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Safety review of hydroxyprogesterone caproate in women with a history of spontaneous preterm birth

17-alpha-hydroxyprogesterone caproate (17P) has been in use for prevention of recurrent preterm birth since 2003 when the Meis trial was published. A requirement for Food and Drug Administration approval of 17P was a confirmatory trial, called “PROLONG”, which was recently completed, but did not rep...

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Autores principales: Sibai, Baha, Saade, George R., Das, Anita F., Gudeman, Jennifer
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group US 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8049867/
https://www.ncbi.nlm.nih.gov/pubmed/33057132
http://dx.doi.org/10.1038/s41372-020-00849-y
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author Sibai, Baha
Saade, George R.
Das, Anita F.
Gudeman, Jennifer
author_facet Sibai, Baha
Saade, George R.
Das, Anita F.
Gudeman, Jennifer
author_sort Sibai, Baha
collection PubMed
description 17-alpha-hydroxyprogesterone caproate (17P) has been in use for prevention of recurrent preterm birth since 2003 when the Meis trial was published. A requirement for Food and Drug Administration approval of 17P was a confirmatory trial, called “PROLONG”, which was recently completed, but did not replicate the efficacy demonstrated in the Meis trial. This review analyzes the safety data from each trial, as well as integrated data from the two trials. The relative risks (95% CI) with 17P versus placebo in the integrated dataset were 0.66 (0.25–1.78) for miscarriage, 1.83 (0.68–4.91) for stillbirth, and 0.86 (0.53–1.41) for all fetal and neonatal death. The rate of gestational diabetes in the integrated dataset was 3.6% for 17P vs. 3.8% for placebo. Similar findings with low and comparable rates between 17P and placebo were also found for other adverse events. The integrated safety data demonstrate a favorable safety profile that was comparable to placebo.
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spelling pubmed-80498672021-04-29 Safety review of hydroxyprogesterone caproate in women with a history of spontaneous preterm birth Sibai, Baha Saade, George R. Das, Anita F. Gudeman, Jennifer J Perinatol Review Article 17-alpha-hydroxyprogesterone caproate (17P) has been in use for prevention of recurrent preterm birth since 2003 when the Meis trial was published. A requirement for Food and Drug Administration approval of 17P was a confirmatory trial, called “PROLONG”, which was recently completed, but did not replicate the efficacy demonstrated in the Meis trial. This review analyzes the safety data from each trial, as well as integrated data from the two trials. The relative risks (95% CI) with 17P versus placebo in the integrated dataset were 0.66 (0.25–1.78) for miscarriage, 1.83 (0.68–4.91) for stillbirth, and 0.86 (0.53–1.41) for all fetal and neonatal death. The rate of gestational diabetes in the integrated dataset was 3.6% for 17P vs. 3.8% for placebo. Similar findings with low and comparable rates between 17P and placebo were also found for other adverse events. The integrated safety data demonstrate a favorable safety profile that was comparable to placebo. Nature Publishing Group US 2020-10-14 2021 /pmc/articles/PMC8049867/ /pubmed/33057132 http://dx.doi.org/10.1038/s41372-020-00849-y Text en © The Author(s) 2020 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 license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license 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 license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Review Article
Sibai, Baha
Saade, George R.
Das, Anita F.
Gudeman, Jennifer
Safety review of hydroxyprogesterone caproate in women with a history of spontaneous preterm birth
title Safety review of hydroxyprogesterone caproate in women with a history of spontaneous preterm birth
title_full Safety review of hydroxyprogesterone caproate in women with a history of spontaneous preterm birth
title_fullStr Safety review of hydroxyprogesterone caproate in women with a history of spontaneous preterm birth
title_full_unstemmed Safety review of hydroxyprogesterone caproate in women with a history of spontaneous preterm birth
title_short Safety review of hydroxyprogesterone caproate in women with a history of spontaneous preterm birth
title_sort safety review of hydroxyprogesterone caproate in women with a history of spontaneous preterm birth
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8049867/
https://www.ncbi.nlm.nih.gov/pubmed/33057132
http://dx.doi.org/10.1038/s41372-020-00849-y
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