Amlodipine (versus unexposed) - Medication and Pregnancy KB

Amlodipine (versus unexposed)

Exposed non-exposed, cohort studies

Study	Country Study period Study design	Data source	Exposure definition	Non-exposure definition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias
Ishikawa (Controls unexposed, disease free) 2023	Japan 2010 - 2019 retrospective cohort (claims database)	A large administrative claims database from JMDC Inc. (Tokyo, Japan), which contained all the inpatient, outpatient, and pharmacy claims received from insurers.	Pregnant women with chronic hypertension and prescribed Amlodipine in the first trimester.	unexposed, disease free Pregnant women without hypertensive disorders in the first trimester.	1st trimester	44 / 74213
Ishikawa (Controls unexposed, disease free) 2023	Japan 2010 - 2019 retrospective cohort (claims database)		A large administrative claims database from JMDC Inc. (Tokyo, Japan), which contained all the inpatient, outpatient, and pharmacy claims received from insurers. These claims include prescribed medications.		1st trimester	44 / 74213
Ishikawa (Controls unexposed, sick) 2023	Japan 2010 - 2019 retrospective cohort (claims database)	A large administrative claims database from JMDC Inc. (Tokyo, Japan), which contained all the inpatient, outpatient, and pharmacy claims received from insurers.	Pregnant women with chronic hypertension and prescribed Amlodipine in the first trimester.	unexposed, sick Pregnant women chronic hypertension but no first-trimester antihypertensive prescriptions.	1st trimester	44 / 1007
Ishikawa (Controls unexposed, sick) 2023	Japan 2010 - 2019 retrospective cohort (claims database)		A large administrative claims database from JMDC Inc. (Tokyo, Japan), which contained all the inpatient, outpatient, and pharmacy claims received from insurers. These claims include prescribed medications.		1st trimester	44 / 1007
Mito 2019	Japan 2008 - 2016 retrospective cohort	National Center for Child Health and Development (NCCHD, Tokyo), Osaka Women’s and Children’s Hospital (OWCH, Osaka), and National Cerebral and Cardiovascular Center (NCCC, Osaka), Japan.	Chronic hypertensive pregnant women who received Amlodipine, a calcium channel blocker during the first trimester (from estimated conception to 11 weeks and 6 days’ gestation).	unexposed, sick Chronic hypertensive pregnant women who did not receive any antihypertensive drugs.	at least 1st trimester	48 / 129	Data versus Group O (pregnancies exposed to antihypertensives other than amlodipine (including other calcium channel blockers)) cannot be used, because calcium channel blockers in both groups.
Mito 2019	Japan 2008 - 2016 retrospective cohort		Data extracted from mothers’ electronic health records.		at least 1st trimester	48 / 129
Weber-Schoendorfer 2008	Finland, France, Germany, Israel, Italy, the Netherlands. 1986 - 2003 prospective cohort	A multicenter (n = 11), prospective observational study of the European Network of Teratology Information Services (ENTIS).	Pregnant women with first- trimester exposure to Amlodipine.	unexposed (general population or NOS) Pregnant women who had been counseled during pregnancy about exposures known to be non-teratogenic.	at least 1st trimester	38 / 806
Weber-Schoendorfer 2008			A similarly structured questionnaire was used by all the centres to record the following data at the first contact during (early) pregnancy before the pregnancy outcome was known, including details of drug exposure (timing in pregnancy, dose, and duration).		at least 1st trimester	38 / 806

Case-control studies

Study	Country Study period Study design	Data source	Case	Control	Exposition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias

Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;

Empty. There are no case-control studies available for this drug.

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