Pregabalin (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.
S19324
R81915		 Kim (Controls exposed to LTG) (Pregabalin) (Indications NOS), 2026 Cleft palate without cleft lip 1st trimester population based cohort retrospective exposed to other treatment, sick excluded Adjustment: No 1.60 [0.10;25.65] C
excluded (control group) 		1/449   1/718 2 449
ref
S19317
R81844		 Kim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026 Cleft palate without cleft lip 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes 1.82 [0.25;12.97] 1/449   3,086/2,489,078 3,087 449
ref
S10045
R36373		 Blotière (Controls exposed to Lamotrigine, sick) (Other indications), 2019 Cleft palate 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No Controls: mixed indications 1.79 [0.25;12.75] C
excluded (control group) 		2/1,671   2/2,997 4 1,671
ref
S10046
R36396		 Blotière (Controls unexposed NOS) (Other indications), 2019 Cleft palate 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 1.90 [0.20;6.90] 2/1,671   1,178/1,875,733 1,180 1,671
ref
Total 2 studies 1.86 [0.50;6.96] 4,267 2,120
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 (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026Kim, 2026 1 1.82[0.25; 12.97]3,08744945%ROB confusion: seriousROB selection: lowROB classification: criticalROB missing: unclearROB mesure: moderateROB reporting: moderate Blotière (Controls unexposed NOS) (Other indications), 2019Blotière, 2019 2 1.90[0.20; 6.90]1,1801,67155%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (2 studies) I2 = 0% 1.86[0.50; 6.96]4,2672,1200.55.01.0ROB: A: confounding, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, NOS) (Pregabalin) (Indications NOS; 2: Controls unexposed NOS) (Other indications;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.86[0.50; 6.96]4,2672,1200%NAKim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026 Blotière (Controls unexposed NOS) (Other indications), 2019 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.86[0.50; 6.96]4,2672,1200%NAKim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026 Blotière (Controls unexposed NOS) (Other indications), 2019 2 Tags Adjustment   - No  - No 1.90[0.32; 11.16]1,1801,671 -NABlotière (Controls unexposed NOS) (Other indications), 2019 1   - Yes  - Yes 1.82[0.25; 13.11]3,087449 -NAKim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026 1 All studiesAll studies 1.86[0.50; 6.96]4,2672,1200%NAKim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026 Blotière (Controls unexposed NOS) (Other indications), 2019 20.55.01.0

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 10045, 19324

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.86[0.50; 6.96]4,2672,1200%NAKim (Controls unexposed, NOS) (Pregabalin) (Indications NOS), 2026 Blotière (Controls unexposed NOS) (Other indications), 2019 2 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.73[0.35; 8.57]62,1200%NAKim (Controls exposed to LTG) (Pregabalin) (Indications NOS), 2026 Blotière (Controls exposed to Lamotrigine, sick) (Other indications), 2019 20.510.01.0