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Clinical Trial
. 2018 Oct;219(4):388.e1-388.e17.
doi: 10.1016/j.ajog.2018.07.019. Epub 2018 Jul 26.

Esomeprazole to treat women with preterm preeclampsia: a randomized placebo controlled trial

Catherine A Cluver  1 , Natalie J Hannan  2 , Erika van Papendorp  3 , Richard Hiscock  4 , Sally Beard  2 , Ben W Mol  5 , Gerhard B Theron  3 , David R Hall  3 , Eric H Decloedt  6 , Marietjie Stander  7 , Kim T Adams  7 , Megan Rensburg  8 , Pawel Schubert  8 , Susan P Walker  2 , Stephen Tong  2
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Clinical Trial

Esomeprazole to treat women with preterm preeclampsia: a randomized placebo controlled trial

Catherine A Cluver et al. Am J Obstet Gynecol. 2018 Oct.

Erratum in

Abstract

Background: Preterm preeclampsia has a high rate of fetal death or disability. There is no treatment to slow the disease, except delivery. Preclinical studies have identified proton pump inhibitors as a possible treatment.

Objective: The purpose of this study was to examine whether esomeprazole could prolong pregnancy in women who have received a diagnosis of preterm preeclampsia.

Study design: We performed a double-blind, randomized controlled trial at Tygerberg Hospital in South Africa. Women with preterm preeclampsia (gestational age 26 weeks+0 days to 31 weeks+6 days) were assigned randomly to 40-mg daily esomeprazole or placebo. The primary outcome was a prolongation of gestation of 5 days. Secondary outcomes were maternal and neonatal outcomes. We compared circulating markers of endothelial dysfunction that was associated with preeclampsia and performed pharmacokinetic studies.

Results: Between January 2016 and April 2017, we recruited 120 participants. One participant was excluded because of incorrect randomization, which left 59 participants in the esomeprazole and 60 participants in the placebo group. Median gestational age at enrolment was 29+4 weeks gestation. There were no between-group differences in median time from randomization to delivery: 11.4 days (interquartile range, 3.6-19.7 days) in the esomeprazole group and 8.3 days (interquartile range, 3.8-19.6 days) in the placebo group (3 days longer in the esomeprazole arm; 95% confidence interval, -2.9-8.8; P=.31). There were no placental abruptions in the esomeprazole group and 6 (10%) in the placebo group (P=.01, P=.14 adjusted). There were no differences in other maternal or neonatal outcomes or markers of endothelial dysfunction. Esomeprazole and its metabolites were detected in maternal blood among those treated with esomeprazole, but only trace amounts in the umbilical cord blood.

Conclusion: Daily esomeprazole (40 mg) did not prolong gestation in pregnancies with preterm preeclampsia or decrease circulating soluble fms-like tyrosine kinase 1 concentrations. Higher levels in the maternal circulation may be needed for clinical effect.

Keywords: esomeprazole; pharmacokinetics; preterm preeclampsia; sFlt1; trial.

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