Lamotrigine (All indications) 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.
S12727
R48006
Bjørk (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 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: Yes 1.34 [0.92;1.95]
excluded (control group)
27/7,950   16,384/4,463,879 16,411 7,950
ref
S12728
R48009
Bjørk (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 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: No Controls: epilepsy indication 0.53 [0.35;0.80] C 27/7,950   139/21,634 166 7,950
ref
S8978
R30438
Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Diagnosis Mental retardation (F70–F79) (mean age of 3.6 years old) during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes 2.40 [1.40;4.00] 15/2,813   3,385/1,707,707 3,400 2,813
ref
S8942
R30235
Cummings (Lamotrigine), 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 3 studies 0.98 [0.26;3.76] 3,567 10,798
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 (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2022Bjørk, 2022 1 0.53[0.35; 0.80]1667,95044%ROB confusion: unclearROB selection: lowROB classification: criticalROB missing: unclearROB mesure: moderateROB reporting: moderate Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020Coste, 2020 2 2.40[1.40; 4.00]3,4002,81343%ROB confusion: seriousROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: criticalROB reporting: moderate Cummings (Lamotrigine), 2011Cummings, 2011 3 0.41[0.02; 10.40]13513%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: unclearROB mesure: lowROB reporting: moderate Total (3 studies) I2 = 90% 0.98[0.26; 3.76]3,56710,7980.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Lamotrigine) (Controls unexposed, sick) (Mixed indications; 2: Lamotrigine) (Controls unexposed NOS) (Mixed indications; 3: Lamotrigine;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.98[0.26; 3.76]3,56710,79890%NABjørk (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2022 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Cummings (Lamotrigine), 2011 3 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 2.10[0.84; 5.24]3,4012,84810%NACoste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Cummings (Lamotrigine), 2011 2 unexposed, sickunexposed, sick 0.53[0.35; 0.80]1667,950 -NABjørk (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2022 1 Tags Adjustment   - No  - No 0.52[0.35; 0.79]1677,9850%NABjørk (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2022 Cummings (Lamotrigine), 2011 2   - Yes  - Yes 2.40[1.42; 4.06]3,4002,813 -NACoste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 1 Controls   - epilepsy indication  - epilepsy indication 0.53[0.35; 0.80]1667,950 -NABjørk (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2022 1 All studiesAll studies 0.98[0.26; 3.76]3,56710,79890%NABjørk (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2022 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Cummings (Lamotrigine), 2011 30.25.01.0

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 12727

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.67[0.99; 2.83]19,81210,79848%NABjørk (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2022 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Cummings (Lamotrigine), 2011 3 unexposed, sick controlsunexposed, sick controls 0.53[0.35; 0.80]1667,950 -NABjørk (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 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 0.98[0.26; 3.76]90%10,798----Bjørk (Lamotrigine) (Controls unexposed, sick) (Mixed indications), 2022 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Cummings (Lamotrigine), 2011 30.510.01.0