fil 2.5 mg, 10 mg, 20 mg, 40 mg or placebo, orally once a day as monotherapy or as add-on therapy to bosentan. The primary endpoint was change from baseline to Week 16 in six-minute walk distance (6MWD)(2). Demographics, clinical data and health-related quality of life data were collected at baseline. Clinical and health-related quality of life data were collected again at weeks eight and sixteen(3).
Tadalafil increased 6MWD in a dose-dependent manner, only the 40 mg dose met the pre-specified level of statistical significance of less than 0.01 (p<0.01). Overall, the placebo-corrected treatment effect was 33m (95 percent confidence-interval, 15m to 50m). In the bosentan-naive group, the treatment effect was 44m (95 percent confidence-interval, 20m to 69m), as compared to 23m (95 percent confidence-interval, -2m to 48m) in patients on background bosentan therapy.
Among secondary objectives, patients administered tadalafil 40 mg showed improvement in time to clinical worsening, as compared to placebo (5 percent for tadalafil 40 mg, versus 16 percent with placebo)(4,5). Additionally, the incidence of clinical worsening was reduced in the 40 mg tadalafil group (p=0.038; relative risk reduction 68 percent less than placebo).
Improvements in the tadalafil 40 mg dose group, compared to placebo, from baseline to Week 16 were observed in six of the eight domains of the SF-36 health survey and for all sections of the EQ-5D questionnaire(6).
The most commonly reported adverse events for tadalafil 40 mg were headache (42 percent for tadalafil 40 mg, versus 15 percent with placebo), myalgia (14 percent for tadalafil 40 mg, versus 4 percent with placebo) and flushing (13 percent for tadalafil 40 mg, versus 2 percent with placebo)(7,8,9). Most adverse events were reported as mild or moderate and discontinuation rates were similar across all treatment groups(10).
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