Cargando…
Tadalafil for veterans with chronic obstructive pulmonary disease—pulmonary hypertension: A multicenter, placebo‐controlled randomized trial
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 hosp...
Autores principales: | , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9053004/ https://www.ncbi.nlm.nih.gov/pubmed/35506072 http://dx.doi.org/10.1002/pul2.12043 |
_version_ | 1784696904560410624 |
---|---|
author | Maron, Bradley A. Choudhary, Gaurav Goldstein, Rebekah L. Garshick, Eric Jankowich, Matthew Tucker, Troo J. S. LaCerda, Kathleen A. Hattler, Brack Dempsey, Edward C. Sadikot, Ruxana T. Shapiro, Shelley Rounds, Sharon I. Goldstein, Ronald H. |
author_facet | Maron, Bradley A. Choudhary, Gaurav Goldstein, Rebekah L. Garshick, Eric Jankowich, Matthew Tucker, Troo J. S. LaCerda, Kathleen A. Hattler, Brack Dempsey, Edward C. Sadikot, Ruxana T. Shapiro, Shelley Rounds, Sharon I. Goldstein, Ronald H. |
author_sort | Maron, Bradley A. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9053004 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-90530042022-05-02 Tadalafil for veterans with chronic obstructive pulmonary disease—pulmonary hypertension: A multicenter, placebo‐controlled randomized trial Maron, Bradley A. Choudhary, Gaurav Goldstein, Rebekah L. Garshick, Eric Jankowich, Matthew Tucker, Troo J. S. LaCerda, Kathleen A. Hattler, Brack Dempsey, Edward C. Sadikot, Ruxana T. Shapiro, Shelley Rounds, Sharon I. Goldstein, Ronald H. Pulm Circ Research Articles 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. John Wiley and Sons Inc. 2022-03-14 /pmc/articles/PMC9053004/ /pubmed/35506072 http://dx.doi.org/10.1002/pul2.12043 Text en Published 2022. This article is a U.S. Government work and is in the public domain in the USA. Pulmonary Circulation published by John Wiley & Sons Ltd on behalf of Pulmonary Vascular Research Institute. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Research Articles Maron, Bradley A. Choudhary, Gaurav Goldstein, Rebekah L. Garshick, Eric Jankowich, Matthew Tucker, Troo J. S. LaCerda, Kathleen A. Hattler, Brack Dempsey, Edward C. Sadikot, Ruxana T. Shapiro, Shelley Rounds, Sharon I. Goldstein, Ronald H. Tadalafil for veterans with chronic obstructive pulmonary disease—pulmonary hypertension: A multicenter, placebo‐controlled randomized trial |
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 | Research Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9053004/ https://www.ncbi.nlm.nih.gov/pubmed/35506072 http://dx.doi.org/10.1002/pul2.12043 |
work_keys_str_mv | AT maronbradleya tadalafilforveteranswithchronicobstructivepulmonarydiseasepulmonaryhypertensionamulticenterplacebocontrolledrandomizedtrial AT choudharygaurav tadalafilforveteranswithchronicobstructivepulmonarydiseasepulmonaryhypertensionamulticenterplacebocontrolledrandomizedtrial AT goldsteinrebekahl tadalafilforveteranswithchronicobstructivepulmonarydiseasepulmonaryhypertensionamulticenterplacebocontrolledrandomizedtrial AT garshickeric tadalafilforveteranswithchronicobstructivepulmonarydiseasepulmonaryhypertensionamulticenterplacebocontrolledrandomizedtrial AT jankowichmatthew tadalafilforveteranswithchronicobstructivepulmonarydiseasepulmonaryhypertensionamulticenterplacebocontrolledrandomizedtrial AT tuckertroojs tadalafilforveteranswithchronicobstructivepulmonarydiseasepulmonaryhypertensionamulticenterplacebocontrolledrandomizedtrial AT lacerdakathleena tadalafilforveteranswithchronicobstructivepulmonarydiseasepulmonaryhypertensionamulticenterplacebocontrolledrandomizedtrial AT hattlerbrack tadalafilforveteranswithchronicobstructivepulmonarydiseasepulmonaryhypertensionamulticenterplacebocontrolledrandomizedtrial AT dempseyedwardc tadalafilforveteranswithchronicobstructivepulmonarydiseasepulmonaryhypertensionamulticenterplacebocontrolledrandomizedtrial AT sadikotruxanat tadalafilforveteranswithchronicobstructivepulmonarydiseasepulmonaryhypertensionamulticenterplacebocontrolledrandomizedtrial AT shapiroshelley tadalafilforveteranswithchronicobstructivepulmonarydiseasepulmonaryhypertensionamulticenterplacebocontrolledrandomizedtrial AT roundssharoni tadalafilforveteranswithchronicobstructivepulmonarydiseasepulmonaryhypertensionamulticenterplacebocontrolledrandomizedtrial AT goldsteinronaldh tadalafilforveteranswithchronicobstructivepulmonarydiseasepulmonaryhypertensionamulticenterplacebocontrolledrandomizedtrial |