Preprint Review Version 1 Preserved in Portico This version is not peer-reviewed

Tadalafil for Treatment of Fetal Growth Restriction: A Review of Experimental and Clinical Studies

Shintaro Maki
* ORCID logo ,
Sho Takakura
ORCID logo ,
Makoto Tsuji
,
Shoichi Magawa
,
Yuya Tamaishi
,
Masafumi Nii
,
Michiko Kaneda
,
Kenta Yoshida
,
Kuniaki Toriyabe
ORCID logo ,
Eiji Kondo
,
Tomoaki Ikeda
Version 1 : Received: 6 March 2024 / Approved: 7 March 2024 / Online: 7 March 2024 (11:10:40 CET)

A peer-reviewed article of this Preprint also exists.

Maki, S.; Takakura, S.; Tsuji, M.; Magawa, S.; Tamaishi, Y.; Nii, M.; Kaneda, M.; Yoshida, K.; Toriyabe, K.; Kondo, E.; Ikeda, T. Tadalafil for Treatment of Fetal Growth Restriction: A Review of Experimental and Clinical Studies. Biomedicines 2024, 12, 804. Maki, S.; Takakura, S.; Tsuji, M.; Magawa, S.; Tamaishi, Y.; Nii, M.; Kaneda, M.; Yoshida, K.; Toriyabe, K.; Kondo, E.; Ikeda, T. Tadalafil for Treatment of Fetal Growth Restriction: A Review of Experimental and Clinical Studies. Biomedicines 2024, 12, 804.

Abstract

Fetal growth restriction (FGR) is a major concern in perinatal care. Various medications have been proposed as potential treatments for this serious condition. Nonetheless, there is still no definitive treatment. We studied tadalafil, a phosphodiesterase-5 inhibitor, as a therapeutic agent for FGR in clinical studies and animal experiments. In this review, we summarize our preclinical and clinical data on the use of tadalafil for FGR. Our studies in mouse models indicated that tadalafil improved FGR and hypertensive disorders of pregnancy. In addition, tadalafil protected cerebral nerve development in FGR offspring. The clinical trials we have conducted to date, including a case–control study, a phase I trial, and a phase II trial, have indicated the efficacy of tadalafil in prolonging pregnancy, as well as a good safety profile for fetuses and neonates. The number of fetal, neonatal, and infant deaths was significantly lower in those receiving tadalafil treatment group than that in controls, and no severe adverse maternal events associated with tadalafil were observed. Although further studies are needed to establish the usefulness of tadalafil in FGR treatment, our research indicates that the use of tadalafil in FGR treatment may be a paradigm shift in perinatal care.

Keywords

Phosphodiesterase 5 inhibitor; Tadalafil; Fetal growth restriction

Subject

Medicine and Pharmacology, Obstetrics and Gynaecology

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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