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Article

Safety Evaluation of Tadalafil Treatment for Fetuses with Early-Onset Growth Restriction (TADAFER): Results from the Phase II Trial

by
Shintaro Maki
1,*,
Hiroaki Tanaka
1,
Makoto Tsuji
1,
Fumi Furuhashi
1,
Shoichi Magawa
1,
Michiko K. Kaneda
1,
Masafumi Nii
1,
Kayo Tanaka
1,
Eiji Kondo
1,
Satoshi Tamaru
2,
Toru Ogura
2,
Yuki Nishimura
2,
Masayuki Endoh
3,
Tadashi Kimura
3,
Tomomi Kotani
4,
Akihiko Sekizawa
5 and
Tomoaki Ikeda
1
1
Department of Obstetrics and Gynecology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Mie 514-8507, Japan
2
Clinical Research Support Center, Mie University Hospital, 2-174 Edobashi, Tsu, Mie 514-8507, Japan
3
Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, 2-15 Yamadaoka, Suita, Osaka 565-0871, Japan
4
Department of Obstetrics and Gynecology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya 466-8560, Japan
5
Department of Obstetrics and Gynecology, Showa University Graduate School of Medicine, 1-5-8, Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2019, 8(6), 856; https://doi.org/10.3390/jcm8060856
Submission received: 4 May 2019 / Revised: 12 June 2019 / Accepted: 13 June 2019 / Published: 15 June 2019
(This article belongs to the Special Issue Diagnosis, Treatment and Prevention of Fetal Diseases and Fetal Risk Factors for Non-Communicable Diseases)
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Abstract

Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor with a long half-life, high selectivity, and rapid onset of action. Because the safety of using PDE5 inhibitors as therapeutic agents for fetal growth restriction (FGR) has been a problem worldwide, this paper primarily focuses on the safety assessments performed in the Tadalafil Treatment for Fetuses with Early-Onset Growth Restriction (TADAFER) II population. Neonatal and maternal adverse events were analyzed, in addition to fetal, neonatal, and infant death cases, six months after stopping the trial. Eighty-nine pregnant women with FGR were studied between September 2016 and March 2018 (45 and 44 in the tadalafil and conventional treatment groups, respectively). Seven (16%) deaths (four fetal, one neonatal, and two infant) in the control group, whereas only one neonatal death occurred in the tadalafil group. Although headache, facial flushing, and nasal hemorrhage occurred more frequently in the tadalafil group, these symptoms were Grade 1 and transient. In conclusion, this trial showed that tadalafil decreased the fetal and infant deaths associated with FGR. This is thought to be primarily due to pregnancy prolongation. Further studies are warranted to evaluate the efficacy of tadalafil in treating early-onset FGR.
Keywords: fetal growth restriction; tadalafil; phosphodiesterase 5 inhibitor fetal growth restriction; tadalafil; phosphodiesterase 5 inhibitor

Share and Cite

MDPI and ACS Style

Maki, S.; Tanaka, H.; Tsuji, M.; Furuhashi, F.; Magawa, S.; Kaneda, M.K.; Nii, M.; Tanaka, K.; Kondo, E.; Tamaru, S.; et al. Safety Evaluation of Tadalafil Treatment for Fetuses with Early-Onset Growth Restriction (TADAFER): Results from the Phase II Trial. J. Clin. Med. 2019, 8, 856. https://doi.org/10.3390/jcm8060856

AMA Style

Maki S, Tanaka H, Tsuji M, Furuhashi F, Magawa S, Kaneda MK, Nii M, Tanaka K, Kondo E, Tamaru S, et al. Safety Evaluation of Tadalafil Treatment for Fetuses with Early-Onset Growth Restriction (TADAFER): Results from the Phase II Trial. Journal of Clinical Medicine. 2019; 8(6):856. https://doi.org/10.3390/jcm8060856

Chicago/Turabian Style

Maki, Shintaro, Hiroaki Tanaka, Makoto Tsuji, Fumi Furuhashi, Shoichi Magawa, Michiko K. Kaneda, Masafumi Nii, Kayo Tanaka, Eiji Kondo, Satoshi Tamaru, and et al. 2019. "Safety Evaluation of Tadalafil Treatment for Fetuses with Early-Onset Growth Restriction (TADAFER): Results from the Phase II Trial" Journal of Clinical Medicine 8, no. 6: 856. https://doi.org/10.3390/jcm8060856

APA Style

Maki, S., Tanaka, H., Tsuji, M., Furuhashi, F., Magawa, S., Kaneda, M. K., Nii, M., Tanaka, K., Kondo, E., Tamaru, S., Ogura, T., Nishimura, Y., Endoh, M., Kimura, T., Kotani, T., Sekizawa, A., & Ikeda, T. (2019). Safety Evaluation of Tadalafil Treatment for Fetuses with Early-Onset Growth Restriction (TADAFER): Results from the Phase II Trial. Journal of Clinical Medicine, 8(6), 856. https://doi.org/10.3390/jcm8060856

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