Cardiac Output

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There was no statistically significant difference among the three groups in changes from baseline to week 12 in cardiac output measured at trough levels (p=0.051), so no further statistical comparisons were carried out. The treatment effects at trough levels were -1.0 l/min (95% CI -2.1 to 0.1) and 0.5 l/min (95% CI -0.8 to 1.9) for the lower and higher doses of sildenafil compared with placebo. When patients receiving sildenafil were combined into a single treatment group, cardiac output at trough levels was reduced by was -0.4 l/min (95% CI -1.6 to 0.7) but was not significantly different from placebo. No statistically significant difference was observed among the three groups in changes from baseline to week 12 in cardiac output measured at 1 hour post-dose. The respective treatment effects for the lower and higher doses of sildenafil compared with placebo at 1 hour post-dose were -0.6

l/min (95% CI -1.8 to 0.6) and -0.2 l/min (95% CI -1.2 to 1.6). For the combined sildenafil treatments the effect size was -0.3 l/min (95% CI -1.4 to 0.8) for 1 hour post-dose.

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