Tolerability and effects on quality of life of twice-daily extended-release carbamazepine in adults with seizure disorders: an open-label, 12- to 36-month continuation study.
BACKGROUND
An earlier 6-month, multicenter, open-label study in patients with complex partial seizures found that a switch from multiple daily doses of conventional carbamazepine (CBZ) to twice-daily CBZ extended-release capsules(CBZ-ERC) was well tolerated, with maintenance of seizure control over the study period and significant improvements in quality of life (P < 0.001).


OBJECTIVE
The goal of the present study was to assess the tolerability and effects on quality of life of twice-daily CBZ-ERC over the longer term in patients with seizure disorders.


METHODS
This was a multicenter, open-label assessment of the long-term(12-36 months) tolerability and quality-of-life effects of twice-daily CBZ-ERC given at a daily dose equivalent to the daily dose of CBZ taken before study en-try. The regimen could be adjusted as clinically indicated up to a daily dose of 1600 mg. Patients could receive up to 2 other antiepileptic drugs during the study.


RESULTS
One hundred eighteen patients were enrolled. In patients completing>12 months of study therapy, a significant decrease in the highest mean 2-day frequency of generalized tonic-clonic seizures was observed over the first 12 months (P = 0.005). The significant improvements in quality of life achieved in the earlier study were maintained during the present study. Of 37 patients who were discontinued from the study, 9 met criteria mandating withdrawal from the study due to exacerbation of seizures. Three patients were discontinued from the study for adverse events judged to be unrelated to study drug. Low incidences of rash (3.4%) and weight gain (0.8%) were reported.


CONCLUSIONS
In this population of adults with seizure disorders, CBZ-ERC twice daily was well tolerated during 12 to 36 months of open-label treatment,with no increase in seizure frequency or decrease in quality of life.
Hogan
R Edward
RE
Department of Neurology, Saint Louis University, St. Louis, Missouri, USA. hoganr2@slu.edu
Garnett
William R
WR
Thadani
Vijay M
VM
D000293:Adolescent; D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002220:Carbamazepine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012640:Seizures / Q000188:drug therapy* / Q000523:psychology
D000927:Anticonvulsants; D003692:Delayed-Action Preparations; D002220:Carbamazepine