Abstract
The effects of topiramate in 15 patients with drug refractory partial epilepsy or Lennox-Gastaut syndrome were assessed in an open, add-on prospective study. After a follow-up of 14–21 months, six patients are still on topiramate (mean dosage 583 mg/day, range 400–800 mg/day), and nine have discontinued treatment because of adverse events (n=6), inefficacy (n=2) or poor compliance (n=1). Nine patients (69%) continued to have a ≥50% reduction in seizure frequency during the last two months of treatment, and one has been seizure-free for the last 19 months. The most common adverse events were somnolence, weight loss, mental slowing, fatigue, ataxia and irritability. Most of these events were reversible, but withdrawal of treatment was required in six cases as a result of ataxia (two patients), somnolence, metabolic acidosis, irritability or psychotic symptoms (one patient each). It is concluded that topiramate is a valuable agent for the long-term management of refractory epilepsy.
Sommario
Gli effetti di topiramato utilizzato in aggiunta alla terapia preesistente sono stati valutati nell'ambito di uno studio prospettico in aperto in 15 pazienti farmacoresistenti affetti da epilessia parziale o sindrome Lennox-Gastaut. Dopo un follow-up di 14–21 mesi, 6 pazienti sono tuttora in trattamento (posologia media di topiramato 583 mg/die, range 400–800 mg/die), mentre 9 hanno sospeso il farmaco a causa di eventi avversi (n=6), inefficacia (n=2) o scarsa compliance (n=1). Nove pazienti (69%) continuavano a presentare una riduzione di almeno il 50% della frequenza delle crisi durante gli ultimi 2 mesi di trattamento e un paziente è libero da crisi da 19 mesi. Gli eventi avversi più frequenti erano costituiti da sonnolenza, calo ponderale, rallentamento mentale, astenia, atassia e irritabilità. La maggior parte di questi eventi è risultata reversibile, ma in 6 pazienti si è resa necessaria la sospensione del trattamento a causa di atassia (2 casi), sonnolenza, acidosi metabolica, irritabilità e sintomi psicotici (1 caso ciascuno). Sulla base di questi dati, il topiramato può essere ritenuto un utile presidio nel trattamento a lungo termine dell'epilessia farmacoresistente.
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References
Ben-Menachem E., Henriksen O., Dam M. et al.:Double-blind, placebo-controlled trial of topiramate as add-on therapy in patients with refractory partial seizures. Epilepsia 1996; 37: 539–543, 1996.
Ben-Menachem E.:Long-term follow-up of patients treated with topiramate for partial seizures. Epilepsia 36 (suppl. 3): S152, 1995.
Cowell P.G., Coles H.J., Crawford P.M.:Topiramate as adjunctive therapy in patients with refractory epilepsy: A report of a long-term, open-label study. Epilepsia 376 (suppl. 3): S152, 1995.
Faught E., Wilder B.J., Ramsay R.E. et al.:Topiramate placebo-controlled dose-ranging trial in refractory partial epilepsy using 200-, 400-, and 600-mg daily dosages. Neurology 46: 1684–1690, 1996.
Fincham R.W., Schottelius D.:Long-term therapy with topiramate in patients with partial seizures. Epilepsia 36 (suppl. 4): S56, 1995.
Guidolin L., Canevini M.P., Sgro V. et al.:Topiramate as add-on therapy in drug-resistant partial epilepsy. Epilepsia 36 (suppl. 3): S151, 1995.
Luef G., Bauer G.:Efficacy and safety of topiramate in drug-resistant epilepsies. Epilepsia 36 (suppl. 3): S151, 1995.
Martinez-Lage J., Ben-Menachem E., Shorvon S.D., Weber M.:Double-blind, placebo-controlled trial of 400 mg/day topiramate as add-on therapy in patients with refractory partial epilepsy. Epilepsia 36 (suppl. 3): S149-S150, 1995.
Maryanoff B.E., Nortez S.O., Gardocki J.F. et al.:Anticonvulsant O-alkyl-sulfamates in 2,3:4,5-bis-O-(1-methylethylidene)-beta-D-fructo-pyranose sulfamate and related compounds. J. Med. Chem. 30: 880–887, 1987.
Michelucci R., Passarelli D., Tassinari C.A.:Topiramate in the treatment of refractory epilepsy: A double-blind study with long-term follow-up. Epilepsia 36 (suppl. 3): S150, 1995.
Pavkovic I., Sackellares C., Beydoun A.:Efficacy and safety of topiramate in epilepsy. Epilepsia 36 (suppl. 4): S55, 1995.
Privitera M., Fincham R., Penry J. et al.:Topiramate placebo-controlled dose ranging trial in refractory partial epilepsy using 600-, 800-, and 1,000-mg daily dosages. Neurology 46: 1678–1683, 1996.
Reife R.A., Pledger G.W.:Clinical efficacy of topiramate: U.S. and European experience. Adv. AED Ther. 1: 17–23, 1995.
Reife R.A., Pledger G.W.:Safety of topiramate in clinical use. Adv. AED Ther. 1: 24–29, 1995.
Shank R.P.:Preclinical profile of topiramate, a novel anticonvulsant. Adv. AED Ther. 1: 1–6, 1995.
Shank R.P., Gardocki J.F., Vaught J.L. et al.:Topiramate: Preclinical evaluation of a structurally novel anticonvulsant. Epilepsia 35: 450–460, 1994.
Tassinari C.A., Michelucci R., Chauvel P. et al.:Double-blind, placebo-controlled trial of Topiramate (600 mg daily) for the treatment of refractory partial epilepsy. Epilepsia 37 (8): 763–768, 1996.
Wasserstein A.G., Rak I., Reife R.A.:Investigation of the mechanistic basis for topiramate-associated nephrolithiasis: Examination of urine and serum constituents. Epilepsia 36 (suppl. 3): S153, 1995.
Wasserstein A.G., Rak I., Reife R.A.:Nephrolithiasis during treatment with topiramate. Epilepsia 36 (suppl. 3): S153, 1995.
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Tartara, A., Sartori, I., Manni, R. et al. Efficacy and safety of topiramate in refractory epilepsy: a long-term prospective trial. Ital J Neuro Sci 17, 429–432 (1996). https://doi.org/10.1007/BF01997718
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DOI: https://doi.org/10.1007/BF01997718