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

Cognitive developmental disorders/delay (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.
S17414
R73087		 Madley-Dowd_SE (Levetiracetam) (Controls exposed to LTG) (Mixed indications), 2024 Intellectual disability (intelligence quotient below 70) - ICD-8/9/10 codes - Mean 5-20 years old (according groups_followup LEV 4.41 (2.49-7.56)) during pregnancy (anytime or not specified) population based cohort retrospective exposed to other treatment, sick excluded Adjustment: Yes 0.60 [0.19;1.92]
excluded (control group) 		-/613   60/5,035 - 613
ref
S17415
R73088		 Madley-Dowd_SE (Levetiracetam) (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_followup LEV 4.41 (2.49-7.56)) during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes 0.66 [0.21;2.05] -/613   24,323/2,651,210 - 613
ref
S17416
R73089		 Madley-Dowd_SE (Levetiracetam) (Controls unexposed, sibling) (Mixed indications), 2024 Intellectual disability (intelligence quotient below 70) - ICD-8/9/10 codes - Mean 5-20 years old (according groups_followup LEV 4.41 (2.49-7.56)) during pregnancy (anytime or not specified) population based cohort retrospective sibling excluded Adjustment: Yes 0.71 [0.08;6.47]
excluded (control group) 		-/-   -/- - -
ref
S17267
R72349		 Madley-Dowd_UK (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 Intellectual disability - ICD10 codes - Median 4.19 (2.56-6.79) years old during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 1.19 [0.07;19.11] C 0/193   1,119/514,066 1,119 193
ref
S10071
R48765		 Coste (Levetiracetam) (Controls exposed to Lamotrigine, sick), 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 0.40 [0.10;2.90]
excluded (control group) 		1/621   10/2,108 11 621
ref
S9020
R48766		 Coste (Levetiracetam) (Controls unexposed, NOS), 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 0.70 [0.10;4.90] 1/621   3,398/1,710,441 3,399 621
ref
Total 3 studies 0.71 [0.28;1.80] 4,518 1,427
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 (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024Madley-Dowd_SE, 2024 1 0.66[0.21; 2.05]-61366%ROB confusion: seriousROB selection: lowROB classification: lowROB missing: lowROB mesure: criticalROB reporting: moderate Madley-Dowd_UK (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024Madley-Dowd_UK, 2024 2 1.19[0.07; 19.11]1,11919311%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: unclearROB mesure: criticalROB reporting: moderate Coste (Levetiracetam) (Controls unexposed, NOS), 2020Coste, 2020 3 0.70[0.10; 4.90]3,39962123%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (3 studies) I2 = 0% 0.71[0.28; 1.80]4,5181,4270.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

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

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.71[0.28; 1.80]4,5181,4270%NAMadley-Dowd_SE (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_UK (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 3 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.71[0.28; 1.80]4,5181,4270%NAMadley-Dowd_SE (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_UK (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 3 Tags Adjustment   - No  - No 1.19[0.07; 19.11]1,119193 -NAMadley-Dowd_UK (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 1   - Yes  - Yes 0.67[0.25; 1.79]3,3991,2340%NAMadley-Dowd_SE (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 2 All studiesAll studies 0.71[0.28; 1.80]4,5181,4270%NAMadley-Dowd_SE (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_UK (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 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 10071, 17414, 17416

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 0.71[0.28; 1.80]28,8321,4270%NAMadley-Dowd_SE (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 Madley-Dowd_UK (Levetiracetam) (Controls unexposed, general pop) (Mixed indications), 2024 Coste (Levetiracetam) (Controls unexposed, NOS), 2020 3 exposed to other treatment, sick controlsexposed to other treatment, sick controls 0.53[0.20; 1.37]621,2340%NAMadley-Dowd_SE (Levetiracetam) (Controls exposed to LTG) (Mixed indications), 2024 Coste (Levetiracetam) (Controls exposed to Lamotrigine, sick), 2020 2 siblingssiblings 0.71[0.08; 6.39]-- -NAMadley-Dowd_SE (Levetiracetam) (Controls unexposed, sibling) (Mixed indications), 2024 10.510.01.0