Efficacy and safety of inhaled nitrite in addition to sildenafil in thalassemia patients with pulmonary hypertension: A 12-week randomized, double-blind placebo-controlled clinical trial
Issued Date
2022-03-01
Resource Type
ISSN
10898603
eISSN
10898611
Scopus ID
2-s2.0-85122728262
Pubmed ID
35026396
Journal Title
Nitric Oxide - Biology and Chemistry
Volume
120
Start Page
38
End Page
43
Rights Holder(s)
SCOPUS
Bibliographic Citation
Nitric Oxide - Biology and Chemistry Vol.120 (2022) , 38-43
Suggested Citation
Sasiprapha T., Pussadhamma B., Sibmooh N., Sriwantana T., Pienvichit P., Chuncharunee S., Yingchoncharoen T. Efficacy and safety of inhaled nitrite in addition to sildenafil in thalassemia patients with pulmonary hypertension: A 12-week randomized, double-blind placebo-controlled clinical trial. Nitric Oxide - Biology and Chemistry Vol.120 (2022) , 38-43. 43. doi:10.1016/j.niox.2021.12.009 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/83809
Title
Efficacy and safety of inhaled nitrite in addition to sildenafil in thalassemia patients with pulmonary hypertension: A 12-week randomized, double-blind placebo-controlled clinical trial
Author's Affiliation
Other Contributor(s)
Abstract
Pulmonary hypertension is a significant complication in thalassemia patients. Recent studies showed that inhaled nebulized nitrite could rapidly decrease pulmonary artery pressure. We conducted a multicenter, randomized, double-blind, placebo-controlled trial in thalassemia patients with symptomatic pulmonary hypertension diagnosed by right heart catheterization. Eleven patients were recruited; five were assigned to the nitrite group and six to the placebo group. Patients were treated with the optimal doses of sildenafil for pulmonary hypertension and randomly assigned into the placebo or nitrite groups. Patients in the nitrite group were given inhaled nebulized 30 mg sodium nitrite twice a day for 12 weeks. The clinical outcomes measured at week 12 were the changes in 6-min walk distance (6MWD), mean pulmonary artery pressure (MPAP), and N-terminal pro B-type natriuretic peptide. The MPAP estimated by echocardiography was significantly reduced from 33.6 ± 7.5 mmHg to 25.8 ± 6.0 mmHg (mean difference = 7.76 ± 3.69 mmHg, p = 0.009 by paired t-test). Furthermore, 6MWD was slightly increased from 382.0 ± 54.0 m to 432 ± 53.9 m (mean difference = 50.0 ± 42.8 m, p = 0.059 by paired t-test) in the nitrite group. At week 12, the nitrite group had lower MPAP than the placebo group (25.8 ± 6.0 vs. 45.7 ± 18.5 mmHg, p = 0.048 by unpaired t-test). No significant difference in 6MWD and N-terminal pro B-type natriuretic peptide between the two groups was observed at week 12. There was no hypotension or other significant adverse effects in the nitrite group.