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Double-Blind Crossover of Tegretol-XR and Tegretol in Patients with Epilepsy
Tegretol OROS Study Grp, Neurol 45:1703-17071995., , 1995
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Article Abstract
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.
 
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anticonvulsants
anticonvulsants,compliance
carbamazepine
carbamazepine,controlled release
compliance

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