Abstract：
OBJECTIVE: In pregnancy, it is important to balance the risks of uncontrolled epileptic seizures to the mother and fetus against the potential teratogenic effects of antiseizure medications. Data are limited on pregnancy outcomes among patients taking lacosamide (LCM), particularly when taken as monotherapy. The objective of this analysis was to evaluate the pregnancy outcomes of LCM-exposed pregnancies.
METHODS: This analysis included all reports in the UCB Pharma pharmacovigilance database of exposure to LCM during pregnancy from spontaneous sources (routine clinical settings) or solicited reports from interventional clinical studies and noninterventional postmarketing studies. Prospective and retrospective reports were analyzed separately.
RESULTS: At the data cutoff (August 31, 2021), there were 202 prospective pregnancy cases with maternal exposure to LCM and known outcomes. Among these cases, 44 (21.8%) patients received LCM monotherapy and 158 (78.2%) received LCM polytherapy. Most patients received LCM during the first trimester (LCM monotherapy: 39 [88.6%]; LCM polytherapy: 143 [90.5%]). From the prospective pregnancy cases with maternal LCM exposure, there were 204 reported outcomes (two twin pregnancies occurred in the polytherapy group). The proportion of live births was 84.1% (37/44) in patients who received LCM as monotherapy, and 76.3% (122/160) for LCM polytherapy. The overall proportion of abortions (for any reason) was 15.9% (7/44) with LCM monotherapy, and 22.5% (36/160) with LCM polytherapy. Congenital malformations were reported in 2.3% (1/44) of known pregnancy outcomes with maternal exposure to LCM monotherapy, and 6.9% (11/160) with polytherapy.
CONCLUSIONS: Our preliminary data do not raise major concerns on the use of LCM during pregnancy. Most pregnancies with LCM exposure resulted in healthy live births, and no new safety issues were identified. These findings should be interpreted with caution, as additional data are needed to fully evaluate the safety profile of LCM in pregnancy.
METHODS: This analysis included all reports in the UCB Pharma pharmacovigilance database of exposure to LCM during pregnancy from spontaneous sources (routine clinical settings) or solicited reports from interventional clinical studies and noninterventional postmarketing studies. Prospective and retrospective reports were analyzed separately.
RESULTS: At the data cutoff (August 31, 2021), there were 202 prospective pregnancy cases with maternal exposure to LCM and known outcomes. Among these cases, 44 (21.8%) patients received LCM monotherapy and 158 (78.2%) received LCM polytherapy. Most patients received LCM during the first trimester (LCM monotherapy: 39 [88.6%]; LCM polytherapy: 143 [90.5%]). From the prospective pregnancy cases with maternal LCM exposure, there were 204 reported outcomes (two twin pregnancies occurred in the polytherapy group). The proportion of live births was 84.1% (37/44) in patients who received LCM as monotherapy, and 76.3% (122/160) for LCM polytherapy. The overall proportion of abortions (for any reason) was 15.9% (7/44) with LCM monotherapy, and 22.5% (36/160) with LCM polytherapy. Congenital malformations were reported in 2.3% (1/44) of known pregnancy outcomes with maternal exposure to LCM monotherapy, and 6.9% (11/160) with polytherapy.
CONCLUSIONS: Our preliminary data do not raise major concerns on the use of LCM during pregnancy. Most pregnancies with LCM exposure resulted in healthy live births, and no new safety issues were identified. These findings should be interpreted with caution, as additional data are needed to fully evaluate the safety profile of LCM in pregnancy.
摘要：
目的：在怀孕期间，重要的是要平衡母亲和胎儿不受控制的癫痫发作的风险与抗癫痫药物的潜在致畸作用。服用拉科沙胺（LCM）的患者的妊娠结局数据有限，特别是作为单一疗法服用时。本分析的目的是评估LCM暴露妊娠的妊娠结局。
方法：本分析包括UCBPharma药物警戒数据库中所有来自自发来源（常规临床环境）的妊娠期间LCM暴露报告或来自介入临床研究和非介入上市后研究的征求报告。前瞻性和回顾性报告分别进行分析。
结果：在数据截止日期（2021年8月31日），有202例孕妇暴露于LCM且结局已知的前瞻性妊娠病例.在这些案例中,44例（21.8%）患者接受LCM单药治疗，158例（78.2%）患者接受LCM综合治疗。大多数患者在妊娠早期接受LCM（LCM单药治疗：39[88.6%]；LCM综合治疗：143[90.5%]）。从母体LCM暴露的预期妊娠病例来看，有204例报告结局(多治疗组发生2例双胎妊娠).接受LCM单药治疗的患者活产比例为84.1%(37/44),LCM综合疗法为76.3%(122/160)。使用LCM单药治疗的流产（出于任何原因）的总比例为15.9％（7/44），和22.5％（36/160）的LCM综合疗法。在已知妊娠结局中，有2.3%(1/44)的孕妇暴露于LCM单药治疗，和6.9％（11/160）的综合疗法。
结论：我们的初步数据并未引起对妊娠期间使用LCM的主要关注。大多数LCM暴露的怀孕导致健康的活产，没有发现新的安全问题。这些发现应谨慎解释，因为需要更多的数据来全面评估妊娠LCM的安全性.
方法：本分析包括UCBPharma药物警戒数据库中所有来自自发来源（常规临床环境）的妊娠期间LCM暴露报告或来自介入临床研究和非介入上市后研究的征求报告。前瞻性和回顾性报告分别进行分析。
结果：在数据截止日期（2021年8月31日），有202例孕妇暴露于LCM且结局已知的前瞻性妊娠病例.在这些案例中,44例（21.8%）患者接受LCM单药治疗，158例（78.2%）患者接受LCM综合治疗。大多数患者在妊娠早期接受LCM（LCM单药治疗：39[88.6%]；LCM综合治疗：143[90.5%]）。从母体LCM暴露的预期妊娠病例来看，有204例报告结局(多治疗组发生2例双胎妊娠).接受LCM单药治疗的患者活产比例为84.1%(37/44),LCM综合疗法为76.3%(122/160)。使用LCM单药治疗的流产（出于任何原因）的总比例为15.9％（7/44），和22.5％（36/160）的LCM综合疗法。在已知妊娠结局中，有2.3%(1/44)的孕妇暴露于LCM单药治疗，和6.9％（11/160）的综合疗法。
结论：我们的初步数据并未引起对妊娠期间使用LCM的主要关注。大多数LCM暴露的怀孕导致健康的活产，没有发现新的安全问题。这些发现应谨慎解释，因为需要更多的数据来全面评估妊娠LCM的安全性.
