Evidence map›Paper›PMID 27552848›Full record

Trial reportBMC neurology2016

Comparative effectiveness of levetiracetam, valproate and carbamazepine among elderly patients with newly diagnosed epilepsy: subgroup analysis of the randomized, unblinded KOMET study.

Bernd Pohlmann-Eden, Anthony G Marson, Matthias Noack-Rink, Francisco Ramirez, Azita Tofighy, Konrad J Werhahn, Imane Wild, Eugen Trinka

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC neurology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00175903 (A Therapeutic Confirmatory, Open-label, Multi-center, Randomized 2 Parallel Groups, Community-based Trial Studying the Efficacy and Safety of Levetiracetam), which is not on this map. Cited by 22 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 6 pooled it
4.4field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00175903 phase3completednot on this map

A Therapeutic Confirmatory, Open-label, Multi-center, Randomized 2 Parallel Groups, Community-based Trial Studying the Efficacy and Safety of Levetiracetam (1000 to 3000 mg/Day Oral Tablets 250-500 mg b.i.d.) Compared to Sodium Valproate (1000 to 2000 mg/Day Oral ER Tablets 300-500 mg b.i.d.) and Carbamazepine (600 to 1600 mg/Day Oral CR Tablets 200-400 mg b.i.d.) as Monotherapy in Subjects With Newly Diagnosed Epilepsy.

TypeinterventionalSponsorUCB PharmaRan2005 to 2007Enrolled1,701ConditionsEpilepsyArmsLevetiracetam, Carbamazepine Controlled Release (CBZ-CR), Valproate Extended Release
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 6 syntheses or guidelines pooled it, 65 citations in OpenAlex.

  1. Pooled it
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  7. Article
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  11. Review
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  14. Article
  15. [Epilepsy in the aged : Challenges in diagnostics and treatment].Zeitschrift fur Gerontologie und Geriatrie · 2021
    Article
  16. Review
  17. Article
  18. Pharmacological Treatment of Epilepsy in Elderly Patients.Journal of clinical neurology (Seoul, Korea) · 2020
    Review
  19. Poststroke seizure: optimising its management.Stroke and vascular neurology · 2019
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 5 institutions in 5 countries.

Bernd Pohlmann-EdenEpilepsy Program, Division of Neurology, Queen Elizabeth II Health Science Center, Dalhousie University, Halifax, Canada. B.Pohlmann-Eden@dal.ca.
Anthony G MarsonDepartment of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.
Matthias Noack-RinkUCB Pharma, Monheim am Rhein, Germany.
Francisco RamirezUCB Pharma, Monheim am Rhein, Germany.
Azita TofighyUCB Pharma, Brussels, Belgium.
Konrad J WerhahnUCB Pharma, Monheim am Rhein, Germany.
Imane WildUCB Pharma, Brussels, Belgium.
Eugen TrinkaDepartment of Neurology, Paracelsus Medical University, Christian Doppler Klinik, and Centre for Cognitive Neuroscience, Salzburg, Austria.
UCB Pharma (Germany) · DEUCB Pharma (Belgium) · BEParacelsus Medical University · ATQueen Elizabeth II Health Sciences Centre · CAUniversity of Liverpool · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFew clinical trials have evaluated the efficacy and tolerability of antiepileptic drugs (AEDs) as initial monotherapy for elderly patients.

methodsThis post-hoc subgroup analysis of data from an unblinded, randomized, 52-week superiority study (KOMET) compared the effectiveness of levetiracetam (LEV) with extended-release sodium valproate (VPA-ER) and controlled-release carbamazepine (CBZ-CR) as monotherapy in patients aged ≥ 60 years with newly diagnosed epilepsy. The physician chose VPA or CBZ as preferred standard treatment; patients were randomized to standard AEDs or LEV. The primary endpoint was time to treatment withdrawal. Results are exploratory, since KOMET was not powered for a subgroup analysis by age.

resultsPatients (n = 308) were randomized to LEV (n = 48) or VPA-ER (n = 53) in the VPE-ER stratum or to LEV (n = 104) or CBZ-CR (n = 103) in the CBZ-CR stratum. Mean age was 69.6 years, range 60.2-89.9 years (intention-to-treat population n = 307). Time to treatment withdrawal hazard ratio [HR] (95 % confidence interval [CI]) for LEV vs. standard AEDs was 0.44 (0.28-0.67); LEV vs. VPA-ER: 0.46 (0.16-1.33); LEV vs. CBZ-CR: 0.45 (0.28-0.72). Twelve-month withdrawal rates were: LEV vs. standard AEDs, 20.4 vs. 38.7 %; LEV vs. VPA-ER, 10.4 vs. 23.1 %; LEV vs. CBZ-CR, 25.0 vs. 46.6 %. Time to first seizure was similar between LEV and standard AEDs (HR: 0.92, 95 % CI: 0.63-1.35), LEV and VPA-ER (0.77, 0.38-1.56), and LEV and CBZ-CR (1.02, 0.64-1.63). Adverse events were reported by 76.2, 67.3, and 82.5 % of patients for LEV, VPA-ER, and CBZ-CR, respectively. Discontinuation rates due to AEs were 11.3, 10.2, and 35.0 % for LEV, VPA-ER, and CBZ-CR, respectively.

conclusionsTime to treatment withdrawal was longer with LEV compared with standard AEDs. This finding was driven primarly by the result in the CBZ-CR stratum, which in turn was likely due to the more favorable tolerability profile of LEV. Results of this post-hoc analysis suggest that LEV may be a suitable option for initial monotherapy for patients aged ≥ 60 years with newly diagnosed epilepsy.

trial registrationClinicalTrials.gov: NCT00175903 ; September 9, 2005.

Indexed as

AgedAged, 80 and overAnticonvulsantsCarbamazepineEpilepsyFemaleHumansLevetiracetamMaleMiddle AgedPiracetamSeizuresValproic AcidAnticonvulsantsCarbamazepineLevetiracetamPiracetamValproic AcidAntiepileptic drugElderlyEpilepsyLevetiracetamMonotherapy

Identifiers

PMID27552848
PMCPMC4995751
OpenAlexW2509532991

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.