Parker Claire H, Slattery Craig, Brennan Donal J, le Roux Carel W
Renaissance School of Medicine at Stony Brook University, Stony Brook, New York, USA.
School of Biomolecular and Biomedical Science, University College Dublin, Dublin, Ireland.
Diabetes Obes Metab. 2025 May 6. doi: 10.1111/dom.16437.
The prevalence of diabetes and obesity continues to rise in women of reproductive age, with significant implications for both mother and foetus. Glucagon-like peptide-1 receptor agonists are effective treatments of diabetes and obesity. However, no Glucagon-like peptide-1 receptor agonists are currently approved for use during pregnancy. We describe the outcomes of unplanned pregnancies during regulatory clinical trials of Glucagon-like peptide-1 receptor agonists submitted to the Food and Drug Administration and European Medicines Agency.
A search was conducted of the regulatory documentation published by the European Medicines Agency and the Food and Drug Administration on unplanned pregnancies during regulatory clinical trials of Glucagon-like peptide-1 receptor agonists. Clinical and Medical Reviews published by the Center for Drug Evaluation and Research at the Food and Drug Administration for every Glucagon-like peptide-1 receptor agonist prior to market authorisation were assessed to gather information on unplanned pregnancies that occurred while females were partaking in the clinical development programmes of such drugs.
Evidence in women having planned pregnancies is lacking, and the only evidence thus far relies on pregnancies occurring inadvertently during Glucagon-like peptide-1 receptor agonist trials. The incidence of congenital abnormalities in humans appears relatively low following Glucagon-like peptide-1 receptor agonist use during pregnancy.
Key knowledge gaps must be addressed before the introduction of the Glucagon-like peptide-1 receptor agonist class of drugs for pregnant women. Currently, Glucagon-like peptide-1 receptor agonists should be stopped as soon as the patient becomes aware of a pregnancy. The establishment of patient registries designed to capture data relating to cases of Glucagon-like peptide-1 receptor agonist exposure during pregnancy is a high priority, and where data already exist, the findings need to be published.
育龄女性中糖尿病和肥胖症的患病率持续上升，这对母亲和胎儿都有重大影响。胰高血糖素样肽-1受体激动剂是治疗糖尿病和肥胖症的有效药物。然而，目前尚无胰高血糖素样肽-1受体激动剂被批准用于孕期。我们描述了提交给美国食品药品监督管理局和欧洲药品管理局的胰高血糖素样肽-1受体激动剂监管临床试验期间意外怀孕的结果。
检索欧洲药品管理局和美国食品药品监督管理局发布的关于胰高血糖素样肽-1受体激动剂监管临床试验期间意外怀孕的监管文件。评估美国食品药品监督管理局药物评价和研究中心在每种胰高血糖素样肽-1受体激动剂上市前发布的临床和医学综述，以收集女性参与此类药物临床开发项目期间发生的意外怀孕信息。
缺乏关于计划怀孕女性的证据，目前唯一的证据依赖于胰高血糖素样肽-1受体激动剂试验期间意外发生的怀孕。孕期使用胰高血糖素样肽-1受体激动剂后，人类先天性异常的发生率似乎相对较低。
在将胰高血糖素样肽-1受体激动剂类药物引入孕妇群体之前，必须填补关键的知识空白。目前，一旦患者意识到怀孕，应立即停用胰高血糖素样肽-1受体激动剂。建立旨在收集孕期接触胰高血糖素样肽-1受体激动剂病例相关数据的患者登记册是当务之急，并且在已有数据的情况下，需要公布研究结果。
