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

R. Canger, A. C. Altamura, O. Belvedere, F. Monaco, G. C. Monza, G. C. Muscas, R. Mutani, B. Panetta, F. Pisani, G. Zaccara, P. G. Zagnoni

Research output: Contribution to journalArticlepeer-review

Abstract

The tolerability and pharmacokinetics of a new controlled-release (CR) formulation of carbamazepine (CBZ), were assessed in a multicentre, double-blind, cross-over trial, carried out in 48 epileptic patients (21 men, 27 women; mean age 34.2 years) on conventional CBZ monotherapy, but without complete seizure control (n = 22) or with intermittent side effects (n = 4), or with both (n = 22). Eligible patients were randomized to conventional CBZ or CR CBZ, each given in sequence at individualized daily doses, subdivided into the lowest number of administrations. Each period of the cross-over consisted of a first phase of optimal dose finding (lasting up to two months) and a second one of maintenance (lasting one month) used for evaluation. At the end of each period, a 10-h plasma CBZ and CBZ-epoxide concentration profile, as well as the tolerability and the efficacy of the drugs, were evaluated. The mean CBZ daily dose increased by 16% during the administration of the CR formulation. Fluctuations of total CBZ and 10, 11-epoxide plasma level daily profiles at steady-state were significantly (p <0.001) lower during CR CBZ treatment, leading to a significant (p <0.001) decrease in intermittent side effects (6 patients on CR CBZ vs 26 on conventional CBZ). Finally, 38 patients on CR CBZ (vs 15 patients on conventional CBZ) were treated with a b.i.d. regimen.

Original languageEnglish
Pages (from-to)9-13
Number of pages5
JournalActa Neurologica Scandinavica
Volume82
Issue number1
Publication statusPublished - 1990

Keywords

  • Anti-epileptic drugs
  • Carbamazepine
  • Controlled-release
  • Slow-release

ASJC Scopus subject areas

  • Clinical Neurology
  • Neuroscience(all)

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