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

Major congenital malformations

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.
S17172
R71996		 Battino (Epilepsy), 2024 Major congenital malformations (MCMs) early pregnancy prospective cohort exposed to other treatment, sick Adjustment: No 2.42 [0.14;43.19] C 0/7   110/3,584 110 7
ref
S17173
R71998		 The NAAED (Indications NOS) (Controls exposed to LTG), 2024 Major congenital malformations 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 2.41 [0.14;42.03] C
excluded (control group) 		0/10   52/2,461 52 10
ref
S17174
R72000		 The NAAED (Indications NOS) (Controls unexposed, disease free), 2024 Major congenital malformations 1st trimester prospective cohort unexposed, disease free Adjustment: No 4.40 [0.25;78.96] C 0/10   15/1,311 15 10
ref
S17190
R72042		 The UKIEPR (Epilepsy) (Controls exposed to Lamotrigine), 2024 Major malformations 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 41.38 [0.81;2106.99] C
excluded (control group) 		0/1   49/2,098 49 1
ref
S17191
R72044		 The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024 Major malformations 1st trimester prospective cohort unexposed, sick Adjustment: No 39.07 [0.75;2043.68] C 0/1   13/541 13 1
ref
Total 3 studies 5.49 [0.90;33.67] 138 18
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 Battino (Epilepsy), 2024Battino, 2024 1 2.42[0.14; 43.19]110740%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate The NAAED (Indications NOS) (Controls unexposed, disease free), 2024The NAAED, 2024 2 4.40[0.25; 78.96]151039%ROB confusion: criticalROB selection: unclearROB classification: moderateROB missing: unclearROB mesure: criticalROB reporting: low The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024The UKIEPR, 2024 3 39.07[0.75; 2043.68]13121%ROB confusion: unclearROB selection: lowROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Total (3 studies) I2 = 0% 5.49[0.90; 33.67]138180.9100.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Epilepsy; 2: Indications NOS) (Controls unexposed, disease free; 3: Epilepsy) (Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 5.49[0.90; 33.67]138180%NABattino (Epilepsy), 2024 The NAAED (Indications NOS) (Controls unexposed, disease free), 2024 The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024 3 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 4.40[0.25; 78.96]1510 -NAThe NAAED (Indications NOS) (Controls unexposed, disease free), 2024 1 unexposed, sickunexposed, sick 39.07[0.75; 2043.68]131 -NAThe UKIEPR (Epilepsy) (Controls unexposed, sick), 2024 1 exposed to other treatment, sickexposed to other treatment, sick 2.42[0.14; 43.19]1107 -NABattino (Epilepsy), 2024 1 Tags Adjustment   - No  - No 5.49[0.90; 33.67]138180%NABattino (Epilepsy), 2024 The NAAED (Indications NOS) (Controls unexposed, disease free), 2024 The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024 3 All studiesAll studies 5.49[0.90; 33.67]138180%NABattino (Epilepsy), 2024 The NAAED (Indications NOS) (Controls unexposed, disease free), 2024 The UKIEPR (Epilepsy) (Controls unexposed, sick), 2024 30.5100.01.0

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 17173, 17190

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 4.40[0.25; 78.96]1510 -NAThe NAAED (Indications NOS) (Controls unexposed, disease free), 2024 1 unexposed, sick controlsunexposed, sick controls Out of scale39.07[0.75; 2043.68]131 -NAThe UKIEPR (Epilepsy) (Controls unexposed, sick), 2024 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 4.39[0.72; 26.66]211180%NABattino (Epilepsy), 2024 The NAAED (Indications NOS) (Controls exposed to LTG), 2024 The UKIEPR (Epilepsy) (Controls exposed to Lamotrigine), 2024 30.510.01.0