| アブストラクト | 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((R)), 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((R)) 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((R)). Future pharmacovigilance studies are needed to confirm these findings. |
|---|
| ジャーナル名 | The journal of headache and pain |
|---|
| 投稿日 | 2024/1/20 |
|---|
| 投稿者 | Noseda, Roberta; Bedussi, Francesca; Gobbi, Claudio; Ceschi, Alessandro; Zecca, Chiara |
|---|
| 組織名 | Division of Clinical Pharmacology and Toxicology, Institute of Pharmacological;Sciences of Southern Switzerland, Ente Ospedaliero Cantonale, Lugano,;Switzerland.;Department of Neurology, Neurocenter of Southern Switzerland, Ente Ospedaliero;Cantonale, Lugano, Switzerland.;Faculty of Biomedical Sciences, Universita della Svizzera Italiana, Lugano,;Department of Neurology, University Hospital Basel, Basel, Switzerland.;Clinical Trial Unit, Ente Ospedaliero Cantonale, Lugano, Switzerland.;Department of Clinical Pharmacology and Toxicology, University Hospital Zurich,;Zurich, Switzerland.;Cantonale, Lugano, Switzerland. chiara.zecca@eoc.ch.;Switzerland. chiara.zecca@eoc.ch. |
|---|
| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38243189/ |
|---|
