Is the change in 6-minute walk distance a valid surrogate endpoint for clinical events in pulmonary arterial hypertension trials?
Patients in Pulmonary Arterial Hypertension trials
Change in 6-Minute Walk Distance (Δ6MWD) as a surrogate endpoint
Validity of Δ6MWD as a surrogate end point for clinical eventssurrogate
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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Nicole B. Gabler
Klinikum rechts der Isar
Benjamin French
Cardiac Imaging
Brian L. Strom
Rutgers, The State University of New Jersey
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.
synapsesocial.com/papers/69d76209ef4aa71f97f31103 — DOI: https://doi.org/10.1161/circulationaha.112.105890
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