Original ResearchObstetricsSafety and pharmacokinetics of pravastatin used for the prevention of preeclampsia in high-risk pregnant women: a pilot randomized controlled trial
Section snippets
Study population
We conducted a multicenter, double-blind, placebo-controlled randomized trial involving pregnant women at high risk for preeclampsia. Eligible women were 18 years old or older, with singleton, nonanomalous pregnancy between 120/7 weeks and 166/7 weeks’ gestation (confirmed with an ultrasound examination), and with a history of severe preeclampsia in a prior pregnancy that required delivery prior to 34 weeks’ gestation (documented by chart review).
We excluded women with known fetal genetic or
Results
Of 22 subjects who consented for the study, 21 were randomized, with 11 assigned to the pravastatin group and 10 to the placebo group. One subject from the pravastatin group withdrew from the study after randomization for social reasons (Supplemental Figure 1). Ten subjects in each group completed the trial, as requested by the FDA. No subjects were lost to follow-up. There was no significant difference in estimated adherence to study medication between the pravastatin group and placebo group
Comment
This pilot randomized controlled trial provides preliminary safety and PK data regarding the use of pravastatin, a drug traditionally avoided in pregnancy, for preventing preeclampsia, a pregnancy complication with serious morbidity. Initiation and completion of this trial was a direct result of collaboration between the NICHD–Obstetric-Fetal Pharmacology Research Units network and the FDA. Although the data are preliminary, no identifiable safety risks were associated with the use of
Acknowledgments
We thank Ms Charlene Williamson and members of the FDA Division of Reproductive and Urologic Products who reviewed our Investigational New Drug application for their thoughtful study design comments. In addition, we thank the following members who participated in protocol development, oversight, data management, and coordination between the clinical research centers: Katrina Burson, RN, and Julie Croxford, RN, MPH. They also thank the following collaborators and study research personnel:
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The views expressed herein are those of the authors and do not necessarily represent the official views of Eunice Kennedy Shriver National Institute of Child Health and Human Development or the National Institutes of Health.
This study was supported by grants U10HD047891, U10HD063094, U10HD047892, U10HD047905, and U10HD057753 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and grants UL1TR000423 and UL1TR001439 from National Institutes of Health and National Center for Advancing Translational Sciences through the Clinical and Translational Science Awards Program.
The authors report no conflict of interest.
Cite this article as: Costantine MM, Cleary K, Hebert MF, et al. Safety and pharmacokinetics of pravastatin used for the prevention of preeclampsia in high-risk pregnant women: a pilot randomized controlled trial. Am J Obstet Gynecol 2016;214:720.e1-17.