Plain language summary of the INCREASE study: inhaled treprostinil (Tyvaso) for the treatment of pulmonary hypertension due to interstitial lung disease
Abstract
What is this summary about?
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.
What were the results?
A total of 326 participants took part in the study. Half the participants took inhaled treprostinil and the other half took placebo. After 16 weeks, the INCREASE study showed that participants with PH-ILD who took inhaled treprostinil could walk around 31 meters (102 feet) 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.
What do the results mean?
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.
This is an abstract of the Plain Language Summary of Publication article.
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Acknowledgments
The authors would like to thank the patients who participated in this study and their families, as well as investigators and staff at all of the clinical sites. The authors also thank the authors of the original article discussed in this summary who were: Aaron Waxman, Ricardo Restrepo-Jaramillo, Thenappan Thenappan, Ashwin Ravichandran, Peter Engel, Abubakr Bajwa, Roblee Allen, Jeremy Feldman, Rahul Argula, Peter Smith, Kristan Rollins, Chunqin Deng, Leigh Peterson, Heidi Bell, Victor Tapson and Steven D. Nathan.
Medical writing assistance was provided by Tom Garry at The Westfield Group. Funding was provided by United Therapeutics.
Financial & competing interests disclosure
United Therapeutics sponsored this study. NW, MM and NP are employees of United Therapeutics. AW has grants or contracts with payments to his institution from United Therapeutics, Gossamer, Acceleron/Merck, ARIA CV and NIH/NHLBI, patents with Johnson & Johnson, and is part of a data safety monitoring board or advisory board for INSMED. The full disclosure can be found in the original article.
Open access
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