The Six Minute Walk Distance ( 6 Mwd )

847 WordsMar 5, 20154 Pages
Galie’s et al. compared the six-minute walk distance (6-MWD) in patients twelve years or older with symptomatic pulmonary arterial hypertension (PAH) who took placebo versus 4 doses of oral tadalafil with or without bosentan. This multi-center, double-blind, placebo-controlled, randomized controlled study lasted 16 weeks. The patients were placed into 5 different groups: tadalafil 2.5mg, 10mg, 20mg, 40mg, or placebo once daily, and stratification was based on walking distance of 325m, type of PAH, and bosentan use. Patients were not qualified to participate in this study if they had a 6-mintue walk distance <150m or > 450m. Safety was determined by the level of adverse events severity. It was shown that all doses, but 2.5mg, improved 6-MWD at week 16, although, the tadalafil 40mg was the only one that was statistically significant (p<0.01). Compared with placebo, tadalafil 40mg had statistical significance of 6-MWD without bosentan therapy at 44m, versus patients with bosentan with a 6-MWD of 23m. The WHO functional class was not statistically significant in comparison with placebo because patients with better WHO functional class showed no difference in comparison to people with worse WHO functional class. After the 341 patients completed the 16 week trial, 334 of them accepted participation in another 16 week trial. Their 6-MWD slightly improved from 37m to 38m after 44 weeks, which was shown to be statistically significant (95% CI, 29 to 47). In addition, WHO functional

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