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Original Research: PULMONARY VASCULAR DISEASE |

Long-term Treatment With Sildenafil Citrate in Pulmonary Arterial HypertensionSildenafil in Pulmonary Arterial Hypertension: The SUPER-2 Study

Lewis J. Rubin, MD, FCCP; David B. Badesch, MD, FCCP; Thomas R. Fleming, PhD; Nazzareno Galiè, MD; Gerald Simonneau, MD; Hossein A. Ghofrani, MD; Michael Oakes, PhD; Gary Layton, MSc; Marjana Serdarevic-Pehar, MD; Vallerie V. McLaughlin, MD, FCCP; Robyn J. Barst, MD, FCCP; on behalf of the SUPER-2 Study Group
Author and Funding Information

From the Department of Medicine, University of California at San Diego (Dr Rubin), La Jolla, CA; the Department of Medicine, University of Colorado Denver (Dr Badesch), Denver, CO; the Department of Biostatistics (Dr Fleming), University of Washington, Seattle, WA; the Institute of Cardiology (Dr Galiè), University of Bologna, Bologna, Italy; Centre des Maladies Vasculaires Pulmonaires (Dr Simonneau), Hôpital Antoine Béclère, Clamart Cedex, France; Medical Clinic II/V (Dr Ghofrani), University Hospital Giessen and Marburg GmbH, Justus-Liebig-University, Giessen, Germany; Pfizer Global Research Division (Drs Oakes and Serdarevic-Pehar and Mr Layton), Pfizer Ltd, Sandwich, England; Department of Internal Medicine (Dr McLaughlin), University of Michigan Health System, Ann Arbor, MI; and the Columbia University College of Physicians and Surgeons (Dr Barst), New York, NY.

Correspondence to: Lewis J. Rubin, MD, FCCP, University of California at San Diego, UCSD Medical Center/Thornton, 9300 Campus Point Dr/MC 7372, La Jolla, CA 92037; e-mail: ljrubin@ucsd.edu


Funding/Support: This study was funded by Pfizer Inc.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).


© 2011 American College of Chest Physicians


Chest. 2011;140(5):1274-1283. doi:10.1378/chest.10-0969
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Background:  The long-term safety and tolerability of sildenafil treatment of pulmonary arterial hypertension (PAH) were assessed.

Methods:  Two hundred fifty-nine of 277 randomized and treated patients completed a 12-week, double-blind, placebo-controlled trial (SUPER-1 [Sildenafil Use in Pulmonary Arterial Hypertension]) of oral sildenafil in treatment-naive patients with PAH (96% functional class II/III) and entered an open-label uncontrolled extension study (SUPER-2) that continued until the last patient completed 3 years of sildenafil treatment. Patients titrated to sildenafil 80 mg tid; one dose reduction for tolerability was allowed during the titration phase.

Results:  The median duration of sildenafil treatment across SUPER-1 and SUPER-2 was 1,242 days (range, 1-1,523 days); 170 patients (61%) completed both studies, and 89 patients discontinued from SUPER-2. After 3 years, 87% of 183 patients on treatment were receiving sildenafil 80 mg tid. Of patients remaining under follow-up, 3%, 10%, and 18% were receiving a second approved PAH therapy at 1, 2, and 3 years, respectively. At 3 years post-SUPER-1 baseline, 127 patients had an increased 6-min walk distance (6MWD); 81 improved and 86 maintained functional class. Most adverse events were of mild or moderate severity. At 3 years, 53 patients had died (censored, n = 37). Three-year estimated survival rate was 79%; if all censored patients were assumed to have died, 3-year survival rate was 68%. No deaths were considered to be treatment related.

Conclusions:  Long-term treatment of PAH initiated as sildenafil monotherapy was generally well tolerated. After 3 years, the majority of patients (60%) who entered the SUPER-1 trial improved or maintained their functional status, and 46% maintained or improved 6MWD.

Trial registry:  ClinicalTrials.gov; No.: NCT00159887; URL: www.clinicaltrials.gov

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