| 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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| S16072 R66698 |
Christensen (Topiramate) (All indications) (Controls exposed to LTG), 2024 | Small for gestational age (a z-score for birth weight ≤10th percentile for gestational week, sex, and country (including newborns with congenital malformations)) | during pregnancy (anytime or not specified) | population based cohort retrospective | exposed to other treatment, sick excluded | Adjustment: No |
1.51 [1.20;1.89] C excluded (control group) |
96/638 920/8,756 | 1,016 | 638 |
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| S16040 R66578 |
Christensen (Topiramate) (All indications) (Controls unexposed, general population), 2024 | Small for gestational age (a z-score for birth weight ≤10th percentile for gestational week, sex, and country (including newborns with congenital malformations)) | during pregnancy (anytime or not specified) | population based cohort retrospective | unexposed (general population or NOS) | Adjustment: Yes | 1.48 [1.18;1.85] | 96/638 446,267/4,467,848 | 446,363 | 638 |
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| S8613 R28735 |
Coste (Topiramate) (Controls unexposed, NOS) (Mixed indications), 2020 | Small for gestational age (weight) | during pregnancy (anytime or not specified) | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No | 1.20 [0.91;1.59] C | 55/477 167,376/1,710,441 | 167,431 | 477 |
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| S8592 R28596 |
Cohen (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 | Small for gestational age (ICD-9 656.5, 764.0, 764.1, 764.9) | early pregnancy | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: Yes |
1.43 [0.96;2.12] excluded (control group) |
88/2,280 106/2,682 | 194 | 2,280 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8593 R28603 |
Cohen (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 | Small for gestational age (ICD-9 656.5, 764.0, 764.1, 764.9) | early pregnancy | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: Yes | 0.95 [0.76;1.17] | 88/2,280 41,653/1,440,631 | 41,741 | 2,280 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8602 R28635 |
Bank (Topiramate) (Mixed indications) , 2017 | Small for Gestational Age birthweight (<10th percentile) | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: No | 11.00 [0.54;223.91] C | 1/2 3/36 | 4 | 2 |
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| S8601 R28633 |
Hernández-Díaz (Topiramate), 2017 | Small for gestational age | during pregnancy (anytime or not specified) | prospective cohort | exposed to other treatment, sick | Adjustment: Yes | 2.40 [1.80;3.10] | -/394 -/1,799 | - | 394 |
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| S8595 R28612 |
Veiby (Topiramate) (Controls unexposed, disease free) (Mixed indications), 2014 | Small for gestational age (SGA) birth weight < 10th percentile | throughout pregnancy | population based cohort retrospective | unexposed, disease free excluded | Adjustment: Yes |
3.29 [1.70;6.39] excluded (control group) |
12/48 68,656/771,412 | 68,668 | 48 |
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| S8596 R28615 |
Veiby (Topiramate) (Controls unexposed, sick) (Mixed indications), 2014 | Small for gestational age (SGA) birth weight < 10th percentile | throughout pregnancy | population based cohort retrospective | unexposed, sick | Adjustment: No Controls: epilepsy indication | 2.90 [1.50;5.62] C | 12/48 389/3,773 | 401 | 48 |
|
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| Total | 6 studies | 1.60 [1.11;2.32] | 655,940 | 3,839 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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: Topiramate) (All indications) (Controls unexposed, general population; 2: Topiramate) (Controls unexposed, NOS) (Mixed indications; 3: Topiramate) (Controls unexposed NOS) (Mixed indications; 4: Topiramate) (Mixed indications; 5: Topiramate; 6: Topiramate) (Controls unexposed, sick) (Mixed indications;
Asymetry test p-value = 0.3275 (by Egger's regression)
slope=-0.0029 (0.3435); intercept=2.5605 (2.2971); t=1.1146; p=0.3275
excluded 8595, 8592, 16072