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Viagra for fetal growth restriction: STRIDER Consortium replies to letter by Symonds and Budge.

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posted on 2019-02-18, 11:36 authored by LC Kenny, Z Alfirevic, PN Baker, W Ganzevoort, C Gluud, KM Groom, JC Jakobsen, K Lim, LA Magee, AT Papageorghiou, P von Dadelszen
[First paragraphs] We read with dismay and concern the misleading comments of Symonds and Budge regarding the Dutch STRIDER Trial based on selective information. Symonds and Budge erroneously stated that the “trial intervention resulted in 11 infant deaths due to lung related problems”. In fact, the study was stopped following an interim analysis that showed possible (but currently unproven) harm and likely lack of benefit (futility); and to allow detailed review and validation of the findings before any further exposure of women and their fetuses to sildenafil. The signal of potential harm related to an increased incidence of persistent pulmonary hypertension of the newborn and a non‐significant trend towards an increase in neonatal death. Pulmonary hypertension is a common complication in this high-risk group of severely growth restricted pre-term newborns; to attribute a newborn loss to that entity without deeper and more thorough analysis (which is currently underway) is presumptive.

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Citation

BMJ, 2018; 362:k3247

Author affiliation

/Organisation/COLLEGE OF LIFE SCIENCES

Version

  • AM (Accepted Manuscript)

Published in

BMJ

Publisher

BMJ Publishing Group

eissn

1756-1833

Copyright date

2018

Available date

2019-02-18

Publisher version

https://www.bmj.com/content/362/bmj.k3247/rr-4

Notes

Related articles Letter Comprehensive literature search for animal studies may have saved STRIDER trial Published: 25 September 2018; BMJ 362 doi:10.1136/bmj.k4007 Letter Protect pregnant women by including them in clinical research Published: 26 September 2018; BMJ 362 doi:10.1136/bmj.k4013 Letter Viagra for fetal growth restriction: STRIDER Consortium replies to letter by Symonds and Budge Published: 22 November 2018; BMJ 363 doi:10.1136/bmj.k4872

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en

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