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Chest. 2011 Nov;140(5):1274-1283. doi: 10.1378/chest.10-0969. Epub 2011 May 5.

Long-term treatment with sildenafil citrate in pulmonary arterial hypertension: the SUPER-2 study.

Author information

1
Department of Medicine, University of California at San Diego, La Jolla, CA. Electronic address: ljrubin@ucsd.edu.
2
Department of Medicine, University of Colorado Denver, Denver, CO.
3
Department of Biostatistics, University of Washington, Seattle, WA.
4
Institute of Cardiology, University of Bologna, Bologna, Italy.
5
Centre des Maladies Vasculaires Pulmonaires, Hôpital Antoine Béclère, Clamart Cedex, France.
6
Medical Clinic II/V, University Hospital Giessen and Marburg GmbH, Justus-Liebig-University, Giessen, Germany.
7
Pfizer Global Research Division, Pfizer Ltd, Sandwich, England.
8
Department of Internal Medicine, University of Michigan Health System, Ann Arbor, MI.
9
Columbia University College of Physicians and Surgeons, New York, NY.

Abstract

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 REGISTRATION:

ClinicalTrials.gov NCT00159887.

PMID:
21546436
DOI:
10.1378/chest.10-0969
[Indexed for MEDLINE]
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