREEZE: Open-label Clinical Study to Evaluate the Safety and Tolerability of Treprostinil Inhalation Powder as Tyvaso DPI in Patients With Pulmonary Arterial Hypertension,” Leslie A. Spikes et al. Pulmonary Circulation Journal https://doi.org/10.1002/pul2.12063.
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