Safety Evaluation of Tadalafil Treatment for Fetuses with Early-Onset Growth Restriction (TADAFER): Results from the Phase II Trial
Autor: | Fumi Furuhashi, Yuki Nishimura, Shintaro Maki, Tadashi Kimura, Masayuki Endoh, Makoto Tsuji, Hiroaki Tanaka, Shoichi Magawa, Akihiko Sekizawa, Satoshi Tamaru, Masafumi Nii, Toru Ogura, Eiji Kondo, Kayo Tanaka, Michiko Kaneda, Tomomi Kotani, Tomoaki Ikeda |
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Jazyk: | angličtina |
Rok vydání: | 2019 |
Předmět: |
medicine.medical_specialty
medicine.drug_mechanism_of_action Population phosphodiesterase 5 inhibitor lcsh:Medicine Article fetal growth restriction 03 medical and health sciences 0302 clinical medicine Internal medicine medicine 030212 general & internal medicine education Adverse effect Pregnancy Fetus education.field_of_study 030219 obstetrics & reproductive medicine business.industry lcsh:R General Medicine medicine.disease Infant mortality Tadalafil cGMP-specific phosphodiesterase type 5 business Phosphodiesterase 5 inhibitor tadalafil medicine.drug |
Zdroj: | Journal of Clinical Medicine Volume 8 Issue 6 Journal of Clinical Medicine, Vol 8, Iss 6, p 856 (2019) |
ISSN: | 2077-0383 |
DOI: | 10.3390/jcm8060856 |
Popis: | 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. |
Databáze: | OpenAIRE |
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