Lamotrigine (All indications)

Severe cognitive developmental delay (Mental retardation) (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.
S8978
R30438
Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 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 2.40 [1.40;4.00] 15/2,813   3,385/1,707,707 3,400 2,813
ref
S8942
R30235
Cummings (Lamotrigine), 2011 Significant delay (score ≥2 SD below the mean) (Bayley Scales of Infant Development or the Griffiths Scale) (mean age in years: m1=2.7 and m0=4.3) throughout pregnancy retrospective cohort (registry) unexposed, disease free Adjustment: No 0.41 [0.02;10.40] C 0/35   1/44 1 35
ref
Total 2 studies 2.10 [0.84;5.24] 3,401 2,848
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 Coste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020Coste, 2020 1 2.40[1.40; 4.00]3,4002,81392%ROB confusion: seriousROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: criticalROB reporting: moderate Cummings (Lamotrigine), 2011Cummings, 2011 2 0.41[0.02; 10.40]1358%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: unclearROB mesure: lowROB reporting: moderate Total (2 studies) I2 = 10% 2.10[0.84; 5.24]3,4012,8480.25.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Lamotrigine) (Controls unexposed NOS) (Mixed indications; 2: Lamotrigine;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 2.10[0.84; 5.24]3,4012,84810%NACoste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Cummings (Lamotrigine), 2011 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 2.10[0.84; 5.24]3,4012,84810%NACoste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Cummings (Lamotrigine), 2011 2 Tags Adjustment   - No  - No 0.41[0.02; 10.40]135 -NACummings (Lamotrigine), 2011 1   - Yes  - Yes 2.40[1.42; 4.06]3,4002,813 -NACoste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 1 All studiesAll studies 2.10[0.84; 5.24]3,4012,84810%NACoste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Cummings (Lamotrigine), 2011 20.25.01.0

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

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 2.10[0.84; 5.24]3,4012,84810%NACoste (Lamotrigine) (Controls unexposed NOS) (Mixed indications), 2020 Cummings (Lamotrigine), 2011 20.510.01.0