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

Preterm (< 37 weeks)

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.
S17225
R72131
Kaskal (Indications NOS), 2024 Preterm deliveries (birth <37 weeks) during pregnancy (anytime or not specified) cohort unexposed (general population or NOS) Adjustment: No 3.77 [1.00;14.20] C 5/27   5/88 10 27
ref
S15251
R62708
Dudukina (Controls exposed to LTG) (Mixed indications), 2023 Preterm birth (gestational age <37 weeks) 3 months (or more) before pregnancy or during pregnancy population based cohort retrospective exposed to other treatment, sick excluded Adjustment: Yes 0.94 [0.79;1.11]
excluded (control group)
188/2,414   540/7,243 728 2,414
ref
S15252
R62729
Dudukina (Controls unexposed, NOS) (Mixed indications), 2023 Preterm birth (gestational age <37 weeks) 3 months (or more) before pregnancy or during pregnancy excluded population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes 1.15 [1.00;1.32]
excluded (exposition period)
188/2,414   151,114/3,009,386 151,302 2,414
ref
S10100
R36794
Coste (Controls exposed to Lamotrigine, sick) (Mixed indications), 2020 Gestational age at birth (< 37 WA) during pregnancy (anytime or not specified) retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No 1.09 [0.85;1.39] C
excluded (control group)
110/1,627   182/2,916 292 1,627
ref
S8541
R28338
Coste (Controls unexposed, NOS) (Mixed indications), 2020 Gestational age at birth (< 37 WA) during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: No 1.29 [1.06;1.56] C 110/1,627   91,255/1,710,441 91,365 1,627
ref
S18025
R75959
Margulis (Pregabalin) (Indications other than epilepsy), 2019 Preterm birth (delivery before 37 completed weeks) during pregnancy (anytime or not specified) population based cohort retrospective exposed to other treatment, sick Adjustment: Yes 1.50 [0.90;2.50] -/492   -/1,787 - 492
ref
S8537
R28309
Kilic (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 Preterm (< 37 weeks) during pregnancy (anytime or not specified) population based cohort retrospective exposed to other treatment, sick excluded Adjustment: No 2.88 [0.78;10.68] C
excluded (control group)
3/13   83/880 86 13
ref
S8538
R28312
Kilic (Controls unexposed NOS) (Mixed indications), 2014 Preterm (< 37 weeks) during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) excluded Adjustment: No 5.68 [1.56;20.63] C
excluded (control group)
3/13   33,974/676,834 33,977 13
ref
S8539
R28315
Kilic (Controls unexposed, sick) (Mixed indications), 2014 Preterm (< 37 weeks) during pregnancy (anytime or not specified) population based cohort retrospective unexposed, sick Adjustment: No Controls: epilepsy indication 3.85 [1.05;14.04] C 3/13   383/5,296 386 13
ref
Total 4 studies 1.60 [1.08;2.38] 91,761 2,159
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 Kaskal (Indications NOS), 2024Kaskal, 2024 1 3.77[1.00; 14.20]10278%ROB confusion: criticalROB selection: unclearROB classification: unclearROB missing: unclearROB mesure: unclearROB reporting: moderate Coste (Controls unexposed, NOS) (Mixed indications), 2020Coste, 2020 2 1.29[1.06; 1.56]91,3651,62754%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Margulis (Pregabalin) (Indications other than epilepsy), 2019Margulis, 2019 3 1.50[0.90; 2.50]-49230%ROB confusion: seriousROB selection: lowROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Kilic (Controls unexposed, sick) (Mixed indications), 2014Kilic, 2014 4 3.85[1.05; 14.04]386138%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Total (4 studies) I2 = 42% 1.60[1.08; 2.38]91,7612,1590.510.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Indications NOS; 2: Controls unexposed, NOS) (Mixed indications; 3: Pregabalin) (Indications other than epilepsy; 4: Controls unexposed, sick) (Mixed indications;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.60[1.08; 2.38]91,7612,15942%NAKaskal (Indications NOS), 2024 Coste (Controls unexposed, NOS) (Mixed indications), 2020 Margulis (Pregabalin) (Indications other than epilepsy), 2019 Kilic (Controls unexposed, sick) (Mixed indications), 2014 4 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.79[0.68; 4.73]91,3751,65460%NAKaskal (Indications NOS), 2024 Coste (Controls unexposed, NOS) (Mixed indications), 2020 2 unexposed, sickunexposed, sick 3.85[1.05; 14.04]38613 -NAKilic (Controls unexposed, sick) (Mixed indications), 2014 1 exposed to other treatment, sickexposed to other treatment, sick 1.50[0.90; 2.50]-492 -NAMargulis (Pregabalin) (Indications other than epilepsy), 2019 1 Tags Adjustment   - No  - No 2.16[0.92; 5.07]91,7611,66760%NAKaskal (Indications NOS), 2024 Coste (Controls unexposed, NOS) (Mixed indications), 2020 Kilic (Controls unexposed, sick) (Mixed indications), 2014 3   - Yes  - Yes 1.50[0.90; 2.50]-492 -NAMargulis (Pregabalin) (Indications other than epilepsy), 2019 1 Controls   - epilepsy indication  - epilepsy indication 3.85[1.05; 14.04]38613 -NAKilic (Controls unexposed, sick) (Mixed indications), 2014 1 All studiesAll studies 1.60[1.08; 2.38]91,7612,15942%NAKaskal (Indications NOS), 2024 Coste (Controls unexposed, NOS) (Mixed indications), 2020 Margulis (Pregabalin) (Indications other than epilepsy), 2019 Kilic (Controls unexposed, sick) (Mixed indications), 2014 40.510.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-1.62.10.8120.000Kaskal (Indications NOS), 2024Coste (Controls unexposed, NOS) (Mixed indications), 2020Margulis (Pregabalin) (Indications other than epilepsy), 2019Kilic (Controls unexposed, sick) (Mixed indications), 2014

Asymetry test p-value = NaN (by Egger's regression)

not enought points

p values plot
0.01.00.01.0

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) 2.57[0.90; 7.32]125,3521,66773%NAKaskal (Indications NOS), 2024 Coste (Controls unexposed, NOS) (Mixed indications), 2020 Kilic (Controls unexposed NOS) (Mixed indications), 2014 3 unexposed, sick controlsunexposed, sick controls 3.85[1.05; 14.04]38613 -NAKilic (Controls unexposed, sick) (Mixed indications), 2014 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.29[0.90; 1.84]3782,13234%NACoste (Controls exposed to Lamotrigine, sick) (Mixed indications), 2020 Margulis (Pregabalin) (Indications other than epilepsy), 2019 Kilic (Controls exposed to Lamotrigine, sick) (Mixed indications), 2014 30.510.01.0