Trial of prophylactic administration of TXA2 synthetase inhibitor, ozagrel hydrochloride, for preeclampsia.
OBJECTIVE
In an attempt to investigate the prophylactic effect of a thromboxane A2 (TXA2) synthetase inhibitor on pregnant women with a high risk of preeclampsia, the following clinical study was undertaken.


METHODS
Forty pregnant women were randomly allocated to control or treatment groups. Ozagrel Hydrochloride (400 mg/day, orally) and placebo were started at 20 weeks of gestation and continued until delivery.


RESULTS
Seventeen of 20 (85%) women in the control group developed preeclampsia, whereas 9 of 20 (45%) in the treatment group developed preeclampsia. Ozagrel Hydrochloride significantly (p < 0.01) reduced the occurrence of preeclampsia, and the incidence of both hypertension (p < 0.05) and proteinuria (p < 0.01) was significantly less in the treatment group compared with the control group. One month after administration, the mean plasma concentration of TXB2, a metabolite of TXA2, was significantly decreased (p < 0.01) to 62.4 +/- 13.6%, whereas that of 6-keto prostaglandin F1 alpha, a metabolite of PGI2, was significantly increased (p < 0.01) to 206.7 +/- 52.8%. There were no maternal or fetal side effects observed.


CONCLUSIONS
It seems likely that Ozagrel Hydrochloride could be used for the prevention of preeclampsia in high-risk pregnant women.
Seki
H
H
Saitama Medical Center, Saitama Medical School, Japan.
Kuromaki
K
K
Takeda
S
S
Kinoshita
K
K
Satoh
K
K
D000284:Administration, Oral; D016009:Chi-Square Distribution; D002851:Chromatography, High Pressure Liquid; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008689:Methacrylates / Q000627:therapeutic use*; D011225:Pre-Eclampsia / Q000517:prevention & control*; D011247:Pregnancy; D011256:Pregnancy Outcome; D018566:Pregnancy, High-Risk; D013930:Thromboxane-A Synthase / Q000037:antagonists & inhibitors*
D004791:Enzyme Inhibitors; D008689:Methacrylates; D013930:Thromboxane-A Synthase; C034364:ozagrel