| 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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| S16072 R66699 |
Christensen (Topiramate) (All indications) (Controls exposed to LTG), 2024 | Microcephaly (z-score for head circumference ≤3rd 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 |
1.42 [0.95;2.11] C excluded (control group) |
28/638 274/8,756 | 302 | 638 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S16040 R66579 |
Christensen (Topiramate) (All indications) (Controls unexposed, general population), 2024 | Microcephaly (z-score for head circumference ≤3rd 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 | 1.35 [0.92;1.99] | 28/638 134,023/4,467,848 | 134,051 | 638 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S10173 R37180 |
Blotière (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 | Microcephaly (until 24 months of age, identifiable by: Q02; brain MRI; according to the EUROCAT definition) | 1st trimester | retrospective cohort (claims database) | exposed to other treatment, sick excluded | Adjustment: No |
5.81 [0.36;92.98] C excluded (control group) |
1/517 1/2,997 | 2 | 517 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S10048 R36431 |
Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 | Microcephaly (until 24 months of age, identifiable by: Q02; brain MRI; according to the EUROCAT definition) | 1st trimester | retrospective cohort (claims database) | unexposed (general population or NOS) | Adjustment: No | 9.00 [0.20;50.80] | 1/517 438/1,875,733 | 439 | 517 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| S8595 R28611 |
Veiby (Topiramate) (Controls unexposed, disease free) (Mixed indications), 2014 | Small for gestational age head circumference at birth (< 2.5th percentile) | throughout pregnancy | population based cohort retrospective | unexposed, disease free | Adjustment: Yes | 7.21 [3.23;16.10] | 7/48 18,514/771,412 | 18,521 | 48 |
|
ref | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Total | 3 studies | 3.61 [0.85;15.40] | 153,011 | 1,203 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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, disease free) (Mixed indications;
Funnel plot not drawn. Less than 3 points.
Asymetry test p-value = NaN (by Egger's regression)
not enought points
Funnel plot not drawn. Less than 3 points.
excluded 10173, 16072