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Sulthiame add-on therapy for epilepsy
Bresnahan, Rebecca Milburn-McNulty, Philip Powell, Graham Sills, Graeme Marson, Anthony G. Martin-McGill, Kirsty J.
Bresnahan, Rebecca
Milburn-McNulty, Philip
Powell, Graham
Sills, Graeme
Marson, Anthony G.
Martin-McGill, Kirsty J.
Advisors
Editors
Other Contributors
EPub Date
Publication Date
2019-08-27
Submitted Date
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Abstract
Background
This is an updated version of the Cochrane Review previously published in the Cochrane Database of Systematic Reviews 2015, Issue 10.
Epilepsy is a common neurological condition, characterised by recurrent seizures. Most people respond to conventional antiepileptic
drugs, however, around 30% will continue to experience seizures, despite treatment with multiple antiepileptic drugs. Sulthiame, also
known as sultiame, is a widely used antiepileptic drug in Europe and Israel. We present a summary of the evidence for the use of
sulthiame as add-on therapy in epilepsy.
Objectives
To assess the efficacy and tolerability of sulthiame as add-on therapy for people with epilepsy of any aetiology compared with placebo
or another antiepileptic drug.
Search methods
For the latest update, we searched the Cochrane Register of Studies (CRS Web), which includes the Cochrane Epilepsy Group’s
Specialized Register and CENTRAL (17 January 2019), MEDLINE Ovid (1946 to January 16, 2019), ClinicalTrials.gov and the
WHO ICTRP Search Portal (17 January 2019). We imposed no language restrictions. We contacted the manufacturers of sulthiame,
and researchers in the field to seek any ongoing or unpublished studies.
Selection criteria
Randomised controlled trials of add-on sulthiame, with any level of blinding (single, double or unblinded) in people of any age, with
epilepsy of any aetiology.
Data collection and analysis
Two review authors independently selected trials for inclusion, and extracted relevant data. We assessed these outcomes: (1) 50% or
greater reduction in seizure frequency between baseline and end of follow-up; (2) complete cessation of seizures during follow-up; (3)
mean seizure frequency; (4) time-to-treatment withdrawal; (5) adverse effects; and (6) quality of life. We used intention-to-treat for
primary analyses. We presented results as risk ratios (RR) with 95% confidence intervals (CIs). However, due to the paucity of trials,
we mainly conducted a narrative analysis.
Sulthiame add-on therapy for epilepsy (Review) 1
Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
For Preview Only
Main results
We included one placebo-controlled trial that recruited 37 infants with newly diagnosed West syndrome. This trial was funded by
DESITIN Pharma, Germany. During the study, sulthiame was given as an add-on therapy to pyridoxine. No data were reported for
the outcomes: 50% or greater reduction in seizure frequency between baseline and end of follow-up; mean seizure frequency; or quality
of life. For complete cessation of seizures during a nine-day follow-up period for add-on sulthiame versus placebo, the RR was 11.14
(95% CI 0.67 to 184.47; very low-certainty evidence), however, this difference was not shown to be statistically significant (P = 0.09).
The number of infants experiencing one or more adverse events was not significantly different between the two treatment groups (RR
0.85, 95% CI 0.44 to 1.64; very low-certainty evidence; P = 0.63). Somnolence was more prevalent amongst infants randomised to
add-on sulthiame compared to placebo, but again, the difference was not statistically significant (RR 3.40, 95% CI 0.42 to 27.59; very
low-certainty evidence; P = 0.25). We were unable to conduct meaningful analysis of time-to-treatment withdrawal and adverse effects
due to incomplete data.
Authors’ conclusions
Sulthiame may lead to a cessation of seizures when used as an add-on therapy to pyridoxine in infants with West syndrome, however,
we are very uncertain about the reliability of this finding. The included study was small and had a significant risk of bias, largely due to
the lack of details regarding blinding and the incomplete reporting of outcomes. Both issues negatively impacted the certainty of the
evidence. No conclusions can be drawn about the occurrence of adverse effects, change in quality of life, or mean reduction in seizure
frequency. No evidence exists for the use of sulthiame as an add-on therapy in people with epilepsy outside West syndrome.
Large, multi-centre randomised controlled trials are needed to inform clinical practice, if sulthiame is to be used as an add-on therapy
for epilepsy
Citation
Bresnahan, R., Martin-McGill, K. J., Milburn-McNulty, P., Powell, G., Sills, G. J. & Marson, A. G. (2019). Sulthiame add-on therapy for epilepsy. Cochrane Database of Systematic Reviews, 8, CD009472
Publisher
Wiley
Journal
Cochrane Database of Systematic Reviews
Research Unit
DOI
10.1002/14651858.CD009472.pub4
PubMed ID
PubMed Central ID
Type
Article
Language
en
Description
Series/Report no.
ISSN
EISSN
1469-493X