Inhaled Treprostinil in Pulmonary Hypertension Due to Interstitial Lung Disease
RCT (n=326) found inhaled treprostinil improved exercise capacity from baseline, assessed with 6-minute walk test, as compared with placebo at week 16 (least-squares mean difference 31.12m;95% CI 16.85-45.39; p<0.001). Clinical worsening occurred in 22.7 vs. 33.1%, respectively.
Source:
New England Journal of Medicine
SPS commentary:
Editorial discusses what end points should be used to study interstitial lung disease–associated pulmonary hypertension. It suggests that targeting the 6-minute walk distance is a practical first step and follows the path taken historically in drug development for pulmonary arterial hypertension (PAH), though most early trials in focused on short-term improvements in 6-minute walk distance that were probably too modest to be unequivocally consequential for many patients. It questions whether the improved outlook for patients is because of or regardless of these short-term changes in 6-minute walk distances. It notes that more-recent trials have been longer-term and have focused on composite clinical primary end points such as hospitalisations, other indications of disease progression, and death. It calls for trials in interstitial lung disease–associated pulmonary hypertension to build on lessons learned from PAH by pivoting to the most consequential end points.