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

Language disorders/delay

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.
S19384
R82306		 Straub (Controls exposed to LTG) (Zonisamide) (Epilepsy), 2026 Speech or language disorder - ICD-10 codes: F80.xx (except F80.4), H93.25 - Mean follow up (full cohort): 3.4 years during pregnancy (anytime or not specified) retrospective cohort (claims database) exposed to other treatment, sick excluded Adjustment: No 0.99 [0.55;1.76] C
excluded (control group) 		13/246   175/3,273 188 246
ref
S19375
R82218		 Straub (Controls unexposed, sick) (Zonisamide) (Epilepsy), 2026 Speech or language disorder - ICD-10 codes: F80.xx (except F80.4), H93.25 - Mean follow up (full cohort): 3.4 years during pregnancy (anytime or not specified) retrospective cohort (claims database) unexposed, sick Adjustment: Yes 1.05 [0.59;1.84] 13/246   456/8,887 469 246
ref
S12806
R48229		 Meador (Zonisamide) (Controls exposed to Lamotrigine, sick), 2021 Language Score in 2 years old children with the Bayley Scales of Infant and Toddler Development (BSID-III) 3rd trimester prospective cohort exposed to other treatment, sick excluded Adjustment: Yes extrapolated (cont. endpoint) 0.33 [0.11;1.04]
excluded (control group) 		-/11   -/93 - 11
ref
S12807
R48230		 Meador (Zonisamide) (Controls unexposed, disease free), 2021 Language Score in 2 years old children with the Bayley Scales of Infant and Toddler Development (BSID-III) 3rd trimester prospective cohort unexposed, disease free Adjustment: Yes extrapolated (cont. endpoint) 0.33 [0.10;1.04] -/11   -/87 - 11
ref
Total 2 studies 0.66 [0.22;2.01] 469 257
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 Straub (Controls unexposed, sick) (Zonisamide) (Epilepsy), 2026Straub, 2026 1 1.05[0.59; 1.84]46924660%ROB confusion: seriousROB selection: lowROB classification: moderateROB missing: unclearROB mesure: criticalROB reporting: moderate Meador (Zonisamide) (Controls unexposed, disease free), 2021Meador, 2021 2 0.33[0.10; 1.04]-1140%ROB confusion: moderateROB selection: lowROB classification: lowROB missing: moderateROB mesure: moderateROB reporting: low Total (2 studies) I2 = 67% 0.66[0.22; 2.01]4692570.25.01.0ROB: A: confounding, B: selection, C: classification, D: missing, E: measurement, F: reportinglow,moderate,serious,critical,unclear,

1: Controls unexposed, sick) (Zonisamide) (Epilepsy; 2: Zonisamide) (Controls unexposed, disease free;

Sensitivity analysis

SubsetTE95% CIn casesn exposedkI2 Type of studies cohort studiescohort studies 0.66[0.22; 2.01]46925767%NAStraub (Controls unexposed, sick) (Zonisamide) (Epilepsy), 2026 Meador (Zonisamide) (Controls unexposed, disease free), 2021 2 case control studiescase control studies 0 Type of controls unexposed (disease free or unspecified)unexposed (disease free or unspecified) 0.33[0.10; 1.06]-11 -NAMeador (Zonisamide) (Controls unexposed, disease free), 2021 1 unexposed, sickunexposed, sick 1.05[0.59; 1.85]469246 -NAStraub (Controls unexposed, sick) (Zonisamide) (Epilepsy), 2026 1 Tags Adjustment   - Yes  - Yes 0.66[0.22; 2.01]46925767%NAStraub (Controls unexposed, sick) (Zonisamide) (Epilepsy), 2026 Meador (Zonisamide) (Controls unexposed, disease free), 2021 2 extrapolated (cont. endpoint)extrapolated (cont. endpoint) 0.33[0.10; 1.06]-11 -NAMeador (Zonisamide) (Controls unexposed, disease free), 2021 1 All studiesAll studies 0.66[0.22; 2.01]46925767%NAStraub (Controls unexposed, sick) (Zonisamide) (Epilepsy), 2026 Meador (Zonisamide) (Controls unexposed, disease free), 2021 20.15.01.0

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 12806, 19384

Sub-groupsTE95% CIn casesn exposedkI2ROB type of controls unexposed controls (disease free or unspecified)unexposed controls (disease free or unspecified) Out of scale0.33[0.10; 1.06]-11 -NAMeador (Zonisamide) (Controls unexposed, disease free), 2021 1 unexposed, sick controlsunexposed, sick controls 1.05[0.59; 1.85]469246 -NAStraub (Controls unexposed, sick) (Zonisamide) (Epilepsy), 2026 1 exposed to other treatment, sick controlsexposed to other treatment, sick controls 0.64[0.22; 1.83]18825765%NAStraub (Controls exposed to LTG) (Zonisamide) (Epilepsy), 2026 Meador (Zonisamide) (Controls exposed to Lamotrigine, sick), 2021 20.510.01.0