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.
J Headache Pain. 2024 Jan 19;25(1):10. doi: 10.1186/s10194-024-01715-4.
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.
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.
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).
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.
目前关于降钙素基因相关肽拮抗剂（CGRP-A）在妊娠期间用于治疗偶发性和慢性偏头痛的安全性的证据有限，尚未提供明确的信息。本研究通过查询世界卫生组织全球药物警戒数据库 VigiBase，旨在检测 CGRP-A 与曲坦类药物在妊娠方面报告频率的差异。
对截至 2023 年 5 月 31 日在 VigiBase 中收集的、已去重的、与妊娠期间暴露于 CGRP-A 相关的安全性报告进行比例失调分析，包括有无妊娠结局。使用报告比值比（ROR）及其 95%置信区间（CI）作为比例失调的衡量指标，检测比例失调信号的阈值设定为 95%CI 下限>1。
467 份安全性报告报告了妊娠期间暴露于 CGRP-A，主要来自美国（360/467，77%），更多由患者报告（225/467，48%），主要为女性（431/467，92%），更多报告妊娠期间暴露于 CGRP-A（400/467，86%）。与曲坦类药物相比，CGRP-A 既未检测到妊娠相关安全性报告的总体报告（ROR 0.91，95%CI 0.78-1.06）、妊娠结局（母亲和/或胎儿/新生儿，ROR 0.54，95%CI 0.45-0.66），也未检测到胎儿/新生儿结局（ROR 0.53，95%CI 0.41-0.68）的报告比例失调信号。
本研究表明，迄今为止，在 VigiBase 中，与曲坦类药物相比，CGRP-A 与妊娠相关的报告增加并无信号。需要进一步的药物警戒研究来证实这些发现。
