Tadalafil for veterans with chronic obstructive pulmonary disease—pulmonary hypertension: A multicenter, placebo‐controlled randomized trial
Abstract Treating Veterans with chronic obstructive pulmonary disease complicated by pulmonary hypertension (COPD‐PH) using phosphodiesterase type‐5 inhibitor pharmacotherapy is common, but efficacy data are lacking. To address this further, patients with COPD‐PH from five Department of Veterans Aff...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2022-01-01
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| Series: | Pulmonary Circulation |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/pul2.12043 |
| _version_ | 1828091317138227200 |
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| author | Bradley A. Maron Gaurav Choudhary Rebekah L. Goldstein Eric Garshick Matthew Jankowich Troo J. S. Tucker Kathleen A. LaCerda Brack Hattler Edward C. Dempsey Ruxana T. Sadikot Shelley Shapiro Sharon I. Rounds Ronald H. Goldstein |
| author_facet | Bradley A. Maron Gaurav Choudhary Rebekah L. Goldstein Eric Garshick Matthew Jankowich Troo J. S. Tucker Kathleen A. LaCerda Brack Hattler Edward C. Dempsey Ruxana T. Sadikot Shelley Shapiro Sharon I. Rounds Ronald H. Goldstein |
| author_sort | Bradley A. Maron |
| collection | DOAJ |
| description | Abstract Treating Veterans with chronic obstructive pulmonary disease complicated by pulmonary hypertension (COPD‐PH) using phosphodiesterase type‐5 inhibitor pharmacotherapy is common, but efficacy data are lacking. To address this further, patients with COPD‐PH from five Department of Veterans Affairs hospitals were randomized (1∶1) to receive placebo or oral tadalafil (40 mg/day) for 12 months. The primary endpoint was changed from baseline in 6‐min walk distance at 12 months. Secondary endpoints included change from baseline in pulmonary vascular resistance, mean pulmonary artery pressure, and symptom burden by the University of California San Diego shortness of breath questionnaire scale at 6 months. A total of 42 subjects (all male; 68 ± 7.6 years old) were randomized to placebo (N = 14) or tadalafil (N = 28). The group imbalance was related to under‐enrollment. Compared to placebo, no significant difference was observed in the tadalafil group for change from the primary endpoint or change in mean pulmonary artery pressure or pulmonary vascular resistance from baseline at 6 months. A clinically meaningful improvement was observed in the secondary endpoint of shortness of breath questionnaire score in the tadalafil versus placebo group at 6 months. There was no significant difference in major adverse events between treatment groups, and tadalafil was well tolerated overall. For Veterans with COPD‐PH enrolled in this study, once‐daily treatment with tadalafil did not improve 6‐min walk distance or cardiopulmonary hemodynamics although a decrease in shortness of breath was observed. Under‐enrollment and imbalanced randomization confound interpreting conclusions from this clinical trial and limit the generalization of our findings. |
| first_indexed | 2024-04-11T06:11:03Z |
| format | Article |
| id | doaj.art-9a254e64ecb7404fbc5c4105f6b0c31b |
| institution | Directory Open Access Journal |
| issn | 2045-8940 |
| language | English |
| last_indexed | 2024-04-11T06:11:03Z |
| publishDate | 2022-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Pulmonary Circulation |
| spelling | doaj.art-9a254e64ecb7404fbc5c4105f6b0c31b2022-12-22T04:41:16ZengWileyPulmonary Circulation2045-89402022-01-01121n/an/a10.1002/pul2.12043Tadalafil for veterans with chronic obstructive pulmonary disease—pulmonary hypertension: A multicenter, placebo‐controlled randomized trialBradley A. Maron0Gaurav Choudhary1Rebekah L. Goldstein2Eric Garshick3Matthew Jankowich4Troo J. S. Tucker5Kathleen A. LaCerda6Brack Hattler7Edward C. Dempsey8Ruxana T. Sadikot9Shelley Shapiro10Sharon I. Rounds11Ronald H. Goldstein12Department of Medicine, Section of Cardiology and Division of Pulmonary, Allergy, Sleep, and Critical Care Medicine Veterans Affairs Boston Healthcare System Boston Massachusetts USADepartment of Medicine Providence Veterans Affairs Medical Center Providence Rhode Island USAResearch and Development Service Veterans Affairs Boston Healthcare System Boston Massachusetts USADepartment of Medicine, Research and Development Service, Pulmonary, Allergy, Sleep, and Critical Care Medicine Section Veterans Affairs Boston Healthcare System Boston Massachusetts USADepartment of Medicine Providence Veterans Affairs Medical Center Providence Rhode Island USADepartment of Medicine Providence Veterans Affairs Medical Center Providence Rhode Island USADepartment of Medicine, Research and Development Service, Pulmonary, Allergy, Sleep, and Critical Care Medicine Section Veterans Affairs Boston Healthcare System Boston Massachusetts USACardiology Section Rocky Mountain Regional Veterans Affairs Medical Center Aurora Colorado USACardiology Section Rocky Mountain Regional Veterans Affairs Medical Center Aurora Colorado USADepartment of Medicine Atlanta Veterans Affairs Medical Center Decatur Georgia USADepartment of Cardiology, Cardiology Section Greater Los Angeles VA Healthcare System Los Angeles California USADepartment of Medicine Providence Veterans Affairs Medical Center Providence Rhode Island USADepartment of Medicine, Research and Development Service, Pulmonary, Allergy, Sleep, and Critical Care Medicine Section Veterans Affairs Boston Healthcare System Boston Massachusetts USAAbstract Treating Veterans with chronic obstructive pulmonary disease complicated by pulmonary hypertension (COPD‐PH) using phosphodiesterase type‐5 inhibitor pharmacotherapy is common, but efficacy data are lacking. To address this further, patients with COPD‐PH from five Department of Veterans Affairs hospitals were randomized (1∶1) to receive placebo or oral tadalafil (40 mg/day) for 12 months. The primary endpoint was changed from baseline in 6‐min walk distance at 12 months. Secondary endpoints included change from baseline in pulmonary vascular resistance, mean pulmonary artery pressure, and symptom burden by the University of California San Diego shortness of breath questionnaire scale at 6 months. A total of 42 subjects (all male; 68 ± 7.6 years old) were randomized to placebo (N = 14) or tadalafil (N = 28). The group imbalance was related to under‐enrollment. Compared to placebo, no significant difference was observed in the tadalafil group for change from the primary endpoint or change in mean pulmonary artery pressure or pulmonary vascular resistance from baseline at 6 months. A clinically meaningful improvement was observed in the secondary endpoint of shortness of breath questionnaire score in the tadalafil versus placebo group at 6 months. There was no significant difference in major adverse events between treatment groups, and tadalafil was well tolerated overall. For Veterans with COPD‐PH enrolled in this study, once‐daily treatment with tadalafil did not improve 6‐min walk distance or cardiopulmonary hemodynamics although a decrease in shortness of breath was observed. Under‐enrollment and imbalanced randomization confound interpreting conclusions from this clinical trial and limit the generalization of our findings.https://doi.org/10.1002/pul2.12043exercise capacitylung diseasepulmonary vascular disease |
| spellingShingle | Bradley A. Maron Gaurav Choudhary Rebekah L. Goldstein Eric Garshick Matthew Jankowich Troo J. S. Tucker Kathleen A. LaCerda Brack Hattler Edward C. Dempsey Ruxana T. Sadikot Shelley Shapiro Sharon I. Rounds Ronald H. Goldstein Tadalafil for veterans with chronic obstructive pulmonary disease—pulmonary hypertension: A multicenter, placebo‐controlled randomized trial Pulmonary Circulation exercise capacity lung disease pulmonary vascular disease |
| title | Tadalafil for veterans with chronic obstructive pulmonary disease—pulmonary hypertension: A multicenter, placebo‐controlled randomized trial |
| title_full | Tadalafil for veterans with chronic obstructive pulmonary disease—pulmonary hypertension: A multicenter, placebo‐controlled randomized trial |
| title_fullStr | Tadalafil for veterans with chronic obstructive pulmonary disease—pulmonary hypertension: A multicenter, placebo‐controlled randomized trial |
| title_full_unstemmed | Tadalafil for veterans with chronic obstructive pulmonary disease—pulmonary hypertension: A multicenter, placebo‐controlled randomized trial |
| title_short | Tadalafil for veterans with chronic obstructive pulmonary disease—pulmonary hypertension: A multicenter, placebo‐controlled randomized trial |
| title_sort | tadalafil for veterans with chronic obstructive pulmonary disease pulmonary hypertension a multicenter placebo controlled randomized trial |
| topic | exercise capacity lung disease pulmonary vascular disease |
| url | https://doi.org/10.1002/pul2.12043 |
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