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

P. Vitulo, A. Stanziola, M. Confalonieri, D. Libertucci, T. Oggionni, P. Rottoli, G. Paciocco, F. Tuzzolino, L. Martino, M. Beretta, A. Callari, A. Amaducci, R. Badagliacca, R. Poscia, F. Meloni, R. M. Refini, P. Geri, S. Baldi, S. Ghio, M. D'AltoP. Argiento, M. Sofia, M. Guardamagna, B. Pezzuto, C. D. Vizza

Research output: Contribution to journalArticlepeer-review


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,
Original languageEnglish
Pages (from-to)166-174
Number of pages9
JournalJournal of Heart and Lung Transplantation
Issue number2
Publication statusPublished - Feb 1 2017


  • Adult
  • Aged
  • Aged, 80 and over
  • Confidence Intervals
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Hemodynamics/drug effects
  • Humans
  • Hypertension, Pulmonary/complications/diagnosis/drug therapy
  • Male
  • Middle Aged
  • Patient Selection
  • Pilot Projects
  • Pulmonary Disease, Chronic Obstructive/complications/diagnosis/drug therapy
  • Pulmonary Gas Exchange/drug effects
  • Reference Values
  • Risk Assessment
  • Severity of Illness Index
  • Sildenafil Citrate/administration & dosage
  • Treatment Outcome
  • Vascular Resistance/drug effects
  • BODE index
  • chronic obstructive pulmonary disease
  • end-stage lung disease
  • lung transplantation
  • pulmonary hypertension
  • sildenafil


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