Inhaled treprostinil improves exercise capacity in patients with pulmonary hypertension due to interstitial lung disease, according to a study published online Jan. 13 in the New England Journal of Medicine.
Aaron Waxman, M.D., Ph.D., from Brigham and Women’s Hospital in Boston, and colleagues enrolled patients with interstitial lung disease and pulmonary hypertension in a randomized trial. Participants were randomly assigned to receive either inhaled treprostinil four times daily or placebo (163 to each group). Change in the peak six-minute walk distance from baseline to week 16 was measured as the primary efficacy end point.
The researchers found that the least-squares mean difference between the treprostinil and placebo groups in the change from baseline in the six-minute walk distance was 31.12 m at week 16. From baseline, there was a 15 percent reduction in NT-pro-B-type natriuretic peptide levels with inhaled treprostinil compared with a 46 percent increase with placebo (treatment ratio, 0.58). Clinical worsening occurred in 22.7 and 33.1 percent of patients in the treprostinil and placebo groups, respectively (hazard ratio, 0.61). Cough, headache, dyspnea, dizziness, nausea, fatigue, and diarrhea were the most frequently reported adverse events.
“Patients treated with inhaled treprostinil had significant improvements in exercise capacity, as evidenced by changes in the 6-minute walk distance,” the authors write. “Treatment with inhaled treprostinil was also associated with a lower risk of clinical worsening than that in patients who received placebo.”
The study was funded by United Therapeutics.