Is the change in 6-minute walk distance a valid surrogate endpoint for clinical events in pulmonary arterial hypertension trials?
Change in 6-minute walk distance has only modest validity and may not be a sufficient surrogate endpoint for clinical events in pulmonary arterial hypertension trials.
Our results suggest that Δ6MWD does not explain a large proportion of the treatment effect, has only modest validity as a surrogate end point for clinical events, and may not be a sufficient surrogate end point. Further research is necessary to determine whether the threshold value of 41.8 m is valid for long-term outcomes or whether it differs among trials using background therapy or lacking placebo controls entirely.
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Circulation
Center for Clinical Research (United States)
Pulmonary and Allergy Associates
Institute of Health Economics
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Gabler et al. (Wed,) studied this question.
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