Placental growth factor as a predictor of the efficacy of tadalafil treatment for fetal growth restriction

Kubo-Kaneda, Michiko; Tanaka, Hiroaki; Maki, Seijiro; Nii, Masafumi; Umekawa, Takashi; Osato, Kazuhiro; Kamimoto, Yuki; Kondo, Eiji; Ikeda, Tomoaki

doi:10.1080/14767058.2018.1450863

Cited by 2 publications

(1 citation statement)

References 9 publications

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“…In previous studies, the efficacy and safety of tadalafil, a PDE5 inhibitor, for fetal growth restriction (FGR) due to placental dysplasia have been verified in animal studies using pregnant mice models of FGR and confirmed in phase II clinical trials. [11][12][13][14][15][16][17][18][19] Based on these studies, we initiated a new study to investigate the efficacy and safety of tadalafil to protect the fetus from hypoxic stress caused by repeated labor pains during delivery and to prevent fetal hypoxic-ischemic encephalopathy. Here, we report the outcomes of a phase I clinical trial to test the safety of administering tadalafil during labor.…”

Section: Introductionmentioning

confidence: 99%

Safety and dose‐finding trial of tadalafil administered for fetus in labor: A phase I clinical study

Tamaishi,

Tanaka,

Hirai

et al. 2024

J of Obstet and Gynaecol

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AimThis study aimed to investigate the safety and efficacy of tadalafil in protecting the fetus from hypoxic stress caused by repeated labor pains during delivery and preventing fetal hypoxic–ischemic encephalopathy.MethodsThe study used a three‐case cohort approach. Three patients were administered 10 mg tadalafil and monitored for serious adverse events. In the absence of serious tadalafil‐associated adverse events as assessed by the Safety Evaluation Committee, three new patients were added to the study and treated with 20 mg/dose. The blood levels of tadalafil were recorded before and after 2, 4, 8, and 12 h of administration and 2 h after delivery.ResultsA total of seven patients were enrolled, and after excluding one patient who delivered before 37 weeks, tadalafil was administered to six patients. Maternal adverse events were considered acceptable from the maternal perspective, with grade 1 headache, anorexia, and myalgia and no obstetrical complications after delivery at both doses. No serious neonatal adverse events were associated with tadalafil. Tadalafil blood levels remained stable at both doses. In addition, the level of soluble fms‐like tyrosine kinase‐1 did not alter, while that of the placental growth factor differed significantly before and after tadalafil administration.ConclusionsThe study confirmed the safety of tadalafil administration during delivery for both mothers and newborns. The stable tadalafil blood levels confirmed the efficacy of the tested administration regime at 12 h interval. These findings would assist in conducting phase II trials to further verify the optimal dose and safety of tadalafil.

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Section: Introductionmentioning

confidence: 99%

Safety and dose‐finding trial of tadalafil administered for fetus in labor: A phase I clinical study

Tamaishi,

Tanaka,

Hirai

et al. 2024

J of Obstet and Gynaecol

Self Cite

View full text Add to dashboard Cite

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Assessment of the value of measuring soluble fms-like tyrosine kinase-1 and placental growth factor levels following administration of tadalafil to treat fetal growth restriction

Tanaka

Koide

Nakamura

et al. 2021

The Journal of Maternal-Fetal & Neonatal Medicine

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Placental growth factor as a predictor of the efficacy of tadalafil treatment for fetal growth restriction

Abstract: Tadalafil treatment may increase maternal serum PlGF levels. Our results suggest that maternal serum PlGF levels can be used as a predictor of the efficacy of tadalafil treatment for FGR.

Cited by 2 publications

References 9 publications

Safety and dose‐finding trial of tadalafil administered for fetus in labor: A phase I clinical study

Safety and dose‐finding trial of tadalafil administered for fetus in labor: A phase I clinical study

Assessment of the value of measuring soluble fms-like tyrosine kinase-1 and placental growth factor levels following administration of tadalafil to treat fetal growth restriction

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