Plain language summary of the INCREASE study: inhaled treprostinil (Tyvaso) for the treatment of pulmonary hypertension due to interstitial lung disease.

Abstract

Here, we summarize the results from the INCREASE study, originally published in the New England Journal of Medicine. The INCREASE study looked at how well a medication called inhaled treprostinil works and how safe it is, compared to placebo (a fake medication), in adults who have pulmonary hypertension associated with interstitial lung disease or PH-ILD. A total of 326 participants took part in the study. Half the participants took inhaled treprostinil and the other half took placebo. After 16weeks, the INCREASE study showed that participants with PH-ILD who took inhaled treprostinil could walk around 31meters (102feet) further than the participants who took placebo. Participants taking inhaled treprostinil also had a decrease in NT-proBNP, which is a protein found in the blood. Lower NT-proBNP levels suggest that the heart is functioning better compared with higher levels. Participants taking inhaled treprostinil showed a decrease of NT-proBNP of 15% compared to a 46% increase in participants taking placebo. More participants taking placebo had worsening of their PH-ILD (33%) compared to participants taking inhaled treprostinil (∼23%). The most common side effects reported in the study were cough, headache, and shortness of breath. In the INCREASE study, on average, people with PH-ILD taking inhaled treprostinil, were able to be more active and had less chance of their PH-ILD getting worse, compared to placebo. Based on inhaled treprostinil showing positive results in most people with PH-ILD in this study, the drug has been approved in the USA for the treatment of PH-ILD. Clinical Trial Registration: NCT02630316 (ClinicalTrials.gov).