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      Safety of Amlodipine in Early Pregnancy

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          Abstract

          Background

          Amlodipine is used for the treatment of hypertension, but reports on its use in early pregnancy are limited.

          Methods and Results

          In the present study, we recruited 231 women with chronic hypertension, including those who received amlodipine or other antihypertensives during early pregnancy, and investigated frequencies of morphologic abnormalities in their 231 offspring. Specifically, we evaluated 48 neonates exposed to amlodipine in the first trimester (amlodipine group, Group A), 54 neonates exposed to antihypertensives other than amlodipine (other antihypertensive group, Group O), and 129 neonates not exposed to antihypertensives (no‐antihypertensive group, Group N). The number of morphologic abnormalities of offspring in each group were 2 in Group A (4.2%; 95% CI, 0.51–14.25); 3 in Group O (5.6%; 95% CI, 1.16–15.39) and 6 in Group N (4.7%; 95% CI, 1.73–9.85). The odds ratio of the primary outcome comparing Group A and Group O was 0.74 (95% CI: 0.118–4.621) and Group A and Group N was 0.89 (95% CI: 0.174–4.575).

          Conclusions

          The odds of birth defects in Group A in the first trimester were not significantly different from those with or without other antihypertensives.

          Abstract

          See Editorial Malha and August

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          Chronic hypertension and pregnancy outcomes: systematic review and meta-analysis

          Kate Bramham, Bethany Parnell, Catherine Nelson-Piercy … (2014)
          Objective To provide an accurate assessment of complications of pregnancy in women with chronic hypertension, including comparison with population pregnancy data (US) to inform pre-pregnancy and antenatal management strategies. Design Systematic review and meta-analysis. Data sources Embase, Medline, and Web of Science were searched without language restrictions, from first publication until June 2013; the bibliographies of relevant articles and reviews were hand searched for additional reports. Study selection Studies involving pregnant women with chronic hypertension, including retrospective and prospective cohorts, population studies, and appropriate arms of randomised controlled trials, were included. Data extraction Pooled incidence for each pregnancy outcome was reported and, for US studies, compared with US general population incidence from the National Vital Statistics Report (2006). Results 55 eligible studies were identified, encompassing 795 221 pregnancies. Women with chronic hypertension had high pooled incidences of superimposed pre-eclampsia (25.9%, 95% confidence interval 21.0% to 31.5 %), caesarean section (41.4%, 35.5% to 47.7%), preterm delivery <37 weeks’ gestation (28.1% (22.6 to 34.4%), birth weight <2500 g (16.9%, 13.1% to 21.5%), neonatal unit admission (20.5%, 15.7% to 26.4%), and perinatal death (4.0%, 2.9% to 5.4%). However, considerable heterogeneity existed in the reported incidence of all outcomes (τ2=0.286-0.766), with a substantial range of incidences in individual studies around these averages; additional meta-regression did not identify any influential demographic factors. The incidences (the meta-analysis average from US studies) of adverse outcomes in women with chronic hypertension were compared with women from the US national population dataset and showed higher risks in those with chronic hypertension: relative risks were 7.7 (95% confidence interval 5.7 to 10.1) for superimposed pre-eclampsia compared with pre-eclampsia, 1.3 (1.1 to 1.5) for caesarean section, 2.7 (1.9 to 3.6) for preterm delivery <37 weeks’ gestation, 2.7 (1.9 to 3.8) for birth weight <2500 g, 3.2 (2.2 to 4.4) for neonatal unit admission, and 4.2 (2.7 to 6.5) for perinatal death. Conclusions This systematic review, reporting meta-analysed data from studies of pregnant women with chronic hypertension, shows that adverse outcomes of pregnancy are common and emphasises a need for heightened antenatal surveillance. A consistent strategy to study women with chronic hypertension is needed, as previous study designs have been diverse. These findings should inform counselling and contribute to optimisation of maternal health, drug treatment, and pre-pregnancy management in women affected by chronic hypertension.
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            Major congenital malformations after first-trimester exposure to ACE inhibitors.

            William Cooper, Sonia Hernandez-Diaz, Patrick G Arbogast … (2006)
            Use of angiotensin-converting-enzyme (ACE) inhibitors during the second and third trimesters of pregnancy is contraindicated because of their association with an increased risk of fetopathy. In contrast, first-trimester use of ACE inhibitors has not been linked to adverse fetal outcomes. We conducted a study to assess the association between exposure to ACE inhibitors during the first trimester of pregnancy only and the risk of congenital malformations. We studied a cohort of 29,507 infants enrolled in Tennessee Medicaid and born between 1985 and 2000 for whom there was no evidence of maternal diabetes. We identified 209 infants with exposure to ACE inhibitors in the first trimester alone, 202 infants with exposure to other antihypertensive medications in the first trimester alone, and 29,096 infants with no exposure to antihypertensive drugs at any time during gestation. Major congenital malformations were identified from linked vital records and hospitalization claims during the first year of life and confirmed by review of medical records. Infants with only first-trimester exposure to ACE inhibitors had an increased risk of major congenital malformations (risk ratio, 2.71; 95 percent confidence interval, 1.72 to 4.27) as compared with infants who had no exposure to antihypertensive medications. In contrast, fetal exposure to other antihypertensive medications during only the first trimester did not confer an increased risk (risk ratio, 0.66; 95 percent confidence interval, 0.25 to 1.75). Infants exposed to ACE inhibitors were at increased risk for malformations of the cardiovascular system (risk ratio, 3.72; 95 percent confidence interval, 1.89 to 7.30) and the central nervous system (risk ratio, 4.39; 95 percent confidence interval, 1.37 to 14.02). Exposure to ACE inhibitors during the first trimester cannot be considered safe and should be avoided. Copyright 2006 Massachusetts Medical Society.
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              Epidemiology of hypertensive disorders in pregnancy: prevalence, risk factors, predictors and prognosis

              Mitsumasa Umesawa, Gen Kobashi (2016)
              Hypertensive disorders in pregnancy (HDP) represent some of the most important problems faced by public health because HDP is a major cause of maternal and prenatal morbidity and mortality. Several epidemiological studies have been performed to determine the prevalence and risk factors of HDP as well as its subtypes. The prevalences of HDP, gestational hypertension and preeclampsia are 5.2-8.2%, 1.8-4.4% and 0.2-9.2%, respectively. Body mass index, anemia and lower education appear to be modifiable risk factors for HDP. Maternal age, primiparous, multiple pregnancy, HDP in previous pregnancy, gestational diabetes mellitus, preexisting hypertension, preexisting type 2 diabetes mellitus, preexisting urinary tract infection and a family history of hypertension, type 2 diabetes mellitus and preeclampsia appear to be nonmodifiable risk factors. Genetic variants including a single-nucleotide polymorphism in the angiotensinogen gene have also been reported to be nonmodifiable risk factors. Epidemiological studies have recently examined the associations between a history of HDP and its subtypes and future risks of other diseases. These studies have reported associations between a history of HDP and a risk of coronary heart disease, heart failure, dysrhythmia, stroke, hypertension, diabetes mellitus, end-stage renal dysfunction and cardiomyopathy. HDP is not associated with the future incidence of total cancer. In conclusion, HDP is not a rare complication of pregnancy and the influence of HDP remains for an extended duration. Physicians should consider the effects of HDP when treating chronic diseases in women.
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                Author and article information

                Contributors
                Asako Mito: mito-a@ncchd.go.jp
                Journal
                Journal ID (nlm-ta): J Am Heart Assoc
                Journal ID (iso-abbrev): J Am Heart Assoc
                Journal ID (doi): 10.1002/(ISSN)2047-9980
                Journal ID (publisher-id): JAH3
                Journal ID (hwp): ahaoa
                Title: Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
                Publisher: John Wiley and Sons Inc. (Hoboken )
                ISSN (Electronic): 2047-9980
                Publication date (Electronic): 26 July 2019
                Publication date Collection: 06 August 2019
                Volume: 8
                Issue: 15 ( doiID: 10.1002/jah3.2019.8.issue-15 )
                Electronic Location Identifier: e012093
                Affiliations
                [ 1 ] Drug Information Institute in Pregnancy Tokyo Japan
                [ 2 ] Division of Maternal Medicine Center for Maternal‐Fetal‐Neonatal and Reproductive Medicine National Center for Child Health and Development Tokyo Japan
                [ 3 ] Department of Obstetric Medicine Osaka Women's and Children's Hospital Osaka Japan
                [ 4 ] Department of Internal Medicine (I) Osaka Medical College Osaka Japan
                [ 5 ] Department of Perinatology and Gynecology National Cerebral and Cardiovascular Center Osaka Japan
                [ 6 ] Division of Obstetrics Center for Maternal‐Fetal‐Neonatal and Reproductive Medicine National Center for Child Health and Development Tokyo Japan
                [ 7 ] Division of Biostatistics Clinical Research Center National Center for Child Health and Development Tokyo Japan
                [ 8 ] Motherisk Program Division of Clinical Pharmacology and Toxicology Department of Paediatrics The Hospital for Sick Children University of Toronto Toronto Canada
                Author notes
                [*] [* ] Correspondence to: Asako Mito, MD, PhD, Drug Information Institute in Pregnancy/Division of Maternal Medicine, Center for Maternal‐Fetal‐Neonatal and Reproductive Medicine, National Center for Child Health and Development, 2‐10‐1 Okura Setagaya, Tokyo 157‐8535, Japan. E‐mail: mito-a@ 123456ncchd.go.jp
                Article
                Publisher ID: JAH34232
                DOI: 10.1161/JAHA.119.012093
                PMC ID: 6761676
                PubMed ID: 31345083
                SO-VID: cf7f6a5e-83e2-480c-80ef-ddb88194b8ff
                Copyright © © 2019 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.
                License:

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                Date received : 23 January 2019
                Date accepted : 28 May 2019
                Page count
                Figures: 2, Tables: 3, Pages: 17, Words: 4927
                Funding
                Funded by: Japan Agency for Medical Research and Development
                Award ID: JP17mk0101086
                Categories
                Subject: Original Research
                Subject: Original Research
                Subject: Hypertension
                Custom metadata
                source-schema-version-number 2.0
                component-id jah34232
                cover-date 06 August 2019
                details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_NLMPMC version:5.6.7 mode:remove_FC converted:06.08.2019

                ScienceOpen disciplines: Cardiovascular Medicine
                Keywords: amlodipine,chronic hypertension,first trimester,pregnancy,high blood pressure,hypertension
                Data availability:
                ScienceOpen disciplines: Cardiovascular Medicine
                Keywords: amlodipine, chronic hypertension, first trimester, pregnancy, high blood pressure, hypertension

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