Suitable patients were randomised to receive sildenafil, 25 mg or 100 mg, or matching placebo every 8 hours for 12 weeks. The study was double blind. The primary end point was the change in mean PAP from baseline (week 0) after 12 weeks of treatment. Other measures of efficacy were the change in PVR (mean PAP (mm Hg) - pulmonary capillary wedge pressure (mm Hg)/cardiac output (CO, l/min) x 80 dynes.s/cm-5), cardiac output (l/min), and 6-minute walk (6MW) distance from week 0 after 12 weeks of treatment. The physical limitation domain of the Kansas City Cardiomyopathy Questionnaire was used to assess activity.
Both the baseline (week 0) and 12-week measurements were made at 760 m in the period 7-10 days after arrival at the hospital. Patients returned to their villages between assessments. Compliance with the protocol was assessed by tablet counts. The 6-minute walk and blood tests were made 24 hours before cardiac catheterisation. Baseline cardiopulmonary haemody-namic measurements were made following standard operating procedures after 30 minutes rest. At 12 weeks, these measurements were made 8-10 hours after administration of the study medication (trough measurements) and repeated 60 minutes after a dose of study medication was given by mouth (1 hour post-dose measurements).
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