Conventional vs controlled-release CBZ: A multicentre, double-blind, cross-over study

R. Canger, D. Belvedere, M. P. Canevini, G. C. Monza, F. Monaco, G. P. Sechi, R. Mutani, M. Gianelli, F. Pisani, G. Oteri, F. Romano, G. Zaccara, G. C. Muscas, P. Zagnoni, D. Seliak, F. Perla, A. C. Altamura, B. Panetta, T. Girardi

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

Efficacy of tolerability of a new controlled-release (CR) formulation of carbamazepine (CBZ) (Tegretol CR), were assessed in a formal multicentre, double-blind, cross-over trial, carried out in 48 epileptic patients (21 men, 27 women; mean age 34 years). Before entering the study, patietns (pts) had been taking conventional CBZ monotherapy, but without a complete seizure control (n = 22 pts), or with intermittent side-effects (n = 4 pts), or with seizures and intermittent side-effects (n = 22 pts). Eligible pts were given conventional CBZ and CR CBZ, in randomized sequence, at individualized daily doses, subdivided in the lowest number of administration. Each period of the cross-over consisted of a first phase of titration (lasting up to 2 months) and of a second phase of maintenance (lasting 1 month) used for evaluation. A 12-hour plasma CBZ and CBZ-epoxide profile concentrations, as well as efficacy and tolerability, were evaluated at the end of each period. The mean daily CBZ dose has been increased by 15% during administration of the CR formulation. Fluctuation indices of total CBZ and 10,11-epoxide plasma levels at steady-state were significantly (p <0.02) lower during CR CBZ treatment, leading to a significant (p <0.001) decrease of intermittent side-effects (6 pts on CR CBZ vs 36 on conventional CBZ). In addition, a complete seizure control was obtained in 4 pts when treated with CR CBZ; 38 pts on CR CBZ (vs 15 pts on conventional CBZ) were treated with a b.i.d. regimen.

Original languageEnglish
Title of host publicationBollettino - Lega Italiana contro l'Epilessia
Pages419-421
Number of pages3
Edition62-63
Publication statusPublished - 1988

ASJC Scopus subject areas

  • Clinical Neurology

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