Pregabalin (All indications)

Low birth weight (< 2500g)

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
R62707
Dudukina (Controls exposed to LTG) (Mixed indications), 2023 Low birth weight (birth weight < 2500 g) 3 months (or more) before pregnancy or during pregnancy population based cohort retrospective exposed to other treatment, sick excluded Adjustment: Yes 0.86 [0.70;1.05]
excluded (control group)
147/2,414   366/7,241 513 2,414
ref
S15252
R62728
Dudukina (Controls unexposed, NOS) (Mixed indications), 2023 Low birth weight (birth weight < 2500 g) 3 months (or more) before pregnancy or during pregnancy excluded population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes 1.04 [0.89;1.23]
excluded (exposition period)
147/2,414   121,039/3,009,100 121,186 2,414
ref
S10100
R36795
Coste (Controls exposed to Lamotrigine, sick) (Mixed indications), 2020 Weight at birth <2500 g during pregnancy (anytime or not specified) retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No 1.20 [0.94;1.52] C
excluded (control group)
118/1,627   179/2,916 297 1,627
ref
S8541
R28339
Coste (Controls unexposed, NOS) (Mixed indications), 2020 Weight at birth <2500 g during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 1.38 [1.15;1.67] C 118/1,627   91,455/1,710,441 91,573 1,627
ref
S8537
R28307
Kilic (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Low birth weight (< 2500 g) during pregnancy (anytime or not specified) population based cohort retrospective exposed to other treatment, sick excluded Adjustment: No 3.14 [0.68;14.55] C
excluded (control group)
2/13   48/876 50 13
ref
S8538
R28310
Kilic (Controls unexposed NOS) (Mixed indications), 2014 Low birth weight (< 2500 g) during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) excluded Adjustment: No 5.03 [1.12;22.70] C
excluded (control group)
2/13   23,503/673,844 23,505 13
ref
S8539
R28313
Kilic (Controls unexposed, sick) (Mixed indications), 2014 Low birth weight (< 2500 g) during pregnancy (anytime or not specified) population based cohort retrospective unexposed, sick Adjustment: No Controls: epilepsy indication 3.67 [0.81;16.65] C 2/13   249/5,275 251 13
ref
Total 2 studies 1.67 [0.79;3.54] 91,824 1,640
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 Coste (Controls unexposed, NOS) (Mixed indications), 2020Coste, 2020 1 1.38[1.15; 1.67]91,5731,62781%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Kilic (Controls unexposed, sick) (Mixed indications), 2014Kilic, 2014 2 3.67[0.81; 16.65]2511319%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Total (2 studies) I2 = 36% 1.67[0.79; 3.54]91,8241,6400.510.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, NOS) (Mixed indications; 2: Controls unexposed, sick) (Mixed indications;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.67[0.79; 3.54]91,8241,64036%NACoste (Controls unexposed, NOS) (Mixed indications), 2020 Kilic (Controls unexposed, sick) (Mixed indications), 2014 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.38[1.15; 1.67]91,5731,627 -NACoste (Controls unexposed, NOS) (Mixed indications), 2020 1 unexposed, sickunexposed, sick 3.67[0.81; 16.65]25113 -NAKilic (Controls unexposed, sick) (Mixed indications), 2014 1 Tags Adjustment   - No  - No 1.67[0.79; 3.54]91,8241,64036%NACoste (Controls unexposed, NOS) (Mixed indications), 2020 Kilic (Controls unexposed, sick) (Mixed indications), 2014 2 Controls   - epilepsy indication  - epilepsy indication 3.67[0.81; 16.65]25113 -NAKilic (Controls unexposed, sick) (Mixed indications), 2014 1 All studiesAll studies 1.67[0.79; 3.54]91,8241,64036%NACoste (Controls unexposed, NOS) (Mixed indications), 2020 Kilic (Controls unexposed, sick) (Mixed indications), 2014 20.510.01.0

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 8537, 8538, 10100, 15251

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 2.11[0.64; 6.89]115,0781,64064%NACoste (Controls unexposed, NOS) (Mixed indications), 2020 Kilic (Controls unexposed NOS) (Mixed indications), 2014 2 unexposed, sick controlsunexposed, sick controls 3.67[0.81; 16.65]25113 -NAKilic (Controls unexposed, sick) (Mixed indications), 2014 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.42[0.69; 2.93]3471,64032%NACoste (Controls exposed to Lamotrigine, sick) (Mixed indications), 2020 Kilic (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 20.510.01.0