Lamotrigine (All indications) updated on 04-22-2025

Cognitive developmental disorders/delay (< 3 years old)

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.
S15218
R62399		 Bromley (Lamotrigine) (Epilepsy), 2023 Cognitive mean score ≤ 88 (below average performance of the cohort mean) - Bayley Scales of Infant and Toddler Development - At 24 months of age during pregnancy (anytime or not specified) prospective cohort unexposed, sick Adjustment: No 0.65 [0.09;4.76] C 2/73   2/48 4 73
ref
S16614
R69687		 Thomas (Lamotrigine) (Epilepsy), 2022 The mental development quotient (MEDQ) - The developmental assessment scale for Indian infants (DASII) - Between 12-24 months of age (mean (SD): 15.3 (3.9) months)) during pregnancy (anytime or not specified) prospective cohort unexposed, sick Adjustment: No extrapolated (cont. endpoint) 0.99 [0.45;2.14] -/26   -/110 - 26
ref
S9947
R53699		 Videman (Lamotrigine), 2016 Griffiths Mental Developmental Scale - General quotient (at the age of 7 months) during pregnancy (anytime or not specified) prospective cohort unexposed, disease free Adjustment: No extrapolated (cont. endpoint) 4.57 [1.17;17.90] -/8   -/59 - 8
ref
S8932
R53697		 Bromley (Lamotrigine) (Controls unexposed, disease free), 2010 Overall ability below average performance (≤ 84) (Griffiths) (mean age 10 months old) during pregnancy (anytime or not specified) prospective cohort unexposed, disease free excluded Adjustment: No Matched 2.03 [0.70;5.89] C
excluded (control group) 		5/34   18/230 23 34
ref
S8935
R53698		 Bromley (Lamotrigine) (Controls unexposed, sick), 2010 Overall ability below average performance (≤ 84) (Griffiths) (mean 10 months old) during pregnancy (anytime or not specified) prospective cohort unexposed, sick Adjustment: No 2.16 [0.38;12.09] C 5/34   2/27 7 34
ref
Total 4 studies 1.55 [0.68;3.52] 11 141
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 Bromley (Lamotrigine) (Epilepsy), 2023Bromley, 2023 1 0.65[0.09; 4.76]47314%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: lowROB reporting: low Thomas (Lamotrigine) (Epilepsy), 2022Thomas, 2022 2 0.99[0.45; 2.14]-2645%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: unclearROB mesure: lowROB reporting: moderate Videman (Lamotrigine), 2016Videman, 2016 3 4.57[1.17; 17.90]-824%ROB confusion: unclearROB selection: lowROB classification: moderateROB missing: criticalROB mesure: lowROB reporting: moderate Bromley (Lamotrigine) (Controls unexposed, sick), 2010Bromley, 2010 4 2.16[0.38; 12.09]73417%ROB confusion: moderateROB selection: lowROB classification: lowROB missing: moderateROB mesure: lowROB reporting: moderate Total (4 studies) I2 = 33% 1.55[0.68; 3.52]111410.210.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Lamotrigine) (Epilepsy; 2: Lamotrigine) (Epilepsy; 3: Lamotrigine; 4: Lamotrigine) (Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.55[0.68; 3.52]1114133%NABromley (Lamotrigine) (Epilepsy), 2023 Thomas (Lamotrigine) (Epilepsy), 2022 Videman (Lamotrigine), 2016 Bromley (Lamotrigine) (Controls unexposed, sick), 2010 4 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 4.57[1.17; 17.88]-8 -NAVideman (Lamotrigine), 2016 1 unexposed, sickunexposed, sick 1.06[0.54; 2.07]111330%NABromley (Lamotrigine) (Epilepsy), 2023 Thomas (Lamotrigine) (Epilepsy), 2022 Bromley (Lamotrigine) (Controls unexposed, sick), 2010 3 Tags Adjustment   - No  - No 1.55[0.68; 3.52]1114133%NABromley (Lamotrigine) (Epilepsy), 2023 Thomas (Lamotrigine) (Epilepsy), 2022 Videman (Lamotrigine), 2016 Bromley (Lamotrigine) (Controls unexposed, sick), 2010 4 extrapolated (cont. endpoint)extrapolated (cont. endpoint) 1.91[0.43; 8.44]-3473%NAThomas (Lamotrigine) (Epilepsy), 2022 Videman (Lamotrigine), 2016 2 All studiesAll studies 1.55[0.68; 3.52]1114133%NABromley (Lamotrigine) (Epilepsy), 2023 Thomas (Lamotrigine) (Epilepsy), 2022 Videman (Lamotrigine), 2016 Bromley (Lamotrigine) (Controls unexposed, sick), 2010 40.210.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-2.42.81.2210.000Bromley (Lamotrigine) (Epilepsy), 2023Thomas (Lamotrigine) (Epilepsy), 2022Videman (Lamotrigine), 2016Bromley (Lamotrigine) (Controls unexposed, sick), 2010

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

not enought points

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 8932

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 2.76[1.19; 6.39]23420%NAVideman (Lamotrigine), 2016 Bromley (Lamotrigine) (Controls unexposed, disease free), 2010 2 unexposed, sick controlsunexposed, sick controls 1.06[0.54; 2.07]111330%NABromley (Lamotrigine) (Epilepsy), 2023 Thomas (Lamotrigine) (Epilepsy), 2022 Bromley (Lamotrigine) (Controls unexposed, sick), 2010 30.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Peron (Epilepsy) (Cognitive developmental del ...Peron (Epilepsy) (Cognitive developmental delay (< 3 years old)) 3.42[1.17; 9.98]0%-Wwhatever (meta-analysis)Anyduring pregnancy (anytime or not specified)studies TTT2 metaPregmetaPreg 1.55[0.68; 3.52]33%141----Bromley (Lamotrigine) (Epilepsy), 2023 Thomas (Lamotrigine) (Epilepsy), 2022 Videman (Lamotrigine), 2016 Bromley (Lamotrigine) (Controls unexposed, sick), 2010 40.510.01.0