Calcitonin gene-related peptide antagonists in pregnancy: a disproportionality analysis in VigiBase

Background Current evidence on the safety of calcitonin gene–related peptide antagonists (CGRP-A) in pregnancy for the treatment of both episodic and chronic migraine is scarce and does not yet provide definitive information. By querying VigiBase ® , the World Health Organization global pharmacovigi...

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Vydáno v:Journal of headache and pain Ročník 25; číslo 1; s. 10 - 6
Hlavní autoři: Noseda, Roberta, Bedussi, Francesca, Gobbi, Claudio, Ceschi, Alessandro, Zecca, Chiara
Médium: Journal Article
Jazyk:angličtina
Vydáno: Milan Springer Milan 19.01.2024
Springer Nature B.V
BMC
Témata:
Antagonists
Brief Report
Calcitonin
Calcitonin gene-related peptide
Calcitonin gene–related peptide antagonists
Disproportionality
Headache
Internal Medicine
Medicine
Medicine & Public Health
Migraine
Neonates
Neurology
Pain Medicine
Peptides
Pharmacovigilance
Pregnancy
Safety
VigiBase
Pregnancy
Disproportionality
Safety
VigiBase
Calcitonin gene–related peptide antagonists
ISSN:1129-2377, 1129-2369, 1129-2377
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Shrnutí:Background Current evidence on the safety of calcitonin gene–related peptide antagonists (CGRP-A) in pregnancy for the treatment of both episodic and chronic migraine is scarce and does not yet provide definitive information. By querying VigiBase ® , the World Health Organization global pharmacovigilance database, this study aimed to detect differences in the reporting frequency between CGRP-A and triptans in relation to pregnancy. Methods Disproportionality analyses on de-duplicated safety reports collected in VigiBase ® as of 31.05.2023 reporting exposure to CGRP-A in pregnancy with or without pregnancy outcomes. A Reporting Odds Ratio (ROR) with a 95% confidence interval (CI) was used as a measure of disproportionality and the threshold for the detection of a signal of disproportionate reporting was set with a 95% CI lower limit > 1. Findings Four hundred sixty-seven safety reports reported exposure to CGRP-A in pregnancy, mostly originating from the United States of America (360/467, 77%), more frequently reported by patients (225/467, 48%), who were mainly females (431/467, 92%), and more frequently reported exposure to CGRP-A during pregnancy (400/467, 86%). Compared to triptans, no signals of disproportionate reporting were detected with CGRP-A either for the overall reporting of pregnancy-related safety reports (ROR 0.91, 95% CI 0.78–1.06), for the reporting of pregnancy outcomes (maternal and/or foetal/neonatal, ROR 0.54, 95% CI 0.45–0.66), or for the reporting of foetal/neonatal outcomes (ROR 0.53, 95% CI 0.41–0.68). Conclusions This study showed that, to date, there are no signals of increased reporting with CGRP-A compared to triptans in relation to pregnancy in VigiBase ® . Future pharmacovigilance studies are needed to confirm these findings.
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ISSN:1129-2377
1129-2369
1129-2377
DOI:10.1186/s10194-024-01715-4