Lacosamide (All indications) - Medication and Pregnancy KB

Lacosamide (All indications)

Exposed non-exposed studies (cohort)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Battino (Epilepsy), 2024	Worldwide (47 countries) 1999 - 2022	Pregnant women with epilepsy exposed to antiseizure medications at the time of conception and enrolled within the 16th week of gestation, where fetal outcome had not yet been determined.	Pregnant women with epilepsy exposed to Gabapentin monotherapy at the time of conception.	exposed to other treatment, sick Pregnant women with epilepsy exposed to lamotrigine monotherapy at the time of conception.	31 / 3584	Overlapping: Battino 2024 (1999-2022) updates and totally includes Tomson 2018 (1999-2016) => Use of Battino 2024 for the 8 (plus 16 in eSupp) ASM monotherapies studied here.
The Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls exposed to LTG), 2024	Australia 1999 - 2023	Women with epilepsy (WWE), with voluntary inclusion, with known outcomes but in which that outcome was unknown at the time of the pregnancy’s enrolment.	Women with epilepsy exposed to Lacosamide monotherapy at time of conception.	exposed to other treatment, sick Women with epilepsy exposed to Lamotrigine monotherapy at time of conception.	2 / 406	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries, and with de-depublication of pregnancies of EURAP registry.
The Australian Pregnancy Register of Antiepileptic Drugs (Mixed indications) (Controls unexposed, sick), 2024	Australia 1999 - 2023	Women with epilepsy (WWE), with voluntary inclusion, with known outcomes but in which that outcome was unknown at the time of the pregnancy’s enrolment.	Women with epilepsy exposed to Lacosamide monotherapy at time of conception.	unexposed, sick Women with epilepsy unexposed to antiseizure medication in at least the first few months of pregnancy.	2 / 207	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries (and Vajda 2024 for the control group), and with de-depublication of pregnancies of EURAP registry.
The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls exposed to Lamotrigine), 2024	India 1998 - 2023	All pregnancies with known outcomes in women with epilepsy enrolled in the registry during 1998 - 2013 and the diagnosis of epilepsy was confirmed before registration.	Children of women with epilepsy using Lacosamide monotherapy any time during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Children of women with epilepsy using lamotrigine monotherapy any time during the first trimester of pregnancy.	6 / 50	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries. Study design and control data based on Thomas et al., 2017 and Thomas et al., 2021.
The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024	India 1998 - 2023	All pregnancies with known outcomes in women with epilepsy enrolled in the registry during 1998 - 2013 and the diagnosis of epilepsy was confirmed before registration.	Children of women with epilepsy using Lacosamide monotherapy any time during the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Children of women with epilepsy not using any antiepileptic drugs during the first trimester.	6 / 340	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries. Study design and control data based on Thomas et al., 2017 and Thomas et al., 2021.
The NAAED (Controls exposed to LTG) (Indications NOS), 2024	North America and Canada 1997 - 2023	Pregnant women who are taking an antiepileptic drug for any reason and had a liveborn infant, a stillborn infant, or a pregnancy terminated because of a fetal abnormality and enrolled as 'pure' or 'traditional' enrollees.	Infants of pregnant women who used Lacosamide as monotherapy, during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Infants of pregnant women who used lamotrigine as monotherapy, during the first trimester.	93 / 2461	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries. Overlapping with Hernández-Díaz et al. 2012 and/or previous website reports.
The NAAED (Controls unexposed, disease free) (Indications NOS), 2024	North America and Canada 1997 - 2023	Pregnant women who are taking an antiepileptic drug for any reason and had a liveborn infant, a stillborn infant, or a pregnancy terminated because of a fetal abnormality and enrolled as 'pure' or 'traditional' enrollees.	Infants of pregnant women who used Lacosamide as monotherapy, during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, disease free Infants of pregnant women, not taking an antiepileptic drug and without epilepsy, who were recruited from among the friends and family members of the enrolled women taking an antiepileptic drug.	93 / 1311	Data extracted from the publication Perucca 2024 (for exposed pregnancies) and the North American AED pregnancy registry website (for controls). Overlapping/update with Hernández-Díaz et al. 2012 and/or previous website reports. Use of internal control.
The UKIEPR (Epilepsy) (Controls exposed to Lamotrigine), 2024	UK and Ireland 1996 - 2023	Pregnant women with epilepsy, whether or not they were taking an antiepileptic drug, either in monotherapy or polytherapy, and who were referred to the register before the outcome of the pregnancy was known.	Infants of women with epilepsy exposed to Lacosamide in monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Infants of women with epilepsy exposed to lamotrigine in monotherapy during the first trimester.	5 / 2098	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries. Study design based on Morrow 2006 and Campbell 2014.
The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024	UK and Ireland 1996 - 2023	Pregnant women with epilepsy, whether or not they were taking an antiepileptic drug, either in monotherapy or polytherapy, and who were referred to the register before the outcome of the pregnancy was known.	Infants of women with epilepsy exposed to Lacosamide in monotherapy during the first trimester. (This is a subgroup of exposure among the whole exposed group considered in the study).	unexposed, sick Infants of women with epilepsy on no antiepileptic drugs during pregnancy.	5 / 541	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries. Study design based on Morrow 2006 and Campbell 2014.
The West China Registry (Epilepsy) (Controls exposed to LTG), 2024	China 2009 - 2023	All pregnant participants occurring between 2009 and 2022 in the cohort of women with epilepsy (WWE) of childbearing age (20–45 years old) enrolled from 31 medical institutions.	Women with epilepsy (WWE) using Lacosamide monotherapy during pregnancy.	exposed to other treatment, sick Women with epilepsy (WWE) using Lamotrigine monotherapy during pregnancy.	5 / 38	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries, and with de-depublication of pregnancies of EURAP registry. Period of exposure not specified => considered as during pregnancy.
The West China Registry (Epilepsy) (Controls unexposed, sick), 2024	China 2009 - 2023	All pregnant participants occurring between 2009 and 2022 in the cohort of women with epilepsy (WWE) of childbearing age (20–45 years old) enrolled from 31 medical institutions.	Women with epilepsy (WWE) using Lacosamide monotherapy during pregnancy.	unexposed, sick Women with epilepsy (WWE) not using antiseizure medications during pregnancy.	5 / 253	Data extracted from the publication Perucca 2024, an update of the Epilepsy-pregnancy registries (and Li 2023 for control group), and with de-depublication of pregnancies of EURAP registry. Period of exposure not specified.

Case-control studies (cohort)

Study	Country Study period	Case	Control	Sample size	Rmk

Warning! There are no case-control studies available for this drug.

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