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Ivabradine use in pregnant women—treatment indications and pregnancy outcome: an evaluation of the German Embryotox database
PURPOSE: Ivabradine has been approved for the treatment of chronic heart failure and chronic stable angina pectoris in Europe. Based on adverse outcomes of reproductive animal studies and the lack of human data, ivabradine is considered contraindicated during pregnancy. The aim of this observational...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Berlin Heidelberg
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8184534/ https://www.ncbi.nlm.nih.gov/pubmed/33501507 http://dx.doi.org/10.1007/s00228-020-03066-w |
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author | Hoeltzenbein, Maria Lehmann, Marie-Louise Beck, Evelin Dathe, Katarina Schaefer, Christof |
author_facet | Hoeltzenbein, Maria Lehmann, Marie-Louise Beck, Evelin Dathe, Katarina Schaefer, Christof |
author_sort | Hoeltzenbein, Maria |
collection | PubMed |
description | PURPOSE: Ivabradine has been approved for the treatment of chronic heart failure and chronic stable angina pectoris in Europe. Based on adverse outcomes of reproductive animal studies and the lack of human data, ivabradine is considered contraindicated during pregnancy. The aim of this observational study is to analyse ivabradine use before and during pregnancy. METHODS: We evaluated all ivabradine-related requests to the German Embryotox Institute from 2007 to 2019. Exposed pregnancies were analysed as to their outcome. RESULTS: Off-label use for supraventricular tachycardia was frequent in women of childbearing age. Of 38 prospectively ascertained pregnancies with ivabradine exposure and completed follow-up, 32 resulted in live births, 3 in spontaneous abortions, and 3 were electively terminated. One neonate presented with major birth defects (atrial septal defect and cleft palate). In 33/38 patients, ivabradine was discontinued after confirmation of pregnancy without cardiac deterioration and 5/38 women continued ivabradine throughout pregnancy. In addition, there were 3 retrospectively reported pregnancies including one major birth defect (tracheal atresia). CONCLUSION: This case series represents the largest cohort of ivabradine-exposed pregnancies, published so far. According to our findings, ivabradine appears not to be a major teratogen. However, established drugs of choice with strong evidence of low risk for the unborn should be preferred in women planning pregnancy. After inadvertent exposure during pregnancy or lack of treatment alternatives, fetal ultrasound for structural anomalies and growth restriction is recommended. In addition, close monitoring is necessary in pregnant women with supraventricular arrhythmias or cardiac disease. |
format | Online Article Text |
id | pubmed-8184534 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer Berlin Heidelberg |
record_format | MEDLINE/PubMed |
spelling | pubmed-81845342021-06-25 Ivabradine use in pregnant women—treatment indications and pregnancy outcome: an evaluation of the German Embryotox database Hoeltzenbein, Maria Lehmann, Marie-Louise Beck, Evelin Dathe, Katarina Schaefer, Christof Eur J Clin Pharmacol Pharmacoepidemiology and Prescription PURPOSE: Ivabradine has been approved for the treatment of chronic heart failure and chronic stable angina pectoris in Europe. Based on adverse outcomes of reproductive animal studies and the lack of human data, ivabradine is considered contraindicated during pregnancy. The aim of this observational study is to analyse ivabradine use before and during pregnancy. METHODS: We evaluated all ivabradine-related requests to the German Embryotox Institute from 2007 to 2019. Exposed pregnancies were analysed as to their outcome. RESULTS: Off-label use for supraventricular tachycardia was frequent in women of childbearing age. Of 38 prospectively ascertained pregnancies with ivabradine exposure and completed follow-up, 32 resulted in live births, 3 in spontaneous abortions, and 3 were electively terminated. One neonate presented with major birth defects (atrial septal defect and cleft palate). In 33/38 patients, ivabradine was discontinued after confirmation of pregnancy without cardiac deterioration and 5/38 women continued ivabradine throughout pregnancy. In addition, there were 3 retrospectively reported pregnancies including one major birth defect (tracheal atresia). CONCLUSION: This case series represents the largest cohort of ivabradine-exposed pregnancies, published so far. According to our findings, ivabradine appears not to be a major teratogen. However, established drugs of choice with strong evidence of low risk for the unborn should be preferred in women planning pregnancy. After inadvertent exposure during pregnancy or lack of treatment alternatives, fetal ultrasound for structural anomalies and growth restriction is recommended. In addition, close monitoring is necessary in pregnant women with supraventricular arrhythmias or cardiac disease. Springer Berlin Heidelberg 2021-01-26 2021 /pmc/articles/PMC8184534/ /pubmed/33501507 http://dx.doi.org/10.1007/s00228-020-03066-w Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Pharmacoepidemiology and Prescription Hoeltzenbein, Maria Lehmann, Marie-Louise Beck, Evelin Dathe, Katarina Schaefer, Christof Ivabradine use in pregnant women—treatment indications and pregnancy outcome: an evaluation of the German Embryotox database |
title | Ivabradine use in pregnant women—treatment indications and pregnancy outcome: an evaluation of the German Embryotox database |
title_full | Ivabradine use in pregnant women—treatment indications and pregnancy outcome: an evaluation of the German Embryotox database |
title_fullStr | Ivabradine use in pregnant women—treatment indications and pregnancy outcome: an evaluation of the German Embryotox database |
title_full_unstemmed | Ivabradine use in pregnant women—treatment indications and pregnancy outcome: an evaluation of the German Embryotox database |
title_short | Ivabradine use in pregnant women—treatment indications and pregnancy outcome: an evaluation of the German Embryotox database |
title_sort | ivabradine use in pregnant women—treatment indications and pregnancy outcome: an evaluation of the german embryotox database |
topic | Pharmacoepidemiology and Prescription |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8184534/ https://www.ncbi.nlm.nih.gov/pubmed/33501507 http://dx.doi.org/10.1007/s00228-020-03066-w |
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