Eslicarbazepine acetate add‐on therapy for drug‐resistant focal epilepsy

Xian-Chao Chang; Hai Yuan; Yi Wang; Hui-Qin Xu; Wen-Ke Hong; Rong-Yuan Zheng

doi:10.1002/14651858.CD008907.pub4

Cochrane Database of Systematic Reviews

Acetato de eslicarbazepina como tratamiento complementario para la epilepsia focal farmacorresistente

Información

DOI:

https://doi.org/10.1002/14651858.CD008907.pub4 Copiar DOI

Base de datos:

Cochrane Database of Systematic Reviews

Versión publicada:

22 junio 2021see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Epilepsia

Copyright:

Copyright © 2021 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Cifras del artículo

Altmetric:

Citado por:

Citado 0 veces por enlace Crossref Cited-by

Contraer

Autores

Xian-Chao Chang

Department of Neurology, Hwa Mei Hospital, University of Chinese Academy of Sciences, Ningbo, China

Ningbo Institute of Life and Health Industry, University of Chinese Academy of Sciences, Ningbo, China
Hai Yuan

Department of Rehabilitation Medicine, The Second People’s Hospital of Hefei City, Hefei, China
Yi Wang

Division of Preventive Medicine, Wenzhou Medical University, Wenzhou, China
Hui-Qin Xu

Department of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China
Wen-Ke Hong

Department of Neurology, Hwa Mei Hospital, University of Chinese Academy of Sciences, Ningbo, China

Ningbo Institute of Life and Health Industry, University of Chinese Academy of Sciences, Ningbo, China
Rong-Yuan Zheng

Correspondencia a: Department of Neurology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China

[email protected]

[email protected]

Contributions of authors

XCC: drafting protocol and review versions; selection of trials for inclusion/exclusion; extraction of data; interpretation of data analyses; updating review.
HY: selection of trials for inclusion/exclusion; extraction of data.
YW: methodology expert.
HQX: drafting review versions; updating review.
WKH: drafting review versions; updating review.
RYZ: correspondence; arbiter of selection of trials for inclusion/exclusion.

Sources of support

Internal sources

No sources of support provided

External sources

National Institute for Health Research (NIHR), UK

Declarations of interest

XCC: none known.
HY: none known.
YW: none known.
HQX: none known.
WKH: none known.
RYZ: none.

Acknowledgements

This review update was supported by the National Institute for Health Research (NIHR), via Cochrane Infrastructure funding to the Epilepsy Group. The views and opinions expressed herein are those of the review authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, National Health Service or the Department of Health and Social Care.

We would like to acknowledge the Cochrane Epilepsy Group for their technical support. We also thank Graham Chan for his assistance in the search of relevant trials.

Version history

Published

Title

Stage

Authors

Version

2021 Jun 22

Eslicarbazepine acetate add‐on therapy for drug‐resistant focal epilepsy

Review

Xian-Chao Chang, Hai Yuan, Yi Wang, Hui-Qin Xu, Wen-Ke Hong, Rong-Yuan Zheng

https://doi.org/10.1002/14651858.CD008907.pub4

2017 Oct 25

Eslicarbazepine acetate add‐on for drug‐resistant focal epilepsy

Review

Xian‐Chao Chang, Hai Yuan, Yi Wang, Hui‐Qin Xu, Wen‐Ke Hong, Rong‐Yuan Zheng

https://doi.org/10.1002/14651858.CD008907.pub3

2011 Dec 07

Eslicarbazepine acetate add‐on for drug‐resistant partial epilepsy

Review

Xian‐Chao Chang, Hai Yuan, Yi Wang, Hui‐Qin Xu, Rong‐Yuan Zheng

https://doi.org/10.1002/14651858.CD008907.pub2

2010 Dec 08

Eslicarbazepine acetate add‐on for drug‐resistant partial epilepsy

Protocol

Xian‐Chao Chang, Hai Yuan, Yi Wang, Hui‐Qin Xu, Rong‐Yuan Zheng

https://doi.org/10.1002/14651858.CD008907

Differences between protocol and review

The term 'partial' has been replaced by 'focal', in accordance with the most recent classification of epilepsies of the International League Against Epilepsy (Scheffer 2017)

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Adolescent; Adult; Aged; Child; Humans; Middle Aged; Young Adult;

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Figure 1

Study flow diagram for update.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.1

Comparison 1: 50% or greater reduction in seizure frequency, Outcome 1: Primary analysis

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.2

Comparison 1: 50% or greater reduction in seizure frequency, Outcome 2: Best‐case scenario

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 1.3

Comparison 1: 50% or greater reduction in seizure frequency, Outcome 3: Worst‐case scenario

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.1

Comparison 2: Freedom from seizures, Outcome 1: Eslicarbazepine acetate 400 mg/day vs placebo

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.2

Comparison 2: Freedom from seizures, Outcome 2: Eslicarbazepine acetate 800 mg/day vs placebo

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.3

Comparison 2: Freedom from seizures, Outcome 3: Eslicarbazepine acetate 1200 mg/day vs placebo

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.4

Comparison 2: Freedom from seizures, Outcome 4: Eslicarbazepine acetate any dose vs placebo in children

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.5

Comparison 2: Freedom from seizures, Outcome 5: Eslicarbazepine acetate any dose vs placebo in adults

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 2.6

Comparison 2: Freedom from seizures, Outcome 6: Eslicarbazepine acetate any dose vs placebo, adults and children

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 3.1

Comparison 3: Treatment withdrawal, Outcome 1: Treatment withdrawal (any reason)

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 3.2

Comparison 3: Treatment withdrawal, Outcome 2: Treatment withdrawal (adverse effect)

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 4.1

Comparison 4: Adverse effects, Outcome 1: Ataxia

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 4.2

Comparison 4: Adverse effects, Outcome 2: Dizziness

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 4.3

Comparison 4: Adverse effects, Outcome 3: Fatigue

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 4.4

Comparison 4: Adverse effects, Outcome 4: Nausea

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 4.5

Comparison 4: Adverse effects, Outcome 5: Somnolence

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 4.6

Comparison 4: Adverse effects, Outcome 6: Rash

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 4.7

Comparison 4: Adverse effects, Outcome 7: Headache

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 4.8

Comparison 4: Adverse effects, Outcome 8: Vomiting

Ir a la figura de la revisiónAbrir en una pestaña nueva

Analysis 4.9

Comparison 4: Adverse effects, Outcome 9: Diplopia

Ir a la figura de la revisiónAbrir en una pestaña nueva

Summary of findings 1. Eslicarbazepine acetate add‐on for drug‐resistant focal epilepsy

Outcomes	*Anticipated absolute effects (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Certainty of the evidence (GRADE)	Comments
Eslicarbazepine acetate add‐on for drug‐resistant focal epilepsy
Patient or population: people with drug‐resistant focal epilepsy Setting: outpatients Intervention: ESL: all doses Comparison: placebo
Outcomes	Risk with placebo	Risk with ESL	Relative effect (95% CI)	No of participants (studies)	Certainty of the evidence (GRADE)	Comments
≥ 50% reduction in seizure frequency (adults) Follow‐up: up to 18 weeks	Study population		RR 1.71 (1.42 to 2.05)	1799 (5 RCTs)	⊕⊕⊕⊝ Moderate^a,b,c,d	Results presented for ITT population.
	203 per 1000	347 per 1000 (288 to 416)	RR 1.71 (1.42 to 2.05)	1799 (5 RCTs)	⊕⊕⊕⊝ Moderate^a,b,c,d	Results presented for ITT population.
≥ 50% reduction in seizure frequency (children aged 6–18 years) Follow‐up: up to 18 weeks	Study population		RR 1.35 (0.98 to 1.87)	322 (2 RCTs)	⊕⊕⊕⊝ Moderate^a,e	ESL may reduce seizures in children aged 6–18 years with drug‐resistant focal epilepsy.
	294 per 1000	397 per 1000 (288 to 550)	RR 1.35 (0.98 to 1.87)	322 (2 RCTs)	⊕⊕⊕⊝ Moderate^a,e
Freedom from seizures Follow‐up: up to 18 weeks	Study population		RR 3.16 (1.73 to 5.78)	1922 (6 RCTs)	⊕⊕⊕⊝ Moderate^a,c	—
Freedom from seizures Follow‐up: up to 18 weeks	20 per 1000	63 per 1000 (34 to 115)	RR 3.16 (1.73 to 5.78)	1922 (6 RCTs)	⊕⊕⊕⊝ Moderate^a,c	—
Treatment withdrawal (any reason) Follow‐up: up to 18 weeks	Study population		RR 1.25 (0.93 to 1.70)	2185 (7 RCTs)	⊕⊕⊕⊝ Moderate^a,c	—
	164 per 1000	205 per 1000 (153 to 279)	RR 1.25 (0.93 to 1.70)	2185 (7 RCTs)	⊕⊕⊕⊝ Moderate^a,c	—
Treatment withdrawal (adverse effect) Follow‐up: up to 18 weeks	Study population		RR 2.72 (1.66 to 4.46)	2185 (7 RCTs)	⊕⊕⊕⊝ Moderate^a,c	—
	38 per 1000	104 per 1000 (64 to 171)	RR 2.72 (1.66 to 4.46)	2185 (7 RCTs)	⊕⊕⊕⊝ Moderate^a,c	—
Adverse effects Follow‐up: up to 18 weeks	Study population		See comment	See comment	⊕⊕⊕⊝ Moderate^a,c	ESL was associated with dizziness, nausea, somnolence, diplopia and vomiting.
Adverse effects Follow‐up: up to 18 weeks	See comment	See comment	See comment	See comment	⊕⊕⊕⊝ Moderate^a,c
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; ESL: eslicarbazepine acetate; ITT: intention to treat; RCT: randomized controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.
^aThese studies were funded by BIAL – Portela & Ca, SA. There was no indication that the source of funding introduced bias. ^bDose‐response analysis indicated an increase in effect with increasing dose. ^cDowngraded one level due to risk of bias: the five included studies in adults were at high risk of attrition bias due to large proportions of missing data. ^dBest‐case and worst‐case scenario analyses were inconsistent with results of ITT analyses. ^eDowngraded one level due to risk of bias: there was an investigational medicinal product recall in children aged two to six years; therefore, we excluded its data here.

Summary of findings 1. Eslicarbazepine acetate add‐on for drug‐resistant focal epilepsy

Ir a la tabla de la revisión

Table 1. Estimated percentage responders per dose

Dose (mg/day)	Responders (%)	95% Confidence intervals
0	19.0	15.9 to 22.7
400	24.5	19.0 to 30.0
800	30.9	27.1 to 35.2
1200	38.2	34.1 to 42.7

Table 1. Estimated percentage responders per dose

Ir a la tabla de la revisión

Table 2. Percentage difference in responders per dose compared to placebo

Dose (mg/day)	Difference	95% Confidence intervals
400	6	–1 to 12
800	13	7 to 17
1200	21	14 to 25

Table 2. Percentage difference in responders per dose compared to placebo

Ir a la tabla de la revisión

Comparison 1. 50% or greater reduction in seizure frequency

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Primary analysis Show forest plot	7		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1.1 Eslicarbazepine acetate 400 mg/day vs placebo	2	398	Risk Ratio (M‐H, Fixed, 95% CI)	1.22 [0.80, 1.85]
1.1.2 Eslicarbazepine acetate 800 mg/day vs placebo	4	1015	Risk Ratio (M‐H, Fixed, 95% CI)	1.66 [1.34, 2.07]
1.1.3 Eslicarbazepine acetate 1200 mg/day vs placebo	4	1006	Risk Ratio (M‐H, Fixed, 95% CI)	1.92 [1.56, 2.37]
1.1.4 Eslicarbazepine acetate any dose vs placebo in children (aged 2–18 years)	2	386	Risk Ratio (M‐H, Fixed, 95% CI)	1.19 [0.88, 1.61]
1.1.5 Eslicarbazepine acetate any dose vs placebo in children (aged 6–18 years)	2	322	Risk Ratio (M‐H, Fixed, 95% CI)	1.35 [0.98, 1.87]
1.1.6 Eslicarbazepine acetate any dose vs placebo in adults	5	1799	Risk Ratio (M‐H, Fixed, 95% CI)	1.71 [1.42, 2.05]
1.1.7 Eslicarbazepine acetate any dose vs placebo, adults and children	7	2185	Risk Ratio (M‐H, Fixed, 95% CI)	1.57 [1.34, 1.83]
1.2 Best‐case scenario Show forest plot	7	2185	Risk Ratio (M‐H, Random, 95% CI)	2.47 [1.84, 3.31]

1.3 Worst‐case scenario Show forest plot	7	2185	Risk Ratio (M‐H, Random, 95% CI)	0.89 [0.79, 1.00]

Comparison 1. 50% or greater reduction in seizure frequency

Ir a la tabla de la revisión

Comparison 2. Freedom from seizures

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 Eslicarbazepine acetate 400 mg/day vs placebo Show forest plot	2	398	Risk Ratio (M‐H, Fixed, 95% CI)	1.03 [0.21, 5.02]

2.2 Eslicarbazepine acetate 800 mg/day vs placebo Show forest plot	4	1015	Risk Ratio (M‐H, Fixed, 95% CI)	3.42 [1.38, 8.46]

2.3 Eslicarbazepine acetate 1200 mg/day vs placebo Show forest plot	4	1006	Risk Ratio (M‐H, Fixed, 95% CI)	3.46 [1.40, 8.54]

2.4 Eslicarbazepine acetate any dose vs placebo in children Show forest plot	1	123	Risk Ratio (M‐H, Fixed, 95% CI)	4.34 [1.06, 17.79]

2.5 Eslicarbazepine acetate any dose vs placebo in adults Show forest plot	5	1799	Risk Ratio (M‐H, Fixed, 95% CI)	2.90 [1.49, 5.68]

2.6 Eslicarbazepine acetate any dose vs placebo, adults and children Show forest plot	6	1922	Risk Ratio (M‐H, Fixed, 95% CI)	3.16 [1.73, 5.78]

Comparison 2. Freedom from seizures

Ir a la tabla de la revisión

Comparison 3. Treatment withdrawal

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
3.1 Treatment withdrawal (any reason) Show forest plot	7		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1.1 Eslicarbazepine acetate 400 mg/day vs placebo	2	398	Risk Ratio (M‐H, Random, 95% CI)	0.93 [0.38, 2.30]
3.1.2 Eslicarbazepine acetate 800 mg/day vs placebo	4	1015	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.74, 1.39]
3.1.3 Eslicarbazepine acetate 1200 mg/day vs placebo	4	1006	Risk Ratio (M‐H, Random, 95% CI)	1.75 [1.26, 2.41]
3.1.4 Eslicarbazepine acetate any dose vs placebo in children	2	386	Risk Ratio (M‐H, Random, 95% CI)	2.01 [0.58, 6.93]
3.1.5 Eslicarbazepine acetate any dose vs placebo in adults	5	1799	Risk Ratio (M‐H, Random, 95% CI)	1.19 [0.86, 1.64]
3.1.6 Eslicarbazepine acetate any dose vs placebo, adults and children	7	2185	Risk Ratio (M‐H, Random, 95% CI)	1.25 [0.93, 1.70]
3.2 Treatment withdrawal (adverse effect) Show forest plot	7		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.2.1 Eslicarbazepine acetate 400 mg/day vs placebo	2	398	Risk Ratio (M‐H, Random, 95% CI)	2.12 [0.53, 8.48]
3.2.2 Eslicarbazepine acetate 800 mg/day vs placebo	4	1015	Risk Ratio (M‐H, Random, 95% CI)	2.52 [1.47, 4.35]
3.2.3 Eslicarbazepine acetate 1200 mg/day vs placebo	4	1006	Risk Ratio (M‐H, Random, 95% CI)	4.66 [2.68, 8.09]
3.2.4 Eslicarbazepine acetate any dose vs placebo in children	2	386	Risk Ratio (M‐H, Random, 95% CI)	2.62 [0.78, 8.76]
3.2.5 Eslicarbazepine acetate any dose vs placebo in adults	5	1799	Risk Ratio (M‐H, Random, 95% CI)	2.66 [1.42, 4.96]
3.2.6 Eslicarbazepine acetate any dose vs placebo, adults and children	7	2185	Risk Ratio (M‐H, Random, 95% CI)	2.72 [1.66, 4.46]

Comparison 3. Treatment withdrawal

Ir a la tabla de la revisión

Comparison 4. Adverse effects

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
4.1 Ataxia Show forest plot	2		Risk Ratio (M‐H, Fixed, 99% CI)	Subtotals only

4.1.1 Eslicarbazepine acetate 400 mg/day vs placebo	1	196	Risk Ratio (M‐H, Fixed, 99% CI)	1.04 [0.21, 5.09]
4.1.2 Eslicarbazepine acetate 800 mg/day vs placebo	2	373	Risk Ratio (M‐H, Fixed, 99% CI)	2.49 [0.75, 8.29]
4.1.3 Eslicarbazepine acetate 1200 mg/day vs placebo	2	365	Risk Ratio (M‐H, Fixed, 99% CI)	2.59 [0.77, 8.64]
4.1.4 Eslicarbazepine acetate any dose vs placebo in children	0	0	Risk Ratio (M‐H, Fixed, 99% CI)	Not estimable
4.1.5 Eslicarbazepine acetate any dose vs placebo in adults	2	647	Risk Ratio (M‐H, Fixed, 99% CI)	2.14 [0.71, 6.48]
4.1.6 Eslicarbazepine acetate any dose vs placebo, adults and children	2	647	Risk Ratio (M‐H, Fixed, 99% CI)	2.14 [0.71, 6.48]
4.2 Dizziness Show forest plot	7		Risk Ratio (M‐H, Fixed, 99% CI)	Subtotals only

4.2.1 Eslicarbazepine acetate 400 mg/day vs placebo	2	398	Risk Ratio (M‐H, Fixed, 99% CI)	2.25 [0.97, 5.22]
4.2.2 Eslicarbazepine acetate 800 mg/day vs placebo	4	1015	Risk Ratio (M‐H, Fixed, 99% CI)	2.41 [1.52, 3.80]
4.2.3 Eslicarbazepine acetate 1200 mg/day vs placebo	4	1006	Risk Ratio (M‐H, Fixed, 99% CI)	3.58 [2.33, 5.52]
4.2.4 Eslicarbazepine acetate any dose vs placebo in children	2	386	Risk Ratio (M‐H, Fixed, 99% CI)	2.02 [0.37, 11.21]
4.2.5 Eslicarbazepine acetate any dose vs placebo in adults	5	1799	Risk Ratio (M‐H, Fixed, 99% CI)	2.81 [1.86, 4.27]
4.2.6 Eslicarbazepine acetate any dose vs placebo, adults and children	7	2185	Risk Ratio (M‐H, Fixed, 99% CI)	2.77 [1.85, 4.15]
4.3 Fatigue Show forest plot	3		Risk Ratio (M‐H, Fixed, 99% CI)	Subtotals only

4.3.1 Eslicarbazepine acetate 400 mg/day vs placebo	1	196	Risk Ratio (M‐H, Fixed, 99% CI)	0.83 [0.15, 4.51]
4.3.2 Eslicarbazepine acetate 800 mg/day vs placebo	2	643	Risk Ratio (M‐H, Fixed, 99% CI)	1.21 [0.43, 3.40]
4.3.3 Eslicarbazepine acetate 1200 mg/day vs placebo	2	635	Risk Ratio (M‐H, Fixed, 99% CI)	1.72 [0.66, 4.50]
4.3.4 Eslicarbazepine acetate any dose vs placebo in children	1	263	Risk Ratio (M‐H, Fixed, 99% CI)	1.60 [0.25, 10.25]
4.3.5 Eslicarbazepine acetate any dose vs placebo in adults	2	1048	Risk Ratio (M‐H, Fixed, 99% CI)	1.39 [0.58, 3.31]
4.3.6 Eslicarbazepine acetate any dose vs placebo, adults and children	3	1352	Risk Ratio (M‐H, Fixed, 99% CI)	1.42 [0.65, 3.13]
4.4 Nausea Show forest plot	6		Risk Ratio (M‐H, Fixed, 99% CI)	Subtotals only

4.4.1 Eslicarbazepine acetate 400 mg/day vs placebo	1	196	Risk Ratio (M‐H, Fixed, 99% CI)	2.08 [0.45, 9.66]
4.4.2 Eslicarbazepine acetate 800 mg/day vs placebo	3	815	Risk Ratio (M‐H, Fixed, 99% CI)	2.12 [0.99, 4.55]
4.4.3 Eslicarbazepine acetate 1200 mg/day vs placebo	3	802	Risk Ratio (M‐H, Fixed, 99% CI)	3.64 [1.80, 7.39]
4.4.4 Eslicarbazepine acetate any dose vs placebo in children	2	386	Risk Ratio (M‐H, Fixed, 99% CI)	2.20 [0.46, 10.55]
4.4.5 Eslicarbazepine acetate any dose vs placebo in adults	4	1397	Risk Ratio (M‐H, Fixed, 99% CI)	2.61 [1.36, 5.01]
4.4.6 Eslicarbazepine acetate any dose vs placebo, adults and children	6	1824	Risk Ratio (M‐H, Fixed, 99% CI)	2.55 [1.39, 4.67]
4.5 Somnolence Show forest plot	7		Risk Ratio (M‐H, Fixed, 99% CI)	Subtotals only

4.5.1 Eslicarbazepine acetate 400 mg/day vs placebo	2	398	Risk Ratio (M‐H, Fixed, 99% CI)	1.15 [0.54, 2.45]
4.5.2 Eslicarbazepine acetate 800 mg/day vs placebo	4	1015	Risk Ratio (M‐H, Fixed, 99% CI)	1.39 [0.83, 2.31]
4.5.3 Eslicarbazepine acetate 1200 mg/day vs placebo	4	1006	Risk Ratio (M‐H, Fixed, 99% CI)	2.10 [1.31, 3.37]
4.5.4 Eslicarbazepine acetate any dose vs placebo in children	2	386	Risk Ratio (M‐H, Fixed, 99% CI)	2.04 [0.73, 5.72]
4.5.5 Eslicarbazepine acetate any dose vs placebo in adults	5	1799	Risk Ratio (M‐H, Fixed, 99% CI)	1.71 [1.11, 2.63]
4.5.6 Eslicarbazepine acetate any dose vs placebo, adults and children	7	2185	Risk Ratio (M‐H, Fixed, 99% CI)	1.75 [1.18, 2.61]
4.6 Rash Show forest plot	4		Risk Ratio (M‐H, Fixed, 99% CI)	Subtotals only

4.6.1 Eslicarbazepine acetate any dose vs placebo	4	1702	Risk Ratio (M‐H, Fixed, 99% CI)	1.24 [0.38, 4.01]
4.7 Headache Show forest plot	7		Risk Ratio (M‐H, Fixed, 99% CI)	Subtotals only

4.7.1 Eslicarbazepine acetate 400 mg/day vs placebo	2	398	Risk Ratio (M‐H, Fixed, 99% CI)	1.17 [0.49, 2.80]
4.7.2 Eslicarbazepine acetate 800 mg/day vs placebo	4	1015	Risk Ratio (M‐H, Fixed, 99% CI)	1.20 [0.71, 2.01]
4.7.3 Eslicarbazepine acetate 1200 mg/day vs placebo	4	1006	Risk Ratio (M‐H, Fixed, 99% CI)	1.55 [0.95, 2.53]
4.7.4 Eslicarbazepine acetate any dose vs placebo in children	2	386	Risk Ratio (M‐H, Fixed, 99% CI)	1.41 [0.64, 3.09]
4.7.5 Eslicarbazepine acetate any dose vs placebo in adults	5	1799	Risk Ratio (M‐H, Fixed, 99% CI)	1.30 [0.84, 2.02]
4.7.6 Eslicarbazepine acetate any dose vs placebo, adults and children	7	2185	Risk Ratio (M‐H, Fixed, 99% CI)	1.32 [0.90, 1.94]
4.8 Vomiting Show forest plot	6		Risk Ratio (M‐H, Fixed, 99% CI)	Subtotals only

4.8.1 Eslicarbazepine acetate 400 mg/day vs placebo	1	196	Risk Ratio (M‐H, Fixed, 99% CI)	1.39 [0.20, 9.59]
4.8.2 Eslicarbazepine acetate 800 mg/day vs placebo	3	815	Risk Ratio (M‐H, Fixed, 99% CI)	2.59 [0.96, 7.02]
4.8.3 Eslicarbazepine acetate 1200 mg/day vs placebo	3	802	Risk Ratio (M‐H, Fixed, 99% CI)	4.59 [1.80, 11.70]
4.8.4 Eslicarbazepine acetate any dose vs placebo in children	2	386	Risk Ratio (M‐H, Fixed, 99% CI)	1.17 [0.38, 3.60]
4.8.5 Eslicarbazepine acetate any dose vs placebo in adults	4	1397	Risk Ratio (M‐H, Fixed, 99% CI)	3.30 [1.34, 8.13]
4.8.6 Eslicarbazepine acetate any dose vs placebo, adults and children	6	1783	Risk Ratio (M‐H, Fixed, 99% CI)	2.37 [1.19, 4.74]
4.9 Diplopia Show forest plot	6		Risk Ratio (M‐H, Fixed, 99% CI)	Subtotals only

4.9.1 Eslicarbazepine acetate 400 mg/day vs placebo	2	398	Risk Ratio (M‐H, Fixed, 99% CI)	2.42 [0.59, 10.01]
4.9.2 Eslicarbazepine acetate 800 mg/day vs placebo	4	1015	Risk Ratio (M‐H, Fixed, 99% CI)	4.03 [1.61, 10.08]
4.9.3 Eslicarbazepine acetate 1200 mg/day vs placebo	4	1006	Risk Ratio (M‐H, Fixed, 99% CI)	5.12 [2.07, 12.62]
4.9.4 Eslicarbazepine acetate any dose vs placebo in children	2	386	Risk Ratio (M‐H, Fixed, 99% CI)	3.74 [0.63, 22.34]
4.9.5 Eslicarbazepine acetate any dose vs placebo in adults	4	1702	Risk Ratio (M‐H, Fixed, 99% CI)	4.14 [1.74, 9.84]
4.9.6 Eslicarbazepine acetate any dose vs placebo, adults and children	6	2088	Risk Ratio (M‐H, Fixed, 99% CI)	4.07 [1.86, 8.89]

Comparison 4. Adverse effects

Ir a la tabla de la revisión

The Cochrane Library

Scolaris Language Selector Scolaris Language Selector

Idioma de la Revisión Cochrane

Idioma de la web

Scolaris Content Language Banner Portlet Scolaris Content Language Banner Portlet

Scolaris Content Display Scolaris Content Display

Acetato de eslicarbazepina como tratamiento complementario para la epilepsia focal farmacorresistente

Información