Evidence for sustained efficacy of levetiracetam as add-on epilepsy therapy.

Abstract

PURPOSE:

To evaluate the long-term clinical usefulness of levetiracetam (LEV, Keppra((R))(1)) as add-on therapy in patients with refractory epilepsy.

METHODS:

Data for all 1422 patients with refractory epilepsy treated with LEV during the development program were analyzed for changes in seizure frequency per week, seizure freedom, and adverse events.

RESULTS:

Median percent reduction from baseline in seizure frequency per week over the whole treatment period was 39.6%, and no decrease over time was observed within each cohort exposed to LEV for durations ranging from 6 to 54 months. The median treatment period was 399 days (range 1-8 years). The proportion of responders during the first 3 months of LEV treatment was 39.2%. This proportion remained stable at 6 months (36.1%). Overall, 38.6 and 20.1% of patients had reductions in seizure frequency of at least 50 and 75%. Sixty-five (4.6%) patients were seizure-free over their entire treatment period, compared with 167 (11.7%) and 126 (8.9%) during their last 6 and 12 months of follow-up. Ninety-seven (19.8%) of 491 patients who received only one other antiepileptic drug (AED) in addition to LEV were seizure-free during their last 6 months. The proportion of patients who reduced their number of concomitant AEDs was 14.4% (205 patients), while 5.5% (79 patients) were treated with LEV only at the end of follow-up. Accidental injury (28.0%), infection (26.6%), headache (25.8%), somnolence (23%), asthenia (22.6%), and dizziness (18.9%) were among the most common adverse events.

CONCLUSION:

LEV offers sustained efficacy in patients with refractory partial seizures, and its long-term tolerability is similar to that seen in the short-term placebo-controlled trials.

• Authors: Elinor Ben-Menachem, Pascal Edrich, Betty Van Vleymen, Josemir W A S Sander, Bernd Schmidt
• Journal: Epilepsy research (Epilepsy Res) Vol. 53 Issue 1-2 Pg. 57-64 (Feb 2003) ISSN: 0920-1211 [Print] Netherlands
• PMID: 12576168 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)

Chemical References

• Anticonvulsants
• Levetiracetam
• Piracetam

Topics

• Adolescent
• Adult
• Anticonvulsants (administration & dosage, adverse effects, therapeutic use)
• Behavior (drug effects)
• Cognition Disorders (chemically induced, psychology)
• Double-Blind Method
• Drug Therapy, Combination
• Epilepsy (drug therapy)
• Female
• Humans
• Levetiracetam
• Male
• Middle Aged
• Piracetam (administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
• Seizures (epidemiology)