Amlodipine (versus unexposed)

Major congenital malformations

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.
S14329
R56694		 Ishikawa (Controls unexposed, disease free), 2023 Major congenital malformations 1st trimester retrospective cohort (claims database) unexposed, disease free excluded Adjustment: No Indications Antihypertensive: Only chronic hypertension indication 1.98 [0.78;5.02] C
excluded (control group) 		5/44   4,519/74,213 4,524 44
ref
S14330
R56696		 Ishikawa (Controls unexposed, sick), 2023 Major congenital malformations 1st trimester retrospective cohort (claims database) unexposed, sick Adjustment: No Indications Antihypertensive: Only chronic hypertension indication 1.69 [0.65;4.42] C 5/44   71/1,007 76 44
ref
S14425
R57257		 Mito, 2019 Major anomalies _ morphologic abnormalities at least 1st trimester retrospective cohort unexposed, sick Adjustment: No Indications Antihypertensive: Only chronic hypertension indication 0.89 [0.17;4.57] 2/48   6/129 8 48
ref
S13989
R54933		 Weber-Schoendorfer, 2008 Major birth defects (chromosomal anomalies/syndromes excluded) at least 1st trimester prospective cohort unexposed (general population or NOS) Adjustment: No Indications Antihypertensive: All hypertensions, any indications or not specified 1.63 [0.21;12.82] C 1/32   14/723 15 32
ref
Total 3 studies 1.46 [0.68;3.15] 99 124
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 Ishikawa (Controls unexposed, sick), 2023Ishikawa, 2023 1 1.69[0.65; 4.42]764464%ROB confusion: criticalROB selection: criticalROB classification: criticalROB missing: unclearROB mesure: moderateROB reporting: moderate Mito, 2019Mito, 2019 0.89[0.17; 4.57]84822%ROB confusion: seriousROB selection: criticalROB classification: criticalROB missing: unclearROB mesure: criticalROB reporting: moderate Weber-Schoendorfer, 2008Weber-Schoendorfer, 2008 1.63[0.21; 12.82]153214%ROB confusion: criticalROB selection: moderateROB classification: moderateROB missing: moderateROB mesure: unclearROB reporting: moderate Total (3 studies) I2 = 0% 1.46[0.68; 3.15]991240.25.01.0ROB: 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 1.46[0.68; 3.15]991240%NAIshikawa (Controls unexposed, sick), 2023 Mito, 2019 Weber-Schoendorfer, 2008 3 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 1.63[0.21; 12.82]1532 -NAWeber-Schoendorfer, 2008 1 unexposed, sickunexposed, sick 1.43[0.63; 3.28]84920%NAIshikawa (Controls unexposed, sick), 2023 Mito, 2019 2 Tags Adjustment   - No  - No 1.46[0.68; 3.15]991240%NAIshikawa (Controls unexposed, sick), 2023 Mito, 2019 Weber-Schoendorfer, 2008 3 Indications Antihypertensive   - All hypertensions, any indications ...  - All hypertensions, any indications or not specified 1.63[0.21; 12.82]1532 -NAWeber-Schoendorfer, 2008 1   - Only chronic hypertension indication  - Only chronic hypertension indication 1.43[0.63; 3.28]84920%NAIshikawa (Controls unexposed, sick), 2023 Mito, 2019 2 All studiesAll studies 1.46[0.68; 3.15]991240%NAIshikawa (Controls unexposed, sick), 2023 Mito, 2019 Weber-Schoendorfer, 2008 30.25.01.0

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 14329

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) 1.91[0.82; 4.47]4,539760%NAIshikawa (Controls unexposed, disease free), 2023 Weber-Schoendorfer, 2008 2 unexposed, sick controlsunexposed, sick controls 1.43[0.63; 3.28]84920%NAIshikawa (Controls unexposed, sick), 2023 Mito, 2019 20.510.01.0