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Original ResearchCARDIOVASCULAR DISEASESildenafil Improves Health-Related Quality of Life in Patients With Pulmonary Arterial Hypertension*
Section snippets
Study Design
The complete details of the double-blind SUPER study design have been published elsewhere.20 Briefly, 278 patients with symptomatic PAH were randomized to receive placebo or sildenafil, 20, 40, or 80 mg orally tid for 12 weeks. Those patients completing this double-blind phase of the study were eligible to participate in an open-label extension at the highest tolerated dose, not exceeding 80 mg tid. Study medication was added to the patient's background therapy. Patients receiving medication
Baseline Characteristics
The baseline characteristics of the patients in the placebo group and the combined sildenafil treatment group were comparable (Table 1), as were those in the individual sildenafil treatment groups.20 The mean 6MWD at baseline in the study population was 344 m, which is a diminished exercise capacity compared to a healthy population.2021 The baseline SF-36 values (Fig 1, top, A) also show impairment compared to the norm,22 with the greatest decreases in scores in the physical functioning and
Discussion
These data demonstrate that, in addition to significant improvements in exercise capacity,20 treatment with sildenafil also results in significant benefits in HRQoL in patients with PAH. As there was no dose effect in 6MWD or HRQoL assessments, the data for all sildenafil-treated patients were combined and analyzed as a single group.
The baseline data confirm the considerable impairment experienced by patients with PAH, both in terms of exercise capacity (6MWD test, 344 m vs 400 to 700 m,
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2020, Life SciencesCitation Excerpt :It is the most important test method to evaluate the exercise tolerance of PAH patients, and it is also the key method to validate whether the treatment is effective. A 12-week, double-blind and placebo-controlled study suggested that Sildenafil can improve health-related quality of life (6MWD, SF-36, and EQ-5D) in patients with PAH and no dose-dependent [24]. In addition, many studies used 6MWD as the measure of exercise capacity to evaluate the outcomes of PH-COPD [25,26].
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This work was sponsored by Pfizer Ltd.
Dr. Pepke-Zaba was a paid consultant for Pfizer, Ltd; Ms. Gilbert and Ms. Collings are current employees of Pfizer, Ltd; and Mr. Brown is a former employee of Pfizer, Ltd.