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Topiramate monotherapy for juvenile myoclonic epilepsy

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Abstract

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Background

Topiramate is a newer broad‐spectrum antiepileptic drug (AED). Some studies have shown the benefits of topiramate monotherapy in the treatment of juvenile myoclonic epilepsy (JME). However, there are no current systematic reviews to determine the efficacy and tolerability of topiramate monotherapy in people with JME. This is an updated version of the original Cochrane Review published in Issue 12, 2015.

Objectives

To evaluate the efficacy and tolerability of topiramate monotherapy in the treatment of JME.

Search methods

For the latest update, on 21 February 2017 we searched Cochrane Epilepsy's Specialized Register, CENTRAL, MEDLINE, and ClinicalTrials.gov. We also searched ongoing trials registers, reference lists and relevant conference proceedings, and contacted study authors and pharmaceutical companies.

Selection criteria

We included randomized controlled trials (RCTs) investigating topiramate monotherapy versus placebo or other AED treatment for people with JME, with the outcomes of proportion of responders or experiencing adverse events (AEs).

Data collection and analysis

Two review authors independently screened the titles and abstracts of identified records, selected studies for inclusion, extracted data, cross‐checked the data for accuracy and assessed the methodological quality. We performed no meta‐analyses due to the limited available data.

Main results

We included three studies with 83 participants. For efficacy, a greater proportion of participants in the topiramate group had a 50% or more reduction in primarily generalized tonic‐clonic seizures (PGTCS) compared with participants in the placebo group. There were no significant differences between topiramate versus valproate in participants responding with a 50% or more reduction in myoclonic seizures or in PGTCS or seizure‐free. Concerning tolerability, we ranked AEDs associated with topiramate as moderate‐to‐severe, while we ranked 59% of AEDs linked to valproate as severe complaints. Moreover, systemic toxicity scores were higher in the valproate group than the topiramate group. We judged the quality of the evidence from the studies to be very low.

Authors' conclusions

Since the last version of this review we found no new studies. This review does not provide sufficient evidence to support topiramate for the treatment of people with JME. Based on the current limited available data, topiramate seems to be better tolerated than valproate, but there were no more benefits of efficacy in topiramate compared with valproate. In the future, well‐designed, double‐blind RCTs with large samples are required to test the efficacy and tolerability of topiramate in people with JME.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Plain language summary

Topiramate monotherapy for juvenile myoclonic epilepsy

Background

Juvenile myoclonic epilepsy (JME) is characterized by involuntary (uncontrolled) twitching of muscles in shoulders and arms after awakening, often starting in childhood.

Study characteristics

We searched scientific databases for clinical trials comparing the antiepileptic drug, topiramate, with placebo (a pretend treatment) or another antiepileptic drug in people with JME. We wanted to evaluate how well topiramate worked and if it had any side effects. The evidence is current to February 2017.

Key results

We included and analyzed three randomized controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) with 83 participants. It seems that topiramate is better tolerated than valproate, but is no more effective than valproate. Topiramate seemed to work better than placebo based on a small number of included people.

Quality of the evidence

The quality of the evidence from the studies was very low and results should be interpreted with caution. In the future, well‐designed, double‐blind (where neither the participant nor the researcher know which treatment has been given until after the results have been collected) RCTs with large numbers of participants are required to test how effective and well tolerated topiramate is in people with JME.