Sertraline updated on 07-01-2025

Cardiac septal defects

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.
S7468
R22160
Anderson, 2020 Septal defects 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.01 [0.73;1.41] -/-   0/- - -
ref
S5398
R14861
Bérard (Controls exposed to non-Sertraline SSRI), 2015 Ventricular/atrial septal defect 1st trimester retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.18 [0.57;2.45] C
excluded (control group)
9/366   41/1,963 50 366
ref
S6705
R18933
Bérard (Controls unexposed, sick), 2015 Ventricular/atrial septal defect 1st trimester retrospective cohort (claims database) unexposed, sick Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy) 1.34 [1.02;1.76] 9/366   272/14,868 281 366
ref
S6008
R15426
Furu, 2015 Atrial and ventricular septal defects 1st trimester population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.05 [0.82;1.35] 70/7,245   17,503/2,266,875 17,573 7,245
ref
S7352
R21550
Wemakor, 2015 Septal defects 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.33 [0.57;3.09] 9/23   8,122/25,191 8,131 23
ref
S6159
R16155
Louik, 2007 Septal defects 1st trimester case control unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among the specific class of antidep (SSRI, SNRI, ...) 2.00 [1.00;4.00] 13/59   1,148/6,962 1,161 59
ref
Total 5 studies 1.18 [0.99;1.41] 27,146 7,693
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 Anderson, 2020Anderson, 2020 1.01[0.73; 1.41]--23%ROB confusion: seriousROB selection: criticalROB classification: criticalROB missing: lowROB mesure: unclearROB reporting: moderate Bérard (Controls unexposed, sick), 2015Bérard, 2015 1 1.34[1.02; 1.76]28136631%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Furu, 2015Furu, 2015 1.05[0.82; 1.35]17,5737,24535%ROB confusion: criticalROB selection: moderateROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Wemakor, 2015Wemakor, 2015 1.33[0.57; 3.09]8,131234%ROB confusion: criticalROB selection: criticalROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Louik, 2007Louik, 2007 2.00[1.00; 4.00]1,161596%ROB confusion: moderateROB selection: criticalROB classification: criticalROB missing: lowROB mesure: criticalROB reporting: moderate Total (5 studies) I2 = 17% 1.18[0.99; 1.41]27,1467,6930.55.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, sick;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.18[0.93; 1.50]17,8547,61140%NABérard (Controls unexposed, sick), 2015 Furu, 2015 2 case control studiescase control studies 1.27[0.83; 1.93]9,2928237%NAAnderson, 2020 Wemakor, 2015 Louik, 2007 3 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.11[0.90; 1.38]26,8657,32713%NAAnderson, 2020 Furu, 2015 Wemakor, 2015 Louik, 2007 4 unexposed, sickunexposed, sick 1.34[1.02; 1.76]281366 -NABérard (Controls unexposed, sick), 2015 1 Tags Adjustment   - Yes  - Yes 1.18[0.99; 1.41]27,1467,69317%NAAnderson, 2020 Bérard (Controls unexposed, sick), 2015 Furu, 2015 Wemakor, 2015 Louik, 2007 5 Monotherapy   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 1.14[0.97; 1.33]25,9857,6340%NAAnderson, 2020 Bérard (Controls unexposed, sick), 2015 Furu, 2015 Wemakor, 2015 4   - substance alone among the specific ...  - substance alone among the specific class of antidep (SSRI, SNRI, ...) 2.00[1.00; 4.00]1,16159 -NALouik, 2007 1 Unexposed sick   - intermediate history of illness/tre ...  - intermediate history of illness/treatment (3-12 months before pregnancy) 1.34[1.02; 1.76]281366 -NABérard (Controls unexposed, sick), 2015 1 All studiesAll studies 1.18[0.99; 1.41]27,1467,69317%NAAnderson, 2020 Bérard (Controls unexposed, sick), 2015 Furu, 2015 Wemakor, 2015 Louik, 2007 50.55.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-1.01.20.5170.000Anderson, 2020Bérard (Controls unexposed, sick), 2015Furu, 2015Wemakor, 2015Louik, 2007

Asymetry test p-value = 0.3492 (by Egger's regression)

slope=-0.0575 (0.2116); intercept=1.3341 (1.2054); t=1.1068; p=0.3492

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 5398

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.11[0.90; 1.38]26,8657,32713%NAAnderson, 2020 Furu, 2015 Wemakor, 2015 Louik, 2007 4 unexposed, sick controlsunexposed, sick controls 1.34[1.02; 1.76]281366 -NABérard (Controls unexposed, sick), 2015 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.18[0.57; 2.45]50366 -NABérard (Controls exposed to non-Sertraline SSRI), 2015 10.510.01.0

Umbrella review (other published meta-analyses)

Published MAControlPeriodTE95% CIn exposedkI2 Shen (Atrial and/or ventricular septal defects)Shen (Atrial and/or ventricular septal defects) 1.36[1.06; 1.76]62.2%-U,GPunexposed (general population or NOS)T11st trimesterstudies TTT8 Reefhuis (Septal defects)Reefhuis (Septal defects) 1.00[0.80; 1.40]NA-Wwhatever (meta-analysis)Anyduring pregnancy (anytime or not specified)studies TTT10 metaPregmetaPreg 1.18[0.99; 1.41]17%7,693----Anderson, 2020 Bérard (Controls unexposed, sick), 2015 Furu, 2015 Wemakor, 2015 Louik, 2007 50.510.01.0