Pregabalin (Epilepsy) 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.
S16713
R70303		 Battino, 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
S7796
R23014		 Vajda (Pregabalin) (Controls exposed to Lamotrigine, sick), 2019 Fetal malformations at least 1st trimester prospective cohort exposed to other treatment, sick excluded Adjustment: No 18.80 [0.36;971.86] C
excluded (control group) 		0/1   20/406 20 1
ref
S7797
R23015		 Vajda (Pregabalin) (Controls unexposed, sick), 2019 Fetal malformations at least 1st trimester prospective cohort unexposed, sick Adjustment: No 31.00 [0.56;1711.11] C 0/1   5/176 5 1
ref
Total 2 studies 5.82 [0.54;62.65] 115 8
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, 2024Battino, 2024 2.42[0.14; 43.19]110766%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate Vajda (Pregabalin) (Controls unexposed, sick), 2019Vajda, 2019 1 31.00[0.56; 1711.11]5134%ROB confusion: criticalROB selection: moderateROB classification: lowROB missing: moderateROB mesure: moderateROB reporting: moderate Total (2 studies) I2 = 2% 5.82[0.54; 62.65]11580.9100.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Pregabalin) (Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 5.82[0.54; 62.65]11582%NABattino, 2024 Vajda (Pregabalin) (Controls unexposed, sick), 2019 2 case control studiescase control studies 0 Type of controls unexposed, sickunexposed, sick 31.00[0.56; 1711.11]51 -NAVajda (Pregabalin) (Controls unexposed, sick), 2019 1 exposed to other treatment, sickexposed to other treatment, sick 2.42[0.14; 43.19]1107 -NABattino, 2024 1 Tags Adjustment   - No  - No 5.82[0.54; 62.65]11582%NABattino, 2024 Vajda (Pregabalin) (Controls unexposed, sick), 2019 2 All studiesAll studies 5.82[0.54; 62.65]11582%NABattino, 2024 Vajda (Pregabalin) (Controls unexposed, sick), 2019 20.5100.01.0

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 7796

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed, sick controlsunexposed, sick controls Out of scale31.00[0.56; 1711.11]51 -NAVajda (Pregabalin) (Controls unexposed, sick), 2019 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 4.94[0.48; 50.63]13080%NABattino, 2024 Vajda (Pregabalin) (Controls exposed to Lamotrigine, sick), 2019 20.510.01.0