EPILEPSY - ADJUNCTIVE THERAPY
DEPAKOTE (divalproex sodium delayed-release tablets) Adjunctive Therapy For Complex Partial Seizures 7
- The primary efficacy measure was the median 8-week baseline complex partial seizure (CPS) rate compared with the rate during add-on treatment with Depakote or placebo
- In the intent-to-treat analysis (137 patients), the Depakote group experienced a median reduction of 7.9 in the CPS rate compared with a median reduction of 2.5 in the placebo group (P<0.001)
- Patients had an average seizure history of 19 years and were treated with an average of 3.1 AEDs
Percentage of Patients Experiencing Reduction From Baseline in Complex Partial Seizures
STUDY DESIGN:
Randomized, multicenter, double-blind, placebo-controlled, parallel-group study that evaluated the efficacy of Depakote as add on therapy in 137 patients with complex partial seizures currently treated with either carbamazepine or phenytoin monotherapy. Patients had inadequate seizure control with current monotherapy.
- Post randomization, 6 patients discontinued because of suspected drug intolerance (5 Depakote patients, 1 placebo patient)
- Adverse events occurring in >5% of complex partial seizure patients and significantly more often with Depakote adjunctive therapy vs placebo: nausea (48% vs 14%), asthenia (27% vs 7%), somnolence (27% vs 11%), vomiting (27% vs 7%), tremor (25% vs 6%), abdominal pain (23% vs 6%), and anorexia (12% vs 0%)
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