The results were presented today at the 55th Annual Meeting of the American Academy of Neurology by Brien Smith, M.D., and colleagues at Henry Ford Hospital in Detroit.
An estimated 2.3 million Americans have epilepsy, and more than 30 percent of patients have inadequate control of seizures with drug therapy, a condition known as medically refractory epilepsy. For these difficult-to-treat patients who have already failed two single anti-epileptic drugs (AEDs), research has shown only a four percent likelihood of becoming seizure-free.
"After failing so many medications, patients with refractory epilepsy and their physicians become frustrated and start to run out of options," said Dr. Smith, neurologist, epileptologist and lead author of this study. "Based on the experience in our clinic, I would suggest other physicians consider the addition of Keppra to existing therapy, as it demonstrated increased efficacy."
In this review of 176 patients, more than 50 percent of the patients had failed five or more AEDs, and the addition of Keppra led to complete seizure control in 29 of the 130 patients (22.3 percent) who had at least 12 months of Keppra treatment. Keppra currently is approved by the U.S. Food and Drug Administration as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. Additionally, the data showed reduction or discontinuation of one other AED was possible in almost half of the seizure-free patients taking Keppra.
Three neuroscience nurses and one physician reviewed documentation of all visits and telephone calls to the Henry Ford Comprehensive Epilepsy Program between April 1, 2000 and September
1, 2002, identifying 210 patients who had received Keppra as adjunctive therapy. Patients excluded from the review were those with inadequate follow-up or those who improved secondary to another treatment (e.g., surgical intervention).
Patients included in this analysis had refractory partial epilepsy and were treated with Keppra for at least 12 months. At the time of treatment, the mean age of patients was 38 years (ranging from three to 77) and mean duration of epilepsy was 19.6 years (one to 52 years). All patients had failed at least two AEDs, with 79.5 percent failing three or more and more than 50 percent failing five or more.
Efficacy of Keppra therapy was determined by comparing seizure frequency at six-month intervals to the baseline seizure frequency at the time of drug initiation. To be considered seizure-free, no seizures could be reported by the patient for at least 12 months.
Seizure-free status was maintained in:
- 22.3 percent of patients (29/130) at 12-month follow-up;
- 28.0 percent of patients (23/82) at 18-month follow-up;
- and 28.6 percent of patients (12/42) at 24-month follow-up.
Final Keppra doses ranged from 200 mg per day to 6,000 mg per day, with:
- 19.6 percent of patients taking 1,000 mg per day;
- 14.4 percent on 2,000 mg per day;
- 18.3 percent on 3,000 mg per day;
- and 13.1 percent taking 4,000 mg per day.
Sedation was the most frequent side effect, but appeared to be reduced when starting at 250 mg twice a day and titrating to 500 mg twice a day during the first few weeks of treatment with Keppra. Some patients also reported behavioral adverse events, most frequently occurring in the first six months of treatment.
Contact: Dwight Angell
Henry Ford Hospital
(313) 876-8709