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NEUROLOGY 1995;45:1703-1707
© 1995 American Academy of Neurology

Double-blind crossover comparison of Tegretol-XR and Tegretol in patients with epilepsy

The Tegretol OROS Osmotic Release Delivery System Study Group*

*See page 1706 for a listing of the members of the study group.
Supported by a grant from Ciba-Geigy Corporation.
Received July 15, 1994. Accepted in final form February 3, 1995.
Address correspondence and reprint requests to Dr Ramsay, International Center for Epilepsy, University of Miami, Professional Arts Center, 1150 NW 14th Street, Suite 410, Miami, FL 33136.

This multicenter, double-blind, crossover study compared Tegretol-XR and Tegretol tablets with respect to trough plasma carbamazepine (CBZ) concentrations, seizure control, tolerability, and safety. We randomized 96 patients with epilepsy to 56-day monotherapy with their usual daily CBZ dose administered as (1) Tegretol-XR 200-mg tablets every 12 hours plus placebo or (2) Tegretol 200-mg tablets three or four times daily plus placebo. Upon completion, patients immediately switched to the alternate treatment for 56 days. During the study, 98% of patients had plasma CBZ concentrations within the recommended therapeutic range during Tegretol-XR treatment and 97% did during Tegretol treatment. The seizure rate during treatment, compared with the baseline seizure rate, decreased in 26% of patients both during treatment with Tegretol-XR and during treatment with Tegretol, and it remained the same in 48% of patients during Tegretol-XR therapy and in 52% of patients during Tegretol therapy. We did not observe any pattern of change in seizure frequency. We switched patients on a milligram-per-milligram basis from multiple-daily-dose Tegretol to Tegretol-XR twice daily from one day to the next without retitrating the daily dose.

NEUROLOGY 1995;45: 1703-1707






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