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

JOURNAL OF HEART AND LUNG TRANSPLANTATION

卷:36

Article

Vita, Patrizio^1,2  Stanziola, Anna³  Confalonieri, Marco^4,5  Libertucci, Daniela⁶  Oggionni, Tiberio⁷  Rottoli, Paola⁸  Paciocco, Giuseppe⁹  Tuzzolino, Fabio¹⁰  Martino, Lavinia^1,2  Beretta, Marta^1,2  Callari, Adriana^1,2  Amaducci, Andrea^1,2  Badagliacca, Roberto¹¹  Poscia, Roberto¹¹  Refini, Rosa Metella⁸  Geri, Pietro^3,4  Baldi, Sergio⁵  Ghio, Stefano¹²  D'Alto, Michele¹³  Argiento, Paola¹³  Sofia, Matteo³  Guardamagna, Mara¹⁴  Pezzuto, Beatrice¹¹  Vizza, Carmine Dario¹¹ 

[1] Ist Mediterraneo Trapianti & Terapie Ad Alta Spec, IRCCS, Dept Treatment, Palermo, Italy

[2] Ist Mediterraneo Trapianti & Terapie Ad Alta Spec, IRCCS, Study Cardiothorac Dis & Cardiothorac Transplanta, Palermo, Italy

[3] Univ Naples Federico II, Dept Clin Med & Surg, Resp Dis Clin 1, Naples, Italy

[4] Univ Hosp Cattinara, Dept Pneumol, Trieste, Italy

[5] Univ Hosp Cattinara, Resp Intermediate Care Unit, Trieste, Italy

[6] Citta Salute & Sci, Dept Internal Med, Div Pneumol, Turin, Italy

[7] Policlin San Matteo, Fdn Ist Ricovero & Cura Carattere Sci, Pulmonol Unit, Pavia, Italy

[8] Univ Siena, Dept Med & Surg Sci & Neurosci, Siena, Italy

[9] Univ Milano Bicocca, San Gerardo Hosp, Pulm Clin Unit, Monza, Italy

[10] Ist Mediterraneo Trapianti & Terapie Ad Alta Spec, IRCCS, Res Off, Palermo, Italy

[11] Sapienza Univ Rome, Dept Cardiovasc & Resp Dis, Pulm Hypertens Unit, Rome, Italy

[12] Italian Assoc Hosp Pneumologists, Ctr Studi AIPO, Milan, Italy

[13] Policlin San Matteo, Fdn Ist Ricovero Cura Carattere Sci, Dept Cardiol, Pavia, Italy

[14] Univ Naples 2, Monaldi Hosp, Dept Cardiol, Naples, Italy

关键词: pulmonary hypertension;    chronic obstructive pulmonary disease;    sildenafil;    BODE index;    end-stage lung disease;    lung transplantation;   

DOI  :  10.1016/j.healun.2016.04.010

来源: Elsevier

【 摘 要 】

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. (C) 2016 International Society for Heart and Lung Transplantation. All rights reserved.

【 授权许可】

Free