A research study found that Tyvaso, a drug approved for enhancing exercise capacity in pulmonary arterial hypertension (PAH), was well tolerated and safe in clinical use.
Researchers set out to characterized the drug’s respiratory-safety profile with help from a large, representative sample of patients with WHO group 1 PAH. The long-term prospective and observational safety clinical trial (NCT01266265) enrolled 1,333 patients from 94 centers throughout the U.S. The study was called “Study of Incidence of Respiratory Tract AEs in Patients Treated With Tyvaso Compared to Other FDA Approved PAH Therapies (Aspire).”
The primary objective aimed to describe the type and incidence of respiratory-related adverse effects likely associated with current or recent treatment with inhaled Tyvaso. The secondary objective was to compare the incidence of respiratory-related adverse effects in patients treated with inhaled Tyvaso (666 patients) with those experienced by patients who used other FDA-approved PAH therapies (667 patients).
From the group of patients treated with inhaled Tyvaso, 403 patients (61%) registered 1,281 respiratory-related adverse effects. From the control group, 388 patients (58%) reported 1,295 respiratory-related negative effects.
The most common adverse respiratory issues included cough, throat irritation, nasal discomfort, and hemoptysis (coughing up of blood). Those events occurred at higher numbers per patient-year of exposure in the inhaled Tyvaso group than in the control group.