Inhaled Treprostinil in Pulmonary Hypertension Due to Interstitial Lung Disease
| Autor: | Chunqin Deng, Leigh Peterson, Kristan Rollins, Roblee P Allen, Rahul G. Argula, Heidi Bell, Aaron B. Waxman, Abubakr Bajwa, Steven D. Nathan, Pete Smith, Ashwin Ravichandran, Jeremy Feldman, Victor F. Tapson, Ricardo Restrepo-Jaramillo, Peter A. Engel, Thenappan Thenappan |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Adult
Male medicine.medical_specialty Hypertension Pulmonary MEDLINE Walk Test 030204 cardiovascular system & hematology law.invention 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial Quality of life law Internal medicine Administration Inhalation medicine Humans In patient 030212 general & internal medicine Least-Squares Analysis Antihypertensive Agents Aged Aged 80 and over Exercise Tolerance Inhalation business.industry Interstitial lung disease General Medicine Middle Aged medicine.disease Epoprostenol Pulmonary hypertension Quality of Life Female Lung Diseases Interstitial business Treprostinil medicine.drug |
| Zdroj: | New England Journal of Medicine. 384:325-334 |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa2008470 |
| Popis: | No therapies are currently approved for the treatment of pulmonary hypertension in patients with interstitial lung disease. The safety and efficacy of inhaled treprostinil for patients with this condition are unclear.We enrolled patients with interstitial lung disease and pulmonary hypertension (documented by right heart catheterization) in a multicenter, randomized, double-blind, placebo-controlled, 16-week trial. Patients were assigned in a 1:1 ratio to receive inhaled treprostinil, administered by means of an ultrasonic, pulsed-delivery nebulizer in up to 12 breaths (total, 72 μg) four times daily, or placebo. The primary efficacy end point was the difference between the two groups in the change in peak 6-minute walk distance from baseline to week 16. Secondary end points included the change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level at week 16 and the time to clinical worsening.A total of 326 patients underwent randomization, with 163 assigned to inhaled treprostinil and 163 to placebo. Baseline characteristics were similar in the two groups. At week 16, the least-squares mean difference between the treprostinil group and the placebo group in the change from baseline in the 6-minute walk distance was 31.12 m (95% confidence interval [CI], 16.85 to 45.39; P0.001). There was a reduction of 15% in NT-proBNP levels from baseline with inhaled treprostinil as compared with an increase of 46% with placebo (treatment ratio, 0.58; 95% CI, 0.47 to 0.72; P0.001). Clinical worsening occurred in 37 patients (22.7%) in the treprostinil group as compared with 54 patients (33.1%) in the placebo group (hazard ratio, 0.61; 95% CI, 0.40 to 0.92; P = 0.04 by the log-rank test). The most frequently reported adverse events were cough, headache, dyspnea, dizziness, nausea, fatigue, and diarrhea.In patients with pulmonary hypertension due to interstitial lung disease, inhaled treprostinil improved exercise capacity from baseline, assessed with the use of a 6-minute walk test, as compared with placebo. (Funded by United Therapeutics; INCREASE ClinicalTrials.gov number, NCT02630316.). |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|