Pregabalin (All indications)

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.
S15251
R62718		 Dudukina (Controls exposed to LTG) (Mixed indications), 2023 Oro-facial clefts 3 months or more before pregnancy or1st trimester population based cohort retrospective exposed to other treatment, sick excluded Adjustment: Yes 3.97 [1.17;13.49]
excluded (control group) 		5/2,332   14/7,005 19 2,332
ref
S15252
R62740		 Dudukina (Controls unexposed, NOS) (Mixed indications), 2023 Oro-facial clefts 3 months or more before pregnancy or1st trimester excluded population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes 3.30 [1.36;8.02]
excluded (exposition period) 		5/2,332   5,541/3,063,173 5,546 2,332
ref
S10045
R46492		 Blotière (Controls exposed to Lamotrigine, sick) (Other indications), 2019 Oro-facial clefts 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No 1.35 [0.30;6.02] C
excluded (control group) 		3/1,671   4/2,997 7 1,671
ref
S10046
R46493		 Blotière (Controls unexposed NOS) (Other indications), 2019 Oro-facial clefts 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 1.20 [0.39;3.72] C 3/1,671   2,815/1,875,733 2,818 1,671
ref
S8534
R28298		 Veiby (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Orofacial clefts throughout pregnancy population based cohort retrospective exposed to other treatment, sick Adjustment: No 9.40 [0.37;235.54] C 0/30   1/833 1 30
ref
Total 2 studies 1.89 [0.35;10.09] 2,819 1,701
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 Blotière (Controls unexposed NOS) (Other indications), 2019Blotière, 2019 1 1.20[0.39; 3.72]2,8181,67178%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Veiby (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014Veiby, 2014 2 9.40[0.37; 235.54]13022%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: moderateROB reporting: moderate Total (2 studies) I2 = 29% 1.89[0.35; 10.09]2,8191,7010.520.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed NOS) (Other indications; 2: Controls exposed to Lamotrigine, sick) (Mixed indications;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.89[0.35; 10.09]2,8191,70129%NABlotière (Controls unexposed NOS) (Other indications), 2019 Veiby (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.20[0.39; 3.72]2,8181,671 -NABlotière (Controls unexposed NOS) (Other indications), 2019 1 exposed to other treatment, sickexposed to other treatment, sick 9.40[0.37; 235.54]130 -NAVeiby (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 1 Tags Adjustment   - No  - No 1.89[0.35; 10.09]2,8191,70129%NABlotière (Controls unexposed NOS) (Other indications), 2019 Veiby (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 2 All studiesAll studies 1.89[0.35; 10.09]2,8191,70129%NABlotière (Controls unexposed NOS) (Other indications), 2019 Veiby (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 20.520.01.0

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, 15251

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.20[0.39; 3.72]2,8181,671 -NABlotière (Controls unexposed NOS) (Other indications), 2019 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 2.06[0.43; 9.98]81,70113%NABlotière (Controls exposed to Lamotrigine, sick) (Other indications), 2019 Veiby (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 20.510.01.0