BMJ_Response_V1.pdf (75.83 kB)
Viagra for fetal growth restriction: STRIDER Consortium replies to letter by Symonds and Budge.
journal contributionposted 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.
CitationBMJ, 2018; 362:k3247
Author affiliation/Organisation/COLLEGE OF LIFE SCIENCES
- AM (Accepted Manuscript)