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Tiagabine add-on for drug-resistant partial epilepsy.
Cochrane Database Syst Rev 2014; (2):CD001908CD

Abstract

BACKGROUND

Epilepsy is a common neurological condition that affects almost 0.5% to 1% of the population. Nearly 30% of people with epilepsy are resistant to currently available drugs. Tiagabine is one of the newer antiepileptic drugs; its effects as an adjunct (add-on) to standard drugs are assessed in this review.

OBJECTIVES

To evaluate the effects of add-on treatment with tiagabine on seizures, adverse effects, cognition and quality of life for people with drug-resistant localisation-related seizures.

SEARCH METHODS

This is an updated version of the original Cochrane review published in 2012 (Issue 5). We searched the Cochrane Epilepsy Group Specialised Register (November 2013), the Cochrane Central Register of Controlled Trials (CENTRAL, 2013, Issue 10) and MEDLINE (1946 to November 2013). No language restrictions were imposed. We also contacted the manufacturers of tiagabine and experts in the field to seek any ongoing or unpublished studies.

SELECTION CRITERIA

Randomised placebo-controlled add-on trials of people of any age with localisation-related seizures in which an adequate method of concealment of randomisation was used were included. The studies could be double-blind, single-blind or unblinded and of parallel or cross-over design. They had to have a minimum treatment period of eight weeks. Trials using an active drug control group were also included.

DATA COLLECTION AND ANALYSIS

Two review authors independently selected trials for inclusion and extracted data. Disagreements were resolved by discussion. Outcomes investigated included 50% or greater reduction in seizure frequency, treatment withdrawal, adverse effects, effects on cognition and quality of life. The primary analyses were performed by intention-to-treat. Worst-case and best-case analyses were calculated for seizure outcomes. Dose response was evaluated in regression models. Risk of bias in each study was assessed by two review authors using the Cochrane 'Risk of bias' tool.

MAIN RESULTS

Four parallel-group and two cross-over group trials were included. The overall risk ratio (RR) with 95% confidence intervals (CIs) for a 50% or greater reduction in seizure frequency (tiagabine vs placebo) was 3.16 (95% CI 1.97 to 5.07). Because of differences in response rates among trials, regression models were unable to provide reliable estimates of response to individual doses. The RR for treatment withdrawal was 1.81 (95% CI 1.25 to 2.62). The 99% CIs for the adverse effects of dizziness, fatigue, nervousness and tremor did not include unity, indicating that they are significantly associated with tiagabine. For cognitive and quality of life outcomes, the limited available data suggested no significant effects on cognition and mood and adjustment. Two of the five studies were judged as having low risk of bias, three studies unclear risk of bias and one study high risk of bias. Overall study quality was rated as high using the GRADE approach.

AUTHORS' CONCLUSIONS

Tiagabine reduces seizure frequency but is associated with some adverse effects when used as an add-on treatment for people with drug-resistant localisation-related seizures.

Authors+Show Affiliations

Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool, Clinical Sciences Centre for Research and Education, Lower Lane, Fazakerley, Liverpool, Merseyside, UK, L9 7LJ.No affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't
Review
Systematic Review

Language

eng

PubMed ID

24500879

Citation

Pulman, Jennifer, et al. "Tiagabine Add-on for Drug-resistant Partial Epilepsy." The Cochrane Database of Systematic Reviews, 2014, p. CD001908.
Pulman J, Hutton JL, Marson AG. Tiagabine add-on for drug-resistant partial epilepsy. Cochrane Database Syst Rev. 2014.
Pulman, J., Hutton, J. L., & Marson, A. G. (2014). Tiagabine add-on for drug-resistant partial epilepsy. The Cochrane Database of Systematic Reviews, (2), p. CD001908. doi:10.1002/14651858.CD001908.pub3.
Pulman J, Hutton JL, Marson AG. Tiagabine Add-on for Drug-resistant Partial Epilepsy. Cochrane Database Syst Rev. 2014 Feb 5;(2)CD001908. PubMed PMID: 24500879.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Tiagabine add-on for drug-resistant partial epilepsy. AU - Pulman,Jennifer, AU - Hutton,Jane L, AU - Marson,Anthony G, Y1 - 2014/02/05/ PY - 2014/2/7/entrez PY - 2014/2/7/pubmed PY - 2014/10/9/medline SP - CD001908 EP - CD001908 JF - The Cochrane database of systematic reviews JO - Cochrane Database Syst Rev IS - 2 N2 - BACKGROUND: Epilepsy is a common neurological condition that affects almost 0.5% to 1% of the population. Nearly 30% of people with epilepsy are resistant to currently available drugs. Tiagabine is one of the newer antiepileptic drugs; its effects as an adjunct (add-on) to standard drugs are assessed in this review. OBJECTIVES: To evaluate the effects of add-on treatment with tiagabine on seizures, adverse effects, cognition and quality of life for people with drug-resistant localisation-related seizures. SEARCH METHODS: This is an updated version of the original Cochrane review published in 2012 (Issue 5). We searched the Cochrane Epilepsy Group Specialised Register (November 2013), the Cochrane Central Register of Controlled Trials (CENTRAL, 2013, Issue 10) and MEDLINE (1946 to November 2013). No language restrictions were imposed. We also contacted the manufacturers of tiagabine and experts in the field to seek any ongoing or unpublished studies. SELECTION CRITERIA: Randomised placebo-controlled add-on trials of people of any age with localisation-related seizures in which an adequate method of concealment of randomisation was used were included. The studies could be double-blind, single-blind or unblinded and of parallel or cross-over design. They had to have a minimum treatment period of eight weeks. Trials using an active drug control group were also included. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion and extracted data. Disagreements were resolved by discussion. Outcomes investigated included 50% or greater reduction in seizure frequency, treatment withdrawal, adverse effects, effects on cognition and quality of life. The primary analyses were performed by intention-to-treat. Worst-case and best-case analyses were calculated for seizure outcomes. Dose response was evaluated in regression models. Risk of bias in each study was assessed by two review authors using the Cochrane 'Risk of bias' tool. MAIN RESULTS: Four parallel-group and two cross-over group trials were included. The overall risk ratio (RR) with 95% confidence intervals (CIs) for a 50% or greater reduction in seizure frequency (tiagabine vs placebo) was 3.16 (95% CI 1.97 to 5.07). Because of differences in response rates among trials, regression models were unable to provide reliable estimates of response to individual doses. The RR for treatment withdrawal was 1.81 (95% CI 1.25 to 2.62). The 99% CIs for the adverse effects of dizziness, fatigue, nervousness and tremor did not include unity, indicating that they are significantly associated with tiagabine. For cognitive and quality of life outcomes, the limited available data suggested no significant effects on cognition and mood and adjustment. Two of the five studies were judged as having low risk of bias, three studies unclear risk of bias and one study high risk of bias. Overall study quality was rated as high using the GRADE approach. AUTHORS' CONCLUSIONS: Tiagabine reduces seizure frequency but is associated with some adverse effects when used as an add-on treatment for people with drug-resistant localisation-related seizures. SN - 1469-493X UR - https://www.unboundmedicine.com/medline/citation/24500879/Tiagabine_add_on_for_drug_resistant_partial_epilepsy_ L2 - https://doi.org/10.1002/14651858.CD001908.pub3 DB - PRIME DP - Unbound Medicine ER -