Rufinamide add‐on therapy for refractory epilepsy

Mariangela Panebianco; Hemanshu Prabhakar; Anthony G Marson

doi:10.1002/14651858.CD011772.pub2

Cochrane Database of Systematic Reviews

Rufinamide輔助治療頑固型癲癇

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DOI:

https://doi.org/10.1002/14651858.CD011772.pub2 Copiar DOI

Base de datos:

Cochrane Database of Systematic Reviews

Versión publicada:

25 abril 2018see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Epilepsia

Copyright:

Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

Mariangela Panebianco

Correspondencia a: Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK

[email protected]

[email protected]
Hemanshu Prabhakar

Department of Neuroanaesthesiology and Critical Care, All India Institute of Medical Sciences, New Delhi, India
Anthony G Marson

Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Liverpool, UK

Contributions of authors

MP was primarily responsible for the writing of this review and completing data extraction and 'Risk of bias' assessments.

AGM provided guidance and manuscript feedback.

HP assessed the studies for eligibility, extracted data and assessed risk of bias.

Sources of support

Internal sources

No sources of support supplied

External sources

National Institute for Health Research, UK.

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

Declarations of interest

MP: none known.

AGM: a consortium of pharmaceutical companies (GSK, Eisai, UCB Pharma) funded the National Audit of Seizure Management in Hospitals (NASH) through grants paid to the University of Liverpool. Professor Tony Marson is part funded by National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care North West Coast (NIHR CLAHRC NWC).

HP: none known.

Acknowledgements

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

Version history

Published

Title

Stage

Authors

Version

2020 Nov 08

Rufinamide add‐on therapy for drug‐resistant epilepsy

Review

Mariangela Panebianco, Hemanshu Prabhakar, Anthony G Marson

https://doi.org/10.1002/14651858.CD011772.pub3

2018 Apr 25

Rufinamide add‐on therapy for refractory epilepsy

Review

Mariangela Panebianco, Hemanshu Prabhakar, Anthony G Marson

https://doi.org/10.1002/14651858.CD011772.pub2

2015 Jun 25

Rufinamide add‐on therapy for refractory epilepsy

Protocol

Mariangela Panebianco, Anthony G Marson

https://doi.org/10.1002/14651858.CD011772

Differences between protocol and review

None.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Adolescent; Adult; Aged; Aged, 80 and over; Child; Child, Preschool; Female; Humans; Male; Middle Aged;

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.

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Figure 2

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

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Figure 3

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

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Figure 4

Rufinamide versus placebo, outcome: 1.1 50% reduction in seizure frequency.

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Figure 5

Forest plot of comparison: 1 Rufinamide versus placebo, outcome: 1.3 Treatment withdrawal.

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Figure 6

Rufinamide versus placebo: 1 Rufinamide versus placebo: 1.4 Adverse effects.

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Analysis 1.1

Comparison 1 Rufinamide versus placebo, Outcome 1 ≥ 50% reduction in seizure frequency.

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Analysis 1.2

Comparison 1 Rufinamide versus placebo, Outcome 2 Seizure freedom.

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Analysis 1.3

Comparison 1 Rufinamide versus placebo, Outcome 3 Treatment withdrawal.

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Analysis 1.4

Comparison 1 Rufinamide versus placebo, Outcome 4 Adverse effects.

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Summary of findings for the main comparison. Rufinamide versus placebo for drug‐resistant focal epilepsy

Rufinamide versus placebo for drug‐resistant focal epilepsy
Patient or population: people with drug‐resistant focal epilepsy Settings: outpatients Intervention: rufinamide Comparison: placebo
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Placebo	Rufinamide
50% or greater reduction in seizure frequency ‐ ITT analysis	Study population		RR 1.79 (1.44 to 2.22)	1759 (6 studies)	⊕⊕⊕⊝ Moderate¹	RR > 1 indicates outcome is more likely in rufinamide group.
	143 per 1000	256 per 1000 (206 to 317)
Treatment withdrawal	Study population		RR 1.83 (1.45 to 2.31)	1759 (6 studies)	⊕⊕⊕⊝ Moderate¹	RR > 1 indicates outcome is more likely in rufinamide group.
	112 per 1000	205 per 1000 (162 to 259)
Adverse effects: dizziness	Study population		RR 2.52 (1.90 to 3.34)	1295 (3 studies)	⊕⊕⊕⊝ Moderate¹	RR > 1 indicates outcome is more likely in rufinamide group.
	108 per 1000	272 per 1000 (205 to 361)
Adverse effects: fatigue	Study population		RR 1.46 (1.08 to 1.97)	1295 (3 studies)	⊕⊕⊕⊝ Moderate¹	RR > 1 indicates outcome is more likely in rufinamide group.
	112 per 1000	164 per 1000 (121 to 221)
Adverse effects: headache	Study population		RR 1.36 (1.08 to 1.69)	1228 (3 studies)	⊕⊕⊕⊝ Moderate¹	RR > 1 indicates outcome is more likely in rufinamide group.
	196 per 1000	267 per 1000 (212 to 331)
Adverse effects: somnolence	Study population		RR 1.94 (1.44 to 2.61)	1759 (6 studies)	⊕⊕⊕⊝ Moderate¹	RR > 1 indicates outcome is more likely in rufinamide group.
	82 per 1000	159 per 1000 (118 to 214)
Adverse effects: nausea	Study population		RR 1.87 (1.33 to 2.64)	1295 (3 studies)	⊕⊕⊕⊝ Moderate¹	RR > 1 indicates outcome is more likely in rufinamide group.
	82 per 1000	153 per 1000 (109 to 216)
Adverse effects: vomiting	Study population		RR 2.95 (1.80 to 4.82)	777 (4 studies)	⊕⊕⊝⊝ Low²	RR > 1 indicates outcome is more likely in rufinamide group.
	49 per 1000	145 per 1000 (88 to 236)
Adverse effects: diplopia	Study population		RR 4.60 (2.53 to 8.38)	1295 (3 studies)	⊕⊕⊝⊝ Low²	RR > 1 indicates outcome is more likely in rufinamide group.
	24 per 1000	110 per 1000 (61 to 201)
The basis for the assumed risk⁴(e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk* (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; ITT: intention to treat; RR: risk ratio.
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
1. Downgraded once due to risk of bias: unclear methodological information provided for some included studies and all included studies pharmaceutical sponsored. 2. Downgraded once due to imprecision: Wide confidence intervals. 3.Assumed risk is calculated as the event rate in the control group per 1000 people (number of events divided by the number of participants receiving control treatment).

Summary of findings for the main comparison. Rufinamide versus placebo for drug‐resistant focal epilepsy

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Comparison 1. Rufinamide versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 ≥ 50% reduction in seizure frequency Show forest plot	6	1759	Risk Ratio (M‐H, Fixed, 95% CI)	1.79 [1.44, 2.22]

2 Seizure freedom Show forest plot	1	73	Risk Ratio (M‐H, Fixed, 95% CI)	1.32 [0.36, 4.86]

3 Treatment withdrawal Show forest plot	6	1759	Risk Ratio (M‐H, Fixed, 95% CI)	1.83 [1.45, 2.31]

4 Adverse effects Show forest plot	6		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.1 Dizziness	3	1295	Risk Ratio (M‐H, Fixed, 95% CI)	2.52 [1.90, 3.34]
4.2 Fatigue	3	1295	Risk Ratio (M‐H, Fixed, 95% CI)	1.46 [1.08, 1.97]
4.3 Headache	3	1228	Risk Ratio (M‐H, Fixed, 95% CI)	1.36 [1.08, 1.69]
4.4 Somnolence	6	1759	Risk Ratio (M‐H, Fixed, 95% CI)	1.94 [1.44, 2.61]
4.5 Nausea	3	1295	Risk Ratio (M‐H, Fixed, 95% CI)	1.87 [1.33, 2.64]
4.6 Vomiting	4	777	Risk Ratio (M‐H, Fixed, 95% CI)	2.95 [1.80, 4.82]
4.7 Diplopia	3	1295	Risk Ratio (M‐H, Fixed, 95% CI)	4.60 [2.53, 8.38]

Comparison 1. Rufinamide versus placebo

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Rufinamide輔助治療頑固型癲癇

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