Chest
Original ResearchPulmonary Vascular DiseaseLong-term Treatment With Sildenafil Citrate in Pulmonary Arterial Hypertension: The SUPER-2 Study
Section snippets
Study Design
The extension study was conducted from December 2002 to February 2007; the study ended when the last patient enrolled in the extension study completed 3 years of sildenafil treatment. All patients entering the extension trial titrated up to sildenafil 80 mg tid, unless the dose was not tolerated. Patients assigned to placebo or sildenafil 20 or 40 mg tid in SUPER-1 initially received sildenafil 40 mg tid; after 6 weeks, they titrated to sildenafil 80 mg tid as tolerated. Patients in the
Patients
Of the 277 patients enrolled and treated in the SUPER-1 study, 259 entered the SUPER-2 extension (Table 1), four died and eight withdrew before completing the SUPER-1 study, and six elected not to enter SUPER-2 (Fig 1). At week 24 (after 12 weeks of SUPER-2), 95%, 3%, and 2% of patients who entered the extension study and remained on treatment (n = 256) were receiving sildenafil 80, 40, and 20 mg tid, respectively. At 3 years, of the 183 patients who remained on sildenafil treatment, 87%, 8%,
Discussion
In this open-label, uncontrolled, observational extension study of patients with PAH treated with sildenafil for ≥ 3 years, 46% of patients increased their 6MWD relative to SUPER-1 baseline (with or without the initiation of additional approved PAH therapies), and 60% maintained or improved their baseline functional status at 3 years. These estimates are downwardly biased because all patients with missing assessments and all patients who discontinued are thereby assumed to have deteriorated.
Acknowledgments
Author contributions: The authors had full and unlimited access to the data and take responsibility for the integrity of the data and the accuracy of the analysis.
Dr Rubin: contributed to study design and conception, acquisition and interpretation of data, critical revision of the manuscript for important intellectual content, and approved the final version for publication.
Dr Badesch: contributed to study design and conception, acquisition and interpretation of data, critical revision of the
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Funding/Support: This study was funded by Pfizer Inc.
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