Bisoprolol (versus unexposed) - Medication and Pregnancy KB

Bisoprolol (versus unexposed)

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Delteil, 2024	France 2004 - 2021	Pregnancies with a known outcome between July 2004 and December 2021 in Haute-Garonne, included in the EFEMERIS database.	Pregnancies with at least one dispensed prescription of Bisoprolol during pregnancy (between last menstrual period and delivery).	unexposed (general population or NOS) Pregnancies without dispensed prescription of beta-blockers and other anti-hypertensive agents during pregnancy.	93 / 172284	When available, data in women with chronic pathology (hypertension or cardiac), treated at least during the 1st trimester were preferred to all indications (including gestational hypertension, ...). Exposure at least T1 considered as chronic indications.
Fitton (Controls unexposed, disease free), 2020	Scotland 2010 - 2014	All women who had a singleton live birth in Scotland during the study period.	All women who had a singleton birth and who were dispensed at least one prescription for Bisoprolol during the 300 days before birth (whatever the indication).	unexposed, disease free All women who had a singleton birth during the same study period who were not dispensed antihypertensive medication during or 60 days following pregnancy, and who did not have an ICD-10 code for hypertension (chronic, gestational, or unspecified hypertension).	106 / 250693	The majority of offspring were exposed to a β-blocker only (58.66%, 4003 children), calcium channel blockers only (8.18%, 558 children), or a combination of >1 antihypertensive medication (20.53%, 1403 children).
Fitton (Controls unexposed, sick), 2020	Scotland 2010 - 2014	All women who had a singleton live birth in Scotland during the study period.	All women who had a singleton birth and who were dispensed at least one prescription for Bisoprolol during the 300 days before birth (whatever the indication).	unexposed, sick All women who had a singleton birth during the same study period, who had an ICD-10 code for hypertension (chronic, gestational, or unspecified hypertension) and who were not dispensed antihypertensive medication at any stage during or 60 days after pregnancy.	106 / 7971	The majority of offspring were exposed to a β-blocker only (58.66%, 4003 children), calcium channel blockers only (8.18%, 558 children), or a combination of >1 antihypertensive medication (20.53%, 1403 children).
Hoeltzenbein, 2018	Germany 2000 - 2015	Pregnancies for which Embryotox service was contacted for risk assessment on drug use in pregnancy.	Pregnancies with bisoprolol exposure at least during the first trimester. Concomitant therapy with other antihypertensive drugs except angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) was possible.	unexposed, disease free Nonhypertensive pregnancies, without use of beta-blockers and other antihypertensives during pregnancy, randomly selected.	339 / 678	The most frequent treatment indications for bisoprolol were hypertension (203/339, 60%) and arrhythmias (115/ 339, 34%). The daily dose was within the recommended range [median 5 mg; min–max 1.25–20mg; information available in 295/339 pregnancies].
Ishibashi, 2017	Japan 2000 - 2016	Congenital long QT syndrome (LQTS)	Pregnancies in long QT patients with Bisoprolol therapy.	unexposed, sick Pregnancies in long QT patients without β-blocker therapy.	10 / 94	Exposure: 10 bisoprolol (5mg/day, 0.072±0.028mg/kg/day).
Tanaka, 2016	Japan 2000 - 2010	Women with singleton pregnancies and with cardiovascular disease who delivered infants at the National Cerebral and Cardiovascular Center in Osaka, Japan.	Pregnant women with cardiovascular disease treated with Atenolol for at least 2 weeks before delivery.	unexposed, sick Pregnant women with cardiovascular disease who were not treated with an oral α/β- or β-adrenergic blocker randomly identified over the same period.	5 / 100	Maternal cardiovascular diseases: congenital heart disease and pulmonary hypertension; aortic disease; valvular heart disease; coronary artery disease and acute coronary syndrome; cardiomyopathy and heart failure; and arrhythmia.
Vaclavik, 2024	The Czech Republic 2012 - 2022	All births and abortions in the period 2012 - 2022 in the Czech Republic.	Births whose mothers were prescribed Bisoprolol during pregnancy (for pre-existing hypertension or pregnancy-induced hypertension).	unexposed, disease free Births whose mothers had no hypertension.	-9 / -9

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk

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

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