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 journalArticle

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

Fingerprint

Carbamazepine
Cross-Over Studies
Seizures
Pharmacokinetics
Maintenance

Keywords

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

ASJC Scopus subject areas

  • Clinical Neurology
  • Neuroscience(all)

Cite this

Canger, R., Altamura, A. C., Belvedere, O., Monaco, F., Monza, G. C., Muscas, G. C., ... Zagnoni, P. G. (1990). Conventional vs controlled-release carbamazepine: A multicentre, double-blind, cross-over study. Acta Neurologica Scandinavica, 82(1), 9-13.

Conventional vs controlled-release carbamazepine : A multicentre, double-blind, cross-over study. / Canger, R.; Altamura, A. C.; Belvedere, O.; Monaco, F.; Monza, G. C.; Muscas, G. C.; Mutani, R.; Panetta, B.; Pisani, F.; Zaccara, G.; Zagnoni, P. G.

In: Acta Neurologica Scandinavica, Vol. 82, No. 1, 1990, p. 9-13.

Research output: Contribution to journalArticle

Canger, R, Altamura, AC, Belvedere, O, Monaco, F, Monza, GC, Muscas, GC, Mutani, R, Panetta, B, Pisani, F, Zaccara, G & Zagnoni, PG 1990, 'Conventional vs controlled-release carbamazepine: A multicentre, double-blind, cross-over study', Acta Neurologica Scandinavica, vol. 82, no. 1, pp. 9-13.
Canger, R. ; Altamura, A. C. ; Belvedere, O. ; Monaco, F. ; Monza, G. C. ; Muscas, G. C. ; Mutani, R. ; Panetta, B. ; Pisani, F. ; Zaccara, G. ; Zagnoni, P. G. / Conventional vs controlled-release carbamazepine : A multicentre, double-blind, cross-over study. In: Acta Neurologica Scandinavica. 1990 ; Vol. 82, No. 1. pp. 9-13.
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