Proton Pump Inhibitors updated on 08-09-2023

Congenital heart 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.
S14453
R57352		 Choi a, 2023 Congenital heart defects 1st trimester retrospective cohort (claims database) unexposed, sick Adjustment: Yes 1.09 [1.01;1.17] 851/40,540   42,154/2,655,676 43,005 40,540
ref
S4446
R10572		 Matok, 2012 Total cardiovascular malformations 1st trimester retrospective cohort (claims database) unexposed (general population or NOS) Adjustment: Yes 0.98 [0.70;1.38] 34/1,159   2,717/108,385 2,751 1,159
ref
S4763
R12130		 Rhim, 2010 Cardiac birth defects during pregnancy (anytime or not specified) excluded nested case control unexposed (general population or NOS) Adjustment: Yes Matched 2.14 [1.37;3.35]
excluded (exposition period) 		-/-   2,454/- - -
ref
S4549
R11040		 Källén, 2003 Any cardiovascular defect (except with chromosome anomaly) early pregnancy population based cohort retrospective unexposed (general population or NOS) Adjustment: Yes 1.04 [0.63;1.71] 16/1,863   5,411/575,867 5,427 1,863
ref
S4861
R12579		 Ruigomez - Omeprazole (Controls exposed to other treatment, sick), 1999 Cardiac malformations 1st trimester retrospective cohort exposed to other treatment, sick excluded Adjustment: No 4.12 [0.58;29.54] C
excluded (control group) 		2/139   2/567 4 139
ref
S4276
R9994		 Ruigomez - Omeprazole (Controls unexposed NOS), 1999 Cardiac malformations 1st trimester retrospective cohort unexposed (general population or NOS) Adjustment: No 3.27 [0.67;15.89] C 2/139   7/1,575 9 139
ref
Total 4 studies 1.09 [1.01;1.17] 51,192 43,701
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 Choi a, 2023Choi a, 2023 1.09[1.01; 1.17]43,00540,54093%ROB confusion: moderateROB selection: lowROB classification: moderateROB missing: unclearROB mesure: NAROB reporting: NA Matok, 2012Matok, 2012 0.98[0.70; 1.38]2,7511,1594%ROB confusion: criticalROB selection: lowROB classification: criticalROB missing: lowROB mesure: moderateROB reporting: moderate Källén, 2003Källén, 2003 1.04[0.63; 1.71]5,4271,8632%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Ruigomez - Omeprazole (Controls unexposed NOS), 1999Ruigomez - Omeprazole, 1999 1 3.27[0.67; 15.89]91390%ROB confusion: NAROB selection: NAROB classification: NAROB missing: NAROB mesure: NAROB reporting: NA Total (4 studies) I2 = 0% 1.09[1.01; 1.17]51,19243,7010.210.01.0ROB: A: confusion, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed NOS;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 1.09[1.01; 1.17]51,19243,7010%NAChoi a, 2023 Matok, 2012 Källén, 2003 Ruigomez - Omeprazole (Controls unexposed NOS), 1999 4 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.04[0.77; 1.40]8,1873,1616%NAMatok, 2012 Källén, 2003 Ruigomez - Omeprazole (Controls unexposed NOS), 1999 3 unexposed, sickunexposed, sick 1.09[1.01; 1.17]43,00540,540 -NAChoi a, 2023 1 Tags Adjustment   - No  - No 3.27[0.67; 15.89]9139 -NARuigomez - Omeprazole (Controls unexposed NOS), 1999 1   - Yes  - Yes 1.08[1.01; 1.16]51,18343,5620%NAChoi a, 2023 Matok, 2012 Källén, 2003 3 All studiesAll studies 1.09[1.01; 1.17]51,19243,7010%NAChoi a, 2023 Matok, 2012 Källén, 2003 Ruigomez - Omeprazole (Controls unexposed NOS), 1999 40.210.01.0

Publication bias and p-hacking diagnosis

funnel plot
0.0-1.92.00.9680.000Choi a, 2023Matok, 2012Källén, 2003Ruigomez - Omeprazole (Controls unexposed NOS), 1999

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 4861

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.04[0.77; 1.40]8,1873,1616%NAMatok, 2012 Källén, 2003 Ruigomez - Omeprazole (Controls unexposed NOS), 1999 3 unexposed, sick controlsunexposed, sick controls 1.09[1.03; 1.15]86,01081,0800%NAChoi a, 2023 Choi a, 2023 2 exposed to other treatment, sick controlsexposed to other treatment, sick controls 4.12[0.58; 29.54]4139 -NARuigomez - Omeprazole (Controls exposed to other treatment, sick), 1999 10.510.01.0