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

Oro-facial clefts

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.
S17498
R73510		 Wiggs (Epilepsy) (Lamotrigine), 2024 Cleft lip and cleft palate early pregnancy population based cohort retrospective unexposed, sick Adjustment: Yes 1.71 [0.54;5.45] -/1,412   -/9,364 - 1,412
ref
S15197
R62330		 Cohen (Lamotrigine) (Mixed indications), 2023 Orofacial clefts 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Partial overlapping 0.84 [0.50;1.42] -/8,339   -/4,866,362 - 8,339
ref
S10035
R40890		 Blotière (Lamotrigine) (Mixed indications), 2019 Oro-facial clefts 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 0.89 [0.33;2.37] C 4/2,997   2,815/1,875,733 2,819 2,997
ref
S8971
R30402		 Dolk (Lamotrigine) (Mixed indications), 2016 Isolated orofacial cleft 1st trimester case control unexposed (general population or NOS) Adjustment: Yes 1.46 [0.76;2.80] -/-   0/- - -
ref
S8921
R30156		 Holmes (Lamotrigine), 2008 All isolated (Cleft palate alone, Cleft lip alone and Cleft lip and palate) 1st trimester prospective cohort unexposed (general population or NOS) Adjustment: No 10.40 [4.30;24.90] 5/684   145/206,224 150 684
ref
Total 5 studies 1.78 [0.74;4.25] 2,969 13,432
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 Wiggs (Epilepsy) (Lamotrigine), 2024Wiggs, 2024 1 1.71[0.54; 5.45]-1,41217%ROB confusion: seriousROB selection: moderateROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Cohen (Lamotrigine) (Mixed indications), 2023Cohen, 2023 2 0.84[0.50; 1.42]-8,33923%ROB confusion: seriousROB selection: lowROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Blotière (Lamotrigine) (Mixed indications), 2019Blotière, 2019 3 0.89[0.33; 2.37]2,8192,99719%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Dolk (Lamotrigine) (Mixed indications), 2016Dolk, 2016 4 1.46[0.76; 2.80]--22%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Holmes (Lamotrigine), 2008Holmes, 2008 5 10.40[4.30; 24.90]15068420%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate Total (5 studies) I2 = 84% 1.78[0.74; 4.25]2,96913,4320.250.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Epilepsy) (Lamotrigine; 2: Lamotrigine) (Mixed indications; 3: Lamotrigine) (Mixed indications; 4: Lamotrigine) (Mixed indications; 5: Lamotrigine;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.89[0.56; 6.34]2,96913,43288%NAWiggs (Epilepsy) (Lamotrigine), 2024 Cohen (Lamotrigine) (Mixed indications), 2023 Blotière (Lamotrigine) (Mixed indications), 2019 Holmes (Lamotrigine), 2008 4 case control studiescase control studies 1.46[0.76; 2.80]-- -NADolk (Lamotrigine) (Mixed indications), 2016 1 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.80[0.64; 5.09]2,96912,02088%NACohen (Lamotrigine) (Mixed indications), 2023 Blotière (Lamotrigine) (Mixed indications), 2019 Dolk (Lamotrigine) (Mixed indications), 2016 Holmes (Lamotrigine), 2008 4 unexposed, sickunexposed, sick 1.71[0.54; 5.43]-1,412 -NAWiggs (Epilepsy) (Lamotrigine), 2024 1 Tags Adjustment   - No  - No 3.07[0.28; 34.20]2,9693,68193%NABlotière (Lamotrigine) (Mixed indications), 2019 Holmes (Lamotrigine), 2008 2   - Yes  - Yes 1.12[0.73; 1.72]-9,75113%NAWiggs (Epilepsy) (Lamotrigine), 2024 Cohen (Lamotrigine) (Mixed indications), 2023 Dolk (Lamotrigine) (Mixed indications), 2016 3 Partial overlappingPartial overlapping 0.84[0.50; 1.42]-8,339 -NACohen (Lamotrigine) (Mixed indications), 2023 1 All studiesAll studies 1.78[0.74; 4.25]2,96913,43284%NAWiggs (Epilepsy) (Lamotrigine), 2024 Cohen (Lamotrigine) (Mixed indications), 2023 Blotière (Lamotrigine) (Mixed indications), 2019 Dolk (Lamotrigine) (Mixed indications), 2016 Holmes (Lamotrigine), 2008 50.250.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-2.82.80.7080.000Wiggs (Epilepsy) (Lamotrigine), 2024Cohen (Lamotrigine) (Mixed indications), 2023Blotière (Lamotrigine) (Mixed indications), 2019Dolk (Lamotrigine) (Mixed indications), 2016Holmes (Lamotrigine), 2008

Asymetry test p-value = 0.4446 (by Egger's regression)

slope=-0.8935 (1.5260); intercept=3.5440 (4.0367); t=0.8779; p=0.4446

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) 1.80[0.64; 5.09]2,96912,02088%NACohen (Lamotrigine) (Mixed indications), 2023 Blotière (Lamotrigine) (Mixed indications), 2019 Dolk (Lamotrigine) (Mixed indications), 2016 Holmes (Lamotrigine), 2008 4 unexposed, sick controlsunexposed, sick controls 1.71[0.54; 5.43]-1,412 -NAWiggs (Epilepsy) (Lamotrigine), 2024 10.510.01.0