Antiepileptic Pharmacotherapy with Slow-Release
Carbamazepine – Clinical and Pharmacokinetic
Investigations
Balogh A. 1 , Rektor I. 2 , Retzow A. 3 , Špalek P. 4
1 Fövárosi Szent Istaván Kórház, II. Idegosztály, Budapest 2 Hospital Sv. Anna, MU, Brno 3 Desitin Arzneimittel GmbH, Medical Research, Hamburg 4 Neurologická klinika IVZ, Nemocnica s poliklinikou Ružinov, Bratislava |
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Abstract:
Aims. The aim of this study was to demonstrate that treatment with Timonil ® retard (slow release
carbomazepine – CBZ) twice daily results in flat plasma concentration time curves and thus offers
effective seizure control combined with a convenient dosing schedule. Methods. Fifty-six patients with
partial seizures were included in this open prospective, multicentre trial. Clinical efficacy in terms of
monthly seizure frequency, carbamazepine plasma level profiling as well as safety and tolerance were
assessed over a three-month treatment period. Results. Fifty-five patients were adequately controlled
by slow-release CBZ (daily doses 450–1,800 mg) twice daily as monotherapy (n = 38) or in combination
with another anticonvulsant drug (n = 17). On average, they experienced only one seizure per month.
Plasma concentration fluctuations for CBZ and CBZ-10, 11-epoxide were low, i.e. mean ± SD PTF(0–24h)
28.4 ± 13.2% and 35.2 ± 27.3%, respectively. Overall efficacy and safety of CBZ was rated „excellent“ in
43 (77%) and 45 (80%) patients, respectively. No significant adverse effect or change in laboratory
parameters were detected. Only one patient terminated the study prematurely due to la ck of efficacy.
Conclusions. These results indicate that treatment with slow-release CBZ (Timonil ® retard) was
effective, well tolerated and well perceived by patients with partial seizures.
Key words:
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