Clinicians should stop prescribing sildenafil for fetal growth restriction (FGR): comment from the STRIDER Consortium - read the UOG Physician Alert here.
The international Sildenafil TheRapy In Dismal prognosis Early-onset intrauterine growth Restriction (STRIDER) Consortium has been running four trials: in the UK (published), Australia/New Zealand (finished and analysed); and The Netherlands and Canada (ongoing). Over the last week, a decision was made to halt the trial in The Netherlands: a planned, independent interim analysis showed a signal of potential harm (an increased incidence of persistent pulmonary hypertension of the newborn and a non-significant trend towards neonatal death), and unlikely benefit (a high chance of futility of the trial to show a significant beneficial effect). The previous trials from the UK and Australia/New Zealand did not demonstrate benefit, but neither did they show harm. The findings are being taken very seriously by the Consortium, and full, detailed data analysis is being undertaken. During this time and until there emerges clarity on the effects of sildenafil treatment in FGR, it should not be prescribed for FGR outside the setting of high-quality randomised clinical trials.