Duloxetine updated on 07-01-2025

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.
S18347
R77387
Martin - Norway, 2024 Preterm delivery (delivery at <259 days (37 weeks’)) during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.95 [1.07;3.54] 13/115   32,190/662,309 32,203 115
ref
S18346
R77384
Martin - UK, 2024 Preterm delivery (delivery at <259 days (37 weeks’)) during pregnancy (anytime or not specified) population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.92 [0.98;3.78] 10/71   21,805/330,696 21,815 71
ref
S15180
R62311
Ankarfeldt (Controls unexposed, NOS), 2023 Preterm births (< 37 weeks of gestation) late pregnancy population based cohort retrospective unexposed (general population or NOS) excluded Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.90 [1.44;2.49]
excluded (control group)
65/450   116,041/2,082,019 116,106 450
ref
S15181
R62315
Ankarfeldt (Controls unexposed, sick), 2023 Preterm births (< 37 weeks of gestation) late pregnancy population based cohort retrospective unexposed, sick Adjustment: Yes Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) Unexposed sick: intermediate history of illness/treatment (3-12 months before pregnancy) 1.67 [1.24;2.23] 69/450   335/3,772 404 450
ref
S13147
R50193
Marks (Controls exposed to Bupropion), 2021 Preterm Birth during pregnancy (anytime or not specified) retrospective cohort exposed to other treatment, sick Adjustment: No Monotherapy: substance alone among all Antidep (SSRI, SNRI, ...) 1.69 [1.05;2.73] C 32/139   61/406 93 139
ref
S11708
R43062
Bahat, 2020 Preterm birth (NOS) 1st trimester prospective cohort unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 4.84 [2.31;10.15] -/-   -/- - -
ref
S11747
R43158
Huybrechts (Controls unexposed, NOS), 2020 Preterm birth late pregnancy retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes Monotherapy: no or not specified 1.19 [1.04;1.37] 179/880   147,007/1,364,101 147,186 880
ref
S11788
R43372
Ozturk, 2016 Preterm Births (<37 weeks) at least 1st trimester prospective cohort unexposed (general population or NOS) Adjustment: No Monotherapy: no or not specified 5.59 [0.25;125.61] C 0/3   8/246 8 3
ref
Total 7 studies 1.82 [1.32;2.51] 201,709 1,658
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 Martin - Norway, 2024Martin - Norway, 2024 1.95[1.07; 3.54]32,20311514%ROB confusion: seriousROB selection: lowROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Martin - UK, 2024Martin - UK, 2024 1.92[0.98; 3.78]21,8157112%ROB confusion: seriousROB selection: lowROB classification: criticalROB missing: criticalROB mesure: moderateROB reporting: moderate Ankarfeldt (Controls unexposed, sick), 2023Ankarfeldt, 2023 1 1.67[1.24; 2.23]40445021%ROB confusion: seriousROB selection: lowROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: low Marks (Controls exposed to Bupropion), 2021Marks, 2021 2 1.69[1.05; 2.73]9313916%ROB confusion: criticalROB selection: lowROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: moderate Bahat, 2020Bahat, 2020 4.84[2.31; 10.15]--11%ROB confusion: unclearROB selection: unclearROB classification: moderateROB missing: unclearROB mesure: unclearROB reporting: unclear Huybrechts (Controls unexposed, NOS), 2020Huybrechts, 2020 3 1.19[1.04; 1.37]147,18688025%ROB confusion: moderateROB selection: lowROB classification: moderateROB missing: unclearROB mesure: moderateROB reporting: low Ozturk, 2016Ozturk, 2016 5.59[0.25; 125.61]831%ROB confusion: criticalROB selection: unclearROB classification: moderateROB missing: lowROB mesure: moderateROB reporting: moderate Total (7 studies) I2 = 71% 1.82[1.32; 2.51]201,7091,6580.520.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, sick; 2: Controls exposed to Bupropion; 3: Controls unexposed, NOS;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.82[1.32; 2.51]201,7091,65871%NAMartin - Norway, 2024 Martin - UK, 2024 Ankarfeldt (Controls unexposed, sick), 2023 Marks (Controls exposed to Bupropion), 2021 Bahat, 2020 Huybrechts (Controls unexposed, NOS), 2020 Ozturk, 2016 7 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 2.08[1.17; 3.71]201,2121,06977%NAMartin - Norway, 2024 Martin - UK, 2024 Bahat, 2020 Huybrechts (Controls unexposed, NOS), 2020 Ozturk, 2016 5 unexposed, sickunexposed, sick 1.67[1.25; 2.24]404450 -NAAnkarfeldt (Controls unexposed, sick), 2023 1 exposed to other treatment, sickexposed to other treatment, sick 1.69[1.05; 2.73]93139 -NAMarks (Controls exposed to Bupropion), 2021 1 Tags Adjustment   - No  - No 1.74[1.08; 2.79]1011420%NAMarks (Controls exposed to Bupropion), 2021 Ozturk, 2016 2   - Yes  - Yes 1.85[1.26; 2.72]201,6081,51679%NAMartin - Norway, 2024 Martin - UK, 2024 Ankarfeldt (Controls unexposed, sick), 2023 Bahat, 2020 Huybrechts (Controls unexposed, NOS), 2020 5 Monotherapy   - no or not specified  - no or not specified 2.54[0.73; 8.85]147,19488386%NABahat, 2020 Huybrechts (Controls unexposed, NOS), 2020 Ozturk, 2016 3   - substance alone among all Antidep ( ...  - substance alone among all Antidep (SSRI, SNRI, ...) 1.73[1.39; 2.16]54,5157750%NAMartin - Norway, 2024 Martin - UK, 2024 Ankarfeldt (Controls unexposed, sick), 2023 Marks (Controls exposed to Bupropion), 2021 4 Unexposed sick   - intermediate history of illness/tre ...  - intermediate history of illness/treatment (3-12 months before pregnancy) 1.67[1.25; 2.24]404450 -NAAnkarfeldt (Controls unexposed, sick), 2023 1 All studiesAll studies 1.82[1.32; 2.51]201,7091,65871%NAMartin - Norway, 2024 Martin - UK, 2024 Ankarfeldt (Controls unexposed, sick), 2023 Marks (Controls exposed to Bupropion), 2021 Bahat, 2020 Huybrechts (Controls unexposed, NOS), 2020 Ozturk, 2016 70.520.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-3.74.31.9060.000Martin - Norway, 2024Martin - UK, 2024Ankarfeldt (Controls unexposed, sick), 2023Marks (Controls exposed to Bupropion), 2021Bahat, 2020Huybrechts (Controls unexposed, NOS), 2020Ozturk, 2016

Asymetry test p-value = 0.0171 (by Egger's regression)

slope=0.0471 (0.0996); intercept=2.2523 (0.6416); t=3.5106; p=0.0171

p values plot
0.01.00.01.0

Sub-groups analysis using all included studies

excluded 15180

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.96[1.31; 2.93]317,3181,51979%NAMartin - Norway, 2024 Martin - UK, 2024 Ankarfeldt (Controls unexposed, NOS), 2023 Bahat, 2020 Huybrechts (Controls unexposed, NOS), 2020 Ozturk, 2016 6 unexposed, sick controlsunexposed, sick controls 1.67[1.25; 2.24]404450 -NAAnkarfeldt (Controls unexposed, sick), 2023 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 1.69[1.05; 2.73]93139 -NAMarks (Controls exposed to Bupropion), 2021 10.510.01.0