Esomeprazole

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Choi a, 2023 South Korea
2011 - 2020
All pregnancies (in women aged 19-44 years) resulting in live births during the study period. Pregnant women with one or more prescriptions for Esomeprazole during the first trimester (defined as the start of pregnancy to the 90th day of gestation). unexposed, sick
Pregnant women with no filled Proton Pump Inhibitor prescriptions from 90 days before pregnancy through the end of the first trimester (with a propensity-score, made by stratification notably concerning the indications => unexposed sick).
12516 / 2655676 In South Korea, 7 PPIs (omeprazole, esomeprazole, lansoprazole, dexlansoprazole, pantoprazole, rabeprazole, and ilaprazole) are available only with a prescription, and no over-the-counter PPIs are available.
Choi b, 2023 South Korea
2008 - 2019
All pregnancies in women < 44 years old resulting in live births during the study period. Pregnant women that filled a prescription for Esomeprazole between the start of pregnancy and the 245th day of gestation. unexposed, sick
Pregnant women without exposure to proton pump inhibitors (PPIs) from 90 days before pregnancy to the delivery date.
12868 / 2121323 Unexposed group adjusted with propensity-score, made by stratification, notably concerning the indications => considered as unexposed sick (mathematical deformation of total population). In South Korea, PPIs only available with a prescription.
Cluver, 2018 South Africa
2016 - 2017
Pregnant women with singleton pregnancies diagnosed with preterm preeclampsia between 26 and 31 weeks. Women with early onset pre-eclampsia between 26 and 31 weeks exposed with a 40 mg daily dose of esomeprazole. unexposed, sick
Women with early onset pre-eclampsia between 26 and 31 weeks exposed to placebo.
59 / 60
Pasternak, 2010 Denmark
1996 - 2008
A cohort of all live-born infants in Denmark for the study period. Infants born to women who were exposed to esomeprazole (any filling of esomeprazole prescription at any time during the period from 4 weeks before conception through the end of the first trimester) (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Infants born to women not exposed to PPIs (all the women who were not exposed at any time during their pregnancy).
668 / 832031

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk

master protocol