Exploring efficacy and tolerability outcomes in patients with difficult-to-treat epilepsy receiving adjunctive topiramate at different titration rates - an exploratory study
Objective - To compare rapid vs regular titration of topiramate concerning efficacy and safety. Materials and methods - Open-label, prospective, single-center study exploring efficacy and tolerability of two adjunctive dosing regimens of topiramate (TPM) in adult patients with difficult-to-treat epilepsy. Based on investigator judgment, 21 of 50 consecutive patients received a rapid titration (starting dose 50 mg/day, stepwise increase with 50 mg/day after 3 days each until reaching the target dose), while the other 29 patients received titration according to the German prescribing information (starting dose 25 mg/day, stepwise increase with 25-50 mg/day every 7 days). Patients were observed until the target dose was reached and 3 months thereafter. Results - Mean final dosages were 136 mg/day (regular titration) and 213 mg/day (rapid titration). Efficacy and tolerability measures did not differ significantly. Forty-six percent of all patients experienced a seizure reduction of >= 50%; 14% became seizure free. No serious adverse events occurred. The most common adverse effects were tiredness (20%), memory and language difficulties (18% each), slowness in thinking and speech (10%), psychomotor disturbance (8%) and paresthesia (8%). Conclusions - This study suggests that rapid and conventional titration generate similar tolerability, safety and effectiveness in selected patients.
机构:
Oklahoma Cardiovasc & Hypertens Ctr, Dept Cardiol & Hypertens, Oklahoma City, OK 73132 USA
Univ Oklahoma, Sch Med, Oklahoma City, OK USAOklahoma Cardiovasc & Hypertens Ctr, Dept Cardiol & Hypertens, Oklahoma City, OK 73132 USA
Chrysant, S. G.
Lee, J.
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机构:
Daiichi Sankyo Pharma Dev, Clin Dev, Edison, NJ USAOklahoma Cardiovasc & Hypertens Ctr, Dept Cardiol & Hypertens, Oklahoma City, OK 73132 USA
Lee, J.
Melino, M.
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机构:
Daiichi Sankyo Pharma Dev, Clin Dev, Edison, NJ USAOklahoma Cardiovasc & Hypertens Ctr, Dept Cardiol & Hypertens, Oklahoma City, OK 73132 USA
Melino, M.
Karki, S.
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Daiichi Sankyo Pharma Dev, Clin Dev, Edison, NJ USAOklahoma Cardiovasc & Hypertens Ctr, Dept Cardiol & Hypertens, Oklahoma City, OK 73132 USA
Karki, S.
Heyrman, R.
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Daiichi Sankyo Pharma Dev, Clin Dev, Edison, NJ USAOklahoma Cardiovasc & Hypertens Ctr, Dept Cardiol & Hypertens, Oklahoma City, OK 73132 USA