Atenolol (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
Albertini
2023 		Canada
2012 - 2021
retrospective cohort 		The tertiary Pregnancy and Heart Disease Program at the University of Toronto, Canada. Babies born to mothers with long QT syndrome who had taken Atenolol during pregnancy. unexposed, sick
Babies born to mothers with long QT syndrome who had not taken beta-blockers during pregnancy. 		during pregnancy (anytime or not specified) 16 / 7
Maternal clinical history including medications was collected (no other details).
Bateman
2016 		USA
2003 - 2007
retrospective cohort (claims database) 		The US Medicaid Analytic eXtract (MAX). Maternal consumption of Atenolol at the time of delivery, i.e prescriptions that were filled between 5 months after the last menstrual period and the day of delivery. unexposed, sick
Pregnant patients without any β blocker exposure at the time of delivery, notably matched on the preexisting hypertension. 		late pregnancy 1121 / 3363
Claims database of dispensed prescriptions for outpatient medications.
Bayliss
2002 		United Kingdom (UK)
1980 - 1999
retrospective cohort 		The antenatal hypertension clinics in two district general hospitals (Birmingham and Sutton Coldfield), United Kingdom Pregnancies in patient who had been taking atenolol from either conception or during the first trimester of pregnancy (i.e., before 15 weeks) until delivery. unexposed, sick
Pregnancies in women with hypertension who took no anti-hypertensive medication at all throughout their pregnancy. 		2nd trimester, throughout pregnancy 50 / 189 Patients who suffered a miscarriage or intra-uterine death were excluded from the analysis. Also patients who started their pregnancies on one drug and later had a second added were excluded from the main analysis.
Clinical data are collected on drug treatment used before and during pregnancy. Data is collected prospectively from the clinics (patient’s hospital records) onto a proforma and entered into a computer database by a research associate (MB).
Darcie
2004 		Brazil
1994 - 1997
prospective cohort 		A randomized, longitudinal, prospective study conducting at the Neonatal Pediatrics Service, Faculty of Medicine, University of São Paulo. Newborns of hypertensive mothers treated with atenolol (50 mg twice a day) for at least 2 weeks before the delivery. unexposed, sick
Newborns of hypertensive mothers whose hypertension was controlled with diet only (without antihypertensive medication), for a minimum period of 2 weeks. 		late pregnancy 40 / 14 Study considered as a prospective cohort because no precision indicating that a randomization was carried out.
This was a randomized, longitudinal, prospective study comparing 3 groups of patients according to the type of maternal treatment. => Not otherwise specified => Considered as a prospective cohort because no precision indicating that a randomization was carried out.
Delteil
2024 		France
2004 - 2021
retrospective cohort (claims database) 		EFEMERIS (Évaluation chez la Femme Enceinte des MÉdicaments et de leurs RISques) database, and the Registre des Handicaps de l'Enfant en Haute-Garonne (RHE31), Haute-Garonne, France. Pregnancies with at least one dispensed prescription of Atenolol 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. 		at least 1st trimester, during pregnancy (anytime or not specified) 100 / 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.
Women's drug exposure during pregnancy was estimated on the basis of dispensed prescription drugs recorded by the French Assurance Maladie.
Duan
2018 		USA
2003 - 2014
retrospective cohort (claims database) 		The Kaiser Permanente Southern California (KPSC) Region. Pregnant patients that filled a prescription for Atenolol between their estimated conception date and the date of delivery. unexposed (general population or NOS)
Pregnant women who were not exposed to beta‐blockers at any time during their pregnancy. 		during pregnancy (anytime or not specified) 638 / 374391 The 4 most prescribed beta‐blockers were labetalol (n = 3357), atenolol (n = 638), propranolol (n = 489), and metoprolol (n = 324). Health plan members have a demographic and socioeconomic profile similar to the overall southern California population.
Pregnant women exposed to beta‐blockers during their pregnancy were identified using pharmacy dispensing records.
Fitton (Controls unexposed, disease free)
2020 		Scotland
2010 - 2014
retrospective cohort (claims database) 		Linkage of 4 Scottish healthcare databases, held by the Information Statistics Division. All women who had a singleton birth and who were dispensed at least one prescription for Atenolol 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). 		during pregnancy (anytime or not specified) 95 / 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).
The Prescribing Information System which collects information on encashed prescriptions issued by primary care and dispensed from community pharmacies for all Scottish residents.
Fitton (Controls unexposed, sick)
2020 		Scotland
2010 - 2014
retrospective cohort (claims database) 		Linkage of 4 Scottish healthcare databases, held by the Information Statistics Division. All women who had a singleton birth and who were dispensed at least one prescription for Atenolol 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. 		during pregnancy (anytime or not specified) 95 / 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).
The Prescribing Information System which collects information on encashed prescriptions issued by primary care and dispensed from community pharmacies for all Scottish residents.
Ishibashi
2017 		Japan
2000 - 2016
retrospective cohort 		15 Japanese institutions. Pregnancies in long QT patients with Atenolol therapy. unexposed, sick
Pregnancies in long QT patients without β-blocker therapy. 		during pregnancy (anytime or not specified) 1 / 94 Exposure: 1 atenolol (50mg/day, 0.89mg/kg/day).
All data were collected with checking their maternity record book.
Lydakis
1999 		United Kingdom
1980 - 1997
retrospective cohort 		The Antenatal Hypertension Clinic at City Hospital, Birmingham, United Kingdom. Pregnant women with chronic hypertension receiving atenolol (as monotherapy) unexposed, sick
Pregnant women with chronic hypertension receiving no antihypertensive drugs 		during pregnancy (anytime or not specified) 78 / 91 Mean blood pressures did not differ between the three groups in the early (<20 weeks), mid- (between 20 and 30 weeks), and late (>30 weeks) stages of pregnancy.
A retrospective cohort study from a computerized database of a clinic => medical records.
Orbach
2013 		Israel
1998 - 2008
retrospective cohort (claims database) 		A retrospective cohort study that involved members of 'Clalit Health services' in southern Israel that gave birth at the Soroka Medical Center. Pregnant women with Atenolol dispensed during the third trimester of pregnancy. unexposed, disease free
All pregnant women without diagnosis of chronic hypertension and who were not exposed to antihypertensive drugs through the first or the third trimester during the study period. 		3rd trimester 107 / 97820 Chromosomal diseases were excluded. Five hundred fifteen infants who were exposed to antihypertensive drugs in utero for maternal indications other than hypertension were excluded from the cohort.
The medication data of Clalit members are stored in the Clalit data warehouse. This database contains information about dispensing date, the ATC code of the drug (including the commercial and generic names), dose schedule of drugs administration, and dose dispensed in defined daily dose.
Tanaka
2016 		Japan
2000 - 2010
retrospective cohort 		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. 		during pregnancy (anytime or not specified) 6 / 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.
Patient data were collected from their medical records and included medication(s) used (β-blockers and other ones).

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
Caton
2009 		USA
1997 - 2003
case control 		The National Birth Defects Prevention Study (NBDPS). Cases of cardiovascular malformations in live births, fetal deaths occurring after 20 weeks, and elective pregnancy terminations. Live births without birth defects randomly selected from birth certificates or hospital discharge listings in the same geographic areas as the cases. Data were collected via a computer-assisted telephone interview of infant's mothers within 24 months of the expected delivery date. Interviewers asked detailed questions about the diagnosis, timing, and treatment of high blood pressure. 1st trimester 5021 / 4796
Case infants were identified from the population-based birth defects surveillance systems of the participating centers. Control infants were randomly selected from birth certificates or hospital discharge listings in the same geographic areas as the cases.
Van Zutphen
2014 		USA
1997 - 2009
case control 		The National Birth Defects Prevention Study, USA. All cases (liveborn, stillborn after 20 weeks gestation, or induced abortions) with severe hypospadias (ie, subcoronal or penile, scrotal, or perineal meatal opening) diagnosed at the time of physical examination, surgery, or autopsy. Male live births without birth defects randomly selected from birth certificates or hospital discharge listings in the same population as the case neonates. Antihypertensive medication use were collected by trained interviewers who conducted maternal telephone interviews within 24 months of delivery. early pregnancy 2131 / 5129 Mothers reporting antihypertensive medications for the treatment of other indications (eg, b-blockers for migraine headaches) were excluded from the analyses. Overlapping: Caton 2008 (1997-2002) totally included in Van Zutphen 2014 (1997-2009).
Data were abstracted from medical record, birth certificates or hospital discharge records. To confirm cases, clinical geneticists reviewed data, including consultations (urology, endocrinology, and genetic), reports (operative, pathology, and autopsy), and radiographic results.

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

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