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Tiagabine add-on for drug-resistant partial epilepsy.
Cochrane Database Syst Rev 2012; (5):CD001908CD

Abstract

BACKGROUND

Epilepsy is a common neurological condition, affecting 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 and 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 upon 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 issue 10, 2010. We searched the Cochrane Epilepsy Group's Specialised Register (December 2011), the Cochrane Central Register of Controlled Trials (CENTRAL, issue 4, 2011 of The Cochrane Library), and MEDLINE (1948 to November 2011). 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 We also contacted the manufacturers of tiagabine and experts in the field to seek any ongoing or unpublished studies.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, single or unblinded and be of parallel or crossover 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. Any 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 by intention-to-treat. Worst case and best case analyses were also calculated for seizure outcomes. Dose response was evaluated in regression models.

MAIN RESULTS

Four parallel group and two crossover group trials were included. The overall relative risk (RR) with 95% confidence intervals (CIs) for a 50% or greater reduction in seizure frequency (tiagabine versus placebo) was 3.16 (95% CI 1.97 to 5.07). Due to differences in response rates among trials, regression models were unable to provide reliable estimates of responses to individual doses. The RR for treatment withdrawal was 1.81 (95% CI 1.25 to 2.62). The 99% CIs for the following adverse effects: 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 data available suggested that there were no significant effects on cognition and mood and adjustment.

AUTHORS' CONCLUSIONS

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

Authors+Show Affiliations

Department of Molecular and Clinical Pharmacology, Cochrane Epilepsy Group, Liverpool, UK. jennifer.pulman@liv.ac.uk.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

22592677

Citation

Pulman, Jennifer, et al. "Tiagabine Add-on for Drug-resistant Partial Epilepsy." The Cochrane Database of Systematic Reviews, 2012, p. CD001908.
Pulman J, Marson AG, Hutton JL. Tiagabine add-on for drug-resistant partial epilepsy. Cochrane Database Syst Rev. 2012.
Pulman, J., Marson, A. G., & Hutton, J. L. (2012). Tiagabine add-on for drug-resistant partial epilepsy. The Cochrane Database of Systematic Reviews, (5), p. CD001908. doi:10.1002/14651858.CD001908.pub2.
Pulman J, Marson AG, Hutton JL. Tiagabine Add-on for Drug-resistant Partial Epilepsy. Cochrane Database Syst Rev. 2012 May 16;(5)CD001908. PubMed PMID: 22592677.
* 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 - Marson,Anthony G, AU - Hutton,Jane L, Y1 - 2012/05/16/ PY - 2012/5/18/entrez PY - 2012/5/18/pubmed PY - 2012/8/2/medline SP - CD001908 EP - CD001908 JF - The Cochrane database of systematic reviews JO - Cochrane Database Syst Rev IS - 5 N2 - BACKGROUND: Epilepsy is a common neurological condition, affecting 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 and 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 upon 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 issue 10, 2010. We searched the Cochrane Epilepsy Group's Specialised Register (December 2011), the Cochrane Central Register of Controlled Trials (CENTRAL, issue 4, 2011 of The Cochrane Library), and MEDLINE (1948 to November 2011). 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, single or unblinded and be of parallel or crossover 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. Any 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 by intention-to-treat. Worst case and best case analyses were also calculated for seizure outcomes. Dose response was evaluated in regression models. MAIN RESULTS: Four parallel group and two crossover group trials were included. The overall relative risk (RR) with 95% confidence intervals (CIs) for a 50% or greater reduction in seizure frequency (tiagabine versus placebo) was 3.16 (95% CI 1.97 to 5.07). Due to differences in response rates among trials, regression models were unable to provide reliable estimates of responses to individual doses. The RR for treatment withdrawal was 1.81 (95% CI 1.25 to 2.62). The 99% CIs for the following adverse effects: 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 data available suggested that there were no significant effects on cognition and mood and adjustment. AUTHORS' CONCLUSIONS: Tiagabine reduces seizure frequency but is associated with some adverse effects when used as an add-on for people with drug-resistant localisation-related seizures. SN - 1469-493X UR - https://www.unboundmedicine.com/medline/citation/22592677/Tiagabine_add_on_for_drug_resistant_partial_epilepsy_ L2 - https://doi.org/10.1002/14651858.CD001908.pub2 DB - PRIME DP - Unbound Medicine ER -