| 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| S19392 R82384 |
Honybun (Controls exposed to LTG) (Topiramate) (Epilepsy), 2026 | Verbal Comprehension Index - Wechsler Intelligence Scale - Children aged 3–18 years (mean age about 10 years) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick excluded | Adjustment: No extrapolated (cont. endpoint) |
2.43 [0.65;9.11] excluded (control group) |
-/11 -/23 | - | 11 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S19388 R82344 |
Honybun (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026 | Verbal Comprehension Index - Wechsler Intelligence Scale - Children aged 3–18 years (mean age about 10 years) | during pregnancy (anytime or not specified) | prospective cohort | unexposed, sick | Adjustment: No extrapolated (cont. endpoint) | 7.49 [2.15;26.10] | -/19 -/19 | - | 19 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S19379 R82266 |
Straub (Controls exposed to LTG) (Topiramate) (Epilepsy), 2026 | Speech or language disorder - ICD-10 codes: F80.xx (except F80.4), H93.25 - Mean follow up (full cohort): 3.4 years | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: No |
1.10 [0.80;1.49] C excluded (control group) |
56/961 175/3,273 | 231 | 961 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S19372 R82170 |
Straub (Controls unexposed, sick) (Topiramate) (Epilepsy), 2026 | Speech or language disorder - ICD-10 codes: F80.xx (except F80.4), H93.25 - Mean follow up (full cohort): 3.4 years | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed, sick | Adjustment: Yes | 0.89 [0.66;1.19] | 56/961 456/8,887 | 512 | 961 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S19337 R82023 |
Moore (Controls exposed to LTG) (Topiramate) (Indication NOS), 2025 | Speech, language and communication disorders - Assessment offered to all children - At the 27–30 months | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
0.65 [0.40;1.05] C excluded (control group) |
22/172 172/934 | 194 | 172 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S19330 R82044 |
Moore (Controls unexposed, general pop) (Topiramate) (Indication NOS), 2025 | Speech, language and communication disorders - Assessment offered to all children - At the 27–30 months | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: No Matched | 1.22 [0.76;1.95] C | 22/172 185/1,720 | 207 | 172 |
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ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S12810 R48233 |
Meador (Topiramate) (Controls exposed to Lamotrigine, sick), 2021 | Language Score in 2 years old children with the Bayley Scales of Infant and Toddler Development (BSID-III) | 3rd trimester | prospective cohort | exposed to other treatment, sick excluded | Adjustment: Yes extrapolated (cont. endpoint) |
2.58 [0.50;13.27] excluded (control group) |
-/5 -/93 | - | 5 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S12811 R48234 |
Meador (Topiramate) (Controls unexposed, disease free), 2021 | Language Score in 2 years old children with the Bayley Scales of Infant and Toddler Development (BSID-III) | 3rd trimester | prospective cohort | unexposed, disease free | Adjustment: Yes extrapolated (cont. endpoint) | 2.49 [0.48;12.82] | -/5 -/87 | - | 5 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S10103 R36820 |
Coste (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2020 | Visits to a speech therapist (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 |
1.20 [0.80;1.80] excluded (control group) |
33/477 157/2,916 | 190 | 477 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8613 R28742 |
Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 | Health care utilization: Speech therapy (mean age of 3.6 years old) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: Yes | 1.40 [1.00;2.00] | 33/477 72,012/1,710,441 | 72,045 | 477 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8583 R28561 |
Husebye (Topiramate) (Controls exposed to Lamotrigine, sick), 2020 | Language impairment age 8 years (Language 20) | during pregnancy (anytime or not specified) | population based cohort propective | exposed to other treatment, sick excluded | Adjustment: No |
1.19 [0.11;12.82] C excluded (control group) |
1/4 9/41 | 10 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8584 R28563 |
Husebye (Topiramate) (Controls unexposed, disease free), 2020 | Language impairment age 8 years (Language 20) | during pregnancy (anytime or not specified) | population based cohort propective | unexposed, disease free excluded | Adjustment: Yes |
1.10 [0.10;10.90] excluded (control group) |
1/4 8,250/42,550 | 8,251 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8585 R28565 |
Husebye (Topiramate) (Controls unexposed, sick), 2020 | Language impairment age 8 years (Language 20) | during pregnancy (anytime or not specified) | population based cohort propective | unexposed, sick | Adjustment: No | 1.10 [0.11;10.87] C | 1/4 35/150 | 36 | 4 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8582 R28544 |
Bromley (Topiramate), 2016 | Verbal abilities <85 (Wechsler Preschool and Primary Scale of Intelligence (WPPSI) / Wechsler Intelligence Scale for Children (WISC)) (5-9 years old) | during pregnancy (anytime or not specified) | retrospective cohort (registry) | unexposed, sick | Adjustment: No | 1.59 [0.33;7.69] C | 3/27 4/55 | 7 | 27 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8615 R28766 |
Rihtman (Topiramate) (Mixed indications), 2012 | Verbal IQ (Stanford Binet) (mean age around 4 years old) | at least 1st trimester | prospective cohort | unexposed (general population or NOS) | Adjustment: No extrapolated (cont. endpoint) Matched | 5.71 [1.23;26.53] | -/9 -/18 | - | 9 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total | 8 studies | 1.56 [1.02;2.37] | 72,807 | 1,674 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
1: Controls unexposed, sick) (Topiramate) (Epilepsy; 2: Controls unexposed, sick) (Topiramate) (Epilepsy; 3: Controls unexposed, general pop) (Topiramate) (Indication NOS; 4: Topiramate) (Controls unexposed, disease free; 5: Topiramate) (Controls unexposed, NOS) (Mixed indications; 6: Topiramate) (Controls unexposed, sick; 7: Topiramate; 8: Topiramate) (Mixed indications;
Asymetry test p-value = 0.0694 (by Egger's regression)
slope=-0.1805 (0.2094); intercept=1.6439 (0.7449); t=2.2071; p=0.0694
excluded 10103, 8583, 8584, 12810, 19337, 19392, 19379