Lacosamide (Epilepsy) updated on 04-22-2025

Major congenital malformations

R analysis
id Study   Lib. in paper Exposition period    Study type 
 Control type 
 
Tags OR 95%CI x1/n1 x0/n0 no cases no exposed ROB Ref.
S16708
R70293		 Battino, 2024 Major congenital malformations (MCMs) early pregnancy prospective cohort exposed to other treatment, sick Adjustment: No 0.52 [0.03;8.48] C 0/31   110/3,584 110 31
ref
S17198
R72074		 The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls exposed to Lamotrigine), 2024 Major congenital malformations 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 2.94 [0.11;81.30] C
excluded (control group) 		0/6   1/50 1 6
ref
S17199
R72076		 The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024 Major congenital malformations 1st trimester prospective cohort unexposed, sick Adjustment: No 1.78 [0.09;33.62] C 0/6   16/340 16 6
ref
S17188
R72038		 The UKIEPR (Epilepsy) (Controls exposed to Lamotrigine), 2024 Major malformations 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 4.60 [0.24;86.58] C
excluded (control group) 		0/5   49/2,098 49 5
ref
S17189
R72040		 The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024 Major malformations 1st trimester prospective cohort unexposed, sick Adjustment: No 4.34 [0.22;84.74] C 0/5   13/541 13 5
ref
S17219
R72116		 The West China Registry (Epilepsy) (Controls exposed to LTG), 2024 Major congenital malformation during pregnancy (anytime or not specified) prospective cohort exposed to other treatment, sick excluded Adjustment: No 8.33 [0.15;473.61] C
excluded (control group) 		0/5   0/38 0 5
ref
S17220
R72118		 The West China Registry (Epilepsy) (Controls unexposed, sick), 2024 Major congenital malformation during pregnancy (anytime or not specified) excluded prospective cohort unexposed, sick Adjustment: No 3.64 [0.18;73.84] C
excluded (exposition period) 		0/5   7/253 7 5
ref
Total 3 studies 1.52 [0.28;8.10] 139 42
x1: number of endpoints among exposed, n1: number of exposed; x0: number of endpoints among non exposed, n0: number of non exposed; C: calculated odds ratio from numbers of events and effectives

Forest plot

StudyTE95% CIn casesn exposedweightROBABCDEF Battino, 2024Battino, 2024 0.52[0.03; 8.48]1103136%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024The Kerala Registry for Epile..., 2024 1 1.78[0.09; 33.62]16633%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024The UKIEPR, 2024 2 4.34[0.22; 84.74]13532%ROB confusion: unclearROB selection: lowROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Total (3 studies) I2 = 0% 1.52[0.28; 8.10]139420.210.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Epilepsy) (Controls unexposed, sick; 2: Epilepsy) (Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.52[0.28; 8.10]139420%NABattino, 2024 The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024 The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024 3 case control studiescase control studies 0 Type of controls unexposed, sickunexposed, sick 2.77[0.34; 22.35]29110%NAThe Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024 The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024 2 exposed to other treatment, sickexposed to other treatment, sick 0.52[0.03; 8.48]11031 -NABattino, 2024 1 Tags Adjustment   - No  - No 1.52[0.28; 8.10]139420%NABattino, 2024 The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024 The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024 3 All studiesAll studies 1.52[0.28; 8.10]139420%NABattino, 2024 The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024 The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024 30.210.01.0

Publication bias and p-hacking diagnosis

funnel plot

Funnel plot not drawn. Less than 3 points.

Asymetry test p-value = NaN (by Egger's regression)

not enought points

p values plot

Funnel plot not drawn. Less than 3 points.

Sub-groups analysis using all included studies

excluded 17198, 17188, 17219

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed, sick controlsunexposed, sick controls 2.77[0.34; 22.35]29110%NAThe Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls unexposed, sick), 2024 The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024 2 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.77[0.31; 9.97]160420%NABattino, 2024 The Kerala Registry for Epilepsy and Pregnancy (Epilepsy) (Controls exposed to Lamotrigine), 2024 The UKIEPR (Epilepsy) (Controls exposed to Lamotrigine), 2024 30.510.01.0