Topiramate (All indications)

Microcephaly / Small head circumference for gestational age

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.
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 2 studies 7.34 [3.39;15.86] 18,960 565
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 Blotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019Blotière, 2019 1 9.00[0.20; 50.80]4395178%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Veiby (Topiramate) (Controls unexposed, disease free) (Mixed indications), 2014Veiby, 2014 2 7.21[3.23; 16.10]18,5214892%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate Total (2 studies) I2 = 0% 7.34[3.39; 15.86]18,9605650.920.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Topiramate) (Controls unexposed NOS) (Mixed indications; 2: Topiramate) (Controls unexposed, disease free) (Mixed indications;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 7.34[3.39; 15.86]18,9605650%NABlotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 Veiby (Topiramate) (Controls unexposed, disease free) (Mixed indications), 2014 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 7.34[3.39; 15.86]18,9605650%NABlotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 Veiby (Topiramate) (Controls unexposed, disease free) (Mixed indications), 2014 2 Tags Adjustment   - No  - No 9.00[0.56; 143.44]439517 -NABlotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 1   - Yes  - Yes 7.21[3.23; 16.10]18,52148 -NAVeiby (Topiramate) (Controls unexposed, disease free) (Mixed indications), 2014 1 All studiesAll studies 7.34[3.39; 15.86]18,9605650%NABlotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 Veiby (Topiramate) (Controls unexposed, disease free) (Mixed indications), 2014 20.520.01.0

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 10173

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 7.34[3.39; 15.86]18,9605650%NABlotière (Topiramate) (Controls unexposed NOS) (Mixed indications), 2019 Veiby (Topiramate) (Controls unexposed, disease free) (Mixed indications), 2014 2 exposed to other treatment, sick controlsexposed to other treatment, sick controls 5.81[0.36; 92.98]2517 -NABlotière (Topiramate) (Controls exposed to Lamotrigine, sick) (Mixed indications), 2019 10.510.01.0