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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...

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Autores principales: Hoeltzenbein, Maria, Lehmann, Marie-Louise, Beck, Evelin, Dathe, Katarina, Schaefer, Christof
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2021
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.
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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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