TY - JOUR
T1 - Conventional vs controlled-release carbamazepine
T2 - A multicentre, double-blind, cross-over study
AU - Canger, R.
AU - Altamura, A. C.
AU - Belvedere, O.
AU - Monaco, F.
AU - Monza, G. C.
AU - Muscas, G. C.
AU - Mutani, R.
AU - Panetta, B.
AU - Pisani, F.
AU - Zaccara, G.
AU - Zagnoni, P. G.
PY - 1990
Y1 - 1990
N2 - 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.
AB - 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.
KW - Anti-epileptic drugs
KW - Carbamazepine
KW - Controlled-release
KW - Slow-release
UR - http://www.scopus.com/inward/record.url?scp=0025180697&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0025180697&partnerID=8YFLogxK
M3 - Article
C2 - 2239143
AN - SCOPUS:0025180697
SN - 0001-6314
VL - 82
SP - 9
EP - 13
JO - Acta Neurologica Scandinavica
JF - Acta Neurologica Scandinavica
IS - 1
ER -