Topiramate (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.
S17285
R72338
Madley-Dowd_UK (Topiramate) (Controls exposed to LTG) (Mixed indications), 2024 Intellectual disability - ICD10 codes - Median follow up 5.41 (3.59-8.40) years old during pregnancy (anytime or not specified) retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: Yes 1.98 [0.23;17.02]
excluded (control group)
-/154   -/939 - 154
ref
S17270
R72295
Madley-Dowd_UK (Topiramate) (Controls unexposed, general pop) (Mixed indications), 2024 Intellectual disability - ICD10 codes - Median follow up 5.41 (3.59-8.40) years old during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes 3.12 [0.43;22.82] -/154   1,119/514,066 - 154
ref
S17278
R72320
Madley-Dowd_UK (Topiramate) (Controls unexposed, sibling) (Mixed indications), 2024 Intellectual disability - ICD10 codes - Median follow up 5.41 (3.59-8.40) years old during pregnancy (anytime or not specified) retrospective cohort (claims database) sibling excluded Adjustment: Yes 1.35 [0.14;12.70]
excluded (control group)
-/-   -/- - -
ref
S12715
R47969
Bjørk (Topiramate) (Controls exposed to Lamotrigine, 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 topiramate 5.7 (2.9-9.1) years old during pregnancy (anytime or not specified) population based cohort retrospective exposed to other treatment, sick excluded Adjustment: No 3.79 [1.56;9.22] C
excluded (control group)
6/471   27/7,950 33 471
ref
S12716
R47972
Bjørk (Topiramate) (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 topiramate 5.7 (2.9-9.1) years old during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) excluded Adjustment: Yes 3.92 [1.76;8.74]
excluded (control group)
6/471   16,384/4,463,879 16,390 471
ref
S12718
R47978
Bjørk (Topiramate) (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 topiramate 5.7 (2.9-9.1) years old during pregnancy (anytime or not specified) population based cohort retrospective unexposed, sick Adjustment: No Controls: epilepsy indication 2.00 [0.88;4.54] C 6/471   139/21,634 145 471
ref
S10103
R36819
Coste (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2020 Diagnosis Mental retardation (F70–F79) (mean age of 3.7 years old) during pregnancy (anytime or not specified) retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: Yes 0.50 [0.10;3.30]
excluded (control group)
2/477   15/2,916 17 477
ref
S8613
R28739
Coste (Topiramate) (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 1.70 [0.40;6.80] 2/477   3,398/1,710,441 3,400 477
ref
Total 3 studies 2.03 [1.04;3.96] 3,545 1,102
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_UK (Topiramate) (Controls unexposed, general pop) (Mixed indications), 2024Madley-Dowd_UK, 2024 1 3.12[0.43; 22.82]-15411%ROB confusion: seriousROB selection: lowROB classification: criticalROB missing: unclearROB mesure: criticalROB reporting: moderate Bjørk (Topiramate) (Controls unexposed, sick) (Mixed indications), 2022Bjørk, 2022 2 2.00[0.88; 4.54]14547166%ROB confusion: unclearROB selection: lowROB classification: criticalROB missing: unclearROB mesure: moderateROB reporting: moderate Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020Coste, 2020 3 1.70[0.40; 6.80]3,40047722%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (3 studies) I2 = 0% 2.03[1.04; 3.96]3,5451,1020.510.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Topiramate) (Controls unexposed, general pop) (Mixed indications; 2: Topiramate) (Controls unexposed, sick) (Mixed indications; 3: Topiramate) (Controls unexposed, NOS) (Mixed indications;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 2.03[1.04; 3.96]3,5451,1020%NAMadley-Dowd_UK (Topiramate) (Controls unexposed, general pop) (Mixed indications), 2024 Bjørk (Topiramate) (Controls unexposed, sick) (Mixed indications), 2022 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 3 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 2.09[0.66; 6.61]3,4006310%NAMadley-Dowd_UK (Topiramate) (Controls unexposed, general pop) (Mixed indications), 2024 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 2 unexposed, sickunexposed, sick 2.00[0.88; 4.54]145471 -NABjørk (Topiramate) (Controls unexposed, sick) (Mixed indications), 2022 1 Tags Adjustment   - No  - No 2.00[0.88; 4.54]145471 -NABjørk (Topiramate) (Controls unexposed, sick) (Mixed indications), 2022 1   - Yes  - Yes 2.09[0.66; 6.61]3,4006310%NAMadley-Dowd_UK (Topiramate) (Controls unexposed, general pop) (Mixed indications), 2024 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 2 Controls   - epilepsy indication  - epilepsy indication 2.00[0.88; 4.54]145471 -NABjørk (Topiramate) (Controls unexposed, sick) (Mixed indications), 2022 1 All studiesAll studies 2.03[1.04; 3.96]3,5451,1020%NAMadley-Dowd_UK (Topiramate) (Controls unexposed, general pop) (Mixed indications), 2024 Bjørk (Topiramate) (Controls unexposed, sick) (Mixed indications), 2022 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 30.510.01.0

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 10103, 12715, 12716, 17285, 17278

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 3.19[1.65; 6.16]20,9001,1020%NAMadley-Dowd_UK (Topiramate) (Controls unexposed, general pop) (Mixed indications), 2024 Bjørk (Topiramate) (Controls unexposed NOS) (Mixed indications), 2022 Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 3 unexposed, sick controlsunexposed, sick controls 2.00[0.88; 4.54]145471 -NABjørk (Topiramate) (Controls unexposed, sick) (Mixed indications), 2022 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.82[0.51; 6.50]501,10252%NAMadley-Dowd_UK (Topiramate) (Controls exposed to LTG) (Mixed indications), 2024 Bjørk (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2022 Coste (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2020 3 siblingssiblings 1.35[0.14; 12.86]-- -NAMadley-Dowd_UK (Topiramate) (Controls unexposed, sibling) (Mixed indications), 2024 10.510.01.0