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

Severe cognitive developmental delay (Mental retardation) (> 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.
S17412
R73051
Madley-Dowd_SE (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 Intellectual disability (intelligence quotient below 70) - ICD-8/9/10 codes - Mean 5-20 years old (according groups) during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes 1.09 [0.83;1.44] 60/5,035   24,323/2,651,210 24,383 5,035
ref
S17413
R73057
Madley-Dowd_SE (Lamotrigine) (Controls unexposed, sibling) (Mixed indications), 2024 Intellectual disability (intelligence quotient below 70) - ICD-8/9/10 codes - Mean 5-20 years old (according groups) during pregnancy (anytime or not specified) population based cohort retrospective sibling excluded Adjustment: Yes 1.04 [0.52;2.10]
excluded (control group)
-/-   -/- - -
ref
S17266
R72283
Madley-Dowd_UK (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 Intellectual disability - ICD10 codes - Median 6.18 (3.53-9.94) years old during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes 1.57 [0.57;4.38] -/939   1,119/514,066 - 939
ref
S17274
R72307
Madley-Dowd_UK (Lamotrigine) (Controls unexposed, sibling) (Mixed indications), 2024 Intellectual disability - ICD10 codes - Median 6.18 (3.53-9.94) years old during pregnancy (anytime or not specified) retrospective cohort (claims database) sibling excluded Adjustment: Yes 2.42 [0.46;12.72]
excluded (control group)
-/-   -/- - -
ref
S17470
R73440
Dreier (Lamotrigine) (Epilepsy), 2023 Intellectual disability - Corresponding ICD-10 F-chapter - Up to 22 years of age during pregnancy (anytime or not specified) population based cohort propective unexposed, sick Adjustment: Yes 0.85 [0.58;1.24] 34/5,288   184/22,203 218 5,288
ref
Total 3 studies 1.02 [0.82;1.27] 24,601 11,262
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 Madley-Dowd_SE (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024Madley-Dowd_SE, 2024 1 1.09[0.83; 1.44]24,3835,03563%ROB confusion: seriousROB selection: lowROB classification: lowROB missing: lowROB mesure: criticalROB reporting: moderate Madley-Dowd_UK (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024Madley-Dowd_UK, 2024 2 1.57[0.57; 4.38]-9395%ROB confusion: seriousROB selection: lowROB classification: criticalROB missing: unclearROB mesure: criticalROB reporting: moderate Dreier (Lamotrigine) (Epilepsy), 2023Dreier, 2023 3 0.85[0.58; 1.24]2185,28833%ROB confusion: seriousROB selection: lowROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Total (3 studies) I2 = 0% 1.02[0.82; 1.27]24,60111,2620.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Lamotrigine) (Controls unexposed, general pop) (Mixed indications; 2: Lamotrigine) (Controls unexposed, general pop) (Mixed indications; 3: Lamotrigine) (Epilepsy;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.02[0.82; 1.27]24,60111,2620%NAMadley-Dowd_SE (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_UK (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 Dreier (Lamotrigine) (Epilepsy), 2023 3 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.12[0.86; 1.46]24,3835,9740%NAMadley-Dowd_SE (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_UK (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 2 unexposed, sickunexposed, sick 0.85[0.58; 1.24]2185,288 -NADreier (Lamotrigine) (Epilepsy), 2023 1 Tags Adjustment   - Yes  - Yes 1.02[0.82; 1.27]24,60111,2620%NAMadley-Dowd_SE (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_UK (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 Dreier (Lamotrigine) (Epilepsy), 2023 3 All studiesAll studies 1.02[0.82; 1.27]24,60111,2620%NAMadley-Dowd_SE (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_UK (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 Dreier (Lamotrigine) (Epilepsy), 2023 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 17413, 17274

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.12[0.86; 1.46]25,4935,9740%NAMadley-Dowd_SE (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_UK (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 2 unexposed, sick controlsunexposed, sick controls 0.85[0.58; 1.24]2185,288 -NADreier (Lamotrigine) (Epilepsy), 2023 1 siblingssiblings 1.18[0.62; 2.25]--0%NAMadley-Dowd_SE (Lamotrigine) (Controls unexposed, sibling) (Mixed indications), 2024 Madley-Dowd_UK (Lamotrigine) (Controls unexposed, sibling) (Mixed indications), 2024 20.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Peron (Epilepsy) (Severe cognitive developmen ...Peron (Epilepsy) (Severe cognitive developmental delay (>6 years old)) 0.73[0.46; 1.16]NA-Wwhatever (meta-analysis)Anyduring pregnancy (anytime or not specified)studies TTT1 metaPregmetaPreg 1.02[0.82; 1.27]0%11,262----Madley-Dowd_SE (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_UK (Lamotrigine) (Controls unexposed, general pop) (Mixed indications), 2024 Dreier (Lamotrigine) (Epilepsy), 2023 30.510.01.0