Inadequate evaluation of potential side effects of sildenafil in preterm stopped Dutch trial.
Ethical Commissions
STRIDER
Sildenafil
cardiovascular side effects
death of patients
fetal growth retardation
inadequate patient information
Journal
The International journal of risk & safety in medicine
ISSN: 1878-6847
Titre abrégé: Int J Risk Saf Med
Pays: Netherlands
ID NLM: 9100907
Informations de publication
Date de publication:
2020
2020
Historique:
pubmed:
5
5
2020
medline:
26
8
2021
entrez:
5
5
2020
Statut:
ppublish
Résumé
Recently a drug trial in the Netherlands in which the efficacy of oral sildenafil was compared to placebo in women bearing children with fetal growth restriction was stopped early because of very harmful side effects to the babies. There were quite some unwanted and unscientific aspects related to this study and the manner in which the side effects were communicated to the patients and the community. These have not gained the attention they ought to have. We therefore made an analysis of the basic problems which aims to prevent that the trust in medical research will be weakened.
Identifiants
pubmed: 32364137
pii: JRS202003
doi: 10.3233/JRS-202003
doi:
Substances chimiques
Vasodilator Agents
0
Sildenafil Citrate
BW9B0ZE037
Types de publication
Clinical Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM