Sildenafil in severe pulmonary hypertension associated with chronic obstructive pulmonary disease: A randomized controlled multicenter clinical trial

Patrizio Vitulo, Anna Stanziola, Marco Confalonieri, Daniela Libertucci, Tiberio Oggionni, Paola Rottoli, Giuseppe Paciocco, Fabio Tuzzolino, Lavinia Martino, Marta Beretta, Adriana Callari, Andrea Amaducci, Roberto Badagliacca, Roberto Poscia, Federica Meloni, Rosa Metella Refini, Pietro Geri, Sergio Baldi, Stefano Ghio, Michele D'AltoPaola Argiento, Matteo Sofia, Mara Guardamagna, Beatrice Pezzuto, Carmine Dario Vizza

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Pulmonary hypertension (PH) is a well-known independent prognostic factor in chronic obstructive pulmonary disease (COPD) and a sufficient criterion for lung transplant candidacy. Limited data are currently available on the hemodynamic and clinical effect of phosphodiesterase 5 inhibitors in patients with severe PH associated with COPD. This study assessed the effect of sildenafil on pulmonary hemodynamics and gas exchange in severe PH associated with COPD.

METHODS: After screening, this multicenter, randomized, placebo-controlled double-blind trial randomized patients to receive 20 mg sildenafil or placebo 3 times a day (ratio 2:1) for 16 weeks. The primary end point was the reduction in pulmonary vascular resistance. Secondary end points included BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) index, 6-minute walk test, and quality of life questionnaire. Changes in the partial pressure of arterial oxygen were evaluated as a safety parameter.

RESULTS: The final population included 28 patients, 18 in the sildenafil group and 10 in the placebo group. At 16 week, patients treated with sildenafil had a decrease in pulmonary vascular resistance (mean difference with placebo -1.4 WU; 95% confidence interval, ≤ -0.05; p = 0.04). Sildenafil also improved the BODE index, diffusion capacity of the lung for carbon monoxide percentage, and quality of life. Change from baseline in the partial pressure of arterial oxygen was not significantly different between the sildenafil and placebo groups.

CONCLUSIONS: This pilot study found that treatment with sildenafil reduced pulmonary vascular resistance and improved the BODE index and quality of life, without a significant effect on gas exchange.

Original languageEnglish
Pages (from-to)166-174
Number of pages9
JournalJournal of Heart and Lung Transplantation
Volume36
Issue number2
DOIs
Publication statusPublished - Feb 2017

Fingerprint

Pulmonary Hypertension
Chronic Obstructive Pulmonary Disease
Multicenter Studies
Randomized Controlled Trials
Placebos
Vascular Resistance
Partial Pressure
Quality of Life
Hemodynamics
Oxygen
Pulmonary Gas Exchange
Lung Volume Measurements
Phosphodiesterase 5 Inhibitors
Carbon Monoxide
Sildenafil Citrate
Dyspnea
Body Mass Index
Gases
Confidence Intervals
Exercise

Keywords

  • Journal Article

Cite this

Sildenafil in severe pulmonary hypertension associated with chronic obstructive pulmonary disease : A randomized controlled multicenter clinical trial. / Vitulo, Patrizio; Stanziola, Anna; Confalonieri, Marco; Libertucci, Daniela; Oggionni, Tiberio; Rottoli, Paola; Paciocco, Giuseppe; Tuzzolino, Fabio; Martino, Lavinia; Beretta, Marta; Callari, Adriana; Amaducci, Andrea; Badagliacca, Roberto; Poscia, Roberto; Meloni, Federica; Refini, Rosa Metella; Geri, Pietro; Baldi, Sergio; Ghio, Stefano; D'Alto, Michele; Argiento, Paola; Sofia, Matteo; Guardamagna, Mara; Pezzuto, Beatrice; Vizza, Carmine Dario.

In: Journal of Heart and Lung Transplantation, Vol. 36, No. 2, 02.2017, p. 166-174.

Research output: Contribution to journalArticle

Vitulo, P, Stanziola, A, Confalonieri, M, Libertucci, D, Oggionni, T, Rottoli, P, Paciocco, G, Tuzzolino, F, Martino, L, Beretta, M, Callari, A, Amaducci, A, Badagliacca, R, Poscia, R, Meloni, F, Refini, RM, Geri, P, Baldi, S, Ghio, S, D'Alto, M, Argiento, P, Sofia, M, Guardamagna, M, Pezzuto, B & Vizza, CD 2017, 'Sildenafil in severe pulmonary hypertension associated with chronic obstructive pulmonary disease: A randomized controlled multicenter clinical trial', Journal of Heart and Lung Transplantation, vol. 36, no. 2, pp. 166-174. https://doi.org/10.1016/j.healun.2016.04.010
Vitulo, Patrizio ; Stanziola, Anna ; Confalonieri, Marco ; Libertucci, Daniela ; Oggionni, Tiberio ; Rottoli, Paola ; Paciocco, Giuseppe ; Tuzzolino, Fabio ; Martino, Lavinia ; Beretta, Marta ; Callari, Adriana ; Amaducci, Andrea ; Badagliacca, Roberto ; Poscia, Roberto ; Meloni, Federica ; Refini, Rosa Metella ; Geri, Pietro ; Baldi, Sergio ; Ghio, Stefano ; D'Alto, Michele ; Argiento, Paola ; Sofia, Matteo ; Guardamagna, Mara ; Pezzuto, Beatrice ; Vizza, Carmine Dario. / Sildenafil in severe pulmonary hypertension associated with chronic obstructive pulmonary disease : A randomized controlled multicenter clinical trial. In: Journal of Heart and Lung Transplantation. 2017 ; Vol. 36, No. 2. pp. 166-174.
@article{76a192eedeed400d9d3dafb381971dcc,
title = "Sildenafil in severe pulmonary hypertension associated with chronic obstructive pulmonary disease: A randomized controlled multicenter clinical trial",
abstract = "BACKGROUND: Pulmonary hypertension (PH) is a well-known independent prognostic factor in chronic obstructive pulmonary disease (COPD) and a sufficient criterion for lung transplant candidacy. Limited data are currently available on the hemodynamic and clinical effect of phosphodiesterase 5 inhibitors in patients with severe PH associated with COPD. This study assessed the effect of sildenafil on pulmonary hemodynamics and gas exchange in severe PH associated with COPD.METHODS: After screening, this multicenter, randomized, placebo-controlled double-blind trial randomized patients to receive 20 mg sildenafil or placebo 3 times a day (ratio 2:1) for 16 weeks. The primary end point was the reduction in pulmonary vascular resistance. Secondary end points included BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) index, 6-minute walk test, and quality of life questionnaire. Changes in the partial pressure of arterial oxygen were evaluated as a safety parameter.RESULTS: The final population included 28 patients, 18 in the sildenafil group and 10 in the placebo group. At 16 week, patients treated with sildenafil had a decrease in pulmonary vascular resistance (mean difference with placebo -1.4 WU; 95{\%} confidence interval, ≤ -0.05; p = 0.04). Sildenafil also improved the BODE index, diffusion capacity of the lung for carbon monoxide percentage, and quality of life. Change from baseline in the partial pressure of arterial oxygen was not significantly different between the sildenafil and placebo groups.CONCLUSIONS: This pilot study found that treatment with sildenafil reduced pulmonary vascular resistance and improved the BODE index and quality of life, without a significant effect on gas exchange.",
keywords = "Journal Article",
author = "Patrizio Vitulo and Anna Stanziola and Marco Confalonieri and Daniela Libertucci and Tiberio Oggionni and Paola Rottoli and Giuseppe Paciocco and Fabio Tuzzolino and Lavinia Martino and Marta Beretta and Adriana Callari and Andrea Amaducci and Roberto Badagliacca and Roberto Poscia and Federica Meloni and Refini, {Rosa Metella} and Pietro Geri and Sergio Baldi and Stefano Ghio and Michele D'Alto and Paola Argiento and Matteo Sofia and Mara Guardamagna and Beatrice Pezzuto and Vizza, {Carmine Dario}",
note = "Copyright {\circledC} 2016 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.",
year = "2017",
month = "2",
doi = "10.1016/j.healun.2016.04.010",
language = "English",
volume = "36",
pages = "166--174",
journal = "Journal of Heart and Lung Transplantation",
issn = "1053-2498",
publisher = "Elsevier USA",
number = "2",

}

TY - JOUR

T1 - Sildenafil in severe pulmonary hypertension associated with chronic obstructive pulmonary disease

T2 - A randomized controlled multicenter clinical trial

AU - Vitulo, Patrizio

AU - Stanziola, Anna

AU - Confalonieri, Marco

AU - Libertucci, Daniela

AU - Oggionni, Tiberio

AU - Rottoli, Paola

AU - Paciocco, Giuseppe

AU - Tuzzolino, Fabio

AU - Martino, Lavinia

AU - Beretta, Marta

AU - Callari, Adriana

AU - Amaducci, Andrea

AU - Badagliacca, Roberto

AU - Poscia, Roberto

AU - Meloni, Federica

AU - Refini, Rosa Metella

AU - Geri, Pietro

AU - Baldi, Sergio

AU - Ghio, Stefano

AU - D'Alto, Michele

AU - Argiento, Paola

AU - Sofia, Matteo

AU - Guardamagna, Mara

AU - Pezzuto, Beatrice

AU - Vizza, Carmine Dario

N1 - Copyright © 2016 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

PY - 2017/2

Y1 - 2017/2

N2 - BACKGROUND: Pulmonary hypertension (PH) is a well-known independent prognostic factor in chronic obstructive pulmonary disease (COPD) and a sufficient criterion for lung transplant candidacy. Limited data are currently available on the hemodynamic and clinical effect of phosphodiesterase 5 inhibitors in patients with severe PH associated with COPD. This study assessed the effect of sildenafil on pulmonary hemodynamics and gas exchange in severe PH associated with COPD.METHODS: After screening, this multicenter, randomized, placebo-controlled double-blind trial randomized patients to receive 20 mg sildenafil or placebo 3 times a day (ratio 2:1) for 16 weeks. The primary end point was the reduction in pulmonary vascular resistance. Secondary end points included BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) index, 6-minute walk test, and quality of life questionnaire. Changes in the partial pressure of arterial oxygen were evaluated as a safety parameter.RESULTS: The final population included 28 patients, 18 in the sildenafil group and 10 in the placebo group. At 16 week, patients treated with sildenafil had a decrease in pulmonary vascular resistance (mean difference with placebo -1.4 WU; 95% confidence interval, ≤ -0.05; p = 0.04). Sildenafil also improved the BODE index, diffusion capacity of the lung for carbon monoxide percentage, and quality of life. Change from baseline in the partial pressure of arterial oxygen was not significantly different between the sildenafil and placebo groups.CONCLUSIONS: This pilot study found that treatment with sildenafil reduced pulmonary vascular resistance and improved the BODE index and quality of life, without a significant effect on gas exchange.

AB - BACKGROUND: Pulmonary hypertension (PH) is a well-known independent prognostic factor in chronic obstructive pulmonary disease (COPD) and a sufficient criterion for lung transplant candidacy. Limited data are currently available on the hemodynamic and clinical effect of phosphodiesterase 5 inhibitors in patients with severe PH associated with COPD. This study assessed the effect of sildenafil on pulmonary hemodynamics and gas exchange in severe PH associated with COPD.METHODS: After screening, this multicenter, randomized, placebo-controlled double-blind trial randomized patients to receive 20 mg sildenafil or placebo 3 times a day (ratio 2:1) for 16 weeks. The primary end point was the reduction in pulmonary vascular resistance. Secondary end points included BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) index, 6-minute walk test, and quality of life questionnaire. Changes in the partial pressure of arterial oxygen were evaluated as a safety parameter.RESULTS: The final population included 28 patients, 18 in the sildenafil group and 10 in the placebo group. At 16 week, patients treated with sildenafil had a decrease in pulmonary vascular resistance (mean difference with placebo -1.4 WU; 95% confidence interval, ≤ -0.05; p = 0.04). Sildenafil also improved the BODE index, diffusion capacity of the lung for carbon monoxide percentage, and quality of life. Change from baseline in the partial pressure of arterial oxygen was not significantly different between the sildenafil and placebo groups.CONCLUSIONS: This pilot study found that treatment with sildenafil reduced pulmonary vascular resistance and improved the BODE index and quality of life, without a significant effect on gas exchange.

KW - Journal Article

U2 - 10.1016/j.healun.2016.04.010

DO - 10.1016/j.healun.2016.04.010

M3 - Article

C2 - 27329400

VL - 36

SP - 166

EP - 174

JO - Journal of Heart and Lung Transplantation

JF - Journal of Heart and Lung Transplantation

SN - 1053-2498

IS - 2

ER -