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Meta-Analysis
. 2019 Jun 24;6(6):CD012065.
doi: 10.1002/14651858.CD012065.pub3.

Topiramate versus carbamazepine monotherapy for epilepsy: an individual participant data review

Sarah J Nevitt  1 , Maria Sudell, Catrin Tudur Smith, Anthony G Marson
Affiliations
Meta-Analysis

Topiramate versus carbamazepine monotherapy for epilepsy: an individual participant data review

Sarah J Nevitt et al. Cochrane Database Syst Rev. .

Abstract

Background: This is an updated version of the original Cochrane Review published in Issue 12, 2016. This review is one in a series of Cochrane Reviews investigating pair-wise monotherapy comparisons.Epilepsy is a common neurological condition in which abnormal electrical discharges from the brain cause recurrent unprovoked seizures. It is believed that with effective drug treatment, up to 70% of individuals with active epilepsy have the potential to become seizure-free and go into long-term remission shortly after starting drug therapy, the majority of which may be able to achieve remission with a single antiepileptic drug (AED).The correct choice of first-line AED for individuals with newly diagnosed seizures is of great importance and should be based on the highest-quality evidence available regarding the potential benefits and harms of various treatments for an individual.Topiramate and carbamazepine are commonly used AEDs. Performing a synthesis of the evidence from existing trials will increase the precision of results of outcomes relating to efficacy and tolerability, and may help inform a choice between the two drugs.

Objectives: To review the time to treatment failure, remission and first seizure with topiramate compared with carbamazepine when used as monotherapy in people with focal onset seizures (simple or complex focal and secondarily generalised), or generalised onset tonic-clonic seizures (with or without other generalised seizure types).

Search methods: For the latest update we searched the Cochrane Register of Studies (CRS Web), which includes the Cochrane Epilepsy Group Specialized Register and the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (Ovid); ClinicalTrials.gov; and the WHO International Clinical Trials Registry Platform (ICTRP) to 22 May 2018. We imposed no language restrictions. We also contacted pharmaceutical companies and trial investigators.

Selection criteria: Randomised controlled trials (RCTs) comparing monotherapy with either topiramate or carbamazepine in children or adults with focal onset seizures or generalised onset tonic-clonic seizures (with or without other generalised seizure types).

Data collection and analysis: This was an individual participant data (IPD), review. Our primary outcome was time to treatment failure. Our secondary outcomes were time to first seizure post-randomisation, time to six-month remission, time to 12-month remission, and incidence of adverse events. We used Cox proportional hazards regression models to obtain trial-specific estimates of hazard ratios (HRs), with 95% confidence intervals (CIs), using the generic inverse variance method to obtain the overall pooled HR and 95% CI.

Main results: IPD were available for 1151 of 1239 eligible individuals from two of three eligible studies (93% of the potential data). A small proportion of individuals recruited into these trials had 'unclassified seizures;' for analysis purposes, these individuals are grouped with those with generalised onset seizures. For remission outcomes, a HR < 1 indicated an advantage for carbamazepine, and for first seizure and treatment failure outcomes, a HR < 1 indicated an advantage for topiramate.The main overall results for the primary outcome, time to treatment failure, given as pooled HR adjusted for seizure type were: time to failure for any reason related to treatment 1.16 (95% CI 0.97 to 1.38); time to failure due to adverse events 1.02 (95% CI 0.82 to 1.27); and time to failure due to lack of efficacy 1.46 (95% CI 1.08 to 1.98). Overall results for secondary outcomes were time to first seizure 1.11 (95% CI 0.96 to 1.29); and time to six-month remission 0.88 (0.76 to 1.01). There were no statistically significant differences between the drugs. A statistically significant advantage for carbamazepine was shown for time to 12-month remission: 0.84 (95% CI 0.71 to 0.99).The results of this review are applicable mainly to individuals with focal onset seizures; 81% of individuals included within the analysis experienced seizures of this type at baseline. For individuals with focal onset seizures, a statistically significant advantage for carbamazepine was shown for time to failure for any reason related to treatment (HR 1.21, 95% CI 1.01 to 1.46), time to treatment failure due to lack of efficacy (HR 1.47, 95% CI 1.07 to 2.02), and time to 12-month remission (HR 0.82, 95% CI 0.69 to 0.99). There was no statistically significant difference between topiramate and carbamazepine for 'time to first seizure' and 'time to six-month remission'.Evidence for individuals with generalised tonic-clonic seizures (9% of participants contributing to the analysis), and unclassified seizure types (10% of participants contributing to the analysis) was very limited; no statistically significant differences were found but CIs were wide; therefore we cannot exclude an advantage to either drug, or a difference between drugs.The most commonly reported adverse events with both drugs were drowsiness or fatigue, "pins and needles" (tingling sensation), headache, gastrointestinal disturbance and anxiety or depression. The rate of adverse events was similar across the two drugs.We judged the methodological quality of the included trials generally to be good; however, there was some evidence that the open-label design of the larger of the two trials may have influenced the treatment failure rate within the trial. Hence, we judged the certainty of the evidence for treatment failure to be moderate for individuals with focal onset seizures and low for individuals with generalised onset seizures. For efficacy outcomes (first seizure, remission), we judged the certainty of evidence from this review to be high for individuals with focal onset seizures and moderate for individuals with generalised onset or unclassified seizures.

Authors' conclusions: For individuals with focal onset seizures, there is moderate-certainty evidence that carbamazepine is less likely to be withdrawn and high-certainty evidence that 12-month remission will be achieved earlier than with topiramate. We did not find any differences between the drugs in terms of the other outcomes measured in the review and for individuals with generalised tonic-clonic seizures or unclassified epilepsy; however, we encourage caution in the interpretation of results including small numbers of participants with these seizure types.Future trials should be designed to the highest quality possible and take into consideration masking, choice of population, classification of seizure type, duration of follow-up, choice of outcomes and analysis, and presentation of results.

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Conflict of interest statement

SJN: none known MS: none known CTS: 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).

Figures

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Study flow diagram.
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'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
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Time to treatment failure ‐ any reason related to the treatment (CBZ: carbamazepine; TPM: Topiramate)
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Time to treatment failure ‐ any reason related to the treatment, by seizure type (CBZ: carbamazepine; TPM: Topiramate)
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Time to treatment failure due to adverse events (CBZ: carbamazepine; TPM: Topiramate)
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Time to treatment failure due to adverse events, by seizure type (CBZ: carbamazepine; TPM: Topiramate)
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Time to treatment failure due to lack of efficacy (CBZ: carbamazepine; TPM: Topiramate)
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Time to treatment failure due to lack of efficacy, by seizure type (CBZ: carbamazepine; TPM: Topiramate)
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Time to first seizure after randomisation (CBZ: carbamazepine; TPM: Topiramate)
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Time to first seizure after randomisation, by seizure type (CBZ: carbamazepine; TPM: Topiramate)
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Time to 12‐month remission (CBZ: carbamazepine; TPM: Topiramate)
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Time to 12‐month remission by seizure type (CBZ: carbamazepine; TPM: Topiramate)
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Time to 6‐month remission (CBZ: carbamazepine; TPM: Topiramate)
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Time to 6‐month remission by seizure type (CBZ: carbamazepine; TPM: Topiramate)
1.1
1.1. Analysis
Comparison 1 Topiramate monotherapy versus carbamazepine monotherapy, Outcome 1 Time to treatment failure (any reason related to the treatment).
1.2
1.2. Analysis
Comparison 1 Topiramate monotherapy versus carbamazepine monotherapy, Outcome 2 Time to treatment failure due to adverse events.
1.3
1.3. Analysis
Comparison 1 Topiramate monotherapy versus carbamazepine monotherapy, Outcome 3 Time to treatment failure due to lack of efficacy.
1.4
1.4. Analysis
Comparison 1 Topiramate monotherapy versus carbamazepine monotherapy, Outcome 4 Time to treatment failure (any reason related to the treatment) ‐ by epilepsy type.
1.5
1.5. Analysis
Comparison 1 Topiramate monotherapy versus carbamazepine monotherapy, Outcome 5 Time to treatment failure due to adverse events ‐ by epilepsy type.
1.6
1.6. Analysis
Comparison 1 Topiramate monotherapy versus carbamazepine monotherapy, Outcome 6 Time to treatment failure due to lack of efficacy ‐ by epilepsy type.
1.7
1.7. Analysis
Comparison 1 Topiramate monotherapy versus carbamazepine monotherapy, Outcome 7 Time to first seizure after randomisation.
1.8
1.8. Analysis
Comparison 1 Topiramate monotherapy versus carbamazepine monotherapy, Outcome 8 Time to first seizure after randomisation ‐ by epilepsy type.
1.9
1.9. Analysis
Comparison 1 Topiramate monotherapy versus carbamazepine monotherapy, Outcome 9 Time to 12‐month remission of seizures.
1.10
1.10. Analysis
Comparison 1 Topiramate monotherapy versus carbamazepine monotherapy, Outcome 10 Time to 12‐month remission of seizures ‐ by epilepsy type.
1.11
1.11. Analysis
Comparison 1 Topiramate monotherapy versus carbamazepine monotherapy, Outcome 11 Time to 6‐month remission of seizures.
1.12
1.12. Analysis
Comparison 1 Topiramate monotherapy versus carbamazepine monotherapy, Outcome 12 Time to 6‐month remission of seizures ‐ by epilepsy type.
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