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Topiramat in der Behandlung älterer Patienten mit Epilepsie

Ergebnisse einer klinischen Prüfung

Epilepsy outcome in elderly treated with topiramate

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Abstract

Objectives

To explore effectiveness, tolerability and quality of life in elderly patients with epilepsy treated with topiramate.

Methods

This was a one year, open-label, flexible-dosing clinical trial.

Results

A total of 107 patients (mean age 69 years, 53% men) were studied during 273±141 days. The average final dose in monotherapy was 98 mg/d vs 153 mg/d in adjunctive treatment. Mean monthly cumulative seizure frequency decreased from 3.7±15 to 1.6±7.7 (n=101, P<0.0001); 78% of patients with seizures at baseline (n=102) achieved at least 50% reduction in seizure frequency, while 44% were seizure free throughout the trial. Total scores on the quality of life in epilepsy inventory (QOLIE-31) improved from 57±17 to 68±18 (n=64, P<0.0001). The most frequently reported adverse events included convulsions, dizziness and tiredness.

Conclusions

Elderly patients treated with topiramate showed marked reductions in seizures, good tolerability and significant improvements in several aspects of quality of life.

Zusammenfassung

Ziele

Untersuchung zur Wirksamkeit, Verträglichkeit und Veränderungen der Lebensqualität bei älteren Patienten mit Epilepsie unter einer Behandlung mit Topiramat.

Methoden

Einjährige, offene, klinische Prüfung mit flexibler Dosierung.

Ergebnisse

107 Patienten (mittleres Alter 69 Jahre, 53% Männer) wurden über einen Zeitraum von 273±141 Tagen untersucht. Die durchschnittliche Enddosis betrug in der Monotherapie 98 mg/Tag und 153 mg/Tag unter Zusatztherapie. Die mittlere monatliche kumulative Anfallshäufigkeit nahm ab von 3,7±15 auf 1,6±7,7 ab (n=101, p<0,0001); 78% der Patienten mit Anfällen in der Ausgangsphase (n=102) erreichten eine Reduktion der Anfallshäufigkeit um mindestens 50%; 44% waren während der gesamten Studie anfallsfrei. Die Gesamtscores im Quality of Life in Epilepsy Inventory (QOLIE-31) stiegen von 57±17 auf 68±18 an (n=64, p<0,0001). Die am häufigsten berichteten unerwünschten Ereignisse waren u. a. epileptische Anfälle, Schwindel und Müdigkeit.

Schlussfolgerungen

Topiramat in der Behandlung der Epilepsie älterer Patienten war mit einer guten Verträglichkeit, signifikanten Verbesserungen mehrerer Aspekte der Lebensqualität sowie einer signifikanten Verbesserung der Anfallssituation assoziiert.

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Author information

Authors and Affiliations

  1. Epilepsie-Zentrum, Universität Erlangen, Erlangen

    Hermann Stefan & Burkhard Kasper

  2. Neurologische Praxis, Oelde

    Ludwig J. Hubbertz

  3. Neurologische Praxis, Klinik für Neurologie, Berlin

    Ines Peglau

  4. Kreiskrankenhaus Altenburg, Altenburg

    Jörg Berrouschot

  5. Janssen-Cilag EMEA, Neuss

    Andreas Schreiner

  6. Clin Assess, Leverkusen

    Jürgen Krimmer

  7. Therapeutic Area CNS, Janssen-Cilag GmbH, Raiffeisenstraße 8, 41470, Neuss, Germany

    Barbara Schäuble MD

Authors
  1. Hermann Stefan
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  2. Ludwig J. Hubbertz
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  3. Ines Peglau
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  4. Jörg Berrouschot
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  5. Burkhard Kasper
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  6. Andreas Schreiner
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  7. Jürgen Krimmer
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  8. Barbara Schäuble MD
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Consortia

für die TOP-GER-13-Studienärzte

Corresponding author

Correspondence to Barbara Schäuble MD.

Additional information

Originalpublikation: Stefan H, Hubbertz L, Peglau I, Berrouschot J, Kasper B, Schreiner A, Krimmer J, Schauble B, on behalf of the TOP-GER-13 investigators. Epilepsy outcomes in elderly treated with topiramate. Acta Neurol Scand: DOI 10.1111/j.1600-0404.2008.01018.x

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Stefan, H., Hubbertz, L.J., Peglau, I. et al. Topiramat in der Behandlung älterer Patienten mit Epilepsie. Z. Epileptol. 21, 82–94 (2008). https://doi.org/10.1007/s10309-008-0308-y

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  • DOI: https://doi.org/10.1007/s10309-008-0308-y

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