Lamotrigine (All indications) updated on 04-22-2025

Cleft palate

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.
S19314
R81799		 Kim (Lamotrigine) (Indications NOS), 2026 Cleft palate without cleft lip 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes 0.72 [0.08;6.51] 1/718   3,086/2,489,078 3,087 718
ref
S10035
R36160		 Blotière (Lamotrigine) (Mixed indications), 2019 Cleft palate 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 1.10 [0.10;3.90] 2/2,997   1,178/1,875,733 1,180 2,997
ref
S8971
R30404		 Dolk (Lamotrigine) (Mixed indications), 2016 Isolated cleft palate 1st trimester case control unexposed (general population or NOS) Adjustment: Yes 1.23 [0.39;3.89] -/-   0/- - -
ref
S8921
R30149		 Holmes (Lamotrigine), 2008 Cleft palate alone isolated 1st trimester prospective cohort unexposed (general population or NOS) Adjustment: No 21.00 [6.80;65.10] 3/684   43/206,224 46 684
ref
Total 4 studies 2.36 [0.42;13.41] 4,313 4,399
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 Kim (Lamotrigine) (Indications NOS), 2026Kim, 2026 1 0.72[0.08; 6.51]3,08771821%ROB confusion: seriousROB selection: lowROB classification: criticalROB missing: unclearROB mesure: moderateROB reporting: moderate Blotière (Lamotrigine) (Mixed indications), 2019Blotière, 2019 2 1.10[0.10; 3.90]1,1802,99723%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Dolk (Lamotrigine) (Mixed indications), 2016Dolk, 2016 3 1.23[0.39; 3.89]--28%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Holmes (Lamotrigine), 2008Holmes, 2008 4 21.00[6.80; 65.10]4668428%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate Total (4 studies) I2 = 82% 2.36[0.42; 13.41]4,3134,3990.250.01.0ROB: A: confounding, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Lamotrigine) (Indications NOS; 2: Lamotrigine) (Mixed indications; 3: Lamotrigine) (Mixed indications; 4: Lamotrigine;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 2.91[0.28; 30.42]4,3134,39983%NAKim (Lamotrigine) (Indications NOS), 2026 Blotière (Lamotrigine) (Mixed indications), 2019 Holmes (Lamotrigine), 2008 3 case control studiescase control studies 1.23[0.39; 3.88]-- -NADolk (Lamotrigine) (Mixed indications), 2016 1 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 2.36[0.42; 13.41]4,3134,39982%NAKim (Lamotrigine) (Indications NOS), 2026 Blotière (Lamotrigine) (Mixed indications), 2019 Dolk (Lamotrigine) (Mixed indications), 2016 Holmes (Lamotrigine), 2008 4 Tags Adjustment   - No  - No 5.27[0.29; 94.28]1,2263,68186%NABlotière (Lamotrigine) (Mixed indications), 2019 Holmes (Lamotrigine), 2008 2   - Yes  - Yes 1.10[0.40; 3.04]3,0877180%NAKim (Lamotrigine) (Indications NOS), 2026 Dolk (Lamotrigine) (Mixed indications), 2016 2 All studiesAll studies 2.36[0.42; 13.41]4,3134,39982%NAKim (Lamotrigine) (Indications NOS), 2026 Blotière (Lamotrigine) (Mixed indications), 2019 Dolk (Lamotrigine) (Mixed indications), 2016 Holmes (Lamotrigine), 2008 40.250.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-3.73.71.3470.000Kim (Lamotrigine) (Indications NOS), 2026Blotière (Lamotrigine) (Mixed indications), 2019Dolk (Lamotrigine) (Mixed indications), 2016Holmes (Lamotrigine), 2008

Asymetry test p-value = NaN (by Egger's regression)

not enought points

p values plot
0.01.00.01.0

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) 2.36[0.42; 13.41]4,3134,39982%NAKim (Lamotrigine) (Indications NOS), 2026 Blotière (Lamotrigine) (Mixed indications), 2019 Dolk (Lamotrigine) (Mixed indications), 2016 Holmes (Lamotrigine), 2008 40.510.01.0