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    Racial differences in the effect of granulocyte macrophage colony-stimulating factor on improved walking distance in peripheral artery disease: The PROPEL randomized clinical trial

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    Author
    McDermott, M.M.
    Polonsky, T.S.
    Guralnik, J.M.
    Date
    2019
    Journal
    Journal of the American Heart Association
    Publisher
    American Heart Association Inc.
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://dx.doi.org/10.1161/JAHA.118.011001
    Abstract
    Background The effects of race on response to medical therapy in people with peripheral artery disease (PAD) are unknown. Methods and Results In the PROPEL (Progenitor Cell Release Plus Exercise to Improve Functional Performance in PAD) Trial, PAD participants were randomized to 1 of 4 groups for 6 months: supervised treadmill exercise+granulocyte‐macrophage colony‐stimulating factor (GM‐CSF) (Group 1), exercise+placebo (Group 2), attention control+GM‐CSF (Group 3), or attention control+placebo (Group 4). Change in 6‐minute walk distance was measured at 12‐ and 26‐week follow‐up. In these exploratory analyses, groups receiving GM‐CSF (Groups 1 and 3), placebo (Groups 2 and 4), exercise (Groups 1 and 2), and attention control (Groups 2 and 4) were combined, maximizing statistical power for studying the effects of race on response to interventions. Of 210 PAD participants, 141 (67%) were black and 64 (30%) were white. Among whites, GM‐CSF improved 6‐minute walk distance by +22.0 m (95% CI: −4.5, +48.5, P=0.103) at 12 weeks and +44.4 m (95% CI: +6.9, +82.0, P=0.020) at 26 weeks, compared with placebo. Among black participants, there was no effect of GM‐CSF on 6‐minute walk distance at 12‐week (P=0.26) or 26‐week (−5.0 m [−27.5, +17.5, P=0.66]) follow‐up, compared with placebo. There was an interaction of race on the effect of GM‐CSF on 6‐minute walk change at 26‐week follow‐up (P=0.018). Exercise improved 6‐minute walk distance in black (P=0.006) and white (P=0.034) participants without interaction. Conclusions GM‐CSF improved 6‐minute walk distance in whites with PAD but had no effect in black participants. Further study is needed to confirm racial differences in GM‐CSF efficacy in PAD. Copyright 2019 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.
    Sponsors
    This work was funded by the National Heart, Lung, and Blood Institute (R01-HL107510), was also supported by the intramural division of the National Institute on Aging and by Jesse Brown VA Medical Center.
    Keyword
    Exercise training
    Peripheral artery disease
    Peripheral vasculature
    Stem cell
    Identifier to cite or link to this item
    https://www.scopus.com/inward/record.uri?eid=2-s2.0-85060151089&doi=10.1161%2fJAHA.118.011001&partnerID=40&md5=5d818f426288ea8c6514c2ed66ba3b0a; http://hdl.handle.net/10713/8685
    ae974a485f413a2113503eed53cd6c53
    10.1161/JAHA.118.011001
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