Topiramate monotherapy as broad-spectrum antiepileptic drug in a naturalistic clinical setting

Renzo Guerrini, Johannes Carpay, Jože Grošelj, Joop van Oene, Andreas Schreiner, Marjolein Lahaye, Susanne Schwalen, L. Lagae, B. Sadzot, P. Van Bogaert, K. van Rijckevorsel, C. Willems, A. Alexiev, S. Bojinov, D. Chavdarov, G. Ganeva, D. Minchev, S. Hajnsek-Propadalo, I. Lusic, B. Marusic-Della MarinaE. Paucic-Kirincic, Z. Poljakovic, D. Skarpa, I. Valic, A. Andersen, B. Anthonisen, M. Grønbech-Jensen, G. Gulliksen, J. Jansen, K. Luhdorf, J. Mai, S. Østergaard, T. Sørensen, P. Thorvaldsen, M. Worm, I. Talvik, M. Barthez, B. De Toffol, P. Derambure, E. Hirsch, E. Josien, J. Pedespan, C. Rouselle, P. McKee, P. Smith, S. Balogiannis, N. Diamantopoulos, K. Karageorgioy, A. Kyritsis, I. Mylonas, A. Papavasiliou, H. Piperidoy, D. Vassilopoulos, M. Neufeld, M. Rabey, U. Aguglia, P. Balestri, G. Capovilla, G. Cristofori, R. Di Perri, A. Ganga, P. G. Garofalo, G. L. Gigli, G. Gobbi, M. Manfredi, M. G. Marciani, A. Martinuzzi, R. Michelucci, F. Minicucci, A. Romeo, F. Sasanelli, P. Veggiotti, C. Zucca, S. Al-Yamani, M. Jan, B. Yaqub, A. Al Shubaili, E. Vtols, M. Mikati, P. Bejjani, N. Riachi, G. W A Den Hartog, J. J M Hagemans, J. P M Hillegers, D. J. Kamphuis, R. W M Keunen, P. J J Koehler, Q. A H Leyten, P. H M Pop, M. G. Smits, H. J M Van der Leeuw, C. A. Van Donselaar, M. M. Veering, C. Albretsen, T. Hagen, B. Kåss, E. Kinge, A. Lillebö, T. Svendsen

Research output: Contribution to journalArticle

Abstract

Topiramate was assessed in an open-label trial as broad-spectrum antiepileptic monotherapy, independently from the epilepsy type or syndrome. Adults and children aged 2 years and older, who were diagnosed with epilepsy within the last 5 years, treatment-naive or failing prior treatment with one antiepileptic drug (AED), received individually adjusted doses of topiramate, after escalation to 100 mg/day over 4 weeks (maximum 400 mg/day) or 3 mg/kg/day over 6 weeks (maximum 9 mg/kg/day), respectively. Patients were followed for ≥7 months and optionally up to a maximum of 13 months. Data were analysed for all patients (n = 692), as well as for focal (n = 421) and generalized epilepsies (n = 148). The median topiramate dose used was 125 mg/day in adults and 3.3 mg/kg/day in children (≤12 years). Overall, 80% of patients completed the 7-month study. During this period, 44.3% were seizure-free, while 76.3% achieved ≥50% reduction in mean monthly seizure frequency. Patients with focal and generalized epilepsies alike responded to treatment (73.9 and 83.8% with at least 50% seizure reduction): 39.4% of patients with focal epilepsy and 61.5% of those with generalized epilepsy were seizure-free. The mean monthly seizure frequency was significantly reduced versus baseline at all visits (p <0.001). Similar response rates were obtained from the 237 patients completing the 1-year observation period. During the mandatory 7-month period of study, 8.8% of patients reported insufficient tolerability as a reason for dropout. The most frequent adverse event was paraesthesia. Our results support findings that emerge from controlled studies that topiramate is effective and well tolerated when used as initial or second monotherapy. They also suggest that in a naturalistic setting, overall good retention on treatment and seizure freedom are observed at low doses in a broad spectrum of epilepsies.

Original languageEnglish
Pages (from-to)371-380
Number of pages10
JournalSeizure
Volume14
Issue number6
DOIs
Publication statusPublished - Sep 2005

Fingerprint

Anticonvulsants
Seizures
Generalized Epilepsy
Epilepsy
Partial Epilepsy
Paresthesia
Therapeutics
topiramate
Observation

Keywords

  • Antiepileptic drug
  • Broad-spectrum
  • Focal epilepsy
  • Generalized epilepsy
  • Monotherapy
  • Topiramate

ASJC Scopus subject areas

  • Clinical Neurology
  • Pediatrics, Perinatology, and Child Health
  • Neurology
  • Psychology(all)

Cite this

Guerrini, R., Carpay, J., Grošelj, J., van Oene, J., Schreiner, A., Lahaye, M., ... Svendsen, T. (2005). Topiramate monotherapy as broad-spectrum antiepileptic drug in a naturalistic clinical setting. Seizure, 14(6), 371-380. https://doi.org/10.1016/j.seizure.2005.05.001

Topiramate monotherapy as broad-spectrum antiepileptic drug in a naturalistic clinical setting. / Guerrini, Renzo; Carpay, Johannes; Grošelj, Jože; van Oene, Joop; Schreiner, Andreas; Lahaye, Marjolein; Schwalen, Susanne; Lagae, L.; Sadzot, B.; Van Bogaert, P.; van Rijckevorsel, K.; Willems, C.; Alexiev, A.; Bojinov, S.; Chavdarov, D.; Ganeva, G.; Minchev, D.; Hajnsek-Propadalo, S.; Lusic, I.; Marusic-Della Marina, B.; Paucic-Kirincic, E.; Poljakovic, Z.; Skarpa, D.; Valic, I.; Andersen, A.; Anthonisen, B.; Grønbech-Jensen, M.; Gulliksen, G.; Jansen, J.; Luhdorf, K.; Mai, J.; Østergaard, S.; Sørensen, T.; Thorvaldsen, P.; Worm, M.; Talvik, I.; Barthez, M.; De Toffol, B.; Derambure, P.; Hirsch, E.; Josien, E.; Pedespan, J.; Rouselle, C.; McKee, P.; Smith, P.; Balogiannis, S.; Diamantopoulos, N.; Karageorgioy, K.; Kyritsis, A.; Mylonas, I.; Papavasiliou, A.; Piperidoy, H.; Vassilopoulos, D.; Neufeld, M.; Rabey, M.; Aguglia, U.; Balestri, P.; Capovilla, G.; Cristofori, G.; Di Perri, R.; Ganga, A.; Garofalo, P. G.; Gigli, G. L.; Gobbi, G.; Manfredi, M.; Marciani, M. G.; Martinuzzi, A.; Michelucci, R.; Minicucci, F.; Romeo, A.; Sasanelli, F.; Veggiotti, P.; Zucca, C.; Al-Yamani, S.; Jan, M.; Yaqub, B.; Al Shubaili, A.; Vtols, E.; Mikati, M.; Bejjani, P.; Riachi, N.; Den Hartog, G. W A; Hagemans, J. J M; Hillegers, J. P M; Kamphuis, D. J.; Keunen, R. W M; Koehler, P. J J; Leyten, Q. A H; Pop, P. H M; Smits, M. G.; Van der Leeuw, H. J M; Van Donselaar, C. A.; Veering, M. M.; Albretsen, C.; Hagen, T.; Kåss, B.; Kinge, E.; Lillebö, A.; Svendsen, T.

In: Seizure, Vol. 14, No. 6, 09.2005, p. 371-380.

Research output: Contribution to journalArticle

Guerrini, R, Carpay, J, Grošelj, J, van Oene, J, Schreiner, A, Lahaye, M, Schwalen, S, Lagae, L, Sadzot, B, Van Bogaert, P, van Rijckevorsel, K, Willems, C, Alexiev, A, Bojinov, S, Chavdarov, D, Ganeva, G, Minchev, D, Hajnsek-Propadalo, S, Lusic, I, Marusic-Della Marina, B, Paucic-Kirincic, E, Poljakovic, Z, Skarpa, D, Valic, I, Andersen, A, Anthonisen, B, Grønbech-Jensen, M, Gulliksen, G, Jansen, J, Luhdorf, K, Mai, J, Østergaard, S, Sørensen, T, Thorvaldsen, P, Worm, M, Talvik, I, Barthez, M, De Toffol, B, Derambure, P, Hirsch, E, Josien, E, Pedespan, J, Rouselle, C, McKee, P, Smith, P, Balogiannis, S, Diamantopoulos, N, Karageorgioy, K, Kyritsis, A, Mylonas, I, Papavasiliou, A, Piperidoy, H, Vassilopoulos, D, Neufeld, M, Rabey, M, Aguglia, U, Balestri, P, Capovilla, G, Cristofori, G, Di Perri, R, Ganga, A, Garofalo, PG, Gigli, GL, Gobbi, G, Manfredi, M, Marciani, MG, Martinuzzi, A, Michelucci, R, Minicucci, F, Romeo, A, Sasanelli, F, Veggiotti, P, Zucca, C, Al-Yamani, S, Jan, M, Yaqub, B, Al Shubaili, A, Vtols, E, Mikati, M, Bejjani, P, Riachi, N, Den Hartog, GWA, Hagemans, JJM, Hillegers, JPM, Kamphuis, DJ, Keunen, RWM, Koehler, PJJ, Leyten, QAH, Pop, PHM, Smits, MG, Van der Leeuw, HJM, Van Donselaar, CA, Veering, MM, Albretsen, C, Hagen, T, Kåss, B, Kinge, E, Lillebö, A & Svendsen, T 2005, 'Topiramate monotherapy as broad-spectrum antiepileptic drug in a naturalistic clinical setting', Seizure, vol. 14, no. 6, pp. 371-380. https://doi.org/10.1016/j.seizure.2005.05.001
Guerrini, Renzo ; Carpay, Johannes ; Grošelj, Jože ; van Oene, Joop ; Schreiner, Andreas ; Lahaye, Marjolein ; Schwalen, Susanne ; Lagae, L. ; Sadzot, B. ; Van Bogaert, P. ; van Rijckevorsel, K. ; Willems, C. ; Alexiev, A. ; Bojinov, S. ; Chavdarov, D. ; Ganeva, G. ; Minchev, D. ; Hajnsek-Propadalo, S. ; Lusic, I. ; Marusic-Della Marina, B. ; Paucic-Kirincic, E. ; Poljakovic, Z. ; Skarpa, D. ; Valic, I. ; Andersen, A. ; Anthonisen, B. ; Grønbech-Jensen, M. ; Gulliksen, G. ; Jansen, J. ; Luhdorf, K. ; Mai, J. ; Østergaard, S. ; Sørensen, T. ; Thorvaldsen, P. ; Worm, M. ; Talvik, I. ; Barthez, M. ; De Toffol, B. ; Derambure, P. ; Hirsch, E. ; Josien, E. ; Pedespan, J. ; Rouselle, C. ; McKee, P. ; Smith, P. ; Balogiannis, S. ; Diamantopoulos, N. ; Karageorgioy, K. ; Kyritsis, A. ; Mylonas, I. ; Papavasiliou, A. ; Piperidoy, H. ; Vassilopoulos, D. ; Neufeld, M. ; Rabey, M. ; Aguglia, U. ; Balestri, P. ; Capovilla, G. ; Cristofori, G. ; Di Perri, R. ; Ganga, A. ; Garofalo, P. G. ; Gigli, G. L. ; Gobbi, G. ; Manfredi, M. ; Marciani, M. G. ; Martinuzzi, A. ; Michelucci, R. ; Minicucci, F. ; Romeo, A. ; Sasanelli, F. ; Veggiotti, P. ; Zucca, C. ; Al-Yamani, S. ; Jan, M. ; Yaqub, B. ; Al Shubaili, A. ; Vtols, E. ; Mikati, M. ; Bejjani, P. ; Riachi, N. ; Den Hartog, G. W A ; Hagemans, J. J M ; Hillegers, J. P M ; Kamphuis, D. J. ; Keunen, R. W M ; Koehler, P. J J ; Leyten, Q. A H ; Pop, P. H M ; Smits, M. G. ; Van der Leeuw, H. J M ; Van Donselaar, C. A. ; Veering, M. M. ; Albretsen, C. ; Hagen, T. ; Kåss, B. ; Kinge, E. ; Lillebö, A. ; Svendsen, T. / Topiramate monotherapy as broad-spectrum antiepileptic drug in a naturalistic clinical setting. In: Seizure. 2005 ; Vol. 14, No. 6. pp. 371-380.
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author = "Renzo Guerrini and Johannes Carpay and Jože Grošelj and {van Oene}, Joop and Andreas Schreiner and Marjolein Lahaye and Susanne Schwalen and L. Lagae and B. Sadzot and {Van Bogaert}, P. and {van Rijckevorsel}, K. and C. Willems and A. Alexiev and S. Bojinov and D. Chavdarov and G. Ganeva and D. Minchev and S. Hajnsek-Propadalo and I. Lusic and {Marusic-Della Marina}, B. and E. Paucic-Kirincic and Z. Poljakovic and D. Skarpa and I. Valic and A. Andersen and B. Anthonisen and M. Gr{\o}nbech-Jensen and G. Gulliksen and J. Jansen and K. Luhdorf and J. Mai and S. {\O}stergaard and T. S{\o}rensen and P. Thorvaldsen and M. Worm and I. Talvik and M. Barthez and {De Toffol}, B. and P. Derambure and E. Hirsch and E. Josien and J. Pedespan and C. Rouselle and P. McKee and P. Smith and S. Balogiannis and N. Diamantopoulos and K. Karageorgioy and A. Kyritsis and I. Mylonas and A. Papavasiliou and H. Piperidoy and D. Vassilopoulos and M. Neufeld and M. Rabey and U. Aguglia and P. Balestri and G. Capovilla and G. Cristofori and {Di Perri}, R. and A. Ganga and Garofalo, {P. G.} and Gigli, {G. L.} and G. Gobbi and M. Manfredi and Marciani, {M. G.} and A. Martinuzzi and R. Michelucci and F. Minicucci and A. Romeo and F. Sasanelli and P. Veggiotti and C. Zucca and S. Al-Yamani and M. Jan and B. Yaqub and {Al Shubaili}, A. and E. Vtols and M. Mikati and P. Bejjani and N. Riachi and {Den Hartog}, {G. W A} and Hagemans, {J. J M} and Hillegers, {J. P M} and Kamphuis, {D. J.} and Keunen, {R. W M} and Koehler, {P. J J} and Leyten, {Q. A H} and Pop, {P. H M} and Smits, {M. G.} and {Van der Leeuw}, {H. J M} and {Van Donselaar}, {C. A.} and Veering, {M. M.} and C. Albretsen and T. Hagen and B. K{\aa}ss and E. Kinge and A. Lilleb{\"o} and T. Svendsen",
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language = "English",
volume = "14",
pages = "371--380",
journal = "Seizure : the journal of the British Epilepsy Association",
issn = "1059-1311",
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TY - JOUR

T1 - Topiramate monotherapy as broad-spectrum antiepileptic drug in a naturalistic clinical setting

AU - Guerrini, Renzo

AU - Carpay, Johannes

AU - Grošelj, Jože

AU - van Oene, Joop

AU - Schreiner, Andreas

AU - Lahaye, Marjolein

AU - Schwalen, Susanne

AU - Lagae, L.

AU - Sadzot, B.

AU - Van Bogaert, P.

AU - van Rijckevorsel, K.

AU - Willems, C.

AU - Alexiev, A.

AU - Bojinov, S.

AU - Chavdarov, D.

AU - Ganeva, G.

AU - Minchev, D.

AU - Hajnsek-Propadalo, S.

AU - Lusic, I.

AU - Marusic-Della Marina, B.

AU - Paucic-Kirincic, E.

AU - Poljakovic, Z.

AU - Skarpa, D.

AU - Valic, I.

AU - Andersen, A.

AU - Anthonisen, B.

AU - Grønbech-Jensen, M.

AU - Gulliksen, G.

AU - Jansen, J.

AU - Luhdorf, K.

AU - Mai, J.

AU - Østergaard, S.

AU - Sørensen, T.

AU - Thorvaldsen, P.

AU - Worm, M.

AU - Talvik, I.

AU - Barthez, M.

AU - De Toffol, B.

AU - Derambure, P.

AU - Hirsch, E.

AU - Josien, E.

AU - Pedespan, J.

AU - Rouselle, C.

AU - McKee, P.

AU - Smith, P.

AU - Balogiannis, S.

AU - Diamantopoulos, N.

AU - Karageorgioy, K.

AU - Kyritsis, A.

AU - Mylonas, I.

AU - Papavasiliou, A.

AU - Piperidoy, H.

AU - Vassilopoulos, D.

AU - Neufeld, M.

AU - Rabey, M.

AU - Aguglia, U.

AU - Balestri, P.

AU - Capovilla, G.

AU - Cristofori, G.

AU - Di Perri, R.

AU - Ganga, A.

AU - Garofalo, P. G.

AU - Gigli, G. L.

AU - Gobbi, G.

AU - Manfredi, M.

AU - Marciani, M. G.

AU - Martinuzzi, A.

AU - Michelucci, R.

AU - Minicucci, F.

AU - Romeo, A.

AU - Sasanelli, F.

AU - Veggiotti, P.

AU - Zucca, C.

AU - Al-Yamani, S.

AU - Jan, M.

AU - Yaqub, B.

AU - Al Shubaili, A.

AU - Vtols, E.

AU - Mikati, M.

AU - Bejjani, P.

AU - Riachi, N.

AU - Den Hartog, G. W A

AU - Hagemans, J. J M

AU - Hillegers, J. P M

AU - Kamphuis, D. J.

AU - Keunen, R. W M

AU - Koehler, P. J J

AU - Leyten, Q. A H

AU - Pop, P. H M

AU - Smits, M. G.

AU - Van der Leeuw, H. J M

AU - Van Donselaar, C. A.

AU - Veering, M. M.

AU - Albretsen, C.

AU - Hagen, T.

AU - Kåss, B.

AU - Kinge, E.

AU - Lillebö, A.

AU - Svendsen, T.

PY - 2005/9

Y1 - 2005/9

N2 - Topiramate was assessed in an open-label trial as broad-spectrum antiepileptic monotherapy, independently from the epilepsy type or syndrome. Adults and children aged 2 years and older, who were diagnosed with epilepsy within the last 5 years, treatment-naive or failing prior treatment with one antiepileptic drug (AED), received individually adjusted doses of topiramate, after escalation to 100 mg/day over 4 weeks (maximum 400 mg/day) or 3 mg/kg/day over 6 weeks (maximum 9 mg/kg/day), respectively. Patients were followed for ≥7 months and optionally up to a maximum of 13 months. Data were analysed for all patients (n = 692), as well as for focal (n = 421) and generalized epilepsies (n = 148). The median topiramate dose used was 125 mg/day in adults and 3.3 mg/kg/day in children (≤12 years). Overall, 80% of patients completed the 7-month study. During this period, 44.3% were seizure-free, while 76.3% achieved ≥50% reduction in mean monthly seizure frequency. Patients with focal and generalized epilepsies alike responded to treatment (73.9 and 83.8% with at least 50% seizure reduction): 39.4% of patients with focal epilepsy and 61.5% of those with generalized epilepsy were seizure-free. The mean monthly seizure frequency was significantly reduced versus baseline at all visits (p <0.001). Similar response rates were obtained from the 237 patients completing the 1-year observation period. During the mandatory 7-month period of study, 8.8% of patients reported insufficient tolerability as a reason for dropout. The most frequent adverse event was paraesthesia. Our results support findings that emerge from controlled studies that topiramate is effective and well tolerated when used as initial or second monotherapy. They also suggest that in a naturalistic setting, overall good retention on treatment and seizure freedom are observed at low doses in a broad spectrum of epilepsies.

AB - Topiramate was assessed in an open-label trial as broad-spectrum antiepileptic monotherapy, independently from the epilepsy type or syndrome. Adults and children aged 2 years and older, who were diagnosed with epilepsy within the last 5 years, treatment-naive or failing prior treatment with one antiepileptic drug (AED), received individually adjusted doses of topiramate, after escalation to 100 mg/day over 4 weeks (maximum 400 mg/day) or 3 mg/kg/day over 6 weeks (maximum 9 mg/kg/day), respectively. Patients were followed for ≥7 months and optionally up to a maximum of 13 months. Data were analysed for all patients (n = 692), as well as for focal (n = 421) and generalized epilepsies (n = 148). The median topiramate dose used was 125 mg/day in adults and 3.3 mg/kg/day in children (≤12 years). Overall, 80% of patients completed the 7-month study. During this period, 44.3% were seizure-free, while 76.3% achieved ≥50% reduction in mean monthly seizure frequency. Patients with focal and generalized epilepsies alike responded to treatment (73.9 and 83.8% with at least 50% seizure reduction): 39.4% of patients with focal epilepsy and 61.5% of those with generalized epilepsy were seizure-free. The mean monthly seizure frequency was significantly reduced versus baseline at all visits (p <0.001). Similar response rates were obtained from the 237 patients completing the 1-year observation period. During the mandatory 7-month period of study, 8.8% of patients reported insufficient tolerability as a reason for dropout. The most frequent adverse event was paraesthesia. Our results support findings that emerge from controlled studies that topiramate is effective and well tolerated when used as initial or second monotherapy. They also suggest that in a naturalistic setting, overall good retention on treatment and seizure freedom are observed at low doses in a broad spectrum of epilepsies.

KW - Antiepileptic drug

KW - Broad-spectrum

KW - Focal epilepsy

KW - Generalized epilepsy

KW - Monotherapy

KW - Topiramate

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