Lamotrigine (Epilepsy) updated on 04-22-2025

Severe cognitive developmental delay (Mental retardation) (3-6 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.
S12723
R73453
Bjørk (Controls unexposed, NOS), 2022 Diagnosis of intellectual disability (ID): mild ID (F70), moderate ID (F71), severe ID (F72), and profound ID (F73) - Median follow up lamotrigine 5.1 (2.4-8.5) years old during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) excluded Adjustment: No 1.13 [0.73;1.73] C
excluded (control group)
21/5,073   16,384/4,463,879 16,405 5,073
ref
S12722
R73452
Bjørk (Controls unexposed, sick), 2022 Diagnosis of intellectual disability (ID): mild ID (F70), moderate ID (F71), severe ID (F72), and profound ID (F73) - Median follow up lamotrigine 5.1 (2.4-8.5) years old during pregnancy (anytime or not specified) population based cohort retrospective unexposed, sick Adjustment: Yes 0.73 [0.46;1.16] 21/5,073   139/21,634 160 5,073
ref
S6940
R25096
Cummings, 2011 Significant delay (score ≥2 SD below the mean) (Bayley Scales of Infant Development or the Griffiths Scale) (mean age in years: m1=2.7 and m0=4.3) throughout pregnancy retrospective cohort (registry) unexposed, disease free Adjustment: No 0.41 [0.02;10.40] C 0/35   1/44 1 35
ref
Total 2 studies 0.72 [0.46;1.14] 161 5,108
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 Bjørk (Controls unexposed, sick), 2022Bjørk, 2022 1 0.73[0.46; 1.16]1605,07398%ROB confusion: seriousROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Cummings, 2011Cummings, 2011 0.41[0.02; 10.40]1352%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: unclearROB mesure: lowROB reporting: moderate Total (2 studies) I2 = 0% 0.72[0.46; 1.14]1615,1080.22.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.72[0.46; 1.14]1615,1080%NABjørk (Controls unexposed, sick), 2022 Cummings, 2011 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.41[0.02; 10.40]135 -NACummings, 2011 1 unexposed, sickunexposed, sick 0.73[0.46; 1.16]1605,073 -NABjørk (Controls unexposed, sick), 2022 1 Tags Adjustment   - No  - No 0.41[0.02; 10.40]135 -NACummings, 2011 1   - Yes  - Yes 0.73[0.46; 1.16]1605,073 -NABjørk (Controls unexposed, sick), 2022 1 All studiesAll studies 0.72[0.46; 1.14]1615,1080%NABjørk (Controls unexposed, sick), 2022 Cummings, 2011 20.210.01.0

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 12723

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.11[0.72; 1.70]16,4065,1080%NABjørk (Controls unexposed, NOS), 2022 Cummings, 2011 2 unexposed, sick controlsunexposed, sick controls 0.73[0.46; 1.16]1605,073 -NABjørk (Controls unexposed, sick), 2022 10.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Peron (Epilepsy) (Severe cognitive developmen ...Peron (Epilepsy) (Severe cognitive developmental delay (3-6 years old)) Out of scale0.41[0.02; 10.40]NA-Wwhatever (meta-analysis)Anyduring pregnancy (anytime or not specified)studies TTT1 metaPregmetaPreg 0.72[0.46; 1.14]0%5,108----Bjørk (Controls unexposed, sick), 2022 Cummings, 2011 20.510.01.0